Reata shares surge after surprise FDA nod for rare disease drug

Reata Pharmaceuticals

01/03/2023 13:20

March 1 (Reuters) - Shares of U.S. biotech firm Reata
Pharmaceuticals Inc  RETA.O  more than doubled in premarket
trading on Wednesday, a day after the Food and Drug
Administration (FDA) approved its rare disease drug and ended
years of uncertainty over its future.
    The drug Skyclarys is the first approved treatment for
Friedreich's Ataxia, a rare genetic disorder that causes
progressive damage to the nervous system and can lead to
premature death. It is also Reata's first approved product.
    The approval follows years of back and forth between Reata
and the FDA, which in 2020 said the data from a mid-stage trial
was not enough to support an approval. In 2022, the regulator
extended its review after Reata submitted additional analyses. 
    "We've followed some pretty dramatic stories in the past,
but the Reata odyssey is in the Hall of Fame," said Baird
analyst Brian Skorney. 
    The FDA has previously approved drugs for neurological
conditions based on limited data such as for Biogen Inc's
 BIIB.O  Alzheimer's drug Aduhelm and Amylyx's  AMLX.O  ALS
drug.
    Those approvals were made under the leadership of Billy
Dunn, who resigned from the agency on Monday after which Reata's
shares tumbled 30% as investors fretted about the possibility of
approval under a new division head.
    The company priced the drug at a wholesale acquisition cost
of $370,000 annually.
    Reata's shares were up 174.2% to $85.47 before the bell. 

 (Reporting by Aditya Samal in Bengaluru; editing by Shweta
Agarwal and Uttaresh Venkateshwaran)
 ((Aditya.Samal@thomsonreuters.com;))