Obeticholic acid

A phase 3 study of Gilead’s Livdelzi has met its primary endpoint, showing that use of the oral treatment can help normalize a key marker of disease progression for those with the primary biliary cholangitis. A phase 3 study of Gilead’s Livdelzi has met its primary endpoint, showing the drug's ability to normalize a key marker of disease progression for those with the rare liver disorder primary biliary cholangitis (PBC). In the IDEAL trial, which compared Livdelzi to placebo, Gilead’s pill allowed significantly more patients to gain control of their alkaline phosphatase (ALP) levels, which are a key signal of disease progression. The trial's primary endpoint hinged on the number of patients who achieved ALP levels in the normal range with at least a 15% decrease from baseline, the company said Tuesday. The trial included 96 participants ages 18 to 75 who had inadequately controlled PBC. Patients in this group are associated with increased risk of progression to liver transplant or death compared with patients at normalized ALP levels, Gilead explained.The patient pool in the trial included only those with an incomplete response or intolerance to ursodeoxycholic acid (UDCA), the standard first-line treatment for PBC. UDCA treatments replace bile acids, slowing disease progression and improving liver function. “These results extend the evidence base for Livdelzi to a broader population of people living with PBC and support ALP normalization as an achievable therapeutic goal in patients with ALP between 1 to 1.67,” Cynthia Levy, M.D., of the University of Miami Miller School of Medicine, said in a release. Gilead said it will provide full results from the trial at a future medical meeting and engage with global regulators on the data.  Livdelzi gained accelerated approval from the FDA in August of 2024 as a second-line treatment for PBC. The company picked up the drug, also known as seladelpar, in early 2024 when it acquired CymaBay Therapeutics for $4.3 billion. Gilead reported sales of Livdelzi at $133 million in the first quarter of this year, up from $40 million over the same period in 2025. In second-line PBC, Gilead is competing with Ipsen and Genfit’s Iqirvo, which was also approved in 2024 and generated sales of 79 million euros ($93 million) in the first quarter.Last year, Intercept pulled its PBC drug Ocaliva from the market after failing to gain a traditional FDA approval, following receipt of an accelerated nod in 2016.

The California-based drugmaker expects its HIV sales to rise 8% in 2026. When Gilead Sciences rolled out its first sales projections for twice-yearly pre-exposure prophylaxis (PrEP) med Yeztugo (lenacapivir) at the start of this year, analysts dubbed the company’s $800 million outlook “probably” conservative and “quite doable.”Now, after gaining greater clarity on Yeztugo’s launch dynamics over the past few months, the company has edited its forecast to stand behind the billion-dollar opportunity that the drug holds in 2026. Over the first quarter, the long-acting injectable locked down $166 million in sales, an “unprecedented launch trajectory” that is so far “exceeding our expectations,” chief commercial officer Johanna Mercier laid out on the company’s first-quarter earnings conference call. In its first full year on the market, Gilead now expects $1 billion to come from the drug, while the next few years should see a “steady and durable build in sales” as the company looks to broaden adoption across the full slate of those who need HIV prevention options.  Within the long-acting injectable market, Yeztugo’s main competition is with GSK’s Apretude, an every-two-month injection that launched years before Yeztugo hit the scene. Already, Yeztugo and its longer protection period is taking away market share from the GSK offering. Other than those who switch from Apretude, PrEP users are also switching from generics of Gilead’s Truvada and its older PrEP Descovy, Mercier explained on the call. While Yeztugo’s largest market currently comes from those switching from other PrEP options, Gilead is seeing “growing momentum in” in the drug among those who are naïve to PrEP, the company said in its presentation (PDF). As Mercier explains, there remains a “high unmet need” for PrEP in several areas of the country, such as the rural south, where Gilead sees “more of the naïve prescriptions” emerging thus far. One way to reach these potential PrEP users is through its direct-to-consumer campaign for Yeztugo, which launched in late February. The marketing has pushed brand awareness and visibility on the upswing, Mercier said, and also helps remind people to come back for their second dose of the twice-yearly injectable. At some 11 months since Gilead first launched the PrEP, it’s now time for many who have already received their first dose of Yeztugo to come in for their second yearly shot. So far, Gilead has reason to expect persistency levels for Yeztugo to “keep growing” over time and result in the highest in the overall HIV market, Mercier said. As it stands, the company is seeing “really good come-back” for the second dose within a certain time frame, which the company considers “really positive and encouraging.” “What we're seeing in early days is definitely much stronger than what the current competition is seeing in the marketplace,” Mercier said, referring to persistency levels. The “really strong” U.S. PrEP market growth of 14% is helping out Descovy as well, Mercier said. Gilead’s own U.S. PrEP business specifically climbed 87% from the same period last year, while Descovy enjoyed a 38% year-over-year sales climb to $807 million. With its PrEP and HIV treatment products combined, the company’s HIV portfolio collected a total of $5 billion over the first quarter, a 10% increase from 2025’s first quarter. Leading HIV treatment Biktarvy took home $3.4 billion in 7% growth of its own.  Upcoming HIV treatment offeringsBiktarvy currently holds on to 52% of the U.S. HIV treatment market, but the first of many lenacapivir combinations Gilead hopes to soon commercialize is looking to corner a specific subset of the treatment market after its August FDA target decision date in people with virally suppressed HIV.  The combo prospect is a single-tablet pairing of capsid inhibitor lenacapivir and bictegravir, one of the three ingredients in Biktarvy. With bic/len, the company looks to offer a simpler option for the 5% to 6% of people with HIV who take multiple pills a day with complex treatment regimens to manage the virus.Importantly, Gilead sees the bic/len combo as a way to get in on the treatment switch market, which is made up of 20% of people with HIV who switch treatments yearly. This switching pattern is based largely on the “innovative life cycle” of HIV treatments, Mercier explained.  While the company expects Biktarvy to hold onto its standard-of-care status until its mid-2030’s patent cliff, bic/len marks a chance to “play in that switch market, which we haven’t had in the past,” as people with HIV could, in theory, switch from Biktarvy to the new combo “if they’re going to switch anyway,” the executive said.Gilead forecasts 8% growth in its HIV business during 2026, while its total product sales are expected to land between $30 billion and $30.4 billion. Over the first quarter, full revenues rose 4% to $7 billion compared to last year’s first quarter.  Liver disease gains, cell therapy woes Aside from Yeztugo and its HIV gains, another growing highlight of Gilead’s product portfolio is primary biliary cholangitis (PBC) med Livdelzi. After launching in 2024, quarterly sales jumped 230% year-over-year to $133 million over 2026’s first quarter, with a sequential decline of 11% attributed to a “switch bolus” over the fourth quarter of 2025, when the drug’s once main rival in Intercept’s Ocaliva was pulled from the market.Meanwhile, a 12% year-over-year decline in Gilead’s cell therapy portfolio of Yescarta and Tecartus were again attributed to “continued competitive headwinds” across regions. Although breast cancer med Trodelvy and its $402 million quarterly haul has long shouldered the bulk of Gilead’s oncology-derived revenues, other potential oncology standouts are on the way. Outside of late-stage multiple myeloma CAR-T prospect anito-cel, which the company has full control of after buying out its partner Arcellx for $7.8 billion earlier this year, Gilead’s April acquisition of Germany-based Tubulis marked a $3.15 billion play for a promising antibody-drug conjugate (ADC) candidate in development for ovarian cancer and lung cancer. The ovarian cancer opportunity alone can justify the transaction price, Chief Financial Officer Andrew Dickinson commented.