MIRA

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.