MIRA Pharmaceuticals

MIRA

Market cap $30.9M

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.

Closing adds $5 million in marketable securities, strengthens financial position, and complements MIRA's advancing programs including Ketamir-2 and MIRA-55 MIAMI, FLORIDA / ACCESS Newswire / September 30, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that it has completed its acquisition of SKNY Pharmaceuticals, Inc. ("SKNY"). As part of the transaction, SKNY fulfilled all closing obligations, contributing $5 million in marketable securities to MIRA, further strengthening the Company's balance sheet.

Study demonstrated Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption, a favorable duration of action supporting once-daily dosing, and no CNS side effects typically seen with ketamine.

MIRA advances Ketamir-2 in the clinic for neuropathic pain while broadening development into neuropsychiatric disorders such as PTSD MIAMI, FLORIDA / ACCESS Newswire / September 16, 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 positive results demonstrating that its oral drug candidate Ketamir-2 restored normalized behavior in stressed animals within a validated model of post-traumatic stress disorder (PTSD). Ketamir-2 is currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a favorable safety profile to date.

SKNY transaction strengthens MIRA pipeline with SKNY-1, a differentiated oral candidate that has demonstrated up to 30% weight loss and nicotine craving reversal in preclinical studies. MIAMI, FL / ACCESS Newswire / September 12, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that its stockholders have approved the acquisition of SKNY Pharmaceuticals, Inc. ("SKNY") at the Company's 2025 Annual Meeting of Stockholders.

Following FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025 MIAMI, FL / ACCESS Newswire / August 19, 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 successful completion of the Single Ascending Dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2. The study, conducted at the Hadassah Clinical Research Center in Israel under the direction of Principal Investigator Prof.

Manuscript accepted for publication in Frontiers in Pharmacology, "Oral Administration of Ketamir-2, a Novel Ketamine Analog, Attenuates Neuropathic Pain in Rodent Models via Selective NMDA Antagonism" details Ketamir-2's superior performance in two validated neuropathic pain models and supports advancement to Phase 2a clinical trials by year-end 2025. MIAMI, FL / ACCESS Newswire / August 12, 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 acceptance of a second peer-reviewed manuscript describing its lead oral drug candidate, Ketamir-2, in Frontiers in Pharmacology.

Topical Ketamir-2 significantly reduced both acute and inflammatory pain behaviors in animals, demonstrating rapid onset, durable effect, and comparable efficacy to injected morphine across both pain phases MIAMI, FLORIDA / ACCESS Newswire / July 30, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced new preclinical data showing that its topical Ketamir-2 cream delivered similar and consistent pain relief compared with injected morphine in a validated animal model of acute and inflammatory pain. In the study, Ketamir-2 cream was applied topically to the affected area 30 minutes before pain was induced using the formalin model, a widely accepted preclinical method for evaluating both acute and inflammatory pain.

Oral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose (SAD) portion as the Company prepares to launch U.S. Phase 2a by year-end MIAMI, FLORIDA / ACCESS Newswire / July 29, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Ketamir-2, a novel oral NMDA receptor antagonist for the treatment of neuropathic pain. The IND submission included a comprehensive data package encompassing preclinical pharmacology, safety, and toxicology studies, including a pivotal neurotoxicity study in Sprague-Dawley rats which showed no evidence of brain lesions or adverse CNS effects-a key distinction from traditional ketamine, which has been associated with NMDA-linked neurotoxicity and the formation of Olney lesions in similar preclinical models.

SKNY-1 was previously shown to achieve up to 30% weight loss, reverse nicotine craving, and preserve muscle mass in an animal model-and is designed to avoid the CNS side effects that halted earlier CB1-targeting drugs MIAMI, FL / ACCESS Newswire / July 11, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) today announced new preclinical results from SKNY-1, an oral drug candidate for obesity and nicotine addiction currently under definitive agreement for acquisition. In a validated behavioral model used to measure Cannabinoid 1 receptor (CB1) related anxiety-like effects, SKNY-1 demonstrated clear reversal of anxiety-related behavior induced by a CB1 activator, setting it apart from earlier CB1-targeting drugs that were discontinued due to serious central nervous system (CNS) effects.