Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences and Kite will showcase advancements in CAR T-cell therapies at the upcoming ASH Annual Meeting (Dec 11-14). Highlights include over 20 abstracts, with the landmark ZUMA-7 study presenting efficacy and safety results in relapsed/refractory large B-cell lymphoma (LBCL). Kite's research aims to improve treatment standards and patient survival rates. Additionally, new findings on investigational magrolimab will be discussed, indicating significant potential in AML treatments. Gilead emphasizes broad potential across its oncology pipeline amid evolving cancer treatment strategies.

Gilead Sciences (GILD) announced interim results from the BICSTaR study, showcasing Biktarvy's effectiveness in treating HIV across 1,135 patients. After one year, 97% of treatment-naïve and 96% of treatment-experienced participants achieved virologic suppression. High adherence to the medication (91%) was reported, with 13% experiencing adverse events, mostly mild. Biktarvy’s robust efficacy in long-term treatment switch scenarios was also emphasized, with 99% maintaining viral suppression over 101 weeks, reinforcing its role in improving the quality of life for diverse HIV populations.

Gilead Sciences (GILD) announced a partnership with Merck to conduct a global Phase 3 clinical trial evaluating the efficacy of Trodelvy (sacituzumab govitecan-hziy) combined with KEYTRUDA (pembrolizumab) for first-line treatment of triple-negative breast cancer (TNBC). Trodelvy is already a second-line treatment option for metastatic TNBC. The trial aims to assess the combination's effectiveness compared to KEYTRUDA plus chemotherapy in patients with advanced TNBC. The combination is still under investigation and has not received regulatory approval.

Gilead Sciences reported a robust third quarter 2021, achieving total revenues of $7.4 billion, a 13% increase year-over-year, driven by strong demand for Veklury and record sales of Biktarvy at $2.3 billion. Diluted EPS surged to $2.05 compared to $0.29 in 2020. The company anticipates total product sales of $26.0-$26.3 billion for the year, with Veklury sales forecasted at $4.5-$4.8 billion. Gilead's cash position remains solid at $6.8 billion, supporting ongoing investments in research and development.

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.