Gilead Sciences Inc Stock Price, News & Analysis

Gilead Sciences (GILD) has achieved a major breakthrough with FDA approval of Yeztugo (lenacapavir), the first and only twice-yearly injectable HIV prevention option. The drug demonstrated exceptional efficacy in Phase 3 trials, with ≥99.9% of participants remaining HIV negative. PURPOSE 1 trial showed zero HIV infections among 2,134 participants, while PURPOSE 2 had only two infections among 2,179 participants. The approval addresses significant gaps in PrEP adoption, as CDC data shows only 36% of eligible individuals currently use PrEP. Gilead is implementing broad access strategies, including assistance programs for both insured and uninsured patients. The drug has received Priority Review and Breakthrough Therapy Designation, with regulatory filings underway globally. This innovation represents a significant advancement in HIV prevention, potentially transforming treatment adherence and reducing stigma-related barriers.

Kite, a Gilead company, presented real-world data at ASCO 2025 demonstrating comparable safety and effectiveness of Yescarta (axicabtagene ciloleucel) in outpatient versus inpatient settings for relapsed/refractory large B-cell lymphoma patients. The analysis, based on CIBMTR registry data from 75 treatment centers comparing 119 outpatients to 119 inpatients, showed no significant differences in adverse events between groups. Notably, 25% of outpatients didn't require hospital admission within 30 days, and 50% avoided admission within 3 days. The study included patients with median age 63 years, 66% male, with 67% having ≥1 comorbidity. These findings suggest potential cost-effective advantages and reduced hospital burden through outpatient administration, marking a significant advancement in CAR-T cell therapy delivery.

Gilead Sciences announced that Trodelvy plus Keytruda demonstrated superior results in treating first-line PD-L1+ metastatic triple-negative breast cancer (TNBC), reducing disease progression or death risk by 35% compared to standard Keytruda plus chemotherapy. The Phase 3 ASCENT-04 trial showed median progression-free survival of 11.2 months with Trodelvy/Keytruda versus 7.8 months with Keytruda/chemotherapy. The combination achieved a 60% response rate versus 53% for standard care, with longer duration of response (16.5 vs 9.2 months). Early positive trends in overall survival were observed, though data remains immature. The safety profile was consistent with known profiles, with fewer treatment discontinuations in the Trodelvy/Keytruda arm (12% vs 31%). This breakthrough could potentially establish a new frontline standard of care for this aggressive breast cancer type.

Gilead Sciences (GILD) announced positive topline results from Phase 3 ASCENT-03 study of Trodelvy® in first-line metastatic triple-negative breast cancer (mTNBC). The study met its primary endpoint, showing highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients who are not candidates for PD-1/PD-L1 inhibitors. Combined with positive ASCENT-04 study results, Trodelvy has potential to become the backbone treatment for all first-line mTNBC patients. The safety profile was consistent with prior studies, with no new safety signals identified. Overall survival data was not mature at time of analysis, but no detriment was observed. Trodelvy is currently the only antibody-drug conjugate with four positive Phase 3 trials in HER2- metastatic breast cancer and has demonstrated meaningful survival advantages in both 2L mTNBC and pre-treated HR+/HER2- mBC.

Gilead Sciences (GILD) and Kite will present over 20 abstracts at the 2025 ASCO Annual Meeting (May 30-June 3) and 2025 EHA Annual Congress (June 12-15). Key highlights include:

1. Late-breaking results from Phase 3 ASCENT-04 study showing significant benefit of Trodelvy® plus Keytruda® in first-line PD-L1+ metastatic triple-negative breast cancer

2. Phase 1 results of a novel CAR T-cell therapy using dual-target approach for recurrent glioblastoma, presented by University of Pennsylvania researchers

3. Updated findings from Phase 2 iMMagine-1 study of anitocabtagene-autoleucel in relapsed/refractory multiple myeloma

The presentations span multiple cancer types including breast cancer, solid tumors (glioblastoma, endometrial cancer, lung cancer, gastric cancer), and blood cancers (multiple myeloma, large B-cell lymphoma, non-Hodgkin lymphoma, acute lymphoblastic leukemia).

Gilead Sciences (NASDAQ: GILD) announced final results from the Phase 3 MYR301 study for bulevirtide in treating chronic hepatitis delta virus (HDV). The study showed that 36% of adults treated with bulevirtide (2 mg or 10 mg) maintained virologic suppression for almost two years after stopping treatment. Notably, 90% of patients who had HDV RNA undetectability for ≥96 weeks at end of treatment remained HDV undetectable off-treatment. The study involved 150 participants, and while post-treatment hepatic serious adverse events were reported in 14% of participants, 85% of these cases were resolved, mostly after restarting bulevirtide. Currently, bulevirtide 2 mg is the only approved treatment for adults with chronic HDV in the EEA, UK, Switzerland, and Australia, while both 2 mg and 10 mg doses remain investigational in the US.

Gilead Sciences (GILD) presented new data at EASL 2025 showcasing the efficacy of Livdelzi® (seladelpar) in treating primary biliary cholangitis (PBC). The interim analysis from the ASSURE study showed that 60% of patients with prior fibrate or obeticholic acid treatment achieved biochemical response. The drug demonstrated consistent efficacy regardless of prior treatment history, with similar safety profiles. Notably, Livdelzi showed significant improvements in pruritus, a debilitating PBC symptom affecting up to 80% of patients. A 3-point improvement in Pruritus NRS was considered meaningful based on patient feedback. The drug recently received conditional marketing authorization in the EU (as Lyvdelzi®), following previous approvals in the US and UK. Livdelzi is positioned as the only once-daily oral treatment showing significant outcomes for both the underlying disease and pruritus in PBC patients.

Gilead Sciences has announced its executive participation in five major healthcare investor conferences scheduled for May and June. The conferences include:

• BofA Securities Health Care Conference - May 13, 11:20 AM PT
• RBC Capital Markets Global Healthcare Conference - May 21, 11:30 AM ET
• Bernstein Annual Strategic Decisions Conference - May 29, 2:30 PM ET
• Jefferies Global Healthcare Conference - June 4, 11:05 AM ET
• Goldman Sachs Annual Global Healthcare Conference - June 10, 11:20 AM ET

All presentations will be available via live webcasts on the company's investor page at investors.gilead.com, with replays accessible for at least 30 days after each event. Gilead, headquartered in Foster City, California, is a biopharmaceutical company focused on developing innovative medicines for HIV, viral hepatitis, COVID-19, and cancer treatments.

Gilead Sciences announced new research presentations at the 2025 European Association for the Study of the Liver (EASL) Congress, showcasing advancements in liver disease treatments. Key highlights include:

• New data on Livdelzi (seladelpar) demonstrating effectiveness in reducing pruritus in primary biliary cholangitis (PBC) patients
• Findings on maintained virologic response with investigational bulevirtide in hepatitis delta virus (HDV) patients
• Initial results from a Phase 1a study of a novel therapeutic vaccine for hepatitis B (HBV)
• Real-world data on hepatitis C (HCV) treatment effectiveness

The company will present 29 abstracts, including two oral presentations on HDV treatment and a late-breaker presentation on the MYR301 Phase 3 study results. Additionally, Gilead will launch "All the Feelings with PBC" campaign with the PBC Foundation, featuring artwork depicting patient experiences.

The presentations reinforce Gilead's commitment to transforming liver disease treatment, particularly in areas of high unmet need.