Gilead Sciences Inc Stock Price, News & Analysis

Gilead Sciences (Nasdaq: GILD) presents promising data from the Phase 3 ASCENT trial of Trodelvy for metastatic triple-negative breast cancer (mTNBC) at the 2020 San Antonio Breast Cancer Symposium. Trodelvy, which targets Trop-2, showed high clinical activity in mTNBC patients with poor outcomes, leading Gilead to submit a supplemental Biologics License Application (sBLA) to the FDA for full approval. The trial included over 500 patients, focusing on efficacy and safety, with positive outcomes noted in overall survival and progression-free survival.

Gilead Sciences (GILD) has announced its acquisition of MYR GmbH for approximately €1.15 billion, plus a potential €300 million milestone payment upon FDA approval. This acquisition aims to enhance Gilead's position in treating chronic hepatitis delta virus (HDV) through Hepcludex, a first-in-class therapy conditionally approved in Europe. The deal is expected to accelerate the global launch of Hepcludex, which blocks the entry of HDV into liver cells. Gilead anticipates the transaction will be neutral to non-GAAP EPS for the first two years and moderately accretive thereafter.

Gilead Sciences (Nasdaq: GILD) announced the appointment of Jeffrey A. Bluestone, PhD, to its Board of Directors. Dr. Bluestone, a prominent figure in immunotherapy, serves as CEO of Sonoma Biotherapeutics and is a distinguished professor at UC San Francisco. With over 500 publications, his research has significantly advanced T-cell activation and immune tolerance. His addition to the board aims to bolster Gilead's commitment to delivering innovative medicines, as noted by CEO Daniel O'Day.

Kite, a Gilead Company (GILD), announced positive interim results from the ZUMA-12 study of Yescarta (axicabtagene ciloleucel) for first-line treatment of high-risk large B-cell lymphoma. In the study, 85% of evaluable patients responded, with 74% achieving complete responses after a single Yescarta infusion. With a median follow-up of 9.5 months, safety evaluations indicated 9% experienced Grade 3 or higher cytokine release syndrome, and 25% had neurologic events. These results mark a significant step forward in CAR T therapy for early-stage high-risk patients.

Gilead Sciences announced positive updates from its magrolimab Phase 1b trial for acute myeloid leukemia (AML) patients ineligible for intensive chemotherapy. The combination of magrolimab and azacitidine showed an overall response rate of 63% and 69% for TP53-mutant patients. Complete remission rates were 42% overall and 45% in TP53-mutant patients. Median duration of response was 9.6 months for evaluable patients, and preliminary overall survival was 18.9 months for wild-type and 12.9 months for mutant patients. Adverse events were mostly manageable.

Kite, a Gilead Company (Nasdaq: GILD), announced positive results from the ZUMA-5 Phase 2 study of Yescarta for treating relapsed/refractory indolent non-Hodgkin lymphoma. In evaluable patients, 92% achieved a response, with 76% complete responses at 17.5 months median follow-up. The FDA has accepted a supplemental Biologics License Application for Yescarta, granting it Priority Review for follicular and marginal zone lymphomas, with a target action date of March 5, 2021. The study highlights Yescarta's potential for patients who have limited treatment options in this setting.

Kite, a Gilead Company (Nasdaq: GILD), presented four-year follow-up data from the ZUMA-1 trial for Yescarta® (axicabtagene ciloleucel) at the ASH Annual Meeting. This data indicates a four-year overall survival (OS) rate of 44% among 101 patients with refractory large B-cell lymphoma (LBCL) after a single infusion. No Yescarta-related secondary malignancies were reported. Notably, 67% of patients exhibited detectable CAR gene-marked cells, suggesting potential for durable remissions. Yescarta remains FDA-approved for adult patients with LBCL following two or more systemic therapy lines.

Kite, a Gilead Company (Nasdaq: GILD), reported promising follow-up results from the ZUMA-2 trial for Tecartus™ in adults with relapsed or refractory mantle cell lymphoma (MCL). With a median follow-up of 17.5 months, 92% of 60 evaluable patients responded, including 67% achieving a complete response. Secondary endpoints like progression-free and overall survival were not yet reached. Tecartus received FDA accelerated approval in July, yet continued approval depends on confirming clinical benefits in future trials. Significant adverse effects were noted, including cytokine release syndrome and neurological events.

Gilead Sciences (Nasdaq: GILD) has announced that Johanna Mercier, Chief Commercial Officer, and Merdad Parsey, MD, PhD, Chief Medical Officer, will participate in a fireside chat at the 3rd Annual Evercore ISI HealthCONx Conference. The event is scheduled for Wednesday, December 2 at 11:20 a.m. Eastern Time. Investors can access the live webcast through Gilead's investor page. A replay will be available for 14 days post-event. Gilead Sciences focuses on developing innovative medicines for life-threatening illnesses and operates in over 35 countries.