Welcome to our dedicated page for Mira Pharma news (Ticker: MIRA), a resource for investors and traders seeking the latest updates and insights on Mira Pharma stock.
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) generates a steady flow of news as a clinical-stage biopharmaceutical company advancing oral and topical therapies for neurologic, neuropsychiatric, metabolic, and pain-related disorders. Company press releases and Form 8-K filings highlight progress across its pipeline, including Ketamir-2 for neuropathic pain and CNS indications, MIRA-55 for chronic inflammatory and nociceptive pain, and SKNY-1 for obesity and nicotine addiction following the acquisition of SKNY Pharmaceuticals.
On this news page, readers can follow updates on clinical trial milestones for Ketamir-2, such as completion of the single ascending dose Phase 1 study, initiation of the multiple ascending dose phase, and plans for Phase 2a evaluation in chemotherapy-induced peripheral neuropathy. News items also cover preclinical data releases, including peer-reviewed publications and conference presentations describing Ketamir-2’s performance versus ketamine, gabapentin, and pregabalin in validated neuropathic pain models, as well as topical Ketamir-2 data showing effects comparable to injected morphine in acute and inflammatory pain models.
MIRA’s news flow further includes pipeline expansion and transaction announcements, such as the closing of the SKNY Pharmaceuticals acquisition and new preclinical results for MIRA-55 demonstrating oral pain normalization and inflammation reduction relative to morphine. Corporate and financing updates, including at-the-market equity offerings and Nasdaq listing compliance developments, are also reported through current reports and press releases.
Investors, clinicians, and researchers can use this page to monitor how MIRA’s programs evolve from preclinical studies into human trials, track regulatory milestones like FDA IND clearance, and review strategic decisions that shape the company’s multi-program portfolio in neuropathic pain, chronic inflammatory pain, obesity, addiction, PTSD, and related areas.
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.
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.