Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences announced a clinical hold imposed by the FDA on injectable lenacapavir for HIV treatment and PrEP due to compatibility issues with borosilicate vials. This hold affects ongoing studies, preventing enrollment and dosing of injectable lenacapavir. However, oral lenacapavir formulations remain unaffected. Gilead is committed to resolving the vial quality issue promptly, noting that lenacapavir is still under investigation and not yet approved. The company emphasized its dedication to addressing this challenge and advancing research on HIV treatments.

Gilead Sciences (GILD) and Arcus Biosciences (RCUS) confirmed the closure of Gilead's option exercises on three of Arcus’ clinical-stage programs, including domvanalimab, AB308, etrumadenant, and quemliclustat, as of November 17, 2021. This transaction, following the expiration of antitrust waiting periods, entitles Arcus to receive $725 million from Gilead. Future collaboration includes co-development and profit-sharing in the U.S., along with tiered royalties on international sales. The collaboration supports advancements in cancer treatment through innovative drug candidates.

Gilead Sciences (GILD) and Arcus Biosciences (RCUS) announced the closing of Gilead's option exercises for three clinical-stage programs in Arcus's portfolio, including anti-TIGIT molecules and other candidates. This agreement results in option payments of $725 million from Gilead to Arcus, expected in early Q1 2022. Under the collaboration, Gilead and Arcus will co-develop the programs and share costs, with Gilead holding exclusive commercialization rights outside the U.S. The transaction followed the expiration of the Hart-Scott-Rodino waiting period.

Gilead Sciences (Nasdaq: GILD) announced its participation in the J.P. Morgan Healthcare Conference on Monday, January 10, starting at 11:15 a.m. Eastern Time. Executives will present and engage in a Q&A breakout session.

The live webcast will be available at investors.gilead.com, with replays accessible for at least 30 days post-event.

Gilead is a biopharmaceutical leader focusing on innovative treatments for serious diseases, operating in over 35 countries.

The European Commission has approved Gilead Sciences' Veklury (remdesivir) for use in adults at high risk of severe COVID-19 who do not require supplemental oxygen. This decision follows a positive recommendation from the Committee for Medicinal Products for Human Use and is based on Phase 3 trial data showing an 87% reduction in hospitalization or death risk compared to placebo. Veklury is expected to relieve pressure on healthcare systems by enabling earlier intervention for high-risk patients.

Kite, a Gilead Company, and Daiichi Sankyo announced an expanded collaboration for YESCARTA^® in Japan, aimed at providing treatment for patients with relapsed or refractory large B-cell lymphomas. The first treatment center has been authorized, continuing an exclusive licensing agreement from January 2017. YESCARTA^® has shown an impressive objective response rate of 86.7% in Japanese clinical trials, with safety profiles aligning with international studies. The partnership emphasizes commitment to patient access and innovative cancer therapies.

Gilead's Kite presents promising Phase 2 results for Yescarta in treating high-risk large B-cell lymphoma (LBCL) as a first-line therapy. In the ZUMA-12 study, 89% of evaluable patients showed a response, with 78% achieving complete response after a single infusion. At 15.9 months median follow-up, 73% maintained ongoing responses. The study highlighted a median turnaround time of 18 days for treatment delivery. Although favorable outcomes were noted, safety observations included Grade 3 cytokine release syndrome (8%) and neurologic events (23%). Yescarta remains unapproved for first-line use.

Kite, a Gilead Company (NASDAQ: GILD), announced updated two-year results from the ZUMA-5 study of Yescarta (axicabtagene ciloleucel) in patients with relapsed/refractory indolent non-Hodgkin lymphoma. Among 86 patients with follicular lymphoma (FL), the objective response rate was 94%, with 79% achieving complete response. The estimated median progression-free survival reached 39.6 months. The study highlights Yescarta's potential impact, with ongoing reviews in the European Union. However, the treatment carries risks, including cytokine release syndrome and neurologic toxicities.

Gilead's Kite presents five-year results from the pivotal ZUMA-1 trial of Yescarta (axicabtagene ciloleucel) for refractory large B-cell lymphoma. Notably, 42.6% of patients are alive after five years, with a remarkable 92% of those needing no further treatment, indicating a potential cure. Among those who achieved a complete response, the five-year overall survival rate is 64.4%. These findings were shared at the 63rd ASH Annual Meeting. Medical experts underscore this as a transformative breakthrough in treatment, contrasting the average six-month life expectancy for these patients.