IMUNON Announces Positive CMC Meeting with FDA for IMNN-001 in Treatment of Advanced Ovarian Cancer
Imunon, Inc. (IMNN)
Company Research
Source: GlobeNewswire
Company aligned with FDA on CMC strategy and requirements in preparation of Phase 3 pivotal trial of IMNN-001 Vertical integration of major components assures a high-quality, commercially viable future manufacturing capability On track to initiate Phase 3 pivotal trial of IMNN-001 in first quarter of 2025 LAWRENCEVILLE, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the positive outcome of a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) regarding production of IMNN-001 for the treatment of women with newly diagnosed advanced ovarian cancer. The goal of the meeting was to seek alignment and agreement with the FDA on key CMC topics to support IMNN-001 production for the planned Phase 3 pivotal trial and a potential future new biologic license application (BLA) submission. IMUNON remains on track
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News
- Imunon, Inc. (NASDAQ: IMNN) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $12.00 price target on the stock.MarketBeat
- Imunon, Inc. (NASDAQ: IMNN) had its "buy" rating re-affirmed by analysts at D. Boral Capital. They now have a $29.00 price target on the stock.MarketBeat
- IMUNON Announces Positive CMC Meeting with FDA for IMNN-001 in Treatment of Advanced Ovarian Cancer [Yahoo! Finance]Yahoo! Finance
- Imunon, Inc. (NASDAQ: IMNN) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $12.00 price target on the stock.MarketBeat
- Imunon, Inc. (NASDAQ: IMNN) had its "buy" rating re-affirmed by analysts at D. Boral Capital. They now have a $29.00 price target on the stock.MarketBeat
IMNN
Sec Filings
- 12/19/24 - Form 4
- 11/27/24 - Form 8-K
- 11/14/24 - Form SC
- IMNN's page on the SEC website