Gilead Sciences (GILD) experienced a significant surge of over 8% in intraday trading on Thursday following the announcement of promising results from a Phase 3 trial of its injectable drug lenacapavir. The biotech firm revealed that the trial demonstrated lenacapavir to be 100% effective in preventing HIV infection among women.
The success of the trial prompted the independent Data Monitoring Committee (DMC) to recommend ending the blind phase of the study early and offering lenacapavir to all participants. This recommendation underscores the robustness of the trial results.
Key Findings:
The Phase 3 trial enrolled 2,134 women, none of whom contracted HIV while receiving lenacapavir. In contrast, cases of HIV infection were reported among participants who took Gilead’s current HIV pills, Truvada and Descovy.
Truvada, the first FDA-approved pre-exposure prophylaxis (PrEP) treatment, and Descovy are currently used for HIV prevention.
Next Steps:
Despite the encouraging results in women, Gilead indicated that additional Phase 3 testing is required. The next trial will involve testing lenacapavir in men who have sex with men and other groups. The company anticipates obtaining these results by late 2024 or early 2025.
Following completion of the necessary trials, Gilead plans to seek FDA approval for lenacapavir as a new option for HIV prevention.
Dr. Linda-Gail Bekker, an expert in HIV research, commented on the potential impact of lenacapavir, stating it “could provide a critical new choice for HIV prevention that fits into the lives of many people who could benefit from PrEP around the world.”
Market Reaction:
Gilead’s stock surged to $68.31 per share as of 3 p.m. ET on Thursday, reflecting investor optimism in response to the promising trial results.
Despite the day’s gains, Gilead Sciences has seen its shares decline approximately 16% since the beginning of the year, indicating ongoing challenges in the broader market context.
The positive outcome of the Phase 3 trial positions lenacapavir as a potentially transformative advancement in HIV prevention, pending further regulatory approvals and market adoption.
