Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (Nasdaq: GILD) announced that the European Commission approved Yescarta for adult patients with diffuse large B-cell lymphoma (DLBCL) who relapse or are refractory after first-line treatment. The approval stems from the pivotal ZUMA-7 study, showing Yescarta provides an event-free survival (EFS) of 8.3 months compared to just 2.0 months with standard care, marking a four-fold improvement. Additionally, Yescarta patients showed a 2.5 fold increase in survival without cancer progression at two years (41% vs. 16%).

Gilead Sciences (NASDAQ: GILD) has secured an exclusive option for the MGD024 molecule, a bispecific antibody targeting CD123 and CD3, through a collaboration with MacroGenics (NASDAQ: MGNX). This molecule aims to treat blood cancers such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Gilead has committed $60 million upfront, with a total potential of $1.7 billion in milestones. The Phase 1 study will assess MGD024's efficacy and safety while Gilead may opt to license it at set decision points.

Gilead Sciences, Inc. (Nasdaq: GILD) will release its third quarter 2022 financial results on October 27 after market close. Following the announcement, management will host a webcast at 4:30 p.m. Eastern Time to discuss results and provide a business update. The webcast will be accessible on Gilead's Investor Relations website and archived for one year. Gilead focuses on developing innovative medicines for serious diseases, including HIV, hepatitis, and cancer, operating in over 35 countries from its headquarters in Foster City, California.

Gilead Sciences, Inc. announced that the FDA accepted its supplemental Biologics License Application (sBLA) for Trodelvy to treat adult patients with unresectable HR+/HER2- metastatic breast cancer who have received prior therapies. The sBLA is based on positive data from the TROPiCS-02 study, showing significant improvements in progression-free survival (PFS) and overall survival (OS) compared to chemotherapy. The PDUFA target date is set for February 2023. While Trodelvy has not yet been approved for this indication, it has shown promise in changing treatment landscapes for breast cancer.

Kite, a Gilead Company (Nasdaq: GILD), has received FDA approval for its retroviral vector manufacturing facility in Oceanside, California. This facility is crucial for producing viral vectors, which are essential in Kite's CAR T-cell therapies aimed at treating blood cancers. Kite stands out as the only cell therapy company with both commercial and clinical trial viral vector manufacturing capabilities. The in-house production will enhance reliability and scalability, meeting increasing patient demand for these therapies.

Gilead Sciences has launched a multi-year, public-private initiative in collaboration with the Partnership for Health Advancement in Vietnam (HAIVN) to enhance hepatitis care and management in Vietnam and the Philippines. This program aims to integrate hepatitis B and C diagnosis and treatment into primary healthcare, addressing barriers to access. With significant hepatitis prevalence in both countries, the initiative aligns with WHO targets for viral hepatitis elimination by 2030, hoping to strengthen healthcare systems and broaden patient access to care.

Gilead Sciences, Inc. (GILD) has successfully completed the acquisition of MiroBio for $405 million in cash. MiroBio, a U.K.-based biotechnology firm, specializes in immune inhibitory receptor agonists. This acquisition grants Gilead access to MiroBio's proprietary discovery platform and its lead investigational antibody, MB272, which is currently in Phase 1 clinical trials. Gilead aims to enhance its portfolio in inflammatory diseases, addressing unmet medical needs.

Kite, a Gilead Company, announced a positive opinion from the European Medicines Agency for Yescarta, a CAR T-cell therapy, for adults with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months post-first-line chemoimmunotherapy. The ZUMA-7 study showed a four-fold improvement in event-free survival at two years (41% for Yescarta vs. 16% for standard care). The final decision from the European Commission is expected soon, potentially transforming treatment for these aggressive lymphomas.

Gilead Sciences announced a positive opinion from the European Medicines Agency (EMA) regarding its COVID-19 treatment, Veklury (remdesivir), for pediatric patients under 12 years. If approved by the European Commission, Veklury would be the only authorized antiviral treatment for this demographic, specifically for children at risk of severe COVID-19 or with pneumonia requiring oxygen. The decision is based on positive results from the ongoing CARAVAN Phase 2/3 study, which showed clinical improvement in 75-85% of pediatric participants.