wall street may have overreacted to fears that the fda could grow less flexible in approving certain new drugs biotech investors panicked on monday when news broke that dr billy dunn who ran the food and drug administration office that decides whether to approve drugs for neurological conditions was retiring effective immediately shares of neurologyfocused biotechs dropped reata pharmaceuticals ticker reta which was awaiting an fda decision due the next day plummeted 307 dunn was the public face of the controversial accelerated approval of biogen ’s biib alzheimer’s disease therapy aduhelm he was seen as a standardbearer for the fda’s push toward more flexibility on approvals of drugs for serious neurological conditions for which few treatment options are available so investors worried that dunn’s departure might signal a step toward a more conservative attitude that could be bad news for drugmakers awaiting decisions from the agency’s neurology office and for companies counting on that flexibility to bring their drugs to market in a note out on friday however citi research analyst neena bitrittogarg wrote that personnel moves at the fda may actually signal more flexibility in certain types of approvals rather than less “the push to flexibility may be coming more broadly from remaining senior fda leadership” bitrittogarg wrote indeed the fda on wednesday said it would approve reata’s drug skyclarys a treatment for an ultrarare neuromuscular disease called friedreich’s ataxia reata shares jumped nearly 200 on wednesday in response to a query about how dunn’s departure would affect the agency’s approach to neurological drug approvals an fda official provided a copy of a letter to agency staff announcing the retirement “billy has been encouraging facilitating and defining neurological drug development and regulation in his leadership roles” wrote dr peter stein dunn’s superior as the director of the office of new drugs “he has made a major impact in how drugs are developed for a range of serious neurological diseases—many that previously had only limited treatment options” dunn who served most recently as director of the fda’s office of neuroscience didn’t immediately respond to a request for comment sent to his fda email address he has been a proponent of the agency being more flexible in approving drugs in cases where the disease is very serious and the unmet medical need is high “it is clear that regulatory flexibility is a fundamental aspect of our general regulatory framework” dunn said at a public meeting last september of an fda advisory committee considering an amyotrophic lateral sclerosis drug from amylyx pharmaceuticals amlx the agency later approved that treatment in her friday note bitrittogarg traced the agency’s shift toward flexibility back to the controversial 2016 approval of sarepta therapeutics ‘s srpt duchenne muscular dystrophy treatment exondys 51 dr janet woodcock who headed the center for drug evaluation and research and is now the fda’s deputy commissioner backed that call other fda officials opposed it dr robert califf the current fda commissioner who also served as fda commissioner at that time eventually sided with woodcock and the drug received accelerated approval bitrittogarg in her note shows that many of the fda leaders who opposed the exondys 51 approval have since left the agency what is more while dunn took substantial public criticism for his role in the aduhelm approval in 2021 bitrittogarg notes that he clearly had the backing of senior fda leaders both stein and dr patrizia cavazzoni woodcock’s successor as head of cder posted public memorandums supporting the decision as it was announced for bitrittogarg this all suggests that the real fda staffing moves to watch are the departures of the officials who opposed the sarepta approval rather than dunn’s retirement “some investors fear flexibility in cns reviews may be over as evidenced by share price moves earlier this week” bitrittogarg wrote “we actually believe the opposite may be true and that his and other highprofile fda departures recently may signal that a greater level of flexibility in cns and some raregenetic diseases than we’ve seen previously may be ahead”