Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (GILD) has announced FDA approval for its antiviral drug Veklury (remdesivir) as the first approved COVID-19 treatment in the U.S. This approval follows emergency use authorization and is based on significant clinical trial data. Veklury demonstrated a reduced recovery time in hospitalized patients, improving recovery by an average of five days compared to placebo. The drug is now available nationwide, supported by expanded manufacturing capacity. Veklury is indicated for adults and pediatric patients aged 12 and older requiring hospitalization.

Gilead Sciences (Nasdaq: GILD) announced the appointment of Anthony Welters to its Board of Directors. Welters, a former Senior Adviser at UnitedHealth Group, brings significant experience in health insurance and managed care. His leadership roles include being Executive Vice President at UHG and founding AmeriChoice. Currently, he is involved with several organizations, providing insights into healthcare delivery. Gilead's CEO, Daniel O’Day, expressed confidence that Welters' expertise will enhance the board's ability to deliver transformational medicines to patients in need.

Gilead Sciences announced results from the BRAAVE 2020 Phase 3 trial, showing that switching to Biktarvy is effective for HIV treatment in Black or African American patients who are virologically suppressed. A total of 495 participants were randomized, with 99% in the Biktarvy group maintaining HIV-1 RNA < 50 copies/mL after 48 weeks. The study highlights Biktarvy's potential, especially for those with prior treatment failures. Gilead also presented findings on tenofovir alafenamide's impact on weight gain in patients switching from TDF to TAF.

Gilead Sciences (Nasdaq: GILD) presented 18 abstracts at IDWeek 2020, showcasing advancements in HIV treatment and COVID-19 clinical developments. Key trials include the DISCOVER trial evaluating Descovy for PrEP and insights on renal outcomes. New data on Biktarvy in underrepresented HIV populations and the efficacy of Veklury for COVID-19 treatment was also shared. Gilead aims to enhance antiviral innovations addressing complex public health challenges, as stated by Diana Brainard, MD.

Kite, a Gilead Company (GILD), announced a positive opinion from the EMA CHMP for KTE-X19, a CAR T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy, including a BTK inhibitor. The recommendation supports conditional marketing authorization based on favorable safety and efficacy data from the ZUMA-2 trial. Mantle cell lymphoma affects a significant number of patients annually in Europe, with a poor prognosis. KTE-X19 remains investigational in Europe, pending a final decision by the European Commission.

Gilead Sciences is set to release its third quarter 2020 financial results on October 28, after market close. A conference call will be held at 4:30 PM ET, where management will discuss the results and provide a business update. Investors can access the live webcast on the company's investor page or via phone. The results will be crucial for stakeholders to assess Gilead's performance, especially given its focus on innovative medicines for severe illnesses.

Gilead Sciences (Nasdaq: GILD) announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act for its cash tender offer for Immunomedics, which expired on October 13, 2020. This marks a significant step towards the completion of the tender offer, which requires a majority of Immunomedics' outstanding shares to be tendered. The offer is set to expire on October 22, 2020. This development is crucial for Gilead as it seeks to enhance its product pipeline, particularly with Immunomedics' Trodelvy.

Gilead Sciences (GILD) and Galapagos presented late-breaking data on filgotinib during the UEGW Virtual Meeting. The Phase 2b/3 SELECTION trial results indicated that patients with moderately to severely active ulcerative colitis achieved higher clinical remission rates at Week 10 and sustained remission through Week 58 with filgotinib 200 mg compared to placebo. Key efficacy measures showed significant improvements, including corticosteroid-free remission. Safety profiles were comparable between filgotinib and placebo, with minimal adverse events reported.

The New England Journal of Medicine has published final results from the ACTT-1 trial of Gilead's Veklury (remdesivir) for hospitalized COVID-19 patients. The trial demonstrated that Veklury significantly reduced recovery time, showing a median recovery of 10 days versus 15 days for placebo. Patients who required oxygen benefited most, recovering seven days faster. The study also indicated a trend towards lower mortality rates. The trial met all primary and secondary endpoints, reinforcing Veklury's potential as a standard treatment for COVID-19 in hospitals.