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MIRA Pharmaceuticals, Inc. develops oral small-molecule therapeutics for neurologic, neuropsychiatric, metabolic and inflammatory disorders. Recurring company news centers on Ketamir-2, a selective oral NMDA receptor modulator studied for neuropathic pain, including chemotherapy-induced peripheral neuropathy, and on clinical safety, tolerability and pharmacokinetic findings from Phase 1 testing.
Updates also cover Mira-55, a cannabinoid analog designed to modulate CB1 and CB2 receptor activity while limiting central nervous system side effects, with preclinical work in inflammatory pain. Following the completed acquisition of SKNY Pharmaceuticals, MIRA’s pipeline also includes SKNY-1 for obesity and nicotine addiction. Company announcements additionally address shareholder voting matters, operating and financial results, capital actions and other corporate developments.
MIRA (NASDAQ:MIRA) reported positive unblinded Phase 1 data for Ketamir-2, an oral selective NMDA receptor modulator. The randomized, double-blind, placebo-controlled SAD/MAD trial enrolled 57 healthy volunteers with no withdrawals or serious adverse events.
Adverse events were mostly mild and occurred more often on placebo. Pharmacokinetics showed rapid absorption, dose-proportional Cmax, and half-lives supporting potential once-daily dosing, subject to further evaluation. MIRA plans a Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy, a condition with no FDA-approved therapies and a market projected at $1.7 billion by 2035.
MIRA Pharmaceuticals (NASDAQ:MIRA) announced acceptance of a peer-reviewed manuscript on SKNY-1, its oral investigational candidate for obesity and nicotine addiction, in the International Journal of Molecular Sciences.
The zebrafish preclinical data show dose‑dependent weight loss of about 30%, improved lipid markers, and reduced compulsive feeding and nicotine-seeking, while additional mammalian and safety studies are still required.
MIRA (NASDAQ:MIRA) reported preclinical data showing Mira-55 produced morphine-comparable analgesia in a validated inflammatory pain model and did not produce THC- or rimonabant-like CNS side effects across behavioral assays at oral doses up to 100 mg/kg.
Findings support advancement toward IND-enabling studies for inflammatory pain and show a dose-dependent increase in open-arm time on the Elevated Plus Maze, without sedation, catalepsy, or motor impairment.
MIRA (NASDAQ:MIRA) completed dosing in its Phase 1 study of Ketamir-2 on March 4, 2026, enrolling 56 healthy volunteers across SAD and MAD cohorts. No serious adverse events or dose-limiting toxicities were reported, and no clinically significant dissociative effects were observed.
Database lock, unblinding, and final audited pharmacokinetic and safety analyses are underway, and Phase 1 data are accepted for AACR presentation. MIRA aims to file a Phase 2a protocol to the FDA under its active IND in H1 2026 targeting chemotherapy-induced peripheral neuropathy.
MIRA (NASDAQ:MIRA) initiated dosing in the final cohort of its Phase 1 multiple ascending dose study of Ketamir-2, an oral NMDA receptor antagonist. To date, 50 healthy volunteers have been dosed and 6 subjects remain.
The company expects to complete Phase 1 by end of Q1 2026, plans to submit a Phase 2a protocol for chemotherapy-induced peripheral neuropathy (CIPN) to the FDA, and anticipates initiating Phase 2a in Q2 2026, subject to regulatory feedback. MIRA will seek Fast Track designation and present Phase 1 data at AACR April 17-22, 2026.
MIRA (NASDAQ:MIRA) announced initiation of the multiple ascending dose (MAD) portion of its Phase 1 trial for oral Ketamir-2 in healthy volunteers and selected chemotherapy-induced peripheral neuropathy (CIPN) as the lead Phase 2a indication on October 24, 2025.
The randomized, double-blind, placebo-controlled study follows completed single ascending dose (SAD) dosing with no serious or dose-limiting adverse events reported to date. MAD cohorts will test repeat daily doses from 150 mg to 600 mg for five days. Pharmacokinetic analyses will be performed after unblinding. Preclinical and peer-reviewed data reported near-complete normalization of pain in a paclitaxel model and superiority versus ketamine, gabapentin, and pregabalin in animal neuropathic pain models.
MIRA (NASDAQ:MIRA) announced preclinical results on October 16, 2025 showing that oral Mira-55 normalized pain thresholds and significantly reduced inflammation in a formalin-induced inflammatory pain animal model, outperforming injected morphine.
The study measured pain with Von Frey testing and inflammation via paw-edema volume, reporting direct CB2 receptor–mediated anti-inflammatory effects for Mira-55 versus partial, centrally mediated effects for morphine. Results support MIRA's plan to pursue an IND for chronic inflammatory pain and reinforce positioning in a projected non-opioid pain market valued at USD 70.3B by 2030.
MIRA Pharmaceuticals (NASDAQ:MIRA) has completed its acquisition of SKNY Pharmaceuticals, gaining $5 million in marketable securities and expanding its pipeline with SKNY-1, a novel therapy for obesity and nicotine addiction. SKNY-1 has shown promising preclinical results, including up to 30% body weight reduction without muscle loss.
The company's portfolio now includes three key programs: SKNY-1 for obesity and smoking cessation, Ketamir-2 (which recently showed positive Phase 1 SAD results), and MIRA-55 for inflammatory pain. This strategic acquisition strengthens MIRA's position in addressing major unmet needs across neurologic, neuropsychiatric, and metabolic disorders.
MIRA Pharmaceuticals (NASDAQ:MIRA) announced positive topline results from its Phase 1 single ascending dose (SAD) study of Ketamir-2, its novel oral ketamine analog for neurologic disorders. The study, involving 32 healthy adults across four dose cohorts (50-600mg), demonstrated favorable safety and pharmacokinetic profiles.
Key findings include dose-proportional exposure, rapid absorption within 1-2 hours, and a terminal half-life of 2-5 hours for Ketamir-2, with its active metabolite showing 6.5-8.5 hours half-life. The drug was well-tolerated with no serious adverse events or typical ketamine-associated CNS side effects, supporting once-daily dosing potential.
MIRA is proceeding with the multiple ascending dose (MAD) portion of the Phase 1 study, followed by a planned Phase 2a trial in neuropathic pain patients.
MIRA Pharmaceuticals (NASDAQ:MIRA) has reported positive results for its oral drug candidate Ketamir-2 in a PTSD animal model study. The drug successfully restored normalized behavior in stressed rats using the Single Prolonged Stress (SPS) model, demonstrating potential efficacy for PTSD treatment.
The study showed that Ketamir-2, currently in Phase 1 clinical trials for neuropathic pain, reversed PTSD-like behaviors in animals after five days of oral administration. This development is significant given that PTSD affects 13 million U.S. adults annually, with an economic burden of $232 billion, and only two FDA-approved medications currently available.