FDA Accepts ImmunityBio's BLA Resubmission As Complete And Sets New PDUFA Date Of April 23, 2024
Portfolio Pulse from Benzinga Newsdesk
The U.S. Food and Drug Administration (FDA) has accepted ImmunityBio's resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. The FDA has set a user fee goal date (PDUFA date) of April 23, 2024.
October 26, 2023 | 1:08 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
The FDA's acceptance of ImmunityBio's BLA resubmission for N-803 could potentially boost the company's stock in the short term as it indicates progress in the regulatory approval process.
The FDA's acceptance of ImmunityBio's BLA resubmission is a positive development for the company. It indicates that the company is making progress in the regulatory approval process for N-803, which could potentially lead to increased investor confidence and a boost in the company's stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100