Company Developing Smoking Cessation therapy, Millions of People in need.
Massively undervalued stock due to manafacturing delays
The market is undervaluing this play because of regulatory delays. But the competitive moat is strong nonetheless.
Their lead asset is poised to become the first newly approved pharmacological treatment for smoking cessation in two decades.
Strong efficacy, good tolerability, and a novel mechanism.
Here is some key points:
Two positive Phase 3 trials (ORCA-2 & ORCA-3) showing statistically significant abstinence rates + craving reduction.
NDA submitted June 2025; FDA accepted with PDUFA target June 20, 2026.
Long-term safety: 52-week continuous treatment data presented (well tolerated).
Vaping cessation: Positive Phase 2 + End of Phase 2 FDA meeting completed.
