Summit Therapeutics Inc. SMMT
Summit Therapeutics Inc. (Nasdaq: SMMT) is an oncology drug developer. Its lead program, ivonescimab (HARMONi), is in Phase 3 for EGFR-mutated non-squamous NSCLC after third-generation EGFR TKI, in combination with chemotherapy. 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.
Next further out: ivonescimab (HARMONi-3 squamous) — Primary PFS analysis (events reached) with early OS interim (H2 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ivonescimab + chemotherapy (HARMONi) | EGFR-mutated NSCLC post-TKI (BLA under review) | antibody | Phase 3 |
| ivonescimab + chemotherapy (HARMONi-3) | first-line metastatic squamous and non-squamous NSCLC | antibody | Phase 3 |
| ivonescimab monotherapy (HARMONi-7) | first-line PD-L1 high metastatic NSCLC | antibody | Phase 3 |
| ivonescimab + chemotherapy (HARMONi-GI3) | first-line unresectable metastatic colorectal cancer | antibody | Phase 3 |
| ivonescimab +/- ligufalimab (ILLUMINE, GORTEC-sponsored) | PD-L1 positive recurrent/metastatic head and neck SCC | antibody | Phase 3 |
| ivonescimab combination collaborations (RevMed, GSK, Arcus) | multiple solid tumors, clear cell RCC | antibody | Phase 2 |
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
- Merck & Co., Inc. MRK
- Astrazeneca PLC AZN
- Bristol Myers Squibb Co BMY
- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- 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.