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Gilead Sciences, Inc. is an American biopharmaceutical company based in Foster City, California. The company specializes in researching, developing, and marketing antiviral drugs used in the treatment of a variety of viral infections including HIV/AIDS, hepatitis B and C, influenza, and COVID-19. Gilead is renowned for its innovative approach to creating life-saving therapies, with a core focus on diseases such as HIV and hepatitis. Some of its groundbreaking products include ledipasvir/sofosbuvir and sofosbuvir, pivotal in the treatment of hepatitis C.
Gilead's extensive portfolio has been significantly enhanced through strategic acquisitions. The purchase of Corus Pharma, Myogen, CV Therapeutics, Arresto Biosciences, and Calistoga has allowed the company to diversify into pulmonary and cardiovascular diseases and cancer treatments. The acquisition of Pharmasset was particularly notable, providing Gilead with the rights to the hepatitis C drug Sovaldi, further combined into the drug Harvoni. Additionally, Gilead has expanded its oncology offerings through the acquisitions of Kite, Forty Seven, and Immunomedics, strengthening its position in both cell therapy and non-cell therapy in oncology.
Gilead continually seeks to innovate and push the boundaries of medicine to offer better therapeutic solutions. Recent projects include expanding its antiviral pipeline and exploring novel treatments for various cancers. Financially, Gilead remains robust, with substantial investments in research and development to drive future growth and maintain its leadership in the biopharmaceutical industry.
Kite, a Gilead Company (Nasdaq: GILD), has partnered with Appia Bio to develop engineered allogeneic cell therapies for hematological malignancies. The collaboration focuses on creating chimeric antigen receptor (CAR)-engineered invariant natural killer T (CAR-iNKT) cells using Appia Bio’s ACUA technology. Appia Bio will lead preclinical and early clinical research, while Kite will oversee development and commercialization. The agreement includes an upfront payment, equity investment, and up to $875 million in milestone payments, signaling a strong commitment to advancing innovative cancer therapies.
BioNTech SE (BNTX) has completed the acquisition of Kite's solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing assets in Gaithersburg, MD. This strategic move enhances BioNTech's cell therapy pipeline and manufacturing capabilities in North America, following its acquisition of Neon Therapeutics in 2020. The deal, which was announced on July 19, 2021, aligns with BioNTech’s strategy of accelerating development through targeted acquisitions. All Kite employees at the facility were offered jobs with BioNTech, ensuring operational continuity.
Gilead Sciences (Nasdaq: GILD) has announced a significant endowment exceeding $200 million to the Gilead Foundation, reinforcing its commitment to enhancing community health globally. Established in 2005, the foundation will focus on health justice, supporting underserved communities, including people of color and LGBTQ+ youth. Key programs include the Creating Possible Fund for grants, charitable donations to local organizations, and an employee donation matching program, increasing annual matches to $15,000. In 2020, Gilead donated $409 million globally for various community needs, including COVID-19 relief.
Gilead Sciences (GILD) reported Q2 2021 revenue of $6.2 billion, up 21% year-over-year, driven by strong sales of Veklury, Biktarvy, and HCV products. Diluted EPS increased to $1.21 from a net loss of $2.66 in Q2 2020. Non-GAAP EPS rose 68% to $1.87. The company updated its guidance, raising total product sales expectations to between $24.4 billion and $25.0 billion. Key pipeline updates include positive results for lenacapavir and Yescarta. Cash reserves stood at $7.4 billion.
BioNTech has entered into a purchase agreement to acquire Kite's solid tumor neoantigen T cell receptor R&D platform and clinical manufacturing facility in Gaithersburg, MD. This facility will bolster BioNTech's capabilities in developing individualized cancer therapies, complementing its existing infrastructure in Germany. Kite will receive an undisclosed upfront payment. The acquisition aims to enhance BioNTech's pipeline, which includes CAR-T therapies. All Kite Gaithersburg employees will be offered employment with BioNTech, indicating a commitment to further investment in the facility.
Gilead Sciences reported that 99% of participants in a pooled analysis of two Phase 3 studies maintained an undetectable HIV-1 viral load after four years on Biktarvy (n=476/480). The study showed zero cases of treatment-emergent resistance. Findings indicate consistent efficacy across demographics, including older adults and Black Americans. Additional studies demonstrated that switching to Biktarvy led to high rates of virologic suppression without resistance. Overall, data supports Biktarvy's durable efficacy and safety as an HIV treatment.
Gilead Sciences (Nasdaq: GILD) announced promising results from the Phase 2/3 CAPELLA trial of lenacapavir, a long-acting HIV-1 capsid inhibitor for treatment-experienced patients with multi-drug resistant HIV. At Week 26, 81% of participants achieved an undetectable viral load. Lenacapavir is submitted for FDA approval as a six-month treatment option. The trial's success highlights the drug's potential and its significance in addressing unmet medical needs in HIV treatment. Lenacapavir is designed to act on multiple stages of the HIV lifecycle, offering a novel therapeutic approach.
Gilead Sciences, Inc. (Nasdaq: GILD) will release its second quarter 2021 financial results on July 29, after market close. A live webcast discussing these results and a business update will begin at 4:30 p.m. Eastern Time on the same day. The webcast will be accessible on the investor relations page of Gilead's website and archived for one year. Gilead is recognized for its breakthroughs in biopharmaceuticals, focusing on innovative treatments for HIV, viral hepatitis, and cancer.
Gilead Sciences (Nasdaq: GILD) announced its participation in the 11th IAS Conference on HIV Science, occurring virtually from July 18-21. The company will present 31 abstracts highlighting advancements in HIV treatment and prevention, including data on Biktarvy and lenacapavir. A symposium will feature discussions among leading researchers and community members on achieving a functional cure for HIV. Gilead emphasizes ongoing scientific innovation to meet critical healthcare needs for those affected by HIV. For details, visit IAS 2021.
Gilead Sciences (Nasdaq: GILD) has submitted a New Drug Application (NDA) to the FDA for lenacapavir, a long-acting HIV-1 capsid inhibitor targeting heavily treatment-experienced patients with multi-drug resistant HIV-1 infection. This submission is based on findings from the Phase 2/3 CAPELLA trial, which demonstrated significant viral load reduction. Lenacapavir is positioned as a potential first-in-class treatment option administered every six months. Gilead plans further applications to the European Medicines Agency and other global entities.
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