Summit Therapeutics Inc. SMMT
Summit Therapeutics Inc. (Nasdaq: SMMT) is an oncology drug developer. Its lead program, ivonescimab (HARMONi-3), is in Phase 3 for first-line metastatic non-small cell lung cancer (squamous and non-squamous). Its next catalyst on record is ivonescimab (HARMONi): FDA PDUFA goal action date for BLA (November 14, 2026).
Upcoming catalysts
- November 14, 2026ivonescimab (HARMONi) — FDA PDUFA goal action date for BLA
The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
- November 14, 2026ivonescimab (HARMONi BLA) — PDUFA goal action date
The FDA provided a Prescription Drug User Fee Act ('PDUFA') goal action date of November 14, 2026.
Next further out: ivonescimab (HARMONi-3 squamous) — Primary PFS analysis (Q4 2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ivonescimab (HARMONi-3 squamous) | first-line metastatic squamous NSCLC | antibody | Phase 3 |
| ivonescimab (HARMONi-3 non-squamous) | first-line metastatic non-squamous NSCLC | antibody | Phase 3 |
| ivonescimab (HARMONi BLA) | EGFR-mutated NSCLC post-TKI with chemotherapy | antibody | Phase 3 |
| ivonescimab (HARMONi-7) | first-line metastatic NSCLC, high PD-L1 expression, monotherapy | antibody | Phase 3 |
| ivonescimab (HARMONi-GI3) | first-line unresectable metastatic colorectal cancer with chemotherapy | antibody | Phase 3 |
| ivonescimab (ILLUMINE cooperative study) | recurrent/metastatic PD-L1+ head and neck squamous cell carcinoma | antibody | Phase 3 |
| ivonescimab (HARMONi-GU1) | first-line urothelial carcinoma with enfortumab vedotin | antibody | Phase 2 |
| ivonescimab (SMT112-216 / AK112-216) | previously untreated advanced clear cell renal cell carcinoma, multiple combination arms | antibody | Phase 2 |
| ivonescimab (EA2251 cooperative study) | advanced biliary tract cancer with chemotherapy | antibody | Phase 2 |
Recent results and decisions
- Nov 4, 2026started Summit expanded its Phase III clinical development program to include urothelial carcinoma (bladder cancer) with HARMONi-GU1.
Summit began its clinical development of ivonescimab in NSCLC (HARMONi, HARMONi-3, HARMONi-7) and expanded its sponsored Phase III clinical development program into colorectal cancer (CRC; HARMONi-GI3) and urothelial carcinoma (bladder cancer; HARMONi-GU1).
Filing - Jan 1, 2026accepted FDA accepted the BLA for ivonescimab for EGFR-mutated NSCLC with a PDUFA goal date of November 14, 2026.
a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.
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 oncology companies
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- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.