Pharmaceutical Industry Sees Executive Moves, Clinical Advances, and Legal Challenges

Takeda Recruits Lilly Executive to Lead US Business

Takeda Pharmaceutical has announced a significant leadership change, appointing Rhonda Pacheco as the new head of its U.S. business unit, effective September 29. Pacheco, who has over a decade of experience at Eli Lilly, most recently served as group vice president of the cardiometabolic health unit, overseeing the successful launches of Lilly's GLP-1 drugs. She will succeed Julie Kim, who is set to take over as CEO in June 2026, replacing the retiring Christophe Weber.

Clinical Advancements and Market Reactions

Maze Therapeutics has reported promising Phase 1 results for its oral medication MZE782, targeting phenylketonuria (PKU). The early data showed good tolerability across all doses with no severe adverse events, and urine levels of a key amino acid exceeded investor expectations. This news led to a more than 50% increase in Maze's share price, with analysts suggesting the potential for a "best-in-class profile" in PKU treatment. Concurrent with the data release, Maze secured $150 million in a private stock offering.

In contrast, Soleno Therapeutics faced a nearly 20% stock decline following the report of a patient death in the FDA's adverse event reporting system for its Prader-Willi syndrome drug, Vykat. Despite the treating physician's assessment that the death was unrelated to the drug, and Soleno's emphasis on the patient's pre-existing health conditions, the market reacted negatively. This comes in the wake of a critical report by short-selling firm Scorpion Capital, which has contributed to a one-third drop in Soleno's stock value since last month.

Regulatory Actions and Legal Disputes

The FDA has requested Intercept Pharmaceuticals, now a subsidiary of Alfasigma, to withdraw its liver disease drug Ocaliva from the U.S. market. This decision follows growing safety concerns, including a black box warning imposed in 2018 and additional liver injury risks noted in December. The agency has also ordered the suspension of all clinical trials involving Ocaliva, which was initially approved for primary biliary cholangitis in 2016.

In the realm of patent disputes, Arrowhead Pharmaceuticals has filed a lawsuit against Ionis Pharmaceuticals, seeking a declaration that Ionis' patent related to familial chylomicronemia syndrome treatment is either invalid or not infringed by Arrowhead's experimental drug. This legal action comes as Arrowhead's therapy is under FDA review, while Ionis' Tryngolza was approved last year for the same condition. Analysts view this as a strategic move by Arrowhead to clear potential obstacles before its drug, plozasiran, enters the market.