Pharmaceutical Executive Daily: September 24, 2025

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, we cover the market reaction to Trump’s Tylenol–autism claim, the FDA’s complete response letter to Scholar Rock for its spinal muscular atrophy treatment, and a closer look at the state of evidence linking Tylenol use and autism risk.

Kenvue shares fell following former President Donald Trump’s claim that prenatal Tylenol use increases the risk of autism. Investors reacted swiftly, concerned about reputational and legal risks tied to one of the company’s best-known products. Analysts noted that while scientific experts strongly dispute the claim, the controversy has fueled renewed attention to ongoing litigation against manufacturers. The episode underscores how political statements can ripple quickly across markets, impacting both corporate strategy and investor confidence.

Meanwhile, the FDA has issued a complete response letter to Scholar Rock regarding its biologics license application for Apitegromab in spinal muscular atrophy. The agency cited deficiencies that need to be resolved before the therapy can move forward. The treatment was viewed as a potential first-in-class muscle-directed therapy for SMA, complementing existing genetic treatments. The CRL represents a significant setback for Scholar Rock, which now faces delays in addressing FDA concerns while balancing investor expectations. The company stated it remains committed to working with regulators to bring the therapy to patients.

And finally, amid heightened public attention, experts are weighing in on what is actually known about Tylenol and autism risk. While litigation and political commentary have kept the issue in the spotlight, the medical consensus is that current data does not establish a causal link. Researchers emphasize the importance of ongoing studies but caution that overstated claims could discourage appropriate prenatal use of acetaminophen, a widely relied-upon treatment for pain and fever in pregnancy. The debate highlights the tension between scientific evidence, public perception, and the courtroom as pharma companies navigate complex challenges around product safety narratives.

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