Achieve Life Sciences Q3 net loss and loss per share beat estimates
ACHV•Achieve Life Sciences reported a third-quarter net loss of $12.11 million, or $0.11 per share, beating analyst estimates of $19.30 million and $0.20 per share. The company expects to resubmit its cytisinicline NDA in Q4 2026 and anticipates potential FDA approval by the end of Q2 2027.
1. Quarterly results
Achieve Life Sciences reported a Q3 net loss of $12.11 million, or $0.11 per share, compared with analyst estimates of a $19.30 million net loss and a $0.20 loss per share. Operating loss was $20.54 million, narrower than the $22.79 million estimate.
2. Cytisinicline timeline
The company expects to resubmit its NDA for cytisinicline in Q4 2026 and anticipates potential FDA approval by the end of Q2 2027. AchieveRx plans a U.S. commercial launch following approval, if granted.
3. Trial and manufacturing
The company said ORCA-OL trial data showed rising quit rates and no new safety signals for cytisinicline. It completed three commercial-scale stability batches, which it said support the NDA resubmission timeline.
