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Gilead Sciences, Inc. (GILD) is a leading biopharmaceutical company focused on developing innovative therapies for life-threatening diseases. This page provides investors and healthcare professionals with timely updates on the company's latest developments, regulatory milestones, and strategic initiatives.
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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.
Kite, a Gilead Company (Nasdaq: GILD), announced top-line results from ZUMA-7, a Phase 3 study demonstrating Yescarta's superiority over standard care in treating relapsed or refractory large B-cell lymphoma (LBCL). With a two-year median follow-up, the study achieved its primary endpoint of event-free survival (EFS) with a hazard ratio of 0.398 (p < 0.0001). The objective response rate (ORR) also met key secondary endpoints. Though overall survival data showed a positive trend, it's still immature. The trial's safety profile remained consistent with previous findings.
Gilead Sciences (Nasdaq: GILD) announced interim results from its Phase 2b and Phase 3 trials of Hepcludex (bulevirtide) for treating chronic hepatitis delta virus (HDV). The Phase 3 study supports the efficacy and safety of bulevirtide 2 mg daily, showing a 36.7% virological response after 24 weeks. Hepcludex has received Breakthrough Therapy Designation and Conditional Marketing Authorization in Europe. With limited HDV treatment options available, these findings highlight the significance of bulevirtide in addressing substantial unmet medical needs.
Kite announced that Fosun Kite Biotechnology has received approval from China's NMPA for axicabtagene ciloleucel (Yescarta) to treat adult patients with relapsed or refractory large B-cell lymphoma. This marks the first CAR T-cell therapy approved in China. The approval follows a successful bridging trial demonstrating safety and efficacy in Chinese patients. Kite emphasizes the need for new treatment options in this patient population, highlighting the significance of this approval for improving survival rates.
Gilead Sciences (Nasdaq: GILD) has announced positive results from three retrospective studies on Veklury (remdesivir) for COVID-19 treatment. The studies, presented at the World Microbe Forum, involved over 98,000 patients and found that Veklury significantly reduced mortality risk and improved hospital discharge rates by Day 28. Notably, a 70% reduction in mortality was observed in patients requiring low-flow oxygen. These findings bolster the existing data on Veklury's effectiveness amidst ongoing global COVID-19 challenges.
