FOSTER CITY, November 7, 2024 – Gilead Sciences’ (GILD.O) breast cancer drug Trodelvy failed to meet the primary endpoint in a Phase 3 trial, sending shares down 3.3% in extended trading 1. The setback raises questions about the drug’s commercial potential in an expanded patient population.
Key Takeaways
- Trodelvy missed primary survival goal in ASCENT-07 study
- Early survival trend favored treatment group despite failure
- Shares declined 3.3% in after-hours trading
Market Reaction & Context
Gilead’s stock dropped following the announcement, reflecting investor disappointment over the latest clinical setback for Trodelvy. The biotech sector has seen mixed results this year, with oncology drugs facing heightened regulatory scrutiny and competitive pressures 2.
This marks another stumble for Trodelvy, which previously failed to meet primary endpoints in other late-stage studies. In January 2024, the EVOKE-01 study also missed its overall survival target 7.
Trial Details
The ASCENT-07 study evaluated Trodelvy (sacituzumab govitecan-hziy) in a global, randomized Phase 3 trial examining efficacy and safety 3. While the primary goal was not achieved, Gilead noted an early trend favoring overall survival in patients treated with Trodelvy compared to the control group 2.
The antibody-drug conjugate targets Trop-2, a protein overexpressed in various cancers. Trodelvy is already approved for certain breast cancer patients, but the company sought to expand its use to additional patient populations.
Company Response
Despite the setback, Gilead emphasized positive signals in the data. The company has not provided detailed commentary on next steps for the program, but analysts expect management to focus on existing approved indications where Trodelvy has shown efficacy.
Gilead previously celebrated success with ASCENT-03, which met its primary endpoint with statistically significant results 6. The mixed trial outcomes highlight the challenges of expanding successful drugs to broader patient groups.
Investment Implications
The failure adds pressure on Gilead’s oncology pipeline and could impact revenue projections for Trodelvy. Investors will likely scrutinize upcoming earnings guidance and management commentary on the drug’s commercial trajectory.
Trodelvy remains a prized asset despite recent setbacks, with analysts noting its potential in approved indications 8. The drug generated significant revenue growth in existing markets, though expansion plans now face uncertainty.
Not investment advice. For informational purposes only.
References
1“Gilead’s breast cancer drug fails to meet main goal of late-stage study” (November 7, 2025). Reuters. Retrieved November 7, 2025.
2“Gilead’s breast cancer drug Trodelvy fails to meet primary endpoint” (November 7, 2025). Investing.com. Retrieved November 7, 2025.
3“Gilead Provides Update on Phase 3 ASCENT-07 Study” (November 6, 2025). Morningstar. Retrieved November 7, 2025.
4“Gilead’s breast cancer drug fails to meet main goal of late-stage study” (November 7, 2025). MarketScreener. Retrieved November 7, 2025.
5“Gilead’s Trodelvy fails to meet main goal in late-stage cancer study” (May 31, 2024). PM360. Retrieved November 7, 2025.
6“Gilead and Kite Reinforce Bold Commitment to Transform Cancer Care” (October 13, 2025). Kite Pharma. Retrieved November 7, 2025.
7“Trodelvy: Breast Cancer Breakthrough & Beyond (Trop-2 ADC)” (May 28, 2025). BiochemPEG. Retrieved November 7, 2025.
8“Gilead’s Trodelvy Stumbles in Late-Stage Trials But Remains Prized” (June 28, 2024). BioSpace. Retrieved November 7, 2025.