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NEWS
IMUNON Announces Positive CMC Meeting with FDA for IMNN-001 in Treatment of Advanced Ovarian Cancer
Thursday, 19th December at 8:05 am
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 to initiate the 500-patient Phase 3 trial of IMNN-001 in the first quarter of 2025.
Thursday, 19th December at 8:05 am
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 to initiate the 500-patient Phase 3 trial of IMNN-001 in the first quarter of 2025.
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