PALSONIFY (paltusotine) The FDA approved it on Sep 25, 2025. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Baker Bros. Advisors | 2,351,465 | $88.0 million | filed August 14, 2026 |
| OrbiMed Advisors | 999,000 | $37.4 million | filed August 14, 2026 |
| Cormorant Asset Management | 125,000 | $4.7 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
No upcoming catalyst is on our calendar for PALSONIFY (paltusotine); 1 FDA decision is on record below.
On Sep 25, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
Yes. The FDA approved an application for PALSONIFY (paltusotine) on Sep 25, 2025; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.