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
varegacestat and IM-1021. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Varegacestat FDA Regulatory Timeline and Events
Varegacestat is a drug developed by Immunome for the following indication: Patients with Desmoid Tumors.
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:
- varegacestat
- Announced Date:
- May 30, 2026
- Indication:
- Patients with Desmoid Tumors
Announcement
Immunome, Inc announced detailed efficacy and safety results from RINGSIDE, the global, randomized, double-blind, placebo-controlled Phase 3 trial of varegacestat in patients with progressing desmoid tumors.
AI Summary
Immunome, Inc. reported detailed efficacy and safety results from RINGSIDE, a global Phase 3 trial testing varegacestat in patients with progressing desmoid tumors. The study was randomized, double-blind, and placebo-controlled, which means neither patients nor doctors knew who got the drug or placebo during the trial. The main result showed a confirmed objective response rate of 56% for varegacestat compared with 9% for placebo, based on independent review. This difference was highly significant. Patients who responded to varegacestat also started to improve faster than those on placebo, with a median time to response of 8.2 months versus 16.7 months. These findings suggest varegacestat may offer meaningful benefit for people with this rare and often difficult-to-treat tumor. The company said the data were presented at the 2026 ASCO meeting.
Read Announcement- Drug:
- varegacestat
- Announced Date:
- April 29, 2026
- Indication:
- Patients with Desmoid Tumors
Announcement
Immunome, Incannounced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for varegacestat, an investigational, oral, once-daily gamma secretase inhibitor (GSI), for the treatment of adults with desmoid tumors.
AI Summary
Immunome announced it submitted a New Drug Application to the U.S. FDA for varegacestat, an investigational oral gamma secretase inhibitor for adults with progressing desmoid tumors. The NDA is supported by positive results from the Phase 3 RINGSIDE trial.
In an exploratory analysis, varegacestat showed a median best change in tumor volume of −83% versus +11% with placebo by blinded review. The trial met all key secondary endpoints, with statistically significant improvements in landmark tumor volume reduction and worst pain intensity.
Varegacestat was generally well tolerated, with a safety profile consistent with the GSI class. Common adverse events included diarrhea (82%), fatigue (44%), rash (43%), nausea (35%) and cough (34%), mostly grade 1–2. RINGSIDE data will be presented at ASCO 2026.
Read Announcement- Drug:
- varegacestat
- Announced Date:
- December 14, 2025
- Indication:
- Patients with Desmoid Tumors
Announcement
Immunome, Inc. announced the company will host a conference call and webcast on Monday, December 15, 2025 at 8:30 am ET to disclose the topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat, an investigational, oral, once-daily gamma secretase inhibitor, in patients with progressing desmoid tumors.
AI Summary
Immunome, Inc. will host a conference call and webcast on Monday, December 15, 2025 at 8:30 a.m. ET to disclose topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat, an investigational, oral, once-daily gamma secretase inhibitor, in patients with progressing desmoid tumors. The company will present the initial, high-level findings from this late-stage study.
The live webcast will include presentation slides and can be accessed through the Events and Presentations section of the Immunome investor website (https://investors.immunome.com/events). The conference call requires online registration to receive a dial-in number or callback. A live question-and-answer session will follow prepared remarks; only participants on the conference call may ask questions, while the webcast is listen-only.
The webcast will be archived on the Immunome website for 90 days after the event for those who cannot join live.
Read Announcement
IM-1021 FDA Regulatory 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:
- October 23, 2025
- Indication:
- In Cancer therapies
Announcement
Immunome, Inc recently presented preclinical data showing its proprietary antibody-drug conjugate (ADC) payload HC74 overcomes multiple mechanisms of ADC resistance, including payload efflux and target heterogeneity.
AI Summary
Immunome, Inc., a biotech company, recently presented preclinical results showing its new antibody-drug conjugate payload HC74 can bypass common ADC resistance mechanisms. HC74, a topoisomerase I inhibitor, avoids drug efflux by transporters like ABCC1 and ABCB1 and shows strong membrane permeability. This leads to enhanced cancer-cell killing and bystander effects. In multiple tumor models, including colorectal cancer resistant to trastuzumab-DXd and irinotecan, ADCs with HC74 demonstrated significant efficacy. They also worked in tumors with acquired resistance to trastuzumab-DXd and in non-small cell lung cancer with uneven target expression. The data were shared in October 2025 at the AACR-NCI-EORTC International Conference in Boston. HC74 serves as the payload in IM-1021, a ROR1-targeted ADC in Phase 1 trials. These findings support HC74’s potential as a best-in-class ADC payload.
Read Announcement- 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
