Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (Nasdaq: GILD) announced its participation in three upcoming investor conferences. The Wells Fargo Healthcare Conference will take place on September 8 at 10:25 AM ET, followed by the Morgan Stanley Annual Global Healthcare Conference on September 13 at 10:35 AM ET, and the Baird Global Healthcare Conference on September 14 at 9:40 AM ET. Live webcasts will be available on the investors.gilead.com page, with replays accessible for 30 days.

Gilead Sciences (GILD) announced new data at the ESMO Congress 2022, showcasing the Phase 3 TROPiCS-02 study results for Trodelvy^® in HR+/HER2- metastatic breast cancer. The study demonstrated significant overall survival benefits for patients pre-treated with endocrine therapies. Gilead has submitted a supplemental Biologics License Application to the FDA for Trodelvy based on these findings, which highlight the drug's potential against a challenging patient population. Additional presentations included health-related quality of life data and efficacy analyses by HER2 status.

Gilead Sciences announced the European Commission has granted marketing authorization for Sunlenca (lenacapavir), a new HIV treatment for patients with multidrug-resistant strains. This first-in-class medication offers an innovative, long-acting option administered bi-annually, addressing a critical unmet need. In the CAPELLA study, 83% of participants achieved an undetectable viral load at Week 52. This approval follows the FDA's consideration of lenacapavir, with a PDUFA action date set for December 27, 2022, signaling a promising future for treatment options in the evolving HIV landscape.

Gilead Sciences announced a $4.5 million funding initiative aimed at improving health outcomes for Black Americans in the Southern United States. This collaboration with the Satcher Health Leadership Institute and Xavier University focuses on addressing inequities in HIV care. The funds will support efforts in Atlanta, Baton Rouge, and New Orleans over three years, enhancing access to culturally appropriate care, training, and understanding COVID-19's impact on healthcare delivery. This initiative aligns with Gilead's broader strategy to advance health equity.

Gilead Sciences has announced an agreement with Everest Medicines to acquire development and commercialization rights for Trodelvy (sacituzumab govitecan) in multiple Asian markets, including Greater China and South Korea. The deal involves a $280 million upfront payment and potential additional payments totaling $175 million based on regulatory standards. Trodelvy is already approved for adult patients with certain types of metastatic breast cancer and ongoing regulatory applications in several regions. This acquisition enhances Gilead's oncology portfolio and aims to expand patient access to Trodelvy.

Gilead Sciences announced significant findings from the second interim analysis of the TROPiCS-02 study, demonstrating Trodelvy's potential to improve overall survival in HR+/HER2- metastatic breast cancer patients who received previous treatments. This analysis showed clinically meaningful results, with safety profiles consistent with prior studies. Gilead has submitted a supplemental Biologics License Application to the FDA for this indication. Trodelvy, though not yet approved for this specific use, is already recognized for treating other cancer types.

Gilead Sciences (Nasdaq: GILD) has announced its acquisition of MiroBio, a UK-based biotechnology company, for approximately $405 million in cash. This strategic move provides Gilead with MiroBio's proprietary discovery platform and its pipeline of immune checkpoint agonists aimed at treating autoimmune diseases. Notably, MiroBio's lead investigational antibody, MB272, which targets immune inhibitory receptors, has entered Phase 1 clinical trials. The acquisition is expected to reduce Gilead's 2022 EPS by $0.30-$0.35.

Gilead Sciences reported a strong Q2 2022, with total revenue rising 1% to $6.3 billion. Noteworthy product sales include Biktarvy, which surged 28% year-over-year to $2.6 billion, and oncology sales, which grew 71% to $527 million. However, diluted EPS decreased to $0.91 from $1.21 due to higher IPR&D expenses from an upfront payment of $300 million. Gilead's updated full-year guidance anticipates total product sales between $24.5 billion and $25.0 billion, and non-GAAP EPS between $6.35 and $6.75.

Gilead Sciences (GILD) has announced positive interim results from the ALLIANCE trial, showing that Biktarvy is effective for HIV patients with HBV coinfection. The trial demonstrated superior suppression of HBV DNA with Biktarvy compared to an alternative regimen. Additionally, data from five years of two Phase 3 studies revealed no treatment failures due to resistance. Overall, 99% of participants maintained an undetectable viral load. These findings highlight Biktarvy's potential as a long-term treatment option for individuals with HIV.