Incyte Corp INCY
Incyte Corp (Nasdaq: INCY) is a hematology drug developer. Its lead program, JAKAFI (ruxolitinib) and portfolio of marketed products, is in Phase 3 for myelofibrosis, polycythemia vera, GVHD (plus multiple other marketed indications). Its next catalyst on record is Povorcitinib (HS): Potential EU approval (MAA submitted end of 2025) (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Povorcitinib (HS) — Potential EU approval (MAA submitted end of 2025) (Q4 2026). 16 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| JAKAFI / JAKAFI XR (ruxolitinib) | MF, PV, acute and chronic GVHD | small molecule | Approved |
| OPZELURA (ruxolitinib cream) | atopic dermatitis, nonsegmental vitiligo | small molecule | Approved |
| MONJUVI (tafasitamab-cxix) | r/r DLBCL, r/r follicular lymphoma; 1L DLBCL submitted | antibody | Approved |
| NIKTIMVO (axatilimab-csfr) | chronic GVHD | antibody | Approved |
| PEMAZYRE (pemigatinib) | cholangiocarcinoma, FGFR1 myeloid/lymphoid neoplasms | small molecule | Approved |
| ZYNYZ (retifanlimab-dlwr) | Merkel cell carcinoma, anal canal SCC | antibody | Approved |
| ICLUSIG (ponatinib) - Europe/select countries only | CML, Ph+ ALL | small molecule | Approved |
| Povorcitinib (JAK1) | hidradenitis suppurativa (NDA accepted); vitiligo; prurigo nodularis; asthma | small molecule | Phase 3 |
| INCA033989 (mutCALR antibody) | essential thrombocythemia, myelofibrosis | antibody | Phase 3 |
| Latarcibart (VGA039) | von Willebrand disease | antibody | Phase 3 |
| INCB161734 (KRAS G12D) | pancreatic ductal adenocarcinoma | small molecule | Phase 3 |
| INCA33890 (TGFbR2xPD-1) | MSS colorectal cancer | antibody | Phase 3 |
Recent results and decisions
- Feb 27, 2026CRL FDA issued a CRL for the Zynyz NSCLC sBLA, citing only inspection findings at third-party fill-finish site Catalent Indiana, not efficacy or safety.
The CRL cited the regulatory compliance of Catalent Indiana as the sole approvability issue, and did not cite other approvability concerns, including Zynyz’s efficacy and safety data in NSCLC or the third-party drug substance manufacturer.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 hematology companies
- Grifols SA GRFS
- Disc Medicine, Inc. IRON
- Agios Pharmaceuticals, Inc. AGIO
- Geron Corporation GERN
- Nuvectis Pharma, Inc. NVCT
- X4 Pharmaceuticals, Inc XFOR
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.