Achieve Life Sciences Says NDA Filing Timing May Be Delayed To Address FDA Feedback On Drug Product Candidate, Cytisinicline
Portfolio Pulse from Benzinga Newsdesk
Achieve Life Sciences announced a potential delay in the NDA filing for its drug candidate, Cytisinicline, due to the FDA's request for additional long-term safety data. The FDA supports an NDA submission based on current Phase 3 trials but requires safety data beyond 12 weeks to assess risks for a drug intended for chronic, intermittent use.
December 11, 2023 | 9:17 pm
News sentiment analysis
Sort by:
Ascending
NEGATIVE IMPACT
Achieve Life Sciences may experience a delay in the NDA filing for Cytisinicline due to the FDA's request for extended safety data, potentially impacting the company's timeline for drug approval and market entry.
The news of a potential delay in the NDA filing due to the FDA's request for additional safety data is likely to be viewed negatively by investors, as it could postpone Achieve Life Sciences' ability to bring Cytisinicline to market and generate revenue. This uncertainty may lead to a short-term decline in ACHV's stock price.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100