Gilead Sciences (NASDAQ:GILD) shares surged 8% Thursday after the company announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial.
The company said the data indicates that its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in women.
PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada, Gilead said. They added that based on these results, the independent Data Monitoring Committee (DMC) recommended Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.
"With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” said Merdad Parsey, Chief Medical Officer, Gilead Sciences.
Following the news, analysts at Baird said they think lenacapavir's complete, 100% prevention of HIV infection during the 5,300-patient PURPOSE 1 study is an "impressive result and reflects the potential to become widely adopted as the PrEP treatment of choice, should it be approved."
"This should be supported by the Q6M dosing, which we view as improving the compliance concerns with QD orals," added the firm in a note. "This could be a sentiment booster to a stock that has otherwise seen sentiment sour over the last few years."