IMNM - BUY - 1Q Recap; NDA for Varegacestat Submitted; Initial ROR1 Data in 2026; FAP Trial Initiated; Early Solid Tumor ADC Programs On Track With First of Three INDs Cleared

研报英文原文证据摘录

IMNM - BUY - 1Q Recap; NDA for Varegacestat Submitted; Initial ROR1 Data in 2026; FAP Trial Initiated; Early Solid Tumor ADC Programs On Track With First of Three INDs Cleared

May 12, 2026

Michael Schmidt, Ph.D. michael.schmidt@guggenheimpartners.com IMNM - BUY - 1Q Recap; NDA for Varegacestat

617 859 4636 Submitted; Initial ROR1 Data in 2026; FAP Trial

Rosy Liao, Ph.D.

rosy.liao@guggenheimpartners.com Initiated; Early Solid Tumor ADC Programs On Track

617 859 4663 With First of Three INDs Cleared Paul Jeng, Ph.D.

paul.jeng@guggenheimpartners.com

617 859 4618 Key Message: IMNM reported 1Q26 earnings that included several program updates.

Sarah Bi, Ph.D. The company recently announced NDA submission for varegacestat (gamma secretase

sarah.bi@guggenheimpartners.com inhibitor) in desmoid tumors in April 2026, where potential approval is expected by YE26

857 350 0123 or early 2027, per our estimates, with potential launch in 2027. The announcement is

consistent with expectations, where submission was guided for 2Q26, and follows the

company's positive topline data reported in Dec 2025 demonstrating a best-in-class

profile in desmoid tumors (see here). Full data for the Phase 3 RINGSIDE trial will be

shared during an oral session at ASCO 2026 (see our ASCO 2026 planner) whereIMNM BUY we expect additional details on varegacestat's safety profile as well as patient reported

Immunome, Inc. outcomes. IMNM also expects to submit a marketing application for varegacestat to EMA

Sector: Biotechnology by YE26. The company's ADC pipeline is also on track, where the Ph 1 trial for IM-1021

(ROR1) is ongoing with initial data expected in 2026, and where the first solid tumor ADC Estimate Changes program, IM-1617 (target undisclosed), recently received IND clearance, in-line with prior