MIRA's Ketamir-2 Clears FDA Review, Heads to IRB for Phase 2a CIPN Trial
MIRA sits 18% above its 52-week low of $0.6 on light trading volume (0.1× avg).
Summary
MIRA Pharmaceuticals has completed FDA review of its Ketamir-2 Phase 2a protocol for chemotherapy-induced peripheral neuropathy (CIPN) and submitted it for IRB review at a leading cancer research institution. The company is targeting site initiation in Q1 2027. This is the first clinical evaluation of Ketamir-2 in patients, moving beyond Phase 1 healthy volunteer data. The study is a randomized, double-blind, placebo-controlled crossover design testing 300 mg and 600 mg doses. This follows the 8-K filed today announcing the FDA review completion. The company faces going concern risk with cash into Q1 2027, so advancing this asset is critical. Watch for IRB approval and site activation timing.
At the time of this announcement, 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 news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.