Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences announced that the FDA has lifted the partial clinical hold on studies evaluating its investigational drug magrolimab, allowing U.S. enrollment to resume for trials focused on myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). The decision follows a comprehensive safety review. Gilead plans to re-open enrollment in additional studies for magrolimab, which is granted Breakthrough Therapy designation for MDS. The company anticipates the first interim analysis for the pivotal ENHANCE study to remain on schedule for 2023.

Gilead Sciences (NASDAQ: GILD) announced FDA approval of Yescarta (axicabtagene ciloleucel), marking a significant advancement for adult patients with large B-cell lymphoma (LBCL) who are refractory to first-line treatment or relapse within 12 months. The approval follows the landmark ZUMA-7 study, showing Yescarta improved event-free survival by 4-fold and resulted in 2.5 times more patients surviving without disease progression at two years (40.5% for Yescarta vs. 16.3% for standard care). This positions Yescarta as the first CAR T-cell therapy to receive a NCCN Category 1 recommendation.

Gilead Sciences has announced $24 million in grants aimed at improving healthcare access in under-resourced communities affected by the HIV epidemic and COVID-19. The initiative, Zeroing In: Ending the HIV Epidemic, will support 116 organizations across 41 countries, focusing on Comprehensive HIV Innovation, Digital Health Innovation, and Community Outreach. The program seeks to address health disparities, enhance medical education, and empower community-driven solutions to combat stigma and improve HIV care.

Gilead Sciences (GILD) reported positive results from the Phase 3 TROPiCS-02 study assessing Trodelvy in HR+/HER2- metastatic breast cancer patients who previously underwent endocrine therapy and chemotherapy. The study achieved its primary endpoint, demonstrating a statistically significant improvement in progression-free survival compared to standard chemotherapy. While the first interim analysis showed a trend in overall survival improvement, continued patient monitoring is necessary. Trodelvy remains unapproved for this specific indication but is already available for other cancer types in over 35 countries.

Gilead Sciences received a complete response letter (CRL) from the FDA regarding its New Drug Application for lenacapavir, a long-acting HIV-1 capsid inhibitor. The CRL cites compatibility issues between lenacapavir and the proposed container vial, resulting in a clinical hold on the injectable formulation. Gilead plans to address these concerns and submit data for an alternative vial type. The NDA for lenacapavir was submitted in June 2021, supported by Phase 2/3 trial data, but it remains under review.

Gilead Sciences has announced one-year results from the CAPELLA trial, showcasing lenacapavir's efficacy in heavily treatment-experienced individuals with multi-drug resistant HIV. Administered biannually with other antiretrovirals, 83% of participants achieved undetectable viral loads, alongside a mean CD4 count increase of 83 cells/µL. Lenacapavir, a first-in-class HIV-1 capsid inhibitor, potentially addresses significant unmet needs in treatment. The ongoing CALIBRATE trial also reported high viral suppression rates in treatment-naïve patients, with 90% achieving undetectable viral loads.

Gilead Sciences (NASDAQ: GILD) announced interim data from its Phase 2/3 study of Veklury (remdesivir) for pediatric COVID-19 patients, ages 28 days to under 18 years. Presented at CROI 2022, results indicate that 85% of children showed clinical improvement, while 83% recovered by study's end (N=53). No new safety signals were observed, with 72% experiencing adverse events, mostly mild. Gilead submitted this data to the FDA for further authorization. The study's goal is to evaluate Veklury's safety and efficacy in treating hospitalized pediatric patients with COVID-19.

Gilead Sciences (NASDAQ: GILD) presented five-year results from Phase 3 studies on Biktarvy for HIV treatment at the CROI 2022 conference. The data indicated a high efficacy rate, with over 98% of participants maintaining an undetectable viral load throughout the treatment period. Notably, zero cases of treatment failure due to resistance were reported. Long-term safety assessments revealed stable metabolic, bone, and renal markers, leading to confidence in Biktarvy's long-term use for treatment-naïve adults.

Gilead Sciences has released data demonstrating that Veklury (remdesivir) remains effective against multiple SARS-CoV-2 variants, including Delta and Omicron. The study confirms Veklury's antiviral activity against ten major variants, with consistent results across independent studies in various countries. Notably, the drug targets the conserved nsp12 protein, crucial for replication, ensuring its efficacy remains intact even as variants emerge. Veklury is widely used in the U.S., treating over half of hospitalized COVID-19 patients. This positions Gilead favorably as the demand for effective COVID-19 treatments persists.