Key Takeaways
- A Phase 3 trial of Gilead’s injectable drug lenacapavir found it was 100% effective in preventing HIV infection in women.
- Gilead said the test results were so significant an independent monitor recommended the company give the drug to all participants.
- More testing is needed before Gilead can apply to the U.S. Food and Drug Administration for approval.
- Shares of Gilead surged Thursday following the news.
Gilead Sciences (GILD) surged over 8% in intraday trading Thursday as the biotech firm announced a Phase 3 trial found its injectable lenacapavir was 100% effective in preventing HIV infection in women.
Gilead noted that the results were so successful that the independent Data Monitoring Committee (DMC) recommended that the company end the blind phase of the study and offer lenacapavir to all of the participants.
Zero HIV Infections Among Women Who Took Gilead’s Lenacapavir
The trial found zero cases of HIV infection among the 2,134 women who received the treatment, versus several cases among those who took Gilead’s current HIV pills, Truvada and Descovy. Truvada was the first pre-exposure prophylaxis, or PrEP, treatment approved by the Food and Drug Administration (FDA).
More Testing Needed Before Applying for FDA Approval
The company must run another Phase 3 test of lenacapavir in men who have sex with men and other groups before applying for FDA approval. It expects those results late this year or early next year.
Dr. Linda-Gail Bekker, head of the Desmond Tutu HIV Center at the University of Cape Town, South Africa and former president of the International AIDS Society, said lenacapavir “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.”
Gilead shares were 8.2% higher at $68.31 as of 3 p.m. ET Thursday following the news. Despite Thursday’s advance, shares of Gilead Sciences have lost close to 16% of their value this year.
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