Gilead Sciences won Food and Drug Administration approval for a twice-a-year HIV treatment on Thursday, but GILD stock remained muted.
The landmark move creates a new foundation under Gilead's HIV treatment business — a decadeslong venture. Lenacapavir, now known by the brand name Sunlenca, is a subcutaneous shot given every six months.
It was designed to help people whose human immunodeficiency virus isn't well controlled by tailored regimens. Without viral suppression, patients can develop acquired immunodeficiency syndrome, or AIDS, the disease that arises from the HIV infection. In the pivotal study, the addition of Sunlenca suppressed the virus down to undetectable levels for 83% of patients.
"For some of the patients in the studies that's we've done with lenacapavir, they hadn't been virally suppressed for years," Jared Baeten, Gilead's vice president of clinical development, told Investor's Business Daily.
The approval could provide some fodder to stoke GILD stock, which is trading at a six-year high. Shares recently broke out of a saucer base with a buy point at 74.22, according to MarketSmith.com. Now, Gilead stock is well above its buy zone. But on today's stock market, GILD stock ticked up a penny to 85.28.
GILD Stock: The Trick To HIV Treatment
The virus that causes AIDS wants to replicate, so it mutates rapidly to avoid medication. This is why patients receive multiple drugs — often inside one daily pill — to control their infections. But 2% of patients are heavily treated and still don't reach adequate levels of viral suppression.
This puts them "at risk of all the terrible consequences of the disease." It also means that they are at risk of spreading the infection to sexual partners.
Gilead says Sunlenca could provide a step-change for those patients. Based on the way it's designed, it can live in the body for longer. This means patients don't need a daily dose to experience the benefits. That's an attractive option for patients, many of whom still face stigma attached to HIV, Baeten says.
"We've come so far in the past 40 years with HIV, but we have still, unfortunately, so far to go," he said. Patients "tell us that one way to combat that is to figure out long-acting options so people can make a choice about how to live their life, and to have a choice that is discreet."
Sunlenca is already approved in Europe, the U.K. and Canada.
Expanding Sunlenca To Other Patients
Gilead has a long history in HIV treatment, but only recently has GILD stock hit its stride. In the third quarter, sales of its HIV medications grew a collective 7% to $4.5 billion.
Eventually, the company hopes to expand Sunlenca to more patients with HIV. That includes people at risk for contracting HIV. Gilead is well known for its PrEP program. PrEP stands for pre-exposure prophylaxis. It involves using HIV treatments to prevent people contracting the infection.
Gilead already sells several PrEP drugs, including Descovy and Truvada. But both are daily pills. Sales from Descovy ramped 16% in the third quarter, but generics-facing Truvada saw sales tumble 55%. Still, GILD stock surged in the aftermath of its earnings report, largely on the back of strength from its cancer treatments.
Baeten wouldn't give a timeline on when the company will announce the results of Sunlenca in other patient populations.
"We're working very hard to move those studies along as fast as possible," he said.
Those results could also help GILD stock, which already has a strong Relative Strength Rating of 97 out of a best-possible 99. This puts shared in the top 3% of all stocks in terms of 12-month performance, according to IBD Digital.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
