Mira Pharma Stock Price, News & Analysis

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.

MIRA Pharmaceuticals (NASDAQ:MIRA) announced shareholder approval for its acquisition of SKNY Pharmaceuticals, valued at a combined enterprise value of over $60 million. The transaction includes SKNY contributing $5 million in assets or cash to MIRA.

The acquisition brings SKNY-1, a novel oral therapeutic candidate targeting obesity and smoking cessation, to MIRA's pipeline. Preclinical studies showed promising results with up to 30% body weight reduction and nicotine craving reversal. The drug's unique mechanism selectively targets CB1 and CB2 receptors and MAO-B, potentially offering improved safety compared to earlier treatments.

The combined company aims to address markets projected to reach $150 billion for obesity therapeutics by early 2030s and $50.9 billion for smoking cessation by 2030.

MIRA Pharmaceuticals (NASDAQ:MIRA) has successfully completed the Single Ascending Dose (SAD) portion of its Phase 1 clinical trial for oral Ketamir-2, demonstrating favorable safety and tolerability with no severe adverse effects. The study, conducted at Hadassah Clinical Research Center in Israel, evaluated four cohorts with doses ranging from 50mg to 600mg across 32 participants.

The company is now advancing to the Multiple Ascending Dose (MAD) stage, which will test three cohorts with daily doses of 150mg, 300mg, and 600mg for five consecutive days in up to 24 participants. MIRA plans to initiate a Phase 2a trial for neuropathic pain in Q4 2025, targeting a market of 36-51 million people in North America.

MIRA Pharmaceuticals (NASDAQ:MIRA) announced the acceptance of a second peer-reviewed manuscript in Frontiers in Pharmacology highlighting their lead drug candidate Ketamir-2's superior performance in treating neuropathic pain. The study demonstrated that Ketamir-2 outperformed existing treatments like ketamine, pregabalin, and gabapentin in preclinical models.

The global neuropathic pain market, valued at $7.97 billion in 2024, is projected to reach $16.79 billion by 2034, growing at a CAGR of 7.73%. In the U.S., the market is expected to grow from $2.79 billion to $5.92 billion by 2034.

The company is progressing with its Phase 1 trial in Israel and plans to submit a Phase 2a clinical trial protocol to the FDA in Q4 2025, targeting study initiation by year-end.

MIRA Pharmaceuticals (NASDAQ:MIRA) announced promising preclinical data for its topical Ketamir-2 cream, demonstrating comparable pain relief efficacy to injected morphine in a validated animal model. The study showed the cream effectively reduced both acute and inflammatory pain behaviors, with rapid onset and durable effects.

The research utilized the formalin model to evaluate pain responses, with Ketamir-2 showing strong performance in both initial acute phase and prolonged inflammatory phase. The company is developing Ketamir-2 in both oral and topical forms, targeting the $11.5 billion U.S. topical pain market. MIRA plans to begin a Phase 2a neuropathic pain trial for the oral formulation by year-end, following their current Phase 1 trial in healthy volunteers.

MIRA Pharmaceuticals (NASDAQ:MIRA) announced FDA clearance of its IND application for Ketamir-2, a novel oral NMDA receptor antagonist for neuropathic pain treatment. The drug has shown superior efficacy to existing treatments in preclinical studies, demonstrating up to 112% greater pain relief than pregabalin and 70% more than gabapentin.

The company is completing the Single Ascending Dose (SAD) portion of its Phase 1 trial and preparing for Multiple Ascending Dose (MAD) studies. MIRA plans to initiate a U.S. Phase 2a clinical trial in Q4 2025. Additionally, MIRA's acquisition of SKNY Pharmaceuticals is expected to close in Q3 2025, bringing SKNY-1, a promising obesity and smoking cessation drug candidate, to its pipeline.

MIRA Pharmaceuticals (NASDAQ:MIRA) announced promising new preclinical results for SKNY-1, their oral drug candidate for obesity and nicotine addiction. The drug demonstrated clear reversal of anxiety-related behavior in animal models, while maintaining its previously shown benefits of up to 30% weight loss and craving reduction.

SKNY-1, which is currently under a definitive acquisition agreement, targets the Cannabinoid 1 receptor (CB1) without the serious central nervous system side effects that led to the discontinuation of earlier CB1-targeting drugs. The compound has shown ability to reverse high-calorie food and nicotine cravings while preserving muscle mass in preclinical studies.