MIRA Pharmaceuticals (MIRA)
Develops oral small-molecule candidates for pain, obesity, and addiction-related disorders.
MIRA Pharmaceuticals Advances Non-Opioid Oral MIRA-55 for Inflammatory Pain Toward IND
MIAMI, Sept. 01, 2026 (GLOBE NEWSWIRE) -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics, today announced positive results from completed 7-day dose-range finding toxicology and toxicokinetic studies of MIRA-55 in rats and dogs.
MIRA Reports Positive 7-Day Dog Study Results for SKNY-1
Obesity Treatment Candidate Designed to Preserve Lean Body Mass Toxicokinetic Findings De-Risk Dose Selection and Support Regulatory Pathway Toward IND MIAMI, Aug. 06, 2026 (GLOBE NEWSWIRE) -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics, today announced positive toxicokinetic findings from a 7-day repeated-dose study of SKNY-1 in Beagle dogs. The study demonstrates dose-dependent systemic exposure and rapid absorption that de-risk dose selection and support advancement toward GLP toxicology studies and IND-enabling development.
MIRA Pharmaceuticals Progresses MIRA-55 and SKNY-1 Toward IND-Enabling Studies
MIAMI, July 30, 2026 (GLOBE NEWSWIRE) -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics, today announced continued advancement of its two lead preclinical programs, MIRA-55, an investigational oral non-opioid drug candidate for chronic inflammatory pain, and SKNY-1, an investigational oral drug candidate for obesity and addiction-related disorders. Over the past several weeks, the Company has advanced both programs through multiple coordinated development activities, including formulation optimization, chemistry, manufacturing and controls (CMC) activities, manufacturing development, and exploratory non-GLP toxicology and toxicokinetic studies.
MIRA Pharmaceuticals Reports Successful Formulation Results Supporting Development of MIRA-55 as a Non-Opioid Oral Therapy for Chronic Inflammatory Pain
Optimized Oral Formulation Demonstrates Favorable Oral Bioavailability Together with Robust Brain and Liver Distribution Following Oral Administration MIAMI, FL / ACCESS Newswire / July 10, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company, today announced positive results from preclinical studies evaluating optimized oral formulations of MIRA-55, the Company's oral drug candidate being developed as a non-opioid therapy for chronic inflammatory pain. Following evaluation of multiple oral formulations, the Company selected a lead formulation demonstrating favorable oral bioavailability together with sustained systemic exposure and reproducible distribution into both brain and liver tissue following oral administration.
MIRA Pharmaceuticals Reports Successful Formulation Results for SKNY-1, Its Oral Drug Candidate for Obesity and Addiction
New Preclinical Data Demonstrate Favorable Oral Bioavailability, Robust Brain Penetration and Liver Exposure with Once-Daily Dosing Potential MIAMI, FL / ACCESS Newswire / July 6, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company, today announced positive results from preclinical studies evaluating the optimized oral formulation of SKNY-1, the Company's oral drug candidate being developed for obesity and addiction-related disorders. The studies demonstrated favorable oral bioavailability together with reproducible systemic exposure and robust brain penetration, and substantial liver exposure following oral administration.
MIRA Pharmaceuticals Reports New Preclinical Data Demonstrating Mira-55's Differentiated Mechanism of Action and Anxiolytic Activity Relative to THC
Data show Mira-55 does not produce the central nervous system effects associated with THC and acts through a distinct pharmacological mechanism, while demonstrating anxiolytic activity, which THC does not produce, supporting continued development for chronic inflammatory pain MIAMI, FL / ACCESS Newswire / June 25, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders, today announced new preclinical pharmacology data on Mira-55, the Company's cannabinoid analog in development for chronic inflammatory pain. Mira-55 is designed to act on the same cannabinoid receptors as compounds found in cannabis, including THC.
MIRA Pharmaceuticals Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral Neuropathy
Randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and dose-response efficacy of oral Ketamir-2 at a leading U.S. cancer center MIAMI, FL / ACCESS Newswire / June 17, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the submission of a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration (FDA) for Ketamir-2, the Company's proprietary oral NMDA receptor modulator, in chemotherapy-induced peripheral neuropathy (CIPN). Addressing a Significant Unmet Medical Need Chemotherapy-induced peripheral neuropathy is one of the most common and debilitating consequences of cancer treatment.
MIRA Pharmaceuticals Secures Worldwide Exclusive Rights to MIRA-55 and SKNY-1
Agreement Establishes Global Exclusivity Across MIRA's Core Therapeutic Pipeline and Enhances Strategic Flexibility for Future Licensing and Partnership Opportunities MIAMI, FL / ACCESS Newswire / June 4, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on the development of proprietary therapeutics for neurologic, neuropsychiatric, inflammatory, and metabolic disorders, today announced the execution of an Amended and Restated Exclusive License Agreement with MIRALOGX LLC, securing worldwide exclusive rights to MIRA-55 and SKNY-1. The amended agreement grants MIRA worldwide exclusive development, commercialization, sublicensing, and intellectual property enforcement rights relating to both programs.
MIRA Pharmaceuticals Secures Worldwide Rights for Ketamir-2, Expanding Global IP Portfolio Across 10 Major Markets Ahead of Phase 2a in CIPN
Expanded Global Intellectual Property Portfolio Enhances Strategic Flexibility and Long-Term Value Potential for Ketamir-2 MIAMI, FL / ACCESS Newswire / May 27, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on the development of proprietary therapeutics for neurologic, neuropsychiatric, inflammatory, and metabolic disorders, today announced the execution of Amendment No. 1 to its exclusive Ketamir-2 license agreement with MIRALOGX LLC, expanding the Company's licensed territory from the United States, Canada, and Mexico to worldwide rights across all countries in which patent rights exist.
MIRA Pharmaceuticals Reports Positive Unblinded Phase 1 Data for Ketamir-2
Selective oral NMDA receptor modulator demonstrated favorable safety, tolerability, and pharmacokinetic profile supporting planned Phase 2a development in chemotherapy-induced peripheral neuropathy MIAMI, FL / ACCESS Newswire / May 14, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), today announced positive unblinded results from its completed Phase 1 clinical trial evaluating Ketamir-2, the Company's proprietary selective oral NMDA receptor modulator. The randomized, double-blind, placebo-controlled Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2 in healthy volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.
MIRA Pharmaceuticals Announces Acceptance of Peer-Reviewed SKNY-1 Manuscript Highlighting Oral Obesity and Nicotine Addiction Drug Candidate
Peer-reviewed publication highlights preclinical findings demonstrating weight loss, lipid normalization, and reduction of compulsive feeding and nicotine-seeking behaviors MIAMI, FL / ACCESS Newswire / May 13, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on the development of investigational therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the acceptance and publication of a peer-reviewed manuscript describing the preclinical pharmacology and activity of SKNY-1, the Company's oral investigational drug candidate being evaluated for obesity and nicotine addiction, in the International Journal of Molecular Sciences. The publication, titled "SKNY-1, a THCV Analog, Produces Weight Loss, Lipid Normalization and Attenuation of Reward-Associated Behaviors in an mc4r(G894C) Zebrafish Model of Obesity," describes in vitro pharmacologic characterization and in vivo preclinical findings observed in an MC4R-deficient zebrafish model exhibiting obesity-associated metabolic and reward-related phenotypes.
Visionstate Reports 27% Q2 Revenue Growth as MIRA Platform Gains Traction
Edmonton, Alberta--(Newsfile Corp. - May 6, 2026) - Visionstate Corp. (TSXV: VIS) today reported its financial results for the second quarter ended March 31, 2026, highlighting 27% year-over-year revenue growth and increasing market traction for its MIRA compliance platform, as organizations accelerate adoption of compliance-driven solutions across multiple sectors. Revenue for the three-month period ended March 31, 2026, increased to $262,114, compared to $206,350 in the same period in 2025.
MIRA Pharmaceuticals Reports Mira-55 Shows No THC- or Rimonabant-Associated CNS Side Effects in Preclinical Studies
Previously shown to deliver morphine-comparable pain relief without opioid-related risks in a validated inflammatory pain model, supporting planned IND submission for inflammatory pain MIAMI, FL / ACCESS Newswire / March 23, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders, today announced new preclinical data demonstrating that Mira-55 did not produce cannabinoid-like central nervous system (CNS) side effects across a comprehensive battery of validated behavioral assays. The observed profile was differentiated from both Δ9-tetrahydrocannabinol (THC), the primary psychoactive component of cannabis, and the CB1 receptor antagonist rimonabant.
Visionstate Reports Accelerating Subscription Growth and Expansion of MIRA Compliance Platform
Edmonton, Alberta--(Newsfile Corp. - March 18, 2026) - Visionstate Corp. (TSXV: VIS) today provided an operational update highlighting continued subscription growth and expanding adoption of its MIRA compliance platform, building on the baseline metrics previously reported for fiscal 2026. Since the Company's last update, Visionstate has added 11 new location subscriptions across 12 installations during the period from early February through mid-March 2026, further strengthening its recurring revenue base.
MIRA Pharmaceuticals Completes Phase 1 Dosing of Ketamir-2
Advancing a selective oral NMDA receptor modulator toward Phase 2a in chemotherapy-induced peripheral neuropathy following favorable Phase 1 safety and tolerability findings MIAMI, FLORIDA / ACCESS Newswire / March 4, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications, today announced completion of dosing in its Phase 1 clinical trial evaluating Ketamir-2, the Company's proprietary selective oral NMDA receptor modulator. The randomized, double-blind, placebo-controlled study enrolled 56 healthy adult volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.
MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) Short Interest Up 29.4% in February
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA - Get Free Report) saw a large increase in short interest in the month of February. As of February 13th, there was short interest totaling 568,283 shares, an increase of 29.4% from the January 29th total of 439,335 shares. Based on an average daily volume of 136,480 shares, the short-interest ratio
Visionstate Repositions Under MIRA Compliance Platform and Reports Subscription Growth
Edmonton, Alberta--(Newsfile Corp. - February 19, 2026) - Visionstate Corp. (TSXV: VIS) today announced a strategic repositioning of its technology offerings under a unified compliance-focused platform brand, MIRA, and provided an update on subscription activity entering fiscal 2026. "For several years, Visionstate has been described primarily as an IoT (Internet of Things) facility management solution," said John Putters, CEO of Visionstate Corp. "As regulatory and operational accountability requirements increase, we believe it is more accurate to describe our business as a compliance-focused subscription platform.
MIRA Pharmaceuticals Initiates Final Cohort of Ketamir-2 Phase 1 Clinical Study as Company Prepares for Phase 2a Study
Company to Participate in BIO Partnering Summit and Present Phase 1 Ketamir-2 Data at American Association for Cancer Research (AACR)Annual Meeting MIAMI, FLORIDA / ACCESS Newswire / February 3, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications, today announced that it has initiated dosing in the final cohort of its Phase 1 multiple ascending dose (MAD) clinical trial evaluating Ketamir-2, its lead oral NMDA receptor antagonist. To date, 50 healthy volunteers have already been dosed, while dosing in the final cohort is underway, with 6 last subjects remaining.
MIRA Pharmaceuticals Initiates Multiple Ascending Dose (MAD) Phase 1 Study of Oral Ketamir-2 and Selects Chemotherapy-Induced Neuropathic Pain as Lead Phase 2a Indication
Advancing toward Phase 2a clinical evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track consideration MIAMI, FLORIDA / ACCESS Newswire / October 24, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the initiation of the multiple ascending dose (MAD) portion of its ongoing Phase 1 clinical trial evaluating its lead oral candidate, Ketamir-2, in healthy volunteers. The Company also announced that it has selected chemotherapy-induced peripheral neuropathy (CIPN) - a common and debilitating side effect of cancer treatment - as the lead indication for its planned Phase 2a clinical evaluation.
MIRA Pharmaceuticals Announces Oral Mira-55 Outperformed Injected Morphine in Normalizing Pain and Reducing Inflammation, Supporting Its Planned IND for Chronic Inflammatory Pain
Findings show oral Mira-55 fully normalized pain and significantly reduced inflammation, supporting IND plans and reinforcing MIRA's position in a $70 billion non-opioid pain market. MIAMI, FLORIDA / ACCESS Newswire / October 16, 2025 / MIRA Pharmaceuticals, Inc.