Pharmaceutical Executive Daily: FDA Issues Warning Letter to ImmunityBio

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today's Pharmaceutical Executive Daily, the FDA issues a warning letter to ImmunityBio over misleading promotional claims about its bladder cancer therapy Anktiva, Merck agrees to acquire Terns Pharmaceuticals in a $6.7 billion deal while Shionogi moves to take full ownership of the Shionogi-Apnimed Sleep Science joint venture, and a new commentary examines the structural pricing problem sitting at the center of the GLP-1 access debate.

The FDA's Office of Prescription Drug Promotion has issued a warning letter to ImmunityBio over a direct-to-consumer television advertisement and a podcast episode, both of which the agency says made false or misleading claims about Anktiva, a therapy approved only for a specific type of bladder cancer. The promotional materials suggested the drug could treat all cancers, prevent cancer in radiation-exposed patients, and be administered as a single subcutaneous injection, none of which align with its approved indication or labeling. ImmunityBio shares fell roughly 26% on the news, and the company has 15 working days to submit a corrective action plan to the agency.

In deal news, Merck has agreed to acquire Terns Pharmaceuticals for $6.7 billion, or $53 per share, a roughly 31% premium over Terns' 60-day average share price. The centerpiece of the deal is TERN-701, a promising chronic myeloid leukemia candidate that Merck is positioning as a next-generation asset as it prepares for Keytruda's patent expiration in 2028. Separately, Shionogi has agreed to acquire Apnimed's 50% stake in their joint Shionogi-Apnimed Sleep Science venture for $100 million upfront plus a $50 million milestone payment and royalties, with Apnimed redirecting proceeds toward its lead obstructive sleep apnea program, AD109.

Finally, a new commentary argues that the core problem with GLP-1 access is not list price but the way commercial insurance structures benefits, with accumulators, maximizers, and high-deductible designs that erode manufacturer support and leave patients facing hundreds of dollars in monthly out-of-pocket costs. The piece contends that without benefit design reform, even significant list price reductions will fail to translate into meaningful affordability at the pharmacy counter for the majority of commercially insured patients.

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