Immunome clears FDA IND for IM-1340: what it means for Immunome stock

Published on 10/16/2026 at 04:58 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

FDA cleared IM-1340's IND on September 30, 2026. For Immunome stock, a Phase 1 study is planned for the fourth quarter of 2026.

Clinical milestones and analyst context

Immunome received FDA IND clearance for IM-1340 on September 30, 2026.
The company plans to begin a Phase 1 study in the fourth quarter of 2026.
Immunome had a USD 2.1 billion market capitalization as of October 15, 2026.

IMNM, US45257U1088, Illustration mit AI erstellt.

Immunome (US45257U1088) received U.S. Food and Drug Administration clearance for the IND application for IM-1340 on September 30, 2026, according to Immunome Investor Relations. The antibody-drug conjugate is intended for advanced solid tumors, with a Phase 1 study planned for the fourth quarter of 2026.

Three milestones shape the pipeline

On September 10, 2026, HC Wainwright reaffirmed a Buy rating and a USD 40.00 target for Immunome, as reported by MarketBeat. On September 30, the company announced the IM-1340 IND clearance and identified the program as its fifth clinical development program, according to Immunome Investor Relations. On October 7, 2026, MarketBeat reported 12 Buy ratings, one Hold rating and one Sell rating, alongside a USD 34.25 average target.

What does the clearance mean?

The near-term value of the clearance is a path into human testing. Immunome said the Phase 1 trial is designed to evaluate safety, tolerability, pharmacokinetics and preliminary anti-tumor activity in advanced solid tumors, including neuroendocrine tumors, lung cancer and colorectal cancer. The company also said IM-1340 uses its proprietary HC74 topoisomerase I inhibitor payload, giving the program a defined technology angle.

Pipeline dates investors can track

The next stated development milestone is the planned Phase 1 start in the fourth quarter of 2026, according to Immunome Investor Relations. A separate regulatory date is April 28, 2027, when the Food and Drug Administration has set the PDUFA target action date for Immunome's varegacestat application, according to Simply Wall St.

Market context remains secondary

Immunome had a USD 2.1 billion market capitalization as of October 15, 2026. The valuation reflects a clinical-stage biotechnology company whose upcoming milestones are tied to trial execution and regulatory progress rather than commercial product revenue.