FDA neurosciences chief Billy Dunn to leave immediately, analysts raise concern

Reata Pharmaceuticals

28/02/2023 18:41

Feb 28 (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  RETA.O 
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.
    The FDA declined to comment on the speculation, which hit
the stocks of some neurological drugmakers on Monday - Biogen
 BIIB.O  had fallen marginally and Amylyx Pharmaceuticals
 AMLX.O  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  BIIB.O  and Eisai Co's  4523.T  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 
 AMLX.O  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)
 ((Sriparna.Roy@thomsonreuters.com;))