NEW YORK, March 19, 2026, 16:28 EDT
GSK shares trading in the U.S. edged up 0.6% to $52.39 as of 3:59 p.m. EDT on Thursday. The move followed news that the FDA cleared Lynavoy, the company’s new treatment for severe itching in patients with primary biliary cholangitis, or PBC—a rare autoimmune liver disorder.
GSK gets the green light at a crucial time. With patent cliffs approaching for its top HIV drugs, new CEO Luke Miels is under pressure to prove the company can bring fresh therapies to market. Lynavoy’s approval marks the first liver treatment from GSK’s pipeline to clear regulators, the company said.
Moving fast, Alfasigma is putting $300 million on the table upfront for global rights to linerixibat, according to Reuters. The deal outlined another $100 million if U.S. regulators sign off by March 24, plus additional milestone payouts and double-digit royalties once sales come in.
PBC is a chronic illness where the immune system targets the liver’s small bile ducts. Lynavoy, an IBAT inhibitor taken orally, disrupts bile-acid recycling in the gut. GSK says it’s the first drug cleared in the U.S. for treating cholestatic pruritus—the severe itching linked to the disease.
GSK reports that as many as 89% of people with PBC suffer from the symptom, affecting both sleep and quality of life. Kaivan Khavandi, a senior executive at GSK, described Lynavoy as a “much needed treatment option.” UC Davis’s Christopher Bowlus called the FDA approval an “important opportunity” for patients. GSK
The field is tighter than it appears. According to Reuters, Gilead’s Livdelzi and Ipsen’s Iqirvo treat PBC but skip the itch itself, whereas Mirum Pharmaceuticals’ volixibat is in the works for pruritus tied to PBC.
Shares barely budged—GSK ticked up just 0.6% late in the session, despite the approval. This follows a streak of regulatory successes for the company, including last week’s FDA move that cleared GSK’s RSV vaccine Arexvy for higher-risk adults aged 18 to 49.
Plenty of unknowns persist. Neither GSK nor Alfasigma has shared details on Lynavoy’s launch price or when it will hit the market, according to Reuters. Drug costs remain in the political spotlight; a Reuters analysis this week showed several GSK inhalers listed on TrumpRx were selling for 67% to 82% less in the UK.
Back in February, Miels told Reuters GSK had to “accelerate” its pipeline and pursue smart deals to build out its portfolio. Quilter Cheviot’s Sheena Berry described his early moves as a “steady and credible start.” Thursday’s approval backs up that argument, but for GSK to hit its target of 40 billion pounds-plus in yearly sales by 2031, investors are still looking for bigger launches. Reuters
