Gilead Sciences Inc - GILD STOCK NEWS

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.

Kite, a Gilead Company (Nasdaq: GILD), announced promising results from the ZUMA-3 study evaluating Tecartus^® (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The study reported a response rate of 71% in treated patients, with 97% achieving deep molecular remission. The FDA has accepted a supplemental Biologics License Application for Tecartus, targeting an approval date of October 1, 2021. However, grade ≥3 adverse events were noted in 95% of patients, raising safety concerns.

Gilead Sciences (Nasdaq: GILD) announced promising results from the Phase 3 ASCENT study of Trodelvy for relapsed or refractory metastatic triple-negative breast cancer (TNBC). In brain metastases-negative patients with recent disease progression, Trodelvy improved progression-free survival by 59%, achieving a median of 5.7 months compared to 1.5 months with chemotherapy. Overall survival also significantly increased to 10.9 months from 4.9 months. The safety profile remains consistent, with manageable adverse reactions. The data reaffirms Trodelvy’s potential as a new standard of care in this difficult-to-treat population.