Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences (Nasdaq: GILD) announced that the U.S. FDA has granted Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed after platinum-based chemotherapy. This designation is based on positive results from the Phase 2 TROPiCS-03 study, which showed promising antitumor activity and a consistent safety profile. Gilead plans to initiate a Phase 3 clinical trial in this patient population. Lung cancer is the second most diagnosed cancer in the U.S., with SCLC accounting for about 15% of cases. Approximately 70% of SCLC diagnoses are at the extensive stage, where current treatment options are and prognosis is poor. Trodelvy, a Trop-2-directed antibody-drug conjugate, is already approved for certain types of metastatic breast cancer and is being explored for multiple other cancers.

Gilead Sciences (NASDAQ: GILD) and Terray Therapeutics have announced a strategic collaboration for discovering and developing novel small molecule therapies. Terray will utilize its tNova platform, which combines high-throughput chemical experimentation and AI-driven drug discovery, to work on targets selected by Gilead.

Under the agreement, Gilead receives exclusive options to license compounds and will handle further development and commercialization. Terray will receive an upfront payment plus potential milestone payments and tiered royalties on net sales. The transaction is expected to reduce Gilead's GAAP and non-GAAP 2024 EPS by approximately $0.01.

Gilead Sciences (GILD) received a positive CHMP opinion recommending seladelpar for treating primary biliary cholangitis (PBC) in the EU. The recommendation is based on the RESPONSE study, where 62% of participants achieved composite biochemical response at 12 months versus 20% for placebo. Notably, 25% of participants showed ALP normalization, and significant pruritus reduction was observed.

The treatment demonstrated effectiveness both in combination with ursodeoxycholic acid (UDCA) and as monotherapy for those unable to tolerate UDCA. The final European Commission decision is expected in Q1 2025. This follows the FDA's accelerated approval in August 2024. PBC affects approximately 15 per 100,000 people in Europe, primarily women.

Gilead Sciences (NASDAQ: GILD) has appointed Dietmar Berger, MD, PhD as its new Chief Medical Officer, effective January 2, 2025. Dr. Berger, who succeeds Merdad Parsey, MD, PhD, will oversee the company's global Development and Medical Affairs organizations, managing their virology, oncology, and inflammation portfolio.

Dr. Berger joins from Sanofi, where he served as Chief Medical Officer and Global Head of Development. With over 25 years of experience, he brings extensive expertise in developing innovative medicines across multiple therapeutic areas. His track record includes successful global filings for various cancer treatments and transformative products in immunology, hematology, and infectious diseases.

Kite, a Gilead Company, announced positive five-year follow-up results from the ZUMA-5 Phase 2 study of Yescarta in patients with relapsed/refractory non-Hodgkin lymphomas. After a median follow-up of 64.6 months, the treatment showed:

- 90% overall response rate with 75% complete response
- Median progression-free survival of 62.2 months
- Median duration of response of 60.4 months
- 55% of patients alive without needing new anticancer therapy
- 69% estimated overall survival at 60 months

The study demonstrated durable response and long-term survival potential, with no new safety signals emerging in the five-year analysis. The results suggest potential curative effects for these typically difficult-to-treat blood cancers.

Kite, a Gilead company, presented compelling long-term data for Tecartus® (brexucabtagene autoleucel) at ASH 2024. Key findings include:

- 91% overall response rate and 73% complete response rate in BTKi-naïve R/R MCL patients

- 39% five-year survival rate in R/R MCL patients, making it the only CAR T therapy with such long-term data

- In ZUMA-2 cohort 3 (BTKi-naïve patients), 12-month rates showed 80% duration of response, 75% progression-free survival, and 90% overall survival

Real-world evidence in R/R B-ALL patients showed 80% complete response rate with consistent safety profile across a broader patient population than the ZUMA-3 study.

Kite, a Gilead company, presented three new analyses for Yescarta (axicabtagene ciloleucel) at the ASH Annual Meeting, demonstrating improved outcomes for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL). The largest real-world evidence analysis showed a 71% overall survival rate in second-line treatment, consistent with the ZUMA-7 study results.

Key findings include a decreasing trend in cytokine release syndrome and related adverse events in third-line plus settings during 2017-2023, and stable long-term quality of life outcomes from the ALYCANTE study. The real-world analysis of 446 patients from 89 U.S. centers demonstrated a 79% overall response rate with a 64% complete response rate.

Gilead Sciences (GILD) and Tubulis have entered into an exclusive option and license agreement to develop an antibody-drug conjugate (ADC) for solid tumors. The collaboration leverages Tubulis' Tubutecan and Alco5 platforms to create a Topoisomerase I inhibitor-based ADC candidate. Gilead will pay $20 million upfront and a potential $30 million option exercise fee. Additional development and commercialization milestones could reach $415 million, plus mid-single to low double-digit royalties. Tubulis will lead early-stage R&D, while Gilead will handle development and commercialization if they exercise their option.

Gilead Sciences announced the publication of its Phase 3 PURPOSE 2 trial results in The New England Journal of Medicine, evaluating twice-yearly lenacapavir for HIV prevention. The study demonstrated 96% reduction in HIV infections compared to background incidence, with only two cases among 2,179 participants. The treatment proved superior to once-daily Truvada and was well-tolerated with no significant safety concerns.

These results align with the previous PURPOSE 1 trial, which showed 100% efficacy in cisgender women in sub-Saharan Africa. Gilead plans to begin global regulatory filings for lenacapavir for PrEP by the end of 2024, implementing an access strategy developed with input from over 100 global health advocates.