HQ Team
February 13, 2024: Gilead Sciences is buying CymaBay Therapeutics for $4.3 billion, to access its portfolio of drugs for liver and some other chronic diseases.
The treatment, seladelpar, is an oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist indicated to treat primary biliary cholangitis (PBC) including pruritus. It is under FDA review and could win approval this summer.
Seladelpar showed positive results in Phase III RESPONSE trial.
“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,” Sujal Shah, CymaBay’s president and CEO, said in a statement.
Also, the FDA has completed its filing review and accepted a new drug application for seladelpar, granting it priority review, and set a Prescription Drug User Fee Act (PDUFA) target action date of August 14.
Seladelpar previously received the FDA’s Breakthrough Therapy Designation, the European Medicines Agency (EMA)’s PRIME status, and the orphan drug designations of both regulatory agencies.
Market forces predict a bright future for seladelpar with estimated sales of $1.9 billion by 2029. It is a step in the right direction with the drug on the cusp of all regulatory approvals and in synergy with Gilead’s existing pipeline of liver solutions. The Pharma company has access to 80% of the PBC prescribers, according to analysts.
CymaBay status
The news has pushed the shares of CymaBay by 25% in early trading on the Nasdaq Global Select Market,
This acquisition is a great win for Cymabay as it suffered a setback in 2019 when the company stopped clinical development of the drug in both PBC and non-alcoholic steatohepatitis (NASH)—now known as metabolic dysfunction-associated steatohepatitis or MASH. The phase 11b trial showed atypical histological findings in some 30% of patients and the FDA halted the trial. The ban was lifted in 2020 when a review showed that the patients showing the aberrations in histologies were already suffering from the disease before they enrolled in the trial
Competition
Seladelpar will compete with Ocaliva® (obeticholic acid), developed by Intercept Pharmaceuticals, which won FDA approval for the drug in 2016. Oclavia is also indicated for PBC.
Intercept was acquired by Italian drug developer Alfasigma for $794 million in November 2023.
Seladelpar will complement Gilead’s existing portfolio of liver drugs, which includes Epclusa, Viread, Harvoni and Vemlidy.
Gilead commands a liver drug market share of more than 60% in the U.S. and over 50% in Europe, according to its latest earnings reports,
