Gilead Sciences Inc Stock Price, News & Analysis

Gilead Sciences (Nasdaq: GILD) announced its participation in the Morgan Stanley Annual Global Healthcare Conference on September 15 at 12:30pm ET. The presentation will be available via a live webcast on the company’s investors page, with a replay accessible for 30 days afterward. Gilead is a biopharmaceutical company focused on developing innovative medicines to combat serious diseases like HIV, viral hepatitis, and cancer, operating in over 35 countries.

Gilead Sciences (Nasdaq: GILD) announced the full validation of its Marketing Authorization Application (MAA) for lenacapavir, an investigational HIV-1 capsid inhibitor, by the European Medicines Agency (EMA). This application targets treatment for adults with multidrug resistant HIV-1 infection who are on a failing regimen. The EMA’s Committee for Medicinal Products for Human Use will assess the application. Lenacapavir showed promising results in the CAPELLA study, with 88% of participants achieving significant viral load reduction. It remains investigational and is not yet approved.

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.