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Gilead Sciences Inc (NASDAQ:GILD) agreed to acquire CymaBay Therapeutics Inc (NASDAQ:CBAY) for $32.50 per share in cash or a total equity value of $4.3 billion.
The addition of CymaBay’s investigational lead product candidate, seladelpar for primary biliary cholangitis (PBC) including pruritus, complements Gilead’s existing liver portfolio.
“We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases,” said Gilead’s Chairman and CEO, Daniel O’Day.
Related Content: Investors Eye CymaBay’s AFFIRM Study As Regulatory Uncertainties Ease.
PBC is a rare, chronic, cholestatic liver disease mainly affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the U.S.) that impairs liver function.
PBC’s most common early symptoms are pruritus (itching) and fatigue.
Seladelpar is an investigational, oral, selective peroxisome proliferator-activated receptor delta agonist shown to regulate critical metabolic and liver disease pathways.
The FDA has completed its filing review, 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.
In the pivotal Phase 3 RESPONSE trial, seladelpar 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 (25.0% vs. 0.0%) and statistically significant improvement in pruritus at six months among people living with a moderate-to-severe itch that was sustained through 12 months.
The transaction is anticipated to close during the first quarter of 2024.
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 EPS in 2025 and significantly accretive after that.
Price Action: GILD shares are down 0.16% at $73.55, and CBAY shares are up 24.2% at $31.90 during the premarket session on the last check Monday.
