Seeking to rejuvenate itself after recent disappointments, Gilead Sciences Inc. proposes to bolster its liver portfolio by taking over Cymabay Therapeutics Inc. for $32.50 per share in cash, a total equity value of $4.3 billion. The arrangement brings aboard seladelpar for second-line primary biliary cholangitis (PBC) including pruritis (itch), which is under priority review by the U.S. FDA, with a decision due this year.
Positive phase III data from Cymabay Therapeutics Inc. with seladelpar, the peroxisome proliferator-activated receptor for primary biliary cholangitis (PBC), could mean trouble for Intercept Pharmaceuticals Inc.’s second-line therapy, the farnesoid X receptor agonist Ocaliva (obeticholic acid), which Cymabay aims to replace with its compound as the preferred choice.
Shares of Cymabay Therapeutics Inc. (NASAQ:CBAY) shot 37% higher on Monday after top-line data showed 78.2% of people with primary biliary cholangitis (PBC) in the company's disrupted phase III test of seladelpar achieved the primary composite outcome after just three months on a 10-mg dose of the drug vs. 12.5% in the trial’s placebo arm.
The FDA has lifted all the clinical holds it placed on seladelpar from Cymabay Therapeutics Inc. for INDs in nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC) and primary sclerosing cholangitis, giving the company new hope.
Two companies developing nonalcoholic steatohepatitis (NASH) therapies found themselves at opposite ends of the spectrum Tuesday, with Cymabay Therapeutics Inc. potentially getting a second chance while the door slammed on Genfit SA’s hopes.
Due to the “dynamic nature of the situation,” officials of Cymabay Therapeutics Inc. declined to comment on the stoppage of work with PPAR-delta agonist seladelpar, but in a press release they pointed to “a series of investigative actions [that have begun in order] to better understand these findings.”