Envudeucitinib LUMUS is an Alumis Inc. program. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Sponsor: Alumis Inc. (ALMS). Review status: Alumis presented LUMUS Phase 2b topline results for envudeucitinib in moderate-to-severe systemic lupus erythematosus on September 1, 2026 (8-K exhibit 99.2, investor deck); the deck says key insights support a path to Phase 3 and does not state the primary endpoint result in its summary. This row's earlier label 'anifrolumab' was an extraction error. 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 |
|---|---|---|---|
| Cormorant Asset Management | 3,285,596 | $92.5 million | filed August 14, 2026 |
| Baker Bros. Advisors | 2,012,500 | $56.6 million | filed August 14, 2026 |
| OrbiMed Advisors | 548,163 | $15.4 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.
Envudeucitinib LUMUS's most recent tracked catalyst has already reported: reported data on Sep 1, 2026, per the company's own release (linked in the history below). No further catalyst is on our calendar yet.
No FDA decision for Envudeucitinib LUMUS is in our archive yet.
Alumis Inc. (ALMS).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.