MIRA Pharmaceuticals, Inc. - Common Stock (MIRA)

MIAMI, FL / ACCESS Newswire / March 4, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQMIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced the approval and upcoming initiation of its Phase 1 clinical trial for Ketamir-2, the Company's novel oral ketamine analog in development for neuropathic pain, with subject recruitment scheduled to begin in Q1 2025.

MIAMI, FLORIDA / ACCESSWIRE / December 19, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQMIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ketamir-2, its novel oral ketamine analog for the treatment of neuropathic pain. The IND submission marks a major step in advancing Mira's lead drug candidate while reflecting its commitment to meeting milestones and timelines.

Strong Safety Profile Validated Across Studies, Setting the Stage for Clinical Trials in Neuropathic Pain

Backed by a Strong Balance Sheet, MIRA Accelerates Toward Becoming a Clinical-Stage Company and Advancing Breakthroughs in Pain and Depression Treatment

Promising Preclinical Results Position Ketamir-2 as a Potential Breakthrough Therapy That Surpasses Current Treatments, With Results to Be Presented at the Pain Therapeutics Summit in Boston

MIAMI, FL / ACCESSWIRE / October 21, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQMIRA), a leading pre-clinical-stage pharmaceutical development company, is excited to announce that its novel oral ketamine analog, Ketamir-2, has shown greater pain relief compared to FDA-approved treatments Gabapentin (Neurontin) and Pregabalin (Lyrica). Ketamir-2, a non-opioid, offers tremendous promise for patients seeking better solutions for neuropathic pain without the habit-forming risks or debilitating side effects associated with existing medications.

Study Highlights Superior Efficacy of Ketamir-2 Over Oral Ketamine, Achieving Full Normalization of Pain Thresholds

Latest positive preclinical data provides another step in the path to potential IND submission this year for novel ketamine analog

Conference presentation delivers preclinical results demonstrating Ketamir-2 achieves 100% reversal of neuropathic pain

MIAMI, FL / ACCESSWIRE / September 18, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQMIRA), a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders, today announced significant progress in the clinical development planning for its novel oral ketamine analog. As part of its strategic development plan, MIRA is prioritizing the early demonstration of clinical efficacy, potentially as early as 2025, through innovative Phase I/II study designs.

MIAMI, FL / ACCESSWIRE / September 11, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQMIRA), a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders, announced today that it has selected neuropathic pain as the initial and primary indication for its novel oral ketamine analog, Ketamir-2. The company has submitted a request for a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) and anticipates the meeting to occur in November 2024. All ongoing regulatory IND-enabling studies are advancing smoothly, and MIRA remains on track to submit its IND to the FDA by the end of this year, with human trials expected to begin in the first quarter of 2025.

MIAMI, FL / ACCESSWIRE / August 19, 2024 / MIRA Pharmaceuticals Inc. (NASDAQMIRA) "MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company, is pleased to provide a comprehensive update on its recent achievements and scientific advancements as it nears a crucial milestone: the submission of its Investigational New Drug (IND) application by the end of the year. This update highlights the company's strategic progress, significant scientific breakthroughs, and the expertise driving its innovative drug candidates toward clinical trials.

This breakthrough in bioavailability and formulation showcases the potential for advanced, at home neurological treatments.

New findings highlight potential advantages of MIRA's novel oral ketamine analog for treating neurological and neuropsychiatric disorders

Testing confirms MIRA's preliminary beliefs regarding potential treatment for neurological and neuropsychiatric disorders

PHOENIX, AZ / ACCESSWIRE / August 9, 2023 / The Stock Day Podcast welcomed MIRA Pharmaceuticals, Inc.(Nasdaq:MIRA) ("the Company"), a pre-clinical-stage pharmaceutical development company developing a Novel synthetic THC analog. CEO of the Company, Erez Aminov, joined Stock Day host Kevin Davis following the company's NASDAQ IPO.