MIRA Advances Ketamir-2 to Phase 2a in CIPN After FDA Review
MIRA sits 18% above its 52-week low of $0.6 on light trading volume (0.1× avg).
Summary
MIRA Pharmaceuticals announced FDA review of its Ketamir-2 Phase 2a protocol is complete, with the protocol now submitted for IRB review and site initiation targeted for Q1 2027.
Key Events · Product Development and Regulatory · MIRA
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FDA Review Complete
FDA reviewed the Ketamir-2 Phase 2a protocol for CIPN; MIRA incorporated feedback and submitted the protocol for IRB review at a leading cancer research institution.
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Phase 2a Study Design
Randomized, double-blind, placebo-controlled, three-period crossover study evaluating 300 mg and 600 mg doses in adults with moderate-to-severe persistent CIPN.
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Site Initiation Timeline
Targeting site initiation in Q1 2027, subject to IRB review and routine site activation requirements.
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Upcoming Presentations
Oral presentation at International Conference on Addiction and Psychiatry in Tokyo on October 5-6, 2026; BioJapan participation for licensing and partnership discussions.
Analysis · MIRA · Life Sciences
MIRA Pharmaceuticals has cleared a key regulatory milestone: the FDA reviewed the Phase 2a protocol for Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN), and the company incorporated the agency's feedback and submitted the protocol for IRB review at a leading cancer research institution. This is the first clinical evaluation of Ketamir-2 in patients, moving beyond healthy-volunteer Phase 1 data. The company is targeting site initiation in Q1 2027. Against a backdrop of going-concern risk and a Nasdaq delisting notice, this advancement is a concrete step toward generating efficacy data that could support licensing or partnership discussions — the company explicitly notes ongoing talks at BioJapan in October.
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At the time of this filing, MIRA was trading at $0.71 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $30.2M. The 52-week trading range was $0.60 to $2.45. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.