Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences announced positive results from the Phase 3 TROPiCS-02 study for Trodelvy in treating HR+/HER2- metastatic breast cancer. The study showed a 34% reduction in disease progression risk (median PFS: 5.5 vs. 4 months). At one year, 21% of Trodelvy patients were progression-free, compared to 7% for chemotherapy. A positive trend in overall survival was noted. The quality of life analysis indicated Trodelvy improved global health status and fatigue. No new safety issues emerged, although neutropenia and diarrhea were common. Trodelvy awaits regulatory approval for this indication.

Kite, a Gilead Company (GILD), announced findings from the largest real-world analysis of CAR T-cell therapy, Yescarta, focusing on racial and ethnic differences in outcomes for patients with relapsed or refractory large B-cell lymphoma (LBCL). The study revealed that Black or African American patients had longer times from diagnosis to treatment compared to White patients, potentially affecting response rates. Overall, Yescarta showed consistent efficacy across races. Findings were presented at the 2022 ASCO Annual Meeting, highlighting a need for further research on equity in CAR T-cell therapy access.

Gilead Sciences, Inc. has appointed Dr. Stacey Ma as the new Executive Vice President for Pharmaceutical Development and Manufacturing, effective July 18, 2022. She succeeds Dr. Taiyin Yang, who is retiring after 29 years with the company. Dr. Ma has over 25 years of experience in pharmaceutical development and manufacturing, previously serving as Executive Vice President at Sana Biotechnology. Gilead's CEO, Daniel O'Day, expressed confidence in Dr. Ma's leadership to maintain excellence in drug development and manufacturing during a time of portfolio diversification.

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.