Gilead Sciences Inc Stock Price, News & Analysis

The Phase 2 clinical study has commenced, evaluating a once-weekly oral combination of islatravir and lenacapavir for HIV treatment, led by Gilead Sciences (GILD) and Merck (MRK). This collaboration aims to provide long-acting HIV therapies to address diverse patient needs. The study will assess safety and antiviral effects, with a primary endpoint of HIV-1 RNA viral load at Week 24. Both investigational drugs have shown promise in earlier trials, with the goal of addressing adherence and stigma issues in HIV treatment.

Gilead Sciences (NASDAQ: GILD) will present 44 studies at the 18th European AIDS Conference (EACS 2021) from October 27-30, focusing on HIV treatment and prevention. Key presentations include long-term efficacy data for Biktarvy, emphasizing its safety and effectiveness in individuals with known resistance. The BICSTaR Study results and new insights into long-acting treatment strategies like lenacapavir will also be shared. Gilead aims to enhance patient care and address the changing needs of those living with HIV, reaffirming its commitment to combating the epidemic.

Gilead Sciences (NASDAQ: GILD) announced the donation of 100,000 vials of Veklury^® (remdesivir) to combat rising COVID-19 cases in Indonesia and 3,000 vials to Armenia. This effort supports Gilead's commitment to enhancing healthcare access amid the pandemic. Previously, Gilead donated over 450,000 vials to India and 10,000 to Georgia. Veklury, an antiviral treatment, is now available in around 50 countries, aiding over seven million patients globally, including five million in low-income nations.

FDA Approves Low-Dose Biktarvy for Pediatric HIV Treatment - Gilead Sciences announced the FDA's approval of a new low-dose tablet of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg) for children weighing 14 kg to less than 25 kg who are virologically suppressed. This approval aims to enhance treatment options for children living with HIV. In clinical trials, 91% of participants remained virologically suppressed after 24 weeks of treatment. Gilead emphasizes its commitment to address unmet needs in pediatric HIV treatment.

Gilead Sciences announced a positive opinion from the European Medicines Agency (EMA) for sacituzumab govitecan as a treatment for adults with unresectable or metastatic triple-negative breast cancer (TNBC). This new therapy showed a 49% reduction in mortality risk and improved median overall survival to 11.8 months compared to 6.9 months with standard chemotherapy. Following the Phase 3 ASCENT study, the EMA’s final decision on marketing authorization is expected later in 2021, potentially establishing sacituzumab govitecan as a new standard of care in Europe.

Gilead Sciences, Inc. (GILD) will announce its third quarter 2021 financial results on October 28 after market close. A live webcast discussing these results, along with a business update, will take place at 4:30 p.m. ET. The webcast will be accessible via the company's investor relations page and archived for one year on their website. Gilead is committed to developing innovative medicines for serious diseases, operating in over 35 countries worldwide.

Kite, a Gilead Company (GILD), announced FDA approval for Tecartus (brexucabtagene autoleucel), indicated for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This marks Kite's fourth indication for its CAR T-cell therapies in under four years. In clinical trials, 65% of patients achieved complete remission, with a median duration of over 12 months, addressing a significant unmet need as current therapies have a median overall survival of less than eight months.

Kite, a Gilead Company (NASDAQ: GILD), has filed a supplemental Biologics License Application (sBLA) with the FDA for Yescarta (axicabtagene ciloleucel) to treat adults with relapsed or refractory large B-cell lymphoma in the second-line setting. The filing is based on the ZUMA-7 study, which showed a significant 60% reduction in the risk of event-free survival compared to standard care over a median follow-up of two years. This would make Yescarta the first CAR T-cell therapy for adults in this group if approved.

Gilead Sciences (GILD) announced that Health Canada has approved Trodelvy (sacituzumab govitecan-hziy) as a second-line treatment for adults with metastatic triple-negative breast cancer (TNBC) who have undergone two or more prior therapies. This approval follows Trodelvy's demonstrated survival benefits in the Phase 3 ASCENT study, showing a 49% reduction in the risk of death. Trodelvy is now authorized in multiple countries, including the U.S., Australia, Great Britain, and Switzerland, under the Project Orbis initiative. Concerns include severe adverse reactions, such as neutropenia and diarrhea.