DISC-3405 is a Disc Medicine, Inc. program. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Sponsor: Disc Medicine, Inc. (IRON). Review status: Disc Medicine presented initial results from the RESTORE-PV Phase 2 trial of DISC-3405 in polycythemia vera at the SOHO Annual Meeting, announced September 10, 2026 (8-K exhibit 99.1). Initial results; outcome not characterised in the headline. 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 |
|---|---|---|---|
| RA Capital Management | 2,450,221 | $179.2 million | filed August 14, 2026 |
| BVF Inc. | 1,153,612 | $84.4 million | filed August 14, 2026 |
| OrbiMed Advisors | 357,535 | $26.2 million | filed August 14, 2026 |
| Baker Bros. Advisors | 349,657 | $25.6 million | filed August 14, 2026 |
| RTW Investments | 30,000 | $2.2 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.
DISC-3405's most recent tracked catalyst has already reported: reported data on Sep 10, 2026, per the company's own release (linked in the history below). No further catalyst is on our calendar yet.
No FDA decision for DISC-3405 is in our archive yet.
Disc Medicine, Inc. (IRON).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.