Through the acquisition, Gilead will add Seladelpar, an investigational, oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist intended for the treatment of primary biliary cholangitis (PBC), to its portfolio

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CymaBay is focused on liver and other chronic diseases. (Credit: Towfiqu barbhuiya on Unsplash)

Gilead Sciences has agreed to acquire CymaBay Therapeutics, a clinical-stage biopharmaceutical company focused on liver and other chronic diseases, for a total of $4.3bn.

Under the terms of the agreement, a subsidiary of Gilead will acquire all the outstanding shares of CymaBay’s common stock at $32.50 per share in cash.

After the successful completion of the tender offer, the US drugmaker will acquire all remaining shares not tendered in the offer through a second-step merger at the same price.

The transaction has been approved by the Boards of Directors of both Gilead and CymaBay.

It is expected to be completed during the first quarter of this year, subject to regulatory approvals and other customary closing conditions.

Gilead Sciences chairman and CEO Daniel O’Day said: “We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases.

“Building on the strong research and development work by the CymaBay team to date, we have the potential to address a significant unmet need for people living with PBC and expand on our existing broad range of transformational therapies.”

The acquisition will add CymaBay’s lead candidate Seladelpar to Gilead’s portfolio.

Seladelpar is an investigational, oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, shown to regulate critical metabolic and liver disease pathways.

The drug is indicated for the treatment of primary biliary cholangitis (PBC), a rare, chronic, cholestatic liver disease that primarily affects women.

The most common early symptoms of PBC include pruritus (itching) and fatigue, and the progression of PBC is linked to an increased risk of liver-related mortality.

Seladelpar received the US FDA Breakthrough Therapy Designation for the treatment of PBC, along with Orphan Drug Designation in the US and Europe.

The US FDA accepted a New Drug Application for Seladelpar and granted priority review with a Prescription Drug User Fee Act target action date of August 14, 2024.

Upon FDA approval, the proposed transaction is expected to enhance Gilead’s revenue growth, and the investigational drug will complement Gilead’s existing liver portfolio.

BofA Securities and Guggenheim Securities served as financial advisors to Gilead, and Centerview Partners and Lazard served as financial advisors to CymaBay on this transaction.

CymaBay Therapeutics president and CEO Sujal Shah said: “Today’s agreement with Gilead is the culmination of years of focus and determination at CymaBay to advance seladelpar and bring new hope to people living with PBC and their families.

“Now that seladelpar has achieved priority review with the FDA, we are excited that Gilead, with its long-standing commitment to patients with liver disease, can apply its regulatory and commercial expertise to bring seladelpar as quickly as possible to people with PBC.”