FDA flags possible safety signals in new report, says RBC Capital

RBC Capital notes that the FDA has, for the first time, published a report highlighting potential safety signals from its FDA Adverse Event Reporting System, or FAERS, database for the first quarter, mentioning drugs like Sarepta’s (SRPT) Elevidys and Biogen’s (BIIB) Leqembi. This move appears to support the agency’s broader push for post-marketing transparency championed by figures like RFK Jr. and FDA Commissioner Martin Makary, but it offers little clarity on whether further regulatory action will follow, the analyst tells investors in a research note. Since the data is already publicly known and the risks largely recognized, RBC doesn’t expect significant new regulatory impacts beyond possible label updates, though it may add some overhang for the named companies, which also include Alkermes (ALKS), Biohaven (BHVN), Xenon (XENE), and Argenx (ARGX).