Proactive Investors - Gilead Sciences Inc (NASDAQ:GILD, ETR:GIS) shares added more than 8% after the pharmaceutical firm unveiled new data from a late-stage PURPOSE trial which showed its twice-yearly injectable HIV therapy lenacapavir is 100% effective in preventing HIV in women.
Notably, lenacapavir was shown to be superior to once-daily oral Truvada, which is one of several medications currently used to treat HIV and to prevent HIV infection, known as pre-exposure prophylaxis (PrEP).
The company added that this is the first Phase 3 HIV prevention study to show zero infections.
The study was stopped early by an independent committee as it exceeded efficacy expectations. The committee also recommended the company stop the blinded phase of the trial and offer 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,” Gilead Sciences chief medical officer Dr Merdad Parsey said in a statement.
“We look forward to additional results from the ongoing PURPOSE clinical program and continuing toward our goal of helping to end the HIV epidemic for everyone, everywhere.”
Analysts at Jefferies noted that it was largely expected the results from this trial would be positive, with the drug showing 100% efficacy at the interim analysis, earlier than the second half of 2024 which had been guided for investors.
“Data from the second Phase 3 is expected by the year-end or early 2025 and they guide to a late 2025 launch,” they noted.
The analysts wrote that, for investors, this is partially a “swap market” with PrEP competitors, which could grow by more complete compliance and pricing factors, such as full revenue and price booked for the six-monthly injection. They noted that pills have a lower compliance of about 75% and as such generate less revenue per patient.
Additionally, they see incremental uptake from patients who do not want to take pills daily but would consider single, infrequent injections.
“Around half the $2.5 billion PrEP market is using branded and half is using generic Truvada. So, a $1.5 billion branded PrEP market could go up by $500 million just from revenues from compliance factors (not skipping pills) and hopefully more if they can get patients to come on who are not currently on drugs,” the analysts wrote.
Shares of Gilead added 8.3% at about $68 on Thursday afternoon.