Welcome to our dedicated page for Gilead Sciences news (Ticker: GILD), a resource for investors and traders seeking the latest updates and insights on Gilead Sciences stock.
Gilead Sciences develops and commercializes medicines for HIV, viral hepatitis, COVID-19 and cancer. Company updates regularly cover product sales and operating results, HIV franchises such as Biktarvy, Yeztugo and lenacapavir, and clinical or regulatory activity for investigational HIV regimens that combine established antiretroviral agents with newer mechanisms.
Recurring developments also include oncology pipeline expansion through Kite cell-therapy programs, the completed acquisition of Arcellx and its investigational BCMA-directed CAR T-cell therapy anitocabtagene autoleucel for multiple myeloma, collaboration activity using real-world evidence in oncology R&D, shareholder matters, and capital-structure disclosures tied to material agreements and acquisitions.
Gilead Sciences (Nasdaq: GILD) announced its participation in the 11th IAS Conference on HIV Science, occurring virtually from July 18-21. The company will present 31 abstracts highlighting advancements in HIV treatment and prevention, including data on Biktarvy and lenacapavir. A symposium will feature discussions among leading researchers and community members on achieving a functional cure for HIV. Gilead emphasizes ongoing scientific innovation to meet critical healthcare needs for those affected by HIV. For details, visit IAS 2021.
Gilead Sciences (Nasdaq: GILD) has submitted a New Drug Application (NDA) to the FDA for lenacapavir, a long-acting HIV-1 capsid inhibitor targeting heavily treatment-experienced patients with multi-drug resistant HIV-1 infection. This submission is based on findings from the Phase 2/3 CAPELLA trial, which demonstrated significant viral load reduction. Lenacapavir is positioned as a potential first-in-class treatment option administered every six months. Gilead plans further applications to the European Medicines Agency and other global entities.
Kite, a Gilead Company (Nasdaq: GILD), announced top-line results from ZUMA-7, a Phase 3 study demonstrating Yescarta's superiority over standard care in treating relapsed or refractory large B-cell lymphoma (LBCL). With a two-year median follow-up, the study achieved its primary endpoint of event-free survival (EFS) with a hazard ratio of 0.398 (p 0.0001). The objective response rate (ORR) also met key secondary endpoints. Though overall survival data showed a positive trend, it's still immature. The trial's safety profile remained consistent with previous findings.
Gilead Sciences (Nasdaq: GILD) announced interim results from its Phase 2b and Phase 3 trials of Hepcludex (bulevirtide) for treating chronic hepatitis delta virus (HDV). The Phase 3 study supports the efficacy and safety of bulevirtide 2 mg daily, showing a 36.7% virological response after 24 weeks. Hepcludex has received Breakthrough Therapy Designation and Conditional Marketing Authorization in Europe. With limited HDV treatment options available, these findings highlight the significance of bulevirtide in addressing substantial unmet medical needs.
Kite announced that Fosun Kite Biotechnology has received approval from China's NMPA for axicabtagene ciloleucel (Yescarta) to treat adult patients with relapsed or refractory large B-cell lymphoma. This marks the first CAR T-cell therapy approved in China. The approval follows a successful bridging trial demonstrating safety and efficacy in Chinese patients. Kite emphasizes the need for new treatment options in this patient population, highlighting the significance of this approval for improving survival rates.
Gilead Sciences (Nasdaq: GILD) has announced positive results from three retrospective studies on Veklury (remdesivir) for COVID-19 treatment. The studies, presented at the World Microbe Forum, involved over 98,000 patients and found that Veklury significantly reduced mortality risk and improved hospital discharge rates by Day 28. Notably, a 70% reduction in mortality was observed in patients requiring low-flow oxygen. These findings bolster the existing data on Veklury's effectiveness amidst ongoing global COVID-19 challenges.
Gilead Sciences (Nasdaq: GILD) announced over 70 abstracts on liver disease research will be presented at The International Liver Congress™ 2021, from June 23-26. Highlights include interim Phase 3 data on Hepcludex® for hepatitis delta virus (HDV), the first approved HDV treatment in Europe. Gilead's ongoing studies on hepatitis C (HCV), hepatitis B (HBV), nonalcoholic steatohepatitis (NASH), and primary sclerosing cholangitis (PSC) will emphasize the company's commitment to liver health. Merdad Parsey, Chief Medical Officer, expressed enthusiasm for sharing advancements that could significantly impact patient outcomes.
Kite, a Gilead Company (Nasdaq: GILD), has entered a strategic partnership with Shoreline Biosciences to develop innovative allogeneic cell therapies targeting various cancers. The collaboration will utilize Shoreline’s expertise in iPSC technology and Kite’s leadership in cell therapy. Initial efforts will focus on chimeric antigen receptor NK targets, with potential expansion into iPSC CAR Macrophage programs. Shoreline will receive an upfront payment and could earn over $2.3 billion in additional payments and royalties based on developmental milestones.
Kite, a Gilead Company (Nasdaq: GILD), announced positive follow-up results from the pivotal ZUMA-5 trial of Yescarta® for treating relapsed or refractory follicular lymphoma (FL). At 18 months, 94% of patients achieved a response, outperforming current treatments in overall and progression-free survival metrics. The analysis showed a 58% reduction in death risk and a 70% reduction in disease progression compared to the control cohort, SCHOLAR-5. Safety findings noted Grade 3 or higher cytokine release syndrome (CRS) in 8% and neurologic toxicities in 21% of patients.
Gilead Sciences (Nasdaq: GILD) announced FDA approval to expand the pediatric indication of Epclusa for treating chronic hepatitis C in children as young as 3 years. The new oral pellet formulation includes two strengths, facilitating administration for younger patients. The approval supports treatment for 12 weeks in patients with or without cirrhosis and is based on a Phase 2 trial showing an 83% cure rate. With approximately 35,300 to 60,500 children affected by HCV in the U.S., this advancement aligns with Gilead's commitment to HCV elimination.