FDA Events for Immunome (IMNM)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Immunome (IMNM).
Over the past two years, Immunome has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IM-1021. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
IM-1021 - FDA Regulatory Timeline and Events
IM-1021 is a drug developed by Immunome for the following indication: In Cancer therapies.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IM-1021
- Announced Date:
- March 10, 2025
- Indication:
- In Cancer therapies
Announcement
Immunome, Inc. announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC.
AI Summary
Immunome, Inc. has reached an exciting milestone by dosing the first patient in its Phase 1, first‐in‐human trial of IM-1021, a ROR1-targeted antibody-drug conjugate (ADC). This trial is designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of IM-1021. The study will enroll patients with advanced B-cell lymphomas and solid tumors, aiming to address a significant unmet medical need.
IM-1021 uses Immunome’s proprietary TOP1 inhibitor, HC74, to target cancer cells by homing in on the ROR1 protein. This innovative approach could potentially improve treatment outcomes for patients with difficult-to-treat cancers. As the trial progresses, researchers will closely monitor how the drug performs in patients, focusing on its dosing, pharmacokinetics, and effectiveness, which marks a notable step forward in the field of targeted cancer therapies.
Read Announcement
Immunome FDA Events - Frequently Asked Questions
As of now, Immunome (IMNM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Immunome (IMNM) has reported FDA regulatory activity for IM-1021.
The most recent FDA-related event for Immunome occurred on March 10, 2025, involving IM-1021. The update was categorized as "Dosing Update," with the company reporting: "Immunome, Inc. announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC."
Currently, Immunome has one therapy (IM-1021) targeting the following condition: In Cancer therapies.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:IMNM) was last updated on 7/13/2025 by MarketBeat.com Staff
