USFDAAug 11, 2026, 04:13 PM
Immunome's Varegacestat NDA Accepted, PDUFA Date April 28, 2027
AI Summary
Immunome announced its second quarter 2026 financial results and provided a comprehensive business update. The U.S. FDA accepted the New Drug Application for varegacestat for desmoid tumors, setting a PDUFA target action date of April 28, 2027. Detailed Phase 3 RINGSIDE data for varegacestat, demonstrating statistically significant improvements, was presented at ASCO. Additionally, the company initiated Phase 1 trials for IM-1617 and IM-3050, expanding its clinical pipeline, and reported a net loss of $73.1 million for the quarter.
Key Highlights
- Varegacestat NDA accepted by FDA; PDUFA target action date set for April 28, 2027.
- Varegacestat Phase 3 RINGSIDE data showed 84% reduction in disease progression risk.
- First patient dosed in June 2026 for IM-1617 Phase 1 solid tumor trial.
- First patient dosed in July 2026 for IM-3050 Phase 1 FAP-targeted radioligand trial.
- Cash, cash equivalents, and marketable securities totaled $520.0 million as of June 30, 2026.
- Net loss for Q2 2026 was $73.1 million, compared to $43.4 million in Q2 2025.
- Research and development expenses were $59.9 million in Q2 2026, up from $40.5 million.
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