Gilead has agreed to acquire CymaBay, a Newark, California-based clinical-stage  bio/pharmaceutical company, for $4.3 billion.  

CymaBay’s lead candidate is seladelpar, an oral drug for treating primary biliary cholangitis (PBC), a rare, chronic, cholestatic liver disease. The drug was granted priority review by the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act target action date of August 14, 2024. Seladelpar also received FDA breakthrough therapy designation for treating PBC, including pruritus (itching) in patients without cirrhosis or with compensated cirrhosis. The drug also received PRIME status from the European Medicines Agency (EMA), a process by which EMA facilitates regulatory review for those drugs meeting unmet medical need, as well as orphan drug designation in the US and Europe for treating PBC. 

Under the agreement, a wholly owned subsidiary of Gilead will commence a tender offer to acquire all of the outstanding shares of CymaBay’s common stock at a price of $32.50 per share in cash. Following successful completion of the tender offer, Gilead will acquire all remaining shares not tendered in the offer through a second-step merger at the same price as in the tender offer. Consummation of the tender offer is subject to a minimum tender of at least a majority of then-outstanding CymaBay shares, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and other customary conditions. 

The transaction was approved by both the Gilead and CymaBay Boards of Directors and is anticipated to close during the first quarter of 2024, subject to regulatory approvals and other customary closing conditions. 

Source: Gilead Sciences