Gilead’s $4.3B CymaBay Acquisition Provides Liver Illness Drug Beneath FDA Assessment

Gilead Sciences is buying biotech firm CymaBay Therapeutics in a $4.3 billion deal that comes with a drug candidate at present beneath FDA evaluation in a uncommon liver illness with few remedies.

In keeping with deal phrases introduced Monday, Gilead pays $32.50 money for every share of CymaBay. That value is a 27% premium to CymaBay’s closing inventory value on Friday. The acquisition marks a comeback for the corporate and its drug, which only a few years in the past confronted an unsure future amid security questions.

The primary asset of CymaBay is seladelpar, a drug that the Newark, California-based firm has developed for treating major biliary cholangitis (PBC), a uncommon and progressive autoimmune situation that destroys the bile ducts of the liver. However this small molecule was at one time among the many main drug candidates for nonalcoholic steatohepatitis (NASH), a fatty liver illness that has no FDA-approved remedies.

In 2019, a security sign led CymaBay to cease a mid-stage take a look at of seladelpar in NASH in addition to a lately began research in major sclerosing cholangitis, one other persistent liver dysfunction. The FDA subsequently positioned a proper scientific maintain on the drug. The maintain additionally stalled the event of the drug in PBC. The FDA cleared the corporate to resume testing of the drug in 2020, however CymaBay elected to proceed growth solely in PBC.

PBC is a persistent dysfunction that primarily impacts girls over the age of 40, impairing liver operate. Frequent early signs embrace extreme pruritus (itching) and fatigue. PBC can progress to cirrhosis and liver failure. The primary-line drug remedy for PBC is ursodeoxycholic acid, or ursodiol, an outdated drug for dissolving gallstones that in 1996 gained a further approval as a remedy for PBC. The Intercept Prescription drugs drug Ocaliva was accepted in 2016 as a second-line remedy for PBC. Intercept, which was acquired late final yr by Italian firm Alfasigma, reported $240.4 million in gross sales for the drug within the 9 months ended Sept. 30, 2023.

CymaBay’s seladelpar is a small molecule designed to bind to and activate peroxisome proliferator activated receptor delta (PPAR delta), a receptor that regulates genes concerned within the synthesis of bile acids, metabolism, irritation, and fibrosis. In its placebo-controlled Part 3 scientific trial, outcomes confirmed remedy with the drug led to statistically vital normalization of enzymes indicative of liver illness in addition to enchancment in pruritus. Late final yr, CymaBay submitted a brand new drug software looking for approval of seladelpar as a remedy for sufferers who’re insufficient responders to or illiberal of ursodiol. CymaBay introduced Monday that the FDA will consider the applying beneath precedence evaluation, setting an Aug. 14 goal date for a regulatory determination.

Gilead’s portfolio of liver illness medication embrace the hepatitis B medication Vemlidy and Viread in addition to hepatitis C drug Harvoni. The Foster Metropolis, California-based drugmaker can be within the chase for NASH (now additionally referred to as MASH, for metabolic related steatohepatitis) with cilofexor and firsocostat, that are in Part 2 testing as a part of a mix remedy with Novo Nordisk’s semaglutide.

“Constructing on the sturdy analysis and growth work by the CymaBay group up to now, we now have the potential to deal with a major unmet want for individuals dwelling with PBC and increase on our present broad vary of transformational therapies,” Gilead Chairman and CEO Daniel O’Day stated in a ready assertion.

CymaBay licensed seladelpar from Johnson & Johnson in a 2006 deal. If it’s accepted, J&J is in line to obtain royalties from gross sales. The CymaBay pipeline additionally contains MBX-2982, a molecule in Part 2a testing for treating hypoglycemia in sufferers with sort 1 diabetes.

In a observe despatched to buyers, William Blair analyst Andy Hsieh wrote that the CymaBay acquisition validates the scientific efficiency and business potential of seladelpar in PBC. He referred to as the acquisition “poetic closure” for the corporate following the molecule’s earlier scientific trial setbacks

“We commend administration’s resilience and persistence that finally led to seladelpar demonstrating the best-in-class scientific profile in PBC, and we anticipate the drug to learn 1000’s of sufferers dwelling with PBC as quickly as later this yr,” Hsieh stated.

Hsieh stated the Gilead supply is honest and it’s unlikely one other bidder will emerge. The transaction requires nearly all of CymaBay shareholders to tender their shares. The businesses anticipate to shut the transaction within the present quarter.

Photograph: David Paul Morris/Bloomberg, by way of Getty Pictures