Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (Nasdaq: GILD) and Kite will present over 20 abstracts at the 2022 ASCO Annual Meeting, including groundbreaking findings in breast and blood cancers. Notable studies include the TROPiCS-02 trial for HR+/HER2- breast cancer and analyses from the ZUMA-7 CAR T-cell therapy trial, highlighting treatment options for older patients. Additionally, data on MDS and AML treatment advancements will be showcased. These presentations underscore Gilead's commitment to addressing critical gaps in oncology care.

Gilead Sciences announced that the FDA has lifted the clinical hold on its Investigational New Drug Application for injectable lenacapavir, allowing all clinical studies to resume. This decision follows a review confirming the compatibility of lenacapavir with a new aluminosilicate glass vial. Previously, the hold was due to concerns over borosilicate vials. Lenacapavir is an investigational long-acting HIV treatment and prevention option. The company aims to progress this potential breakthrough, which would provide a biannual treatment option for patients.

Gilead Sciences has entered into a collaboration with Dragonfly Therapeutics to develop immunotherapies utilizing the novel NK cell engager technology. Gilead will receive exclusive worldwide rights to DF7001, a 5T4-targeting investigational candidate aimed at treating solid tumors. The deal includes a $300 million upfront payment and potential further payments based on development milestones and sales. The IND application for DF7001 is expected to be submitted in the first half of 2023.

Gilead Sciences reported first quarter 2022 revenue of $6.6 billion, a 3% increase year-over-year, aided by strong sales of Biktarvy ($2.2 billion, up 18%) and oncology products ($420 million, up 60%). However, diluted EPS fell to $0.02 due to a $2.7 billion impairment. Non-GAAP diluted EPS rose 4% to $2.12. The company updated its full-year EPS guidance to $3.00-$3.50, previously $4.70-$5.20. Gilead's cash and equivalents decreased to $6.8 billion. The ongoing expansion of its oncology portfolio and a strong pipeline are key growth drivers.

Gilead Sciences (NASDAQ: GILD) will present at four upcoming investor conferences. The schedule includes the Bank of America Healthcare Conference on May 10 at 5:00 PM ET, Bernstein’s Annual Strategic Decisions Conference on June 2 at 4:30 PM ET, Jefferies Global Healthcare Conference on June 8 at 11:00 AM ET, and Goldman Sachs Global Healthcare Conference on June 15 at 2:20 PM ET. Live webcasts will be available on Gilead's investors page for 30 days post-presentation.

Gilead Sciences announced that the FDA approved a supplemental new drug application for Veklury (remdesivir), targeting treatment for pediatric patients over 28 days with COVID-19. This expands Veklury's indication for both hospitalized and high-risk non-hospitalized children. Phase 2/3 data showed that Veklury is generally well-tolerated, with 75% improvement at Day 10. Safety evaluations revealed no new concerns among the 53 pediatric participants in the study. This approval emphasizes Gilead's commitment to developing effective treatments for vulnerable populations.

Gilead Sciences (GILD) released findings from two studies on Veklury (remdesivir) for COVID-19, showcasing its importance in treatment protocols. Over 850,000 COVID-19 hospitalized patients were analyzed, revealing that more than 50% were treated with Veklury. A post-hoc analysis indicated that initiating treatment within five days of symptoms reduced hospitalization risk by 90%. The analysis also noted increased early treatment initiation over time, with a stable overall mortality rate of 16%. These results reinforce Veklury's role as a foundational COVID-19 therapy.

Kite, a Gilead Company (GILD), has received FDA approval for its new CAR T-cell therapy manufacturing facility in Frederick, Maryland. This site expands Kite's capacity by 50%, enhancing its ability to meet increasing patient demand for CAR T-cell therapies. Kite’s global manufacturing network, which includes facilities in Southern California and Amsterdam, aims to provide high-quality, individualized cancer treatments for difficult-to-treat blood cancers. Kite expects to employ over 400 staff at the Maryland site by the end of 2022.