declared its $4.3bn acquisition of the liver disease company , thereby gaining CymaBay鈥檚 lead candidate seladelpar, a treatment for PBC, including pruritus.
Following the 12 February announcement, CymaBay鈥檚 stocks soared by more than 25% while Gilead, whose market cap is $94.2bn, also saw a stock price increase of 1.1%.
The companies plan to close the deal during the first quarter of 2024. After closing the deal, Gilead will claim all remaining shares not tendered, in a second-step merger at the same price as in the tender offer. Furthermore, if the US Food and Drug Administration (FDA) approves seladelpar, Gilead predicts that the transaction will become approximately neutral to earnings per share in 2025 and will continue growing the company鈥檚 revenue thereafter.
PBC is an autoimmune disorder that causes the bile ducts to become inflamed and slowly deteriorate. If approved, it will become the second treatment available to patients with PBC, after the FDA granted Intercept approval for Ocaliva (obeticholic acid), in 2016. Since the approval, Alfasigma has gained ownership of the therapy through a November 2023 acquisition.
Seladelpar is an oral, selective peroxisome proliferator-activated receptor delta (PPAR未) agonist that regulates the genes involved in lipid storage and transport. Ocaliva, an oral farnesoid X receptor (FXR) agonist, acts by repairing the regulation of cholesterol and bile acid homeostasis, preventing fibrosis.
Alongside the deal news, CymaBay announced that the FDA had accepted its new drug application (NDA) for seladelpar, giving it a priority review. The therapy鈥檚 Prescription Drug User Fee Act (PDUFA) date has been set to 14 August 2024, with no plans to hold an advisory committee for the approval decision. The NDA takes into account data from the Phase III RESPONSE (NCT04620733) and studies, the ASSURE study (NCT03301506), and previous Phase II studies.
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By GlobalDataThe deal follows a successful financial year for Gilead in 2023. Last year, the California-based company achieved a 22.9% increase in net income, reaching $5.61bn in net income compared to $4.56bn in 2022. Despite a 1% reduction in the company鈥檚 total sales, falling to $27.11bn, the pharma giant maintained growth through a reduction in intellectual property and research and development impairment expenses among other things.
CymaBay鈥檚 seladelpar programme will now join Gilead鈥檚 pipeline, consisting of 55 clinical programs. This includes 14 Phase I studies, 26 Phase II studies, 13 Phase III studies, and two registrational trials. Seladelpar is Gilead鈥檚 first clinical asset in development for PBC.
