Immunome Inc. IMNM
Immunome Inc. (Nasdaq: IMNM) is an oncology drug developer. Its lead program, varegacestat (AL102), is in Phase 3 for progressing desmoid tumors. Its next catalyst on record is varegacestat: FDA PDUFA target action date for NDA (April 28, 2027).
Upcoming catalysts
- April 28, 2027varegacestat — FDA PDUFA target action date for NDA
assigned a Prescription Drug User Fee Act, or PDUFA, target action date of April 28, 2027
Next further out: IM-1335 — IND submission (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| varegacestat | desmoid tumors (Phase 3 RINGSIDE positive; NDA under review) | small molecule | Phase 3 |
| IM-1021 (ROR1 ADC) | B-cell lymphoma / solid tumors | antibody | Phase 1 |
| IM-1617 (solid tumor ADC) | advanced solid tumors (CRC, NSCLC, breast) | antibody | Phase 1 |
| IM-3050 (FAP radioligand) | FAP-expressing solid tumors | radiopharmaceutical | Phase 1 |
| IM-1340 (solid tumor ADC) | NETs, lung, prostate and other carcinomas | antibody | Pre-clinical |
| IM-1335 (solid tumor ADC) | solid tumors | antibody | Pre-clinical |
Recent results and decisions
- Aug 11, 2026accepted FDA accepted the varegacestat NDA in July 2026 with a PDUFA target action date of April 28, 2027.
In July 2026, the U.S. FDA accepted Immunome’s NDA for varegacestat for the treatment of adults with desmoid tumors and assigned a PDUFA target action date of April 28, 2027.
Filing - May 12, 2026submitted NDA for varegacestat in adults with desmoid tumors submitted to FDA in April 2026.
In April 2026, Immunome submitted an NDA to the U.S. FDA for varegacestat for the treatment of adults with desmoid tumors.
Filing - Dec 15, 2025met Phase 3 RINGSIDE met primary endpoint: PFS HR 0.16 (84% risk reduction, p<0.0001); ORR 56% vs 9% placebo (p<0.0001); all key secondaries met.
The trial met its primary endpoint of improving progression-free survival, demonstrating a statistically significant and clinically meaningful improvement vs. placebo, with an 84% reduction in the risk of disease progression or death (hazard ratio (HR) = 0.16, 95% CI: 0.071, 0.375; p<0.0001).
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
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- BioNTech SE BNTX
- Guardant Health, Inc. GH
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The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.