Eli Lilly Wins European Approval for Weight Loss Pill Foundayo as BMY Scores FDA Nod for Myeloma Drug

Eli Lilly secured the first European regulatory approval for its oral weight loss pill Foundayo in the United Kingdom, intensifying a direct battle with Novo Nordisk, whose oral Wegovy was approved in the U.K. two months earlier. The milestone extends Lilly's obesity franchise beyond the U.S. market at a pivotal moment: analysts project Foundayo revenue will reach $840 million in 2026, climb to more than $3 billion in 2027, and more than double again to $6.3 billion in 2028, according to FactSet. Quarterly revenue for the drug came in at $98 million, slightly below the $103 million analyst consensus.

In a separate regulatory development, Bristol Myers Squibb received FDA accelerated approval for ZENBEXUS, the company's first CELMoD therapy, to be used in combination with daratumumab, hyaluronidase-fihj, and dexamethasone for multiple myeloma patients as early as first relapse, based on the Phase 3 EXCALIBER-RRMM trial. BMS also disclosed that the FDA accepted a new drug application for its second CELMoD agent mezigdomide in combination with carfilzomib and dexamethasone, setting a PDUFA decision date of May 13, 2027. Additionally, shares of Capricor Therapeutics surged after the FDA agreed to review new data on its Duchenne muscular dystrophy treatment deramiocel, which carries a PDUFA action date of August 22, 2026.