FDA neurosciences chief Billy Dunn to leave immediately, analysts raise
concern
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[March 01, 2023]
(Reuters) - The U.S. Food and Drug Administration neurosciences
head Billy Dunn will retire from his role effective immediately, the
health regulator told Reuters on Tuesday.
Wall Street analysts said Dunn's departure could impact the regulator's
stance on neurological drug decisions in the near term, sending down
shares of Reata Pharmaceuticals Inc 30% on Monday when media reports on
the exit surfaced.
Texas-based Reata is expecting FDA's decision by Tuesday on its drug to
treat a rare neuromuscular disorder called Friedreich's ataxia.
The departure of Dunn, 53, was announced in an internal message to the
agency's employees on Monday. Newly appointed deputy director Teresa
Buracchio will also serve in Dunn's role on an interim basis at the
Office of Neuroscience, the agency told Reuters.
Jefferies analyst Maury Raycroft said in a research note that while
Dunn's departure may have already been in the works, his immediate exit
ahead of the agency's decision on the Reata drug raised suspicion about
the timing.
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Signage is seen outside of the Food and
Drug Administration (FDA) headquarters in White Oak, Maryland, U.S.,
August 29, 2020. REUTERS/Andrew Kelly
![](http://archives.lincolndailynews.com/2023/Mar/01/images/ads/current/castlemanor_sda_FINANCIAL_2017.png) The FDA declined to comment on the
speculation, which hit the stocks of some neurological drugmakers on
Monday - Biogen had fallen marginally and Amylyx Pharmaceuticals
declined 2.5% in the previous session.
Shares of Reata fell nearly 6% on Tuesday before reversing losses.
Dunn was integral in the FDA's controversial decision to approve
Biogen Inc and Eisai Co's Alzheimer's drug Aduhelm last year despite
a lack of evidence that it worked at slowing the effects of the
disease.
He also backed the approval of Amylyx Pharmaceuticals Inc's Relyvrio
last year, telling a panel of outside advisers that the amyotrophic
lateral sclerosis drug could be pulled from the market if it failed
in a larger trial underway.
(Reporting by Sriparna Roy in Bengaluru; editing by Caroline Humer
and Shinjini Ganguli)
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