Gilead to Buy CymaBay, Lead Liver Disease Asset Seladelpar for $4.3B
Pictured: Gilead sign and building in Silicon Valley/iStock, Sundry Photography
News of the acquisition comes the same day that CymaBay announced that the FDA accepted its New Drug Application (NDA) for seladelpar for the management of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis who are inadequate responders or intolerant to ursodeoxycholic acid.
The regulator has granted a priority review for the candidate with a PDUFA date of Aug. 14, 2024. CymaBay said the FDA is not currently planning to hold an advisory committee meeting to discuss the application, adding that seladelpar is the only investigational agent to have demonstrated a statistically significant improvement in biochemical markers of disease progression and pre-specified measures of PBC-related pruritus in a Phase III study.
“Building on the solid 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,” Gilead CEO Daniel O’Day said in a statement, as the company looks to expands its liver portfolio.
Mizuho Securities analysts in a Monday note to investors said the deal “makes sense to us as a bolt-on and incremental positive” for Gilead as “another asset in liver disease (notably one of the company’s core strengths and can fold it into its existing liver sales force, and not an oncology deal, which has been a struggle for the company).”
Under a tender offer, Gilead will acquire all of the outstanding shares of CymaBay’s common stock at a price of $32.50 per share in cash, a 27% premium to the compny’s closing share price on Feb. 9. Once the tender offer is completed, Gilead plans to acquire all the remaining shares of CymaBay that were not tendered in the offer through a second step merger at the same price.
CymaBay’s stock price increased over 24% before trading on Monday morning.
“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,” CymaBay CEO Sujal Shah said in a statement. “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.”
If seladelpar is approved by the FDA, the deal is expected to enhance Gilead’s revenue growth with the agreement being estimated to be neutral to earnings per share in 2025, according to the announcement.
Seladelpar is an oral selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, which showed statistical significance in the primary composite endpoints in a Phase III trial. The investigational drug responded in 61.7% of patients versus 20% in the placebo group at the endpoint of biochemical response. For the normalization of alkaline phosphatase at 12 months, a 25% response rate was recorded versus 0% for those on the placebo. A statistically significant improvement was also demonstrated in pruritus at six months among people living with moderate-to-severe itch, which was maintained through 12 months.
The CymaBay acquisition follows Gilead’s deal last month with Arcus Biosciences in which the companies amended their collaboration agreement in an effort to accelerate an anti-TIGIT program. Under the agreement, Gilead made an additional equity investment of $320 million and boosted its ownership stake in Arcus to 33%.