Reata in selloff ahead of FDA decision on lead asset as top agency official departs (Update)
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Update: 14:12 EST: Adds Goldman Sachs comments on Reta 
Reata Pharmaceuticals (NASDAQ:RETA) lost ~32% on Monday to reach the lowest level in over four months as a key FDA official leaves the agency while the company awaits the U.S. approval for its Friedreich's ataxia ((F.A.)) therapy, omaveloxolone.
In August, the FDA extended the review period for the company's New Drug Application (NDA) for omaveloxolone in FA by three months, granting February 28, 2023, as the new action date citing the need for more time to review additional data.
Earlier in the day, multiple news outlets reported that FDA's neuroscience chief Billy Dunn who presided over notable drug approvals for Alzheimer's and amyotrophic lateral sclerosis (ALS) has decided to retire.
Dunn "has been known for his flexibility in approving drugs based on more limited/mixed data for high unmet need conditions, as well as a proponent for considering biomarkers," RBC Capital Markets said in a research note.
In an email to FDA staff, Peter Stein, head of the regulator's Office of New Drugs, announced Dunn's departure. "It was with regret that I announce the departure of Dr. Billy Dunn, Director of the Office of Neuroscience," Stein wrote, adding that Teresa Buracchio, the acting deputy director of the FDA's Office of Neuroscience, will succeed him in an acting capacity.
However, Goldman Sachs reiterated the Buy rating and $117 price target on Reta (RETA), arguing that despite prior regulatory flexibility Dunn has indicated in the past, his replacement at the agency Buracchio "has shared many of the same views."
The analysts specifically referred to the second AdCom meeting on AMX0035 in ALS, where Buracchio "reiterated the FDA's views on regulatory flexibility in rare neurological diseases with unmet need." FA is a rare genetically driven neurologically disease with no approved therapies for the treatment.
Meanwhile, RBC analysts, Brian Abrahams and Leonid Timashev expect some continuity to limit near-term impact and urged investors to use "any potential weakness as a buying opportunity for SRPT, as well as BIIB and EWTX."
Edgewise Therapeutics (EWTX) is advancing Phase 2 studies for Duchenne muscular dystrophy and Duchenne muscular dystrophy (DMD). Meanwhile, Sarepta (SRPT)  is on the decline as the gene therapy company is set to hear about its marketing application for DMD candidate SRP-9001 developed with Roche (OTCQX:RHHBY) (OTCQX:RHHBF) for ambulant individuals by May 29
Under Dunn's leadership at the FDA's Office of Neuroscience, Biogen (BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY) won the U.S. approval for Leqembi in Alzheimer's disease in early January, while Amylyx (AMLX) received approval for its ALS medication AMX0035.
Read: Seeking Alpha contributor Stephen Ayers reasons why Reata (RETA) will likely receive a Complete Response Letter for omaveloxolone.