AlphaSigma’s buzzer-beater bet on GSK’s prospects for rare liver diseases has paid off. Last week, the FDA issued its approval days ahead of schedule after signing a deal worth up to $690 million to acquire worldwide rights to the drug.
The drug, approved under the name Lynavoy, is an ileal bile acid transporter inhibitor designed to alleviate multiple factors of chronic itch. With this approval, the medicine is in a position to offer treatment to the 89% of patients with primary biliary cholangitis (PBC) who experience cholestatic pruritus, an often debilitating itchy condition.
The FDA approved the drug days ahead of its March 24 decision target date, based on GSK’s Phase 3 Glisten study, which showed Linavoy significantly improved itch symptoms compared to a placebo over 24 weeks.
Although Linavoy was delivered to AlphaSigma on March 9, Kaivan Kavandi, MD, GSK’s head of research and development for respiratory, immunology and inflammation, said in a company release that the agreement remains a landmark moment for GSK as it is “the first liver drug from our pipeline to receive approval.”
While GSK was “proud of the role” it played in the drug’s discovery and development, the British pharmaceutical giant ultimately landed on AlphaSigma as “the right partner to take this drug forward” based on the Italian drugmaker’s experience in the PBC field, GSK’s chief scientific officer Dr. Tony Wood explained at the time.
The deal gave GSK an upfront payment of $300 million and an additional $100 million subject to FDA approval. The company also expects to receive $20 million related to foreign regulatory approvals, plus up to $270 million in sales-based milestone payments and tiered double-digit royalties on worldwide net sales.
The deal has not yet been completed and AlphaSigma is still “working closely with GSK,” it said in a release Thursday.
CEO Francesco Balestrieri said of the deal that AlphaSigma believes it is “uniquely positioned” to lead the global commercialization of Linavoi, given its “deep hepatology expertise and strong global footprint.”
The company’s PBC experience stems from its $800 million acquisition of Intercept Pharmaceuticals in 2023, which came after years of struggle between Intercept and its PBC drug Ocaliva. After winning early approval for the treatment in 2016, Intercept’s attempts to grow the drug with full approval and expansion into steatohepatitis associated with metabolic dysfunction have repeatedly failed.
The drug disappeared completely last year when Intercept acquiesced to FDA requests to pull Ocaliva from the market due to continued safety concerns.
Approximately six months later, Aflasigma returns to the PBC space through Lynavoy. With Ocaliva out of the competition, the drug enters a crowded market with Ipsen’s Ikirubo and Gilead Sciences’ Libdelge, both of which are expected to hit the market in 2024.
Both companies have recently benefited from headroom in the PBC space, with Gilead reporting increased demand due to Ocaliva withdrawal and Ipsen touting increased momentum due to Ocaliva patient switching. Mr. Ikirubo earned 77 million euros ($88.6 million) in the fourth quarter of 2025, while Mr. Livderj received $150 million.
Meanwhile, Linavoi is poised to corner another core group of PBC patients with its cholestatic pruritus-specific label. The condition can occur at any stage of liver disease and “has been underdiagnosed and ignored for far too long, despite its profound impact on people living with PBC,” Carol Roberts, president of the PBCers Organization, said in a GSK release.
