Gilead Sciences Inc Stock Price, News & Analysis

Gilead Sciences announced the validation of a Type II variation Marketing Authorization Application for Trodelvy (sacituzumab govitecan-hziy) by the European Medicines Agency. This application is aimed at treating adults with HR+/HER2- metastatic breast cancer who have undergone previous therapies. The approval is based on positive survival data from the Phase 3 TROPiCS-02 study, which showed improved progression-free and overall survival compared to standard chemotherapy. The FDA has also accepted a related supplemental application under priority review.

Gilead Sciences (GILD) has amended its license agreement with Jounce Therapeutics (JNCE) to buy out remaining financial obligations associated with GS-1811, an anti-CCR8 antibody designed for solid tumors. Jounce will receive $67 million and will forfeit up to $645 million in potential future payments. Gilead assumes full responsibility for GS-1811’s global development and commercialization, aiming to enhance its oncology portfolio. The buyout is expected to lower Gilead’s GAAP and non-GAAP EPS by approximately $0.04 in 2022.

Gilead Sciences (Nasdaq: GILD) announced its participation in the J.P. Morgan Healthcare Conference on January 9, 2023, at 10:30 a.m. PT. The event will be accessible via live webcast on the company's investor page. A replay will be available for 30 days post-presentation. Gilead Sciences is a biopharmaceutical leader focused on innovative therapies for HIV, viral hepatitis, and cancer, operating in over 35 countries with headquarters in Foster City, California.

Kite Pharma, a Gilead Company, and Daiichi Sankyo announced that Japan's Ministry of Health has approved Yescarta for treating relapsed/refractory large B-cell lymphoma (R/R LBCL). The approval is based on the ZUMA-7 study, which showed Yescarta provided a four-fold increase in event-free survival compared to standard care (8.3 vs. 2 months). Moreover, patients treated with Yescarta were 2.5 times more likely to be alive after two years without disease progression. This marks a significant advancement for patients in Japan, where this cancer type is prevalent.

Sunlenca (lenacapavir) has received FDA approval as the first capsid inhibitor for HIV-1 treatment in adults experiencing multi-drug resistant HIV infections. This drug, distinguished by its unique multi-stage action, offers a twice-yearly treatment option, addressing a critical gap for patients with limited therapy choices. The approval is based on the CAPELLA trial, which demonstrated an 83% success rate in achieving undetectable viral loads at Week 52. Sunlenca’s long-acting properties and broad application potential mark it as a significant advancement in HIV treatment.

Gilead Sciences supports the Transinclusive Group, led by Tatiana Williams, a Black-led advocacy group aimed at improving resources for Trans individuals in Florida. The group has launched a peer-run housing program called CHOICES, funded by a Gilead TRANScend grant, which offers transitional housing along with healthcare, job training, and financial advice. Despite its success, the program faces challenges with increasing demand and limited capacity. The initiative focuses on fostering community resilience among Trans individuals.

Gilead's Kite has announced the acquisition of Tmunity Therapeutics, enhancing its CAR T-therapy capabilities. This strategic move will add pipeline assets and access to innovative research through a partnership with the University of Pennsylvania. Tmunity's armored CAR T technology may improve anti-tumor activity, and Kite will now manage ongoing research collaborations with Penn. The financial terms remain undisclosed, but the deal is forecast to reduce Gilead's 2023 EPS by approximately $0.18-$0.22. The acquisition is expected to close in Q1 2023, pending regulatory approvals.

Gilead Sciences (GILD) and Arcus Biosciences (RCUS) reported positive interim results from the ARC-7 study, a Phase 2 trial in patients with first-line metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. Both doublet and triplet therapy arms containing domvanalimab showed a 35-45% reduction in the risk of progression or death compared to zimberelimab monotherapy, with median progression-free survival (PFS) of 12.0 months for the doublet and 10.9 months for the triplet. Results will be showcased on December 20 during the ASCO Monthly Plenary Series.

Gilead Sciences and Arcus Biosciences reported promising results from the ARC-7 Study, focusing on first-line, metastatic non-small cell lung cancer (NSCLC). The study demonstrated a 35-45% reduction in the risk of progression or death and a significant improvement in median progression-free survival (PFS) with the combination therapies compared to zimberelimab monotherapy. The objective response rates showed a positive trend, with the doublet and triplet arms showing 41% and 40%, respectively. Further detailed results will be presented on December 20.