Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (GILD) announced the retirement of Brett Pletcher, Executive Vice President, Corporate Affairs, after 17 years. Deborah Telman will succeed him as Executive Vice President and General Counsel, effective August 1, 2022. Telman, who joins from Organon, brings over 25 years of legal experience and will oversee legal and corporate affairs. CEO Daniel O'Day praised Telman's leadership and commitment to health equity. Pletcher's tenure included significant contributions to Gilead's global expansion and health policy strategy.

Kite, a Gilead Company (Nasdaq: GILD), announces European Commission approval for Yescarta (axicabtagene ciloleucel) to treat adults with relapsed or refractory follicular lymphoma after three or more lines of therapy. The pivotal ZUMA-5 study demonstrated a 91% overall response rate and a 77% complete response rate among patients treated. Follicular lymphoma, the second most common lymphoma type, has limited treatment options, making this approval significant. Kite aims to improve access to innovative cancer therapies across Europe.

Gilead Sciences has resubmitted the New Drug Application (NDA) for lenacapavir, a long-acting HIV-1 treatment for heavily treatment-experienced patients with multi-drug resistant infections. This follows the FDA's Complete Response Letter issued in February 2022 concerning vial compatibility issues. The resubmission includes comprehensive data on compatibility with a new vial type. If approved, lenacapavir would be the only HIV-1 treatment option administered biannually. The FDA will establish a new PDUFA date upon acceptance of this NDA.

Gilead Sciences has signed the Kigali Declaration to combat neglected tropical diseases (NTDs) by 2030, reinforcing its commitment to global health. This declaration, launched during the Commonwealth Heads of Government Meeting, aims to eliminate 20 diseases by 2030. Gilead's CEO, Daniel O'Day, emphasized the company's long history of supporting NTD efforts. Gilead will continue its product donations for visceral leishmaniasis until 2027, invest in health equity initiatives, and lead discussions on environmental factors contributing to NTDs.

Gilead Sciences announced that the European Medicines Agency's CHMP has issued a positive opinion for lenacapavir, an investigational treatment for HIV-1 infection in adults with multi-drug resistance. This recommendation, based on Week 26 data from the CAPELLA trial, supports lenacapavir as a twice-yearly treatment option for patients with limited options. In the trial, 81% of participants achieved viral suppression, with lenacapavir showing good tolerability. The final decision from the European Commission is anticipated later this year.

Gilead Sciences has released Week 48 results from its pivotal Phase 3 trial assessing Hepcludex (bulevirtide) for chronic hepatitis delta virus (HDV). The data demonstrate significant viral declines and improved patient-reported outcomes (PROs). At Week 48, 45% and 48% of patients treated with bulevirtide achieved combined virological and biochemical responses, compared to only 2% in the untreated group. The treatment's safety profile remains consistent, with no serious adverse events. The findings were presented at the International Liver Congress 2022, reinforcing bulevirtide's potential as a therapeutic option for this high-burden disease.

Gilead Sciences (Nasdaq:GILD) announced over 80 abstracts will be presented at the International Liver Congress™ (ILC) 2022 from June 22-26, 2022. Key highlights include Phase 3 data on Hepcludex (bulevirtide) for treating hepatitis delta virus (HDV), focusing on efficacy and patient-reported outcomes. Presentations will also cover hepatitis C (HCV) elimination efforts, chronic hepatitis B (HBV) treatments, and research in nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). Bulevirtide has received Conditional Marketing Authorization in Europe and is under FDA review in the U.S.

Trodelvy, developed by Gilead Sciences, demonstrated significant benefits in the Phase 3 ASCENT study for patients with relapsed metastatic triple-negative breast cancer (TNBC). The data revealed a median progression-free survival of 4.8 months compared to 1.7 months with chemotherapy (HR: 0.41; p<0.0001) and an overall survival of 11.8 months vs 6.9 months (HR: 0.51; p<0.0001). Additionally, Trodelvy improved health-related quality of life across five domains. The safety profile was consistent with previous reports, with manageable adverse reactions.

Kite, a Gilead Company (GILD), presented three-year follow-up results from the ZUMA-2 trial for Tecartus in relapsed/refractory mantle cell lymphoma (MCL) showing an overall response rate (ORR) of 91% and median overall survival (OS) of 46.6 months. In the ZUMA-3 trial for relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), the two-year follow-up revealed a CR rate of 73.1% with a median OS of 25.4 months. Both trials demonstrated long-term efficacy, with Tecartus being the only CAR T-cell therapy approved for these indications.