Every material Form 8-K MIRA PHARMACEUTICALS, INC. has filed with the SEC since September 17, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
MIRA Pharmaceuticals announced initial results from an exploratory preclinical pilot study of SKNY-1, its oral obesity drug candidate, in diet-induced obese mice. The study reported statistically significant reductions in body weight and fat mass versus vehicle controls, and compared SKNY-1 with semaglutide on food intake, lean mass, and weight regain, but these are early animal results with no financial figures disclosed.
Oral SKNY-1 produced statistically significant reductions in body weight and fat mass versus vehicle-treated mice in a diet-induced obesity model.
At Day 14, SKNY-1 mice showed no statistically significant lean-mass loss, while semaglutide mice showed statistically significant lean-mass loss.
During a two-week observation period after treatment stopped, SKNY-1 mice showed slow, limited weight regain, versus rapid rebound with semaglutide.
The press release is dated October 29, 2026; the company says its next study will measure energy expenditure and metabolic parameters.
MIRA Pharmaceuticals reported positive results from a 21-day preclinical study of oral MIRA-55 in a chronic inflammatory pain model, with pain relief it describes as comparable to celecoxib (Celebrex). The study is early-stage animal work, and the company plans an IND submission in the first quarter of 2027. The filing contains no financial results, so it does not change reported revenue, profit or guidance.
Study used 72 male and female rats over 21 days in the Complete Freund's Adjuvant model, run by an independent contract research organization.
MIRA-55 significantly reduced mechanical and thermal pain hypersensitivity versus vehicle (p < 0.001); no statistically significant difference from celecoxib was observed.
Company plans an IND submission for MIRA-55 in the first quarter of 2027, subject to remaining preclinical and regulatory work.
The U.S. Drug Enforcement Administration has determined MIRA-55 is not a controlled substance; safety and efficacy in humans have not been established.
MIRA Pharmaceuticals said the Phase 2a protocol for Ketamir-2 in chemotherapy-induced peripheral neuropathy has been submitted for Institutional Review Board review at a leading cancer research institution, after incorporating FDA feedback. The company is targeting site initiation in the first quarter of 2027, subject to IRB review and other routine site activation requirements. The filing contains no financial figures, so the update is a clinical development milestone rather than a change to reported results.
Phase 2a protocol submitted for IRB review at a leading cancer research institution, after FDA review and comments
Site initiation targeted for the first quarter of 2027, subject to IRB review and routine site activation requirements
Randomized, placebo-controlled, three-period crossover study with 300 mg and 600 mg Ketamir-2 doses and seven-day treatment periods
Dr. Itzchak Angel to present Ketamir-2 data at a conference in Tokyo, Japan, on October 5–6, 2026
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