Bristol Myers Squibb (NYSE:BMY) will announce results for the third quarter of 2022 on Wednesday, October 26, 2022. Company executives will review financial results and address inquiries from investors and analysts during a conference call at 8:00 a.m. ET on the same date.

Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com . To be directly connected to the conference call, enter your information here ; the link will be active 15 minutes prior to the scheduled start time of the call, and does not require a dial-in number or operator assistance to be connected. Investors and the public can also access the live webcast by dialing in the U.S. toll free 877-502-9276 or international +1 313-209-4906, confirmation code: 8863510. Materials related to the call will be available at http://investor.bms.com prior to the start of the conference call.

A replay of the webcast will be available on http://investor.bms.com approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on October 26 through 11:30 a.m. ET on November 9, 2022, by dialing in the U.S. toll free 888-203-1112 or international +1 719-457-0820, confirmation code: 8863510.

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook , and Instagram .

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BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer and other cancers, is pleased to welcome the appointment of Jane Gross, Ph.D. to its Board of Directors.

Dr. Jane Gross is a highly experienced biotech executive with over 30 years in leading research and development teams from discovery through preclinical evaluation and clinical development of therapeutics for the treatment of cancer and autoimmune and inflammatory diseases. Dr. Gross currently serves as an Independent Director for aTyr Pharmaceuticals (Nasdaq: LIFE), a biotechnology company developing novel therapeutics for respiratory diseases and multiple cancer indications.

"I am pleased to welcome Jane to our Board and look forward to leveraging her decades of industry, scientific, and corporate partnership expertise to advance BriaCell's rich pipeline of novel immunotherapies for cancer," stated Jamieson Bondarenko, BriaCell's Chairman of the Board.

Dr. Gross's experience includes roles as Chief Scientific Officer and SVP, Research and Non-Clinical Development at Aptevo Therapeutics (Nasdaq: APVO), during which she led the discovery of novel antibody-based, bispecific protein therapeutics as immunotherapies to treat diseases like cancer. Previously, Dr. Gross served as VP, Applied Research and Non-Clinical Development at Emergent BioSolutions (NYSE: EBS), during which she successfully introduced a drug to patients from design stage into clinic.  This drug was partnered with Morphosys in a co-development transaction for treatment of metastatic castration resistant prostate cancer. Formerly, as VP, Immunology Research at ZymoGenetics, Dr. Gross discovered and developed 30+ new product candidates, completed partnerships and out-licensing of assets, and helped position ZymoGenetics for a successful acquisition by Bristol Myers Squibb (NYSE: BMY) in 2010.

"I am thrilled to join BriaCell's Board and work with the highly experienced directors and management team to help BriaCell develop its clinical pipeline and achieve its partnership strategy objectives," said Dr. Jane Gross. "I am particularly impressed with the Company's novel, off-the-shelf personalized immunotherapy approach and its potential to destroy cancer cells in a safe and effective manner."

Dr. Gross earned her Ph.D. in Immunology from the University of California, Berkeley under James P. Allison, Ph.D., who gained fame as the co-recipient of the 2018 Nobel Prize in Physiology or Medicine for being a pioneer in cancer immunotherapy, and her Post-Doctoral Fellowship from the University of Washington in Immunology under Dr. Roger M. Perlmutter, M.D., Ph.D., formerly of Merck Research Laboratories and Amgen (Nasdaq: AMGN).

BriaCell also announces that its Board of Directors has approved a grant of 10,000 options to purchase common shares in the capital of BriaCell to Dr. Gross in her role as a director of BriaCell, pursuant to the Company's stock option plan. The options have an exercise price of C$9.92 per share and a term of five years and vest immediately.

Additionally, each member of the Scientific Advisory Board has been awarded 2,600 options pursuant to the Company's stock option plan.  The options have an exercise price of C$9.92 per share and a term of five years and vest in accordance with the terms of each option agreement. The grant of the options is subject to the approval of the TSX Venture Exchange.

Separately, BriaCell has also entered into a 6-month marketing and investor engagement contract with Toronto-based marketing firm North Equities Corp. (the "Contract"). North Equities Corp. specializes in various social media platforms and will be able to facilitate greater awareness and widespread dissemination of the Company's news. In connection with the Contract, the Company will pay North Equities CAD$105,000. North Equities Corp. does not have an equity stake in the Company currently.

BriaCell is an immuno-oncology focused biotechnology company developing targeted and effective approaches for the management of cancer. More information is available at https://BriaCell.com/ .

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BriaCell's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading "Risks and Uncertainties" in the Company's most recent Management's Discussion and Analysis, under "Risks and Uncertainties" in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under our profiles on SEDAR at www.sedar.com and on EDGAR at www.sec.gov . Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Company Contact: William V. Williams, MD President & CEO 1-888-485-6340 info@BriaCell.com

Media Relations: Jules Abraham Director of Public Relations CORE IR 917-885-7378 julesa@coreir.com

Investor Relations Contact: CORE IR investors@briacell.com

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Bristol-Myers Squibb Company (NYSE:BMY) announced its results for the fourth quarter and full year of 2019, highlighting continued strong sales and the ongoing advancement of the company’s pipeline.

As quoted in the press release:

“By all measures, 2019 was a transformative year for Bristol-Myers Squibb as we progressed our strategy through the acquisition of Celgene, delivered strong operational and financial performance, and continued to drive important science for patients,” said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol-Myers Squibb. “With an expanded portfolio of high-performing brands, eight potential commercial launch opportunities, a deep and broad early pipeline, and the financial flexibility to continue to invest in innovation, the company enters 2020 uniquely positioned to transform patients’ lives through science and create long-term sustainable growth.”

Click here to read the full press release.

BriaCell Therapeutics Corp. (TSX:BCT, OTCQB:BCTXF) (“BriaCell”, the “Company”) (TSX-V: BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce that it has initiated patient dosing in a Phase I/IIa study of its lead clinical candidate, Bria-IMT™, in combination with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)] or ipilimumab [YERVOY®; manufactured by Bristol-Myers Squibb Company (NYSE: BMY)]. The combination study is listed in ClinicalTrials.gov as NCT03328026.

“We believe that combination of Bria-IMT™ with immune checkpoint inhibitors should create even more potent anti-cancer immune responses, leading to our strategy of combination studies of Bria-IMT™ with KEYTRUDA® or YERVOY®,” stated BriaCell’s President and CEO, Dr. Bill Williams. “BriaCell is committed to exploring additional ways to address the unmet needs of the advanced breast cancer community. We are very excited to test this novel combination treatment approach which we believe will offer significant clinical benefit to patients with advanced breast cancer.”

On Sept. 26, 2018, BriaCell announced positive proof of concept data in a phase I/IIa study of Bria-IMT™ in advanced breast cancer with outstanding safety and efficacy in patients with HLA matches with Bria-IMT™. Impressively, the safety and efficacy data appeared superior to that of other advanced or approved drugs for breast cancer when they were at a similar stage of clinical development.

Analysis of blood samples collected in the phase I/IIa study showed that circulating tumor-associated cells expressed the immune checkpoint molecule programmed death-ligand 1 (PD-L1). PD-L1 molecules block immune cells from attacking cancer cells. KEYTRUDA® neutralizes the blocking mechanism of PD-L1 while YERVOY® blocks other aspects of immune suppression and as such may also activate the immune system to destroy cancer cells.

BriaCell team hypothesizes that patients in the combination therapy trial may derive particular benefit from these combinations with Bria-IMT™.

Rationale for the combination study of Bria-IMT™ with KEYTRUDA® or YERVOY®

Immune checkpoint inhibitors such as pembrolizumab (KEYTRUDA®; anti-PD-1) and ipilimumab (YERVOY®; anti-CTLA-4), designed to overcome immune suppression in cancer patients, have come to the forefront in the fight against cancer with substantial benefits for some patients. Most recently, the significance of immune checkpoint inhibitors was recognized by the Nobel committee by awarding Dr. Tasuku Honjo (PD-1) and Dr. James P. Allison (CTLA-4) the 2018 Nobel Prize in Physiology or Medicine (Scientists behind game-changing cancer immunotherapies win Nobel medicine prize), validating the Company’s decision to launch a combination therapy with the immune checkpoint inhibitors.

In 2010, an important pre-clinical study by Dr. Allison’s group showed that combination with anti-PD-1 and anti-CTLA-4 antibodies potentiated the tumor-rejection effect of irradiated melanoma cells engineered to produce immune-activating factors.

Bria-IMT™, in essence a breast cancer cell line engineered to produce an immune-activating factor (GM-CSF), has been shown to stimulate T cells, important cells of the immune system. BriaCell has published these findings in a leading immunology journal earlier this year. Based on the published, proposed mechanism of action of Bria-IMT™, the Company envisions that Bria-IMT™ and immune checkpoint inhibitors can exert additive or synergistic tumor-directed effects. It is important to note that pembrolizumab and ipilimumab have not been shown to work on their own in breast cancer but are approved for other indications.

BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer.

BriaCell is currently conducting a Phase I/IIa clinical trial of Bria-IMT™, its lead candidate, in a combination study with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc.] or ipilimumab [YERVOY®; manufactured by Bristol-Myers Squibb Company]. The combination study is listed in ClinicalTrials.gov as NCT03328026.

BriaCell is developing Bria-OTS™, an off-the-shelf personalized immunotherapy, for advanced breast cancer. Bria-OTS™ immunotherapy treatments are personalized to match the patient without the need for personalized manufacturing. Bria-OTS™, which is expected to cover over 90% of the patient population, is designed to produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense, and complex manufacturing logistics associated with other personalized immunotherapies.

For additional information on BriaCell, please visit website: http://www.BriaCell.com

Cautionary Note Regarding Forward-Looking Information

Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com.

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For further information, please contact: BriaCell Therapeutics Corp.: Farrah Dean Manager, Corporate Development Email: farrah@BriaCell.com Phone: 1-888-485-6340

Click here to connect with BriaCell Therapeutics Corp. (TSX:BCT, OTCQB:BCTXF) for an Investor Presentation.

Bristol-Myers Squibb Company (NYSE:BMY) and Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, today announced a clinical trial collaboration to evaluate Bristol-Myers Squibb’s Opdivo in combination with Calithera’s CB-839 in patients with clear cell renal cell carcinoma (ccRCC). CB-839 is an orally administered glutaminase inhibitor currently in Phase 1/2 clinical studies.Preclinical data suggest that CB-839, which is designed to target a pathway to starve tumor cells of the key nutrient glutamine, may enhance the effects of checkpoint inhibitors and may also reverse tumor resistance to checkpoint inhibitors by altering the immune-suppressive microenvironment and promoting an anti-tumor immune response. Opdivo is designed to overcome immune suppression. The companies will explore the potential of combining these two agents with the goal of achieving improved and sustained efficacy in ccRCC patients with cancer that is stable or growing on a PD-1 inhibitor therapy.“Influencing the tumor microenvironment remains a key focus of research, and we are excited to explore the potential benefits of Opdivo plus CB-839 in an effort to advance new combination therapies for difficult to treat cancers,” said Fouad Namouni, M.D., senior vice president, Head of Oncology Development, Bristol-Myers Squibb.“The combination with Opdivo follows our strategy to combine CB-839 with therapies to improve outcomes for RCC patients,” said Susan Molineaux, CEO of Calithera Biosciences. “We believe that by blocking glutamine consumption in tumors, and redirecting this key nutrient for cell growth and proliferation to T‑cells, CB-839 could enhance the effects of Opdivo. With support from Bristol-Myers Squibb, Calithera is excited to advance this combination into the Phase 2 portion of CX-839-004, our ongoing study in ccRCC patients.”Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 57 countries including the United States, Japan, and in the European Union. Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

Bristol-Myers Squibb Media: Ken Dominski, 609-252-5251 ken.dominski@bms.com or Lisa McCormick Lavery, 609-252-7602 lisa.mccormicklavery@bms.com or Investors: Tim Power, 609-252-7509 timothy.power@bms.com or Bill Szablewski, 609-252-5894 william.szablewski@bms.com or Calithera Biosciences Jennifer McNealey, 650-870-1071 ir@Calithera.com

Bristol-Myers Squibb Company (NYSE: BMY) today announced the European Commission approved Opdivo (nivolumab) for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Opdivo is now the first and only PD-1 inhibitor approved for a hematologic malignancy in the European Union (EU). This approval allows for the expanded marketing of Opdivo in relapsed or refractory cHL in all 28 Member States of the EU. The approval is based on an integrated analysis of data from the Phase 2 CheckMate -205 and the Phase 1 CheckMate -039 trials, evaluating patients with relapsed or refractory cHL after ASCT and treatment with brentuximab vedotin. In the subset of patients in the efficacy population (n=95), the primary endpoint of objective response rate (ORR) as assessed by an independent radiologic review committee was 66% (95% CI: 56-76; 63/95 patients). The percentage of patients with a complete response was 6% (95% CI: 2-13; 6/95 patients), and the percentage of patients with a partial response was 60% (95% CI: 49-70; 57/95 patients). At 12 months, the progression-free survival rate was 57% (95% CI: 45-68). Opdivo is associated with warnings and precautions including immune-related: pneumonitis, colitis, hepatitis, nephritis and renal dysfunction, endocrinopathies, rash, and other adverse reactions; infusion reactions, and complications of allogeneic hematopoietic stem cell transplantation (HSCT) in cHL after Opdivo. Emmanuel Blin, senior vice president and chief strategy officer, Bristol-Myers Squibb, commented, “We’re incredibly proud of this approval for Opdivo and what it means for adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin, as it marks the first and only PD-1 inhibitor approved for a hematologic malignancy in the EU. This also is Bristol-Myers Squibb’s second Immuno-Oncology agent approved for a blood cancer in the EU within just six months.” “As a practicing hematologist, I have experienced the challenge of managing classical Hodgkin lymphoma and the need among previously treated patients,” said Andreas Engert, M.D., lead investigator and professor of Internal Medicine, Hematology and Oncology, University Hospital of Cologne, Cologne, Germany. “It is incredibly exciting that with today’s approval of Opdivo for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin in the EU, we now have an entirely new treatment approach that has shown impressive response rates and durability of response in this difficult-to-treat population.” In the integrated analysis of data from CheckMate -205 and CheckMate -039, the median time to response was 2.0 months (range 0.7-11.1), and among responders, the duration of response was maintained over time for a median of 13.1 months (95% CI: 9.5-NE; range 0.0+, 23.1+). Stable disease was observed in 23% of patients. In a post-hoc analysis of the 80 patients in CheckMate -205 cohort B, it was found 37 patients had no response to prior brentuximab vedotin treatment. Among these 37 patients, treatment with Opdivo resulted in an ORR of 59.5% (22/37), and the median duration of response was 13.14 months. The safety of Opdivo in cHL was evaluated in 263 adult patients from CheckMate -205 (n=240) and CheckMate -039 (n=23). Among these patients (total safety population: n=263), serious adverse events (AEs) occurred in 21% of patients. The most common serious AEs (reported in at least 1% of patients) were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis. The most common AEs (reported in at least 20% of patients) were fatigue (32%), upper respiratory tract infection (28%), pyrexia (24%), diarrhea (23%), and cough (22%). Twenty-three percent of patients had a dose delay for an AE, and 4.2% of patients discontinued treatment due to AEs. Six out of 40 patients died from complications of allogeneic HSCT after Opdivo, and these 40 patients had a median follow-up from subsequent allogeneic HSCT of 2.9 months (range: 0-22). About Classical Hodgkin Lymphoma Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. In the European Union, about 12,200 new cases and 2,600 deaths occurred in 2012 as a result of HL. The disease is most often diagnosed in early adulthood (ages 20-40) and late adulthood (older than 55 years of age). Classical Hodgkin lymphoma is the most common type of HL, accounting for 95% of cases. Bristol-Myers Squibb: At the Forefront of Immuno-Oncology Science & Innovation At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer. We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents, including the first combination of two I-O agents in metastatic melanoma, and our differentiated clinical development program, which is studying broad patient populations across more than 20 types of cancers with 11 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and inform which patients will benefit most from I-O therapies. We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice. About Opdivo Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 57 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo + Yervoy combination was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 47 countries, including the United States and the European Union. U.S. FDA-APPROVED INDICATIONS FOR OPDIVO ® OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO® (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. IMPORTANT SAFETY INFORMATION WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests at baseline and before each dose. Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. Immune-Mediated Pneumonitis OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In CheckMate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 4.9% (13/263) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 3.4% (9/263) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=8). Immune-Mediated Colitis OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis. Immune-Mediated Hepatitis OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated hepatitis occurred in 13% (51/407) of patients. In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%. Immune-Mediated Neuropathies In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported. Immune-Mediated Endocrinopathies OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia. In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO with YERVOY, hypophysitis occurred in 9% (36/407) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO with YERVOY, adrenal insufficiency occurred in 5% (21/407) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO with YERVOY, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving OPDIVO with YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO with YERVOY, diabetes occurred in 1.5% (6/407) of patients. In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies. Immune-Mediated Nephritis and Renal Dysfunction OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. Immune-Mediated Skin Adverse Reactions and Dermatitis OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated rash occurred in 22.6% (92/407) of patients. In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis. Immune-Mediated Encephalitis OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO with YERVOY (0.2%) after 1.7 months of exposure. Other Immune-Mediated Adverse Reactions Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO the following clinically significant immune-mediated adverse reactions occurred in <1.0% of patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, rhabdomyolysis, motor dysfunction, vasculitis, and myasthenic syndrome. Infusion Reactions OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients. In patients receiving OPDIVO with YERVOY, infusion-related reactions occurred in 2.5% (10/407) of patients. Complications of Allogeneic HSCT after OPDIVO Complications, including fatal events, occurred in patients who received allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from CheckMate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in 35% (n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic encephalitis without an identified infectious cause, and Grade 3 (n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD) occurred in one patient, who received reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after reduced-intensity conditioned allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. Cases of fatal hyperacute GVHD have also been reported. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT. Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly. Embryo-Fetal Toxicity Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO. Lactation It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose. Serious Adverse Reactions In CheckMate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In CheckMate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In CheckMate 067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In CheckMate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In CheckMate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In CheckMate 205 and 039, among all patients (safety population [n=263]), adverse reactions leading to discontinuation (4.2%) or to dosing delays (23%) occurred. The most frequent serious adverse reactions reported in ≥1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis. Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT. Serious adverse reactions occurred in 21% of patients in the safety population (n=263) and 27% of patients in the subset of patients evaluated for efficacy (efficacy population [n=95]). In CheckMate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO. The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infections, and sepsis. Common Adverse Reactions In CheckMate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In CheckMate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In CheckMate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (≥20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea (31%), and nausea (28%). In CheckMate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In CheckMate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were asthenic conditions (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In CheckMate 205 and 039, among all patients (safety population [n=263]) and the subset of patients in the efficacy population (n=95), respectively, the most common adverse reactions (≥20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%). In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%). In CheckMate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO were cough and dyspnea at a higher incidence than investigator’s choice. In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%). CheckMate Trials and Patient Populations CheckMate 067 – advanced melanoma alone or in combination with YERVOY; CheckMate 037 and 066 – advanced melanoma; CheckMate 017 – squamous non-small cell lung cancer (NSCLC); CheckMate 057 – non-squamous NSCLC; CheckMate 025 – renal cell carcinoma; CheckMate 205/039 – classical Hodgkin lymphoma; CheckMate 141 – squamous cell carcinoma of the head and neck. Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY. About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook. Bristol-Myers Squibb Forward-Looking Statement This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2015 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

- Public-Private Effort to Shift Traditional Model of Hepatitis Management to Primary Care and Help to Expand Care to More People in Need -

Gilead Sciences, Inc. today announced a new public-private initiative with the Partnership for Health Advancement in Vietnam (HAIVN), a collaboration between Brigham and Women's Hospital, Harvard Medical School and Beth Israel Deaconess Medical Center. This multi-year initiative will have a phased approach to help address barriers that limit viral hepatitis diagnosis and care at primary healthcare facilities in Vietnam and the Philippines, two countries with high burdens of hepatitis B and C.

Gilead and HAIVN will work together with a multi-stakeholder coalition, involving national ministries of health, academic stakeholders including the University of Philippines-Manila (UP Manila), provincial hospitals and primary healthcare centers to support this pilot program. The focus of the program will be on person-centered approaches in training non-specialist community-based healthcare providers in prevention and management of viral hepatitis, incorporating education, screening, diagnosis and linkage to care for hepatitis B and C into routine patient visits for at-risk populations. Gilead and HAIVN will also aim to strengthen primary healthcare systems including the referrals and counter-referral systems to enhance coordination between specialist and primary care. The two organizations will make the outcomes and learnings from the initiative public to contribute towards better understanding of adequate public health approaches to improve person-centered, community-based management of viral hepatitis.

"This collaboration will provide evidence to support a shift from the current dependence on scarce and overstretched specialists to a broader group of primary care clinicians while simultaneously strengthening primary health care systems and expanding countries' capacity to diagnose, manage and treat viral hepatitis," said David Duong, MD, MPH, Director of the Harvard Medical School Program in Global Primary Care and Social Change and an internal medicine physician at Brigham and Women's Hospital. "Through this innovative initiative with Gilead, we will apply new patient-centered, community-based models to hepatitis care and treatment, building on the foundation that HAIVN has built."

The initiative will support national priorities for Vietnam and the Philippines: both governments are committed to strengthening primary healthcare and controlling hepatitis. The World Health Organization has set a global target to eliminate viral hepatitis as a public health problem by 2030, calling for 90% of people with hepatitis B and C to be diagnosed, 80% of those eligible for treatment to be treated and a 65% reduction in mortality, in addition to developing preventative actions. 1 However, despite the important gains in biomedical technology and management of viral hepatitis, implementation of best practices and access to diagnostics and treatment in both countries are still significantly limited and inconsistent. At the current pace, Vietnam and the Philippines are not expected to reach WHO targets before 2050.

"This approach has significant potential for application in many other disease areas and low- and middle-income countries where specialist providers are scarce," said Dr. Harald Nusser, Vice President, Head of Global Patient Solutions, Gilead Sciences. "More than proof of concept for eliminating viral hepatitis and strengthening healthcare systems, this initiative demonstrates the potential for the meaningful impact that public, private and academic collaborations can make on improving global health equity and achieving Sustainable Development Goal 3 regarding good health and well-being."

Hepatitis B and C lead to chronic disease in hundreds of millions of people globally and together are the most common cause of liver cirrhosis, liver cancer and viral hepatitis-related deaths. An estimated 354 million people worldwide live with hepatitis B or C, and for most, testing and treatment remain beyond reach. 2 In Vietnam, out of a population of 97 million, nearly 7.8 million people have hepatitis B and over 900,000 have hepatitis C. Based on 2020 estimates from the CDA Foundation's Polaris database, only 30% of Vietnamese people with hepatitis B have been diagnosed and only 3% treated. For hepatitis C, only 14% of cases have been diagnosed and 7% have been treated. 3 In the Philippines, over 10 million people are infected with hepatitis B and nearly 450,000 with hepatitis C, with the care cascade standing at 5% diagnosed and less than 1% treated for hepatitis B and 23% diagnosed and 1% treated for hepatitis C. 3

The 17 Sustainable Development Goals (SDG) were adopted by the United Nations (UN) Member States in 2015, as part of the 2030 Agenda for Sustainable Development. They are call to actions by all countries to unite in a global partnership to ensure peace and prosperity for people and planet. SDG 3 Good Health and Wellbeing is one of the SDGs that Gilead supports to improve global health and sustainable development. SDG 3 consists of several targets, including fighting communicable diseases, achieving universal health coverage, increasing health financing and support for health workforce in developing countries. For more information on the SDGs that Gilead support, please visit www.gilead.com .

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

1 WHO Global Health Sector Strategy on Viral Hepatitis 2016-201: Towards Ending Viral Hepatitis https://apps.who.int/iris/bitstream/handle/10665/246177/WHO-HIV-2016.06-eng.pdf

2 https://www.who.int/health-topics/hepatitis#tab=tab_1

View source version on businesswire.com: https://www.businesswire.com/news/home/20220921005778/en/

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--Initiative Creates Groundbreaking New, Royalty Free Inclusive Image Gallery In Strategic Partnership with Shutterstock Studios--

Today, Allergan Aesthetics, an ABBVie company (NYSE: ABBV), and skinbetter science ® announce a new report from their DREAM (Driving Racial Equity in Aesthetic Medicine) Initiative ® along with a long-term partnership with Shutterstock Studios. The report, titled Forces of Beauty ® provides a new understanding of what inclusive and representative beauty looks like today by shedding light on how narrowly defined Eurocentric ideals continue to impact women of color. By surveying over 4,000 women aged 21-65, from multiple geographic locations and backgrounds, the report explores what defines beauty, how beauty impacts women's lives, and the interplay between beauty and race. Some key insights include:

The full report and findings are available for download at DreamforEquity.com

"We are in a position, as industry leaders, to drive the necessary change within the aesthetics industry. We need to create a candid dialogue about racial representation and perceptions within our aesthetics community.  We hope that the Forces of Beauty ® Report will contribute to moving us all in the right direction," said Jonah Shacknai , Executive Chairman of skinbetter science ® .

Forces of Beauty ® is the third deliverable from The DREAM Initiative ® , following the successful launches of both the Curriculum for Advancing Racial Equity (CARE) produced by Solomé Rose Consulting, LLC - the American Academy of Dermatology and other leading dermatology societies are supporting the curriculum's inaugural implementation in five highly regarded dermatology residency programs- and the Full Spectrum of Dermatology: A Diverse and Inclusive Atlas , developed by co-editors Misty Eleryan , MD, MS, and Adam Friedman , MD FAAD.

Forces of Beauty ® continues the exploration of the unique relationship between racial/ethnic diversity and beauty for women. The companies are raising awareness about the need for inclusive and representative beauty, providing education, and driving action among medical and consumer audiences.

"Historically, the industry hasn't included all women in its definition of beauty," said Carrie Strom , Senior Vice President at AbbVie and President of Global Allergan Aesthetics. "As industry leaders, our goal is to create a more equitable beauty and aesthetics industry that focuses on diversity, representation, and inclusion. That is what Forces of Beauty ® is about, impacting change and creating a space where the origins of beauty are honored, the definition of beauty is vastly expanded upon, and where uniqueness is the standard."

As part of its multi-media launch, Forces of Beauty ® will be brought to life through an engaging and emotional video series, produced by Shutterstock Studios, Shutterstock's end-to-end custom creative shop. The series, directed by Tiffany Frances , will feature four women as they share their stories and experiences linking directly to dedicated chapters within the report: defining beauty, empowering uniqueness, the history of beauty standards, and appropriation. Each chapter will support the report's overall findings which include: that women of all races strongly believe that "one of us cannot represent all of us"; that the standard of beauty should not be defined by only one group; and, that the origins of beauty and cultural practices be celebrated without being exploited.

Coinciding with the launch of Forces of Beauty ® , the DREAM Initiative ® will also unveil a first-of-its-kind partnership in the aesthetics category with Shutterstock Studios and introduce a royalty free, gallery of diverse images available to the public. The thousands of images will showcase beauty across race, culture, gender, age, ability level, and body type and will bring to life a key takeaway from the Forces of Beauty ® report that "one of us is not the face of all of us." A driving force behind the gallery is the goal to encourage industry peers to leverage these assets within their own efforts, creating a first step towards collective change to a more equitable industry. All inclusive marketing materials will be easily accessible on https://www.shutterstock.com/explore/dream .

"The DREAM Initiative ® brought us this incredible idea to create a more diverse royalty-free image set. And through our partnership on the Forces of Beauty ® report it helped us all recognized an important gap in the market. Most of the visuals used in advertising and branding do not reflect the diversity we see around us every day, and an online search of imagery reveals just how underrepresented many groups are in this space," said Aiden Darné, VP and Global Head of Shutterstock Studios. "Shutterstock interviewed over 2,700 marketers around the world last year and found that 74% of them wished they had access to more diverse content. This realization was the catalyst for a unified pledge to close that gap, and we are excited to partner with the DREAM initiative ® on this journey to put authentic representation at the center of all creative content."

To learn more visit DreamForEquity.com or follow us @AllerganAesthetics and @skinbetter

About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com or follow us on Instagram and LinkedIn .

About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

About skinbetter science ® The skinbetter science ® team of aesthetic experts has a profound understanding of skin aging and what it takes to help defy the effects of time. Tapping into a rich dermatological heritage, the team at skinbetter science ® set out to create a new paradigm in clinical skincare. Cutting-edge, data-driven science is the principal driving force behind all our unique formulations. skinbetter science award-winning products are available exclusively through the leading dermatology, plastic surgery and medical aesthetics practices nationwide. For more information, visit us at Skinbetter.com or follow us on Facebook, Instagram and LinkedIn.

About Shutterstock Studios For 20 years, Shutterstock has contributed to films, documentaries, and storytelling of all types with its vast stock library. Now through its Studios arm, Shutterstock is putting forward stories of its own, leveraging the unique expertise of its production and creative professionals, and archive of over 60 million assets across photo and video, covering royals, film, music, sports, wars, politics and celebrities. Shutterstock Studios specializes in producing branded and commercial content plus documentary and nonfiction films. Studios has rapidly emerged as a best-in-class creative partner for brands globally using physical and virtual production to create evocative content. With the acquisition of TurboSquid, the world's largest 3D marketplace, Shutterstock Studios now offers Web3 services, and 2D and 3D animation.

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The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce that it has received a purchase order from the 5-star luxury Four Seasons Hotel San Francisco to become a supplier of gummies for each of the hotel's 277 guest room mini-bars.

"We are thrilled to continue our strategic expansion in the US and honoured to have been selected by the luxury 5-star Four Seasons Hotel San Francisco to be a supplier of Peachy Bees and Watermelon sharks for hotel guest rooms," said Charlie Lamb, President & CEO of GUMY. "We very much look forward to developing a long-term relationship with The Four Seasons Hotel San Francisco, who not only are a world class hotel but who also share our commitment to a more sustainable future for everyone."

The purchase order was received from the Four Seasons Hotel San Francisco on September 12, 2022. The hotel has maintained Five Stars with the world-renowned authority in genuine Five Star service, Forbes Travel Guide. A staple in Bay Area luxury, Four Seasons Hotel San Francisco has been awarded the coveted Forbes Travel Guide Five Stars for the past 19 consecutive years.

"As we've previously mentioned, part of GUMY's multi-channel sales strategy includes targeting hotels and their guest rooms as distribution points for our gummies," said Mr Lamb. "With travel and hotel occupancy now soaring post-COVID, we feel that this will be a very lucrative component of our business model moving forward."

We are a growing community of individuals and organizations who believe small contributions can add up to something big. We sell low sugar, plant based gummy products while raising money (and awareness) to support endangered keystone species. We are the only "better for you" candy company that is built to support our planet's most precious species and ecosystems, while educating our future generations on the steps we must take today, to ensure a viable tomorrow.

Charlie Lamb, President & CEO, Director Telephone: 1(236) 317-2812 - Toll free 1(888) 556-9656 E-mail: investors@shopgummies.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding future financial position, business strategy, use of proceeds, corporate vision, proposed acquisitions, partnerships, joint-ventures and strategic alliances and co-operations, budgets, cost and plans and objectives of or involving the Company. Such forward-looking information reflects management's current beliefs and is based on information currently available to management. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "predicts", "intends", "targets", "aims", "anticipates", "may" or "believes" or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. A number of known and unknown risks, uncertainties and other factors may cause the actual results or performance to materially differ from any future results or performance expressed or implied by the forward-looking information. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company including, but not limited to, the impact of general economic conditions, industry conditions, risks relating to epidemics or pandemics such as COVID-19, including the impact of COVID-19 on the Company's business, financial condition, and results of operations. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. The Company does not assume any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by securities laws.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/138005

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Komo Plant Based Foods Inc. (CSE:YUM) (OTCQB:KOMOF) (FRA:9HB) ("Komo") is pleased to announce Quality Foods will be carrying Komo's 2 serving Lasagna, Shepherd's Pie and Mac & Greens as well as both Meal Helpers (Bolognese and Taco Filling) at all Quality Foods locations

Quality Foods is a British Columbia owned, award-winning leader in the Canadian grocery industry with brick and mortar stores in 13 locations in B.C. including Qualicum Foods in Qualicam Beach, Quality Foods in Parksville, Nanoose Bay, Nanaimo (Harewood), Nanaimo (Northridge Village), Port Alberni, Comox, Courtenay, Campbell River, Powell River, Victoria (Langford) and Victoria (View Royal).

"Quality Foods, the Island original, is thrilled to add this new favourite local brand, Komo Comfort Foods, to their 'Good For You' program. Their ready to bake meals aren't only an easy dinner night, they are also hearty and made with only real ingredients. Perfect to add to your veggie night or simply enjoy a meat free option! Best of all, apart from being healthy - Komo tastes delicious," says Quality Food's Reena Kaback

Quality Foods is BC owned and operated since 1982. The Vancouver Island chain is an award-winning leader in the Canadian grocery industry, employing over 1,000 employees primarily on Vancouver Island (and Powell River). Since opening their original store in 1982 as Qualicum Foods in Qualicum Beach on Vancouver Island, they are proudly "an Island Original". Now they are Quality Foods, a BC owned and operated, award-winning leader in the Canadian grocery industry, employing over 1,000 people in thirteen full service grocery stores. The company was acquired by the Jim Pattison Group in 2017.

Komo Plant Based Foods Inc. is a premium plant-based food company that develops, manufactures and sells a variety of plant-based frozen meals that are always hearty, satisfying, and made with wholesome ingredients. At Komo, our mission is to help make plant-based meals a staple on every dinner table by sharing our love for feel-good food that connects the people to the planet. We believe plant-based eating is the future and - Change can start with a single biteTM. Our experienced plant-based innovation and development team recreates vegan versions of traditionally cheesy and meaty classics, with 100% plants. Komo's products are sold direct-to-consumer through our eCommerce website and a distribution network of online and brick and mortar grocery, convenience and natural retailer channels. Our operating subsidiary Komo Comfort Foods launched in 2021 with our flagship products: plant-based Lasagna, Shepherd's Pie and Chickenless Pot Pie and Komo Plant-Based Meal HelpersTM - versatile meal starters to allow the creation of many dishes at home. Komo's newest product is Mac & Greens. All of our products are 100% plant-based, made with wholesome ingredients, free from preservatives and frozen for freshness. Freezing products is a natural and effective way of keeping food products for longer without having to use any preservatives. Komo's meals have a frozen shelf life of 18 months.

Learn more at: www.komocomfortfoods.com and follow on Instagram: @komocomfortfoods

For further information, please contact: William White, President & CEO, Komo Plant Based Foods Inc. will@komoeats.com +1(236) 8000-YUM / (236) 800-0986

The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or Komo's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Komo's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, Komo's product development plans, its ability to launch its products on food delivery apps, its ability to retain key personnel, its revenues, and its expectation as to the acceptance of its products by retailer stores and consumers constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. Komo disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.

SOURCE: KOMO Plant Based Foods Inc.

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Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire MiroBio, a privately held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, for approximately $405 million in cash. The acquisition provides Gilead with MiroBio's proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio's lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed in early August 2022. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.

"Inflammation is a key area of focus for Gilead, and MiroBio's novel discovery platform technology and pipeline provides the opportunity to develop potentially best-in-class large molecule therapeutics to help patients with currently unmet medical needs," said Flavius Martin, Executive Vice President, Research, Gilead Sciences. "This novel approach to inflammatory diseases has the potential to be an important part of providing durable remission for patients living with complex and chronic immune-mediated conditions."

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, inflammation and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including difficulties or unanticipated expenses in connection with integrating the companies, including the effects of the transaction on relationships with employees, other business partners or governmental entities; the risk that Gilead may not realize the expected benefits of this transaction; the ability of Gilead to advance MiroBio's product pipeline and successfully commercialize MiroBio's products; the ability of the parties to initiate and complete clinical trials involving such products in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such products; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not approve any such products in the anticipated indications or on the timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use; any assumptions underlying any of the foregoing; and other risks and uncertainties detailed from time to time in Gilead's periodic reports filed with the U.S. Securities and Exchange Commission (the "SEC"), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220919005772/en/

Jacquie Ross, Investors Investor_relations@gilead.com

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Five abstracts underscore the long-term safety and efficacy of voclosporin, including in Latino patients and patients with Class V lupus nephritis

Data presentation on pre-clinical asset AUR200 reinforces Aurinia's commitment to autoimmune disease

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, today announced that data from multiple studies of LUPKYNIS® (voclosporin), used to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE), will be presented at American College of Rheumatology (ACR) Convergence 2022. ACR Convergence 2022 will take place November 10-14 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania.

The abstracts for ACR Convergence 2022 are listed below and available online at: https://acrabstracts.org/meetings/acr-convergence-2022/ .

ACR Convergence 2022 Oral and Poster Presentations:

Title: Long-term Use of Voclosporin in Patients with Class V Lupus Nephritis: Results from the AURORA 2 Continuation Study Presenting author: Amit Saxena, M.D., Assistant Professor, Department of Medicine NYU Grossman School of Medicine Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0355

Title: Early Reductions in Proteinuria with Voclosporin Treatment Across Lupus Nephritis Biopsy Classes: Pooled Data from the AURA-LV and AURORA 1 Trials Presenting author: Anca Askanase, M.D., M.P.H., Professor of Medicine, Columbia University Irving Medical Center, Department of Rheumatology Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0356

Title: Voclosporin Is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations Presenting author: Hans-Joachim Anders, M.D., Professor of Nephrology and Head of Renal Division, University of Munich (LMU) Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0357

Title: Long-term Safety and Efficacy of Voclosporin in Hispanic and Latino Patients with Lupus Nephritis Presenting author: Ellen M. Ginzler, M.D., M.P.H., Vice Chair for Research, Department of Medicine Chief, Rheumatology Division, SUNY Downstate Health Science University Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0358

Title: AUR200: An Improved BAFF/APRIL Inhibitor with Increased Potency and Safety for the Treatment of B Cell-Mediated Diseases Presenting author: Shawn Morales, Ph.D., Aurinia Pharmaceuticals Date: Monday, November 14, 2022 Time: 9:00 a.m - 10:00 a.m ET Session: Abstracts: B Cell Biology and Targets in Autoimmune and Inflammatory Disease , Abstract 1629

Title: Voclosporin for Lupus Nephritis: Assessment of Long-Term Safety and Efficacy Including Renal Outcome over Three Years of Treatment in the Phase 3 AURORA 1 and AURORA 2 Studies Presenting author: Cristina Arriens, M.D., Clinical Assistant Member, Oklahoma Medical Research Foundation Date: Monday, November 14, 2022 Time: 9:00 a.m - 10:30 a.m ET Session: Abstracts: SLE-Treatment, Abstract 1653

About Lupus Nephritis LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

About LUPKYNIS LUPKYNIS® is the first U.S. FDA- and EC-approved oral medicine for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications can be made based on Aurinia's proprietary personalized eGFR-based dosing protocol. Boxed Warning, warnings, and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.

About Aurinia Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis. The Company's head office is in Victoria, British Columbia, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.

INDICATION AND IMPORTANT SAFETY INFORMATION

LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.

Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.

Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.

Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.

Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.

Please see Prescribing Information , including Boxed Warning, and Medication Guide for LUPKYNIS.

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Investors DeDe Sheel dsheel@auriniapharma.com

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