Vanda has two upcoming FDA decisions:
- Tradipitant (Motion Sickness) – PDUFA on Dec 30, 2025
- Bysanti (Milsaperidone) – PDUFA on Feb 21, 2026
The company already markets three FDA-approved drugs (Fanapt, Hetlioz, Ponvory).
- Revenues are mostly flat and show limited growth.
- Cash flow remains negative.
- There is strong generic competition, so even with approvals, commercial success is not guaranteed.
Insider Trades
A strong positive signal: CEO and founder Mihael Polymeropoulos recently made significant insider purchases around $4 per share. This reflects high conviction in the company’s future and offers some downside protection.
My Position
For me, this is mainly a PDUFA-driven trade, not a fundamentals story. The low market cap, two near-term FDA catalysts, and insider buying create an attractive setup. I believe the stock is unlikely to drift much lower and more likely to move higher into the decisions.
My plan is to take partial profits ahead of the first PDUFA while keeping exposure for the second decision, balancing risk and upside potential.