Achieve Life Sciences Announces Positive Outcome of Second Data Safety Monitoring Committee Review for the ORCA-OL Clinical Trial
Portfolio Pulse from
Achieve Life Sciences announced a positive outcome from the second Data Safety Monitoring Committee review for its ORCA-OL clinical trial, with no safety concerns identified. The company plans to submit a New Drug Application for cytisinicline in Q2 2025.
February 10, 2025 | 1:45 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Achieve Life Sciences received a positive safety review from the DSMC for its ORCA-OL trial, with no safety concerns identified. This supports the company's plan to submit a New Drug Application for cytisinicline in Q2 2025.
The positive DSMC review indicates that the ORCA-OL trial is progressing well without safety issues, which is crucial for regulatory approval. This news likely boosts investor confidence in Achieve Life Sciences' future prospects, particularly with the planned NDA submission.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100