Seladelpar Granted Revised Breakthrough Therapy Designation For Treatment Of Primary Biliary Cholangitis Including Pruritus In Patients Without Cirrhosis Or With Compensated Cirrhosis
Portfolio Pulse from Benzinga Newsdesk
The FDA has granted a revised Breakthrough Therapy Designation to Seladelpar, a drug developed by CymaBay Therapeutics (CBAY), for the treatment of primary biliary cholangitis including pruritus in patients without cirrhosis or with compensated cirrhosis.
October 23, 2023 | 12:18 pm
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
CymaBay Therapeutics' drug Seladelpar has been granted a revised Breakthrough Therapy Designation by the FDA. This could potentially accelerate the drug's development and approval process, positively impacting CBAY's stock in the short term.
The FDA's Breakthrough Therapy Designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy. This designation for Seladelpar could potentially accelerate its development and approval process, which would be a positive development for CymaBay Therapeutics and could positively impact its stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100