Mira Pharma Stock Price, News & Analysis

MIRA Pharmaceuticals (NASDAQ:MIRA) announced positive preclinical results for Mira-55, its proprietary non-psychotropic marijuana analog, which demonstrated morphine-comparable pain relief in inflammatory pain models without causing inflammation. The drug, engineered to selectively activate CB2 cannabinoid receptors, reduced pain sensitivity by approximately threefold while avoiding euphoria and sedation risks.

Key developments include the DEA's determination that Mira-55 is not classified as a controlled substance, enhancing its clinical and commercial potential. Additionally, MIRA reported progress on its merger with SKNY Pharmaceuticals, whose SKNY-1 therapy showed 30% body weight reduction and nicotine craving reversal in recent studies. The SEC completed its merger proxy review without comments.

[ "Mira-55 demonstrated morphine-equivalent pain relief without addiction or sedation risks", "DEA determined Mira-55 is not a controlled substance, removing development barriers", "SKNY-1 acquisition target showed 30% body weight reduction in studies", "SEC completed merger proxy review with no comments, accelerating SKNY acquisition", "Company advancing two complementary non-opioid pain treatments (Mira-55 and Ketamir-2)" ]

MIRA (NASDAQ:MIRA) has announced promising results from animal studies of SKNY-1, an oral therapeutic candidate under definitive agreement for acquisition. The drug demonstrated up to 30% weight loss and reversed high-calorie and nicotine cravings in zebrafish models within six days of treatment.

Key findings include significant metabolic improvements without muscle loss, normalized liver fat and cholesterol levels, and reduced appetite and nicotine-seeking behaviors. The drug achieved these results through selective modulation of CB1 receptors and activation of CB2 receptors, while maintaining a favorable safety profile.

SKNY-1 is being developed as an oral alternative to GLP-1 injectables, addressing limitations of current obesity and smoking cessation treatments. The compound's unique mechanism targets a combined global market opportunity exceeding $200 billion. Following the acquisition of SKNY Pharmaceuticals, Inc., MIRA plans to advance SKNY-1 toward IND-enabling studies.

MIRA Pharmaceuticals (NASDAQ:MIRA) has revealed promising new in vitro preclinical data for SKNY-1, a novel drug candidate pending acquisition through SKNY Pharmaceuticals. The oral therapy targets both weight loss and smoking cessation markets through a dual-receptor strategy.

SKNY-1 functions as a biased CB1 modulator and partial CB2 agonist, designed to avoid the psychiatric side effects that led to the withdrawal of previous cannabinoid-based therapies. The drug selectively blocks β-arrestin signaling while preserving G-protein signaling, potentially enabling weight reduction and decreased cravings without mood disruption.

The compound also features mild MAO-B inhibition for dopamine regulation, positioning it as a differentiated alternative to injectable GLP-1 drugs. The global obesity drug market is projected to exceed $150 billion by 2030, while the U.S. smoking cessation market is expected to grow from $28 billion in 2024 to over $50 billion by decade's end.

MIRA Pharmaceuticals announced the acceptance of its first manuscript on Ketamir-2, their lead drug candidate, in Frontiers in Pharmacology. The publication validates Ketamir-2's differentiated pharmacology as a novel ketamine analog, highlighting its selective NMDA receptor antagonism, favorable safety profile, and oral bioavailability. Key findings show Ketamir-2's clean pharmacological profile with minimal off-target effects, no hyperlocomotion even at high doses, and demonstrated antidepressant and anxiolytic activity. The company's Phase 1 trial for neuropathic pain is progressing well, with plans to initiate Phase 2a trials by year-end 2025. Additionally, MIRA confirmed its acquisition of SKNY Pharmaceuticals, which includes SKNY-1, a CB1/CB2 inverse agonist for obesity and smoking cessation, is proceeding as planned.

MIRA Pharmaceuticals (NASDAQ:MIRA) announced its participation in the BIO International Convention 2025 in Boston from June 16-19, where it will explore potential licensing, partnerships, and M&A opportunities. The company reported progress on multiple fronts: its lead candidate Ketamir-2, an oral ketamine analog, has completed its second dosing cohort in Phase 1 trials and is preparing for Phase IIa studies in neuropathic pain by year-end. MIRA is also conducting preclinical studies for Ketamir-2 in PTSD and developing a topical formulation for localized inflammatory pain. Additionally, the company is finalizing regulatory filings for its acquisition of SKNY Pharmaceuticals, whose candidate SKNY-1 targets smoking cessation and obesity through CB1, CB2, and MAO-B receptor activity.

MIRA Pharmaceuticals (NASDAQ: MIRA) has announced its Board's approval for the acquisition of SKNY Pharmaceuticals, with a combined enterprise value exceeding $60 million based on independent valuations. The merger, pending shareholder approval, includes a $5 million contribution from SKNY in cash or assets at closing. Moore Financial Consulting valued SKNY at $30.5 million and MIRA at $30 million. SKNY's lead compound, SKNY-1, targets both obesity and nicotine dependence through a novel mechanism modulating CB1/CB2 cannabinoid receptors and MAO-B. The acquisition positions MIRA in two high-growth markets: the global weight loss drug market (projected to exceed $150 billion by 2030) and the U.S. smoking cessation market (expected to reach $50.90 billion by 2030).

MIRA Pharmaceuticals (NASDAQ:MIRA) announced positive results from an FDA-required neurotoxicity study for its novel oral drug Ketamir-2, an NMDA receptor antagonist. The study revealed no evidence of brain toxicity, particularly the absence of Olney lesions commonly associated with ketamine and similar drugs. Ketamir-2, designed as a non-controlled substance with strong oral bioavailability, has shown promising preclinical results including full reversal of pain thresholds in neuropathic pain models, outperforming existing treatments like gabapentin. The company is currently conducting a Phase I clinical trial and preparing for a Phase IIa proof-of-concept trial in diabetic patients with neuropathic pain.

MIRA Pharmaceuticals (NASDAQ:MIRA) has announced positive in vitro release testing (IVRT) results for its topical Ketamir-2 formulation, targeting the $11.5B U.S. topical pain relief market. The 5% ointment formulation demonstrated consistent and dose-proportional release in Franz diffusion cell model testing.

The company is advancing preclinical studies to evaluate the topical formulation for inflammatory and neuropathic pain conditions. The development aims to address chronic pain affecting 51.6 million U.S. adults, including osteoarthritis (32.5 million adults) and diabetic peripheral neuropathy (28% of diabetic adults).

MIRA is exploring FDA Fast Track designation possibilities and is simultaneously conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers, with plans for a Phase 2a study in diabetic neuropathy.

MIRA Pharmaceuticals (NASDAQ:MIRA) has announced positive results for its oral ketamine analog Ketamir-2 in a diabetic neuropathy animal model. The study demonstrated significant reduction in neuropathic pain symptoms, with some subjects achieving complete reversal to pre-diabetic baseline sensitivity.

The company is currently conducting a Phase I clinical trial at Hadassah Medical Center, with completion expected in Q4 2025. MIRA plans to initiate a Phase IIa trial in diabetic neuropathy patients by year-end, with first human efficacy data expected in H1 2026.

Ketamir-2 has shown superior performance compared to FDA-approved medications like pregabalin and gabapentin in preclinical studies. Unlike traditional ketamine, it doesn't cause dissociative effects and offers better blood-brain barrier penetration. The company is also developing a topical slow-release formulation and exploring applications for PTSD treatment.