Gilead Sciences and CymaBay Therapeutics announced a definitive agreement under which Gilead will acquire CymaBay for $32.50 per share in cash or a total equity value of $4.3 billion. Adding CymaBay’s investigational lead product candidate seladelpar for treating primary biliary cholangitis (PBC), including pruritus, complements Gilead’s existing liver portfolio and aligns with its long-standing commitment to bringing transformational medicines to patients.
PBC is a rare, chronic, and cholestatic liver disease mainly affecting women (1 in 1,000 women who are 40+ or about 130,000 total people in the U.S.) that impairs liver func life. And the most common early symptoms of PBC are pruritus (itching) and fatigue, which can be debilitating for some patients. Progression of PBC is associated with an increased risk of liver-related mortality.
Seladelpar is an investigational, oral, and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist shown to regulate critical metabolic and liver disease pathways. And the United States Food and Drug Administration (FDA) has completed its filing review and 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.
Seladelpar received FDA Breakthrough Therapy Designation for the use in the treatment of PBC including pruritus in patients without cirrhosis or with compensated cirrhosis and PRIME status (EMA), and Orphan Drug Designation in the U.S. and Europe for the treatment of patients with PBC.
In the pivotal Phase 3 RESPONSE trial, seladelpar has achieved statistical significance over placebo across primary composite endpoints of biochemical response (61.7% for patients on seladelpar vs 20.0% for placebo), normalization of alkaline phosphatase at 12 months (25% for patients on seladelpar vs 0.0% for placebo) and statistically significant improvement in pruritus at six months among people living with moderate-to-severe itch that was sustained through 12 months.
The deal 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.
Under the terms of the merger agreement entered into in connection with the transaction, a wholly-owned subsidiary of Gilead will commence a tender offer to acquire all of the outstanding shares of CymaBay’s common stock for $32.50 per share in cash, which offer price represents a 27% premium to CymaBay’s closing share price on February 9, 2024.
Following the 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.
Upon FDA approval of seladelpar, the proposed transaction is expected to enhance Gilead’s revenue growth, and it is also expected that the transaction will be approximately neutral to earnings per share in 2025 and significantly accretive after.
The 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, and other customary conditions.
BofA Securities and Guggenheim Securities are acting as financial advisors to Gilead. Centerview Partners LLC and Lazard are acting as CymaBay’s financial advisors.
KEY QUOTES:
“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.”
- Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences
“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.”
- Sujal Shah, President, and CEO at CymaBay Therapeutics
