Medical Innovation Exchange

Gilead pays $4.3B for CymaBay, the biotech that never gave up on liver disease med

Gilead is bolstering its liver disease portfolio with the $4.3 billion acquisition of CymaBay Therapeutics, specifically for the primary biliary cholangitis med seladelpar.

The deal follows a Big Pharma trend of picking up late-stage, validated assets. Seladelpar was submitted to the FDA to treat PBC with pruritus, or itching, without cirrhosis or with compensated cirrhosis in December 2023. The rare liver disease primarily affects women over 40 and is characterized by impaired bile flow and the accumulation of bile acids in the liver, causing an elevation of liver enzymes that can be dangerous.

Seladelpar was granted a priority review for the condition with a due date of August 14 for a decision, according to a separate update from CymaBay this morning.

“We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases,” said Gilead CEO Daniel O’Day in a Monday statement. “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.”

This will not be new territory for Gilead, which has a deep portfolio of HIV meds and has also previously tested GS-9674 for PBC. The med, now known as cilofexor, is currently being tested in combination with Novo Nordisk’s semaglutide for metabolic dysfunction-associated steatohepatitis (MASH—previously known as nonalcoholic steatohepatitis or NASH).

Seladelpar improved levels of serum alkaline phosphatase and bilirubin, as well as reduced itch, in a phase 3 trial that read out in September. The data teed up the regulatory filing.

It wasn’t smooth sailing for the med through the clinic, with seladelpar failing in MASH in 2019. But CymaBay pressed on, culminating in today’s deal with Gilead.

“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,” CymaBay CEO Sujal Shah said in a statement.

The deal has been approved by members of each company’s board and is set to close in the first quarter. CymaBay will become a wholly-owned subsidiary of Gilead at close. Gilead is paying $32.50 per share in cash, a 27% premium to CymaBay’s closing price as of February 9.

CymaBay’s shares climbed 24% in pre-market trading Monday to $32 apiece, compared to $25.69 at close Friday. 

https://www.fiercebiotech.com/biotech/gilead-pays-43b-cymabay-biotech-never-gave-liver-disease-med

Leave a Comment

Your email address will not be published. Required fields are marked *

Leave the field below empty!