Immunome Announces Submission of New Drug Application to U.S. FDA for Varegacestat for the Treatment of Adults with Desmoid Tumors
Immunome, Inc. (IMNM)
Company Research
Source: Business Wire
New Drug Application (NDA) supported by positive Phase 3 RINGSIDE results, including significant improvement in progression-free survival vs. placebo (hazard ratio = 0.16, pTrial also met all key secondary endpoints, with varegacestat delivering an objective response rate of 56%Detailed Phase 3 RINGSIDE data selected for oral presentation at the 2026 ASCO Annual Meeting BOTHELL, Wash.--(BUSINESS WIRE)--Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced 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.“The varegacestat NDA submission marks an important milestone for Immunome. It reflects the strength of the RINGSIDE dataset and the commitment of the team advancing this program,” said Clay B. Siegall, Ph
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News
- A Look At Immunome (IMNM) Valuation As Varegacestat Nears ASCO 2026 Spotlight And FDA NDA Filing [Yahoo! Finance]Yahoo! Finance
- Immunome Announces Oral Presentation of Phase 3 RINGSIDE Data at 2026 ASCO Annual Meeting [Yahoo! Finance]Yahoo! Finance
- Immunome Announces Oral Presentation of Phase 3 RINGSIDE Data at 2026 ASCO Annual MeetingBusiness Wire
- Immunome's Chief Scientist Trimmed His Stake. A Planned FDA Submission Tells You More [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- Immunome's Chief Scientist Trimmed His Stake. A Planned FDA Submission Tells You More [Yahoo! Finance]Yahoo! Finance
IMNM
Earnings
- 8/6/25 - Beat
IMNM
Sec Filings
- 4/24/26 - Form DEFA14A
- 4/24/26 - Form ARS
- 4/24/26 - Form DEF
- IMNM's page on the SEC website