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03.02.2026
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MIRA Pharmaceuticals Initiates Final Cohort of Ketamir-2 Phase 1 Clinical Study as Company Prepares for Phase 2a Study
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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 ora...
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24.10.2025
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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
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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 devel...
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16.10.2025
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MIRA Pharmaceuticals Announces Oral Mira-55 Outperformed Injected Morphine in Normalizing Pain and Reducing Inflammation, Supporting Its Planned IND for Chronic Inflammatory Pain
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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. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmace...
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20.10.2025
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30.09.2025
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MIRA Pharmaceuticals Closes Acquisition of SKNY Pharmaceuticals, Expands Pipeline with SKNY-1 for Obesity and Nicotine Addiction
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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...
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23.01.2026
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22.09.2025
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MIRA Pharmaceuticals Announces Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine Analog
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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 k...
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16.09.2025
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MIRA Pharmaceuticals Reports Positive PTSD Data Demonstrating Ketamir-2 Restores Normalized Behavior in Stressed Animals
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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 therapeutic...
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12.09.2025
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MIRA Pharmaceuticals Shareholders Approve Acquisition of SKNY Pharmaceuticals, Advancing Next-Generation Oral Therapeutic for Obesity and Smoking Cessation
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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 pharmace...
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19.08.2025
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MIRA Pharmaceuticals Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple Ascending Dose Stage
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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, n...
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12.08.2025
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MIRA Pharmaceuticals' Second Ketamir-2 Manuscript Accepted for Peer-Reviewed Publication Demonstrating Superior Efficacy in Preclinical Neuropathic Pain Models Versus Ketamine, Gabapentin, or Pregabalin
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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...
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30.07.2025
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MIRA Pharmaceuticals Reports New Topical Ketamir-2 shows comparable effects to Injected Morphine in Preclinical Pain Study
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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 cl...
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29.07.2025
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MIRA Pharmaceuticals Announces FDA Clearance of IND for Ketamir-2, Enabling U.S. Clinical Trials in Neuropathic Pain
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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 ne...
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11.07.2025
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MIRA Reports Clear Reversal of Anxiety-Related Behavior in Animal Model Using SKNY-1, an Oral Drug Candidate for Obesity and Nicotine Addiction Under Definitive Agreement for Acquisition
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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...
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20.10.2025
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03.07.2025
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MIRA Reports Potent Inflammatory Pain Relief from Non-Psychoactive Marijuana Analog Mira-55 in Animal Model, Matching Morphine Without Opioid Risks
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With Mira-55 and Ketamir-2, MIRA is advancing complementary non-opioid therapies for two of the largest pain markets MIAMI, FLORIDA / ACCESS Newswire / July 3, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsyc...
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30.06.2025
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MIRA Reports Up to 30% Weight Loss and Reversal of High-Calorie and Nicotine Cravings in an Animal Model of Obesity and Craving Using SKNY-1, a Drug Candidate Under Definitive Agreement for Acquisition
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Oral therapy designed to minimize CNS side effects shows dual activity in weight loss and smoking cessation models without muscle loss MIAMI, FLORIDA / ACCESS Newswire / June 30, 2025 / MIRA (NASDAQ:MIRA) today announced new animal study results from SKNY-1, a next-generation oral therapeutic under definitive agreement for acquisition. In a zebrafi...
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25.06.2025
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MIRA Pharmaceuticals Announces New Data Underscoring Potential of SKNY-1 - A Drug Candidate Pending Acquisition - To Disrupt Weight Loss and Smoking Cessation Markets Without CNS Side Effects
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MIAMI, FL / ACCESS Newswire / June 25, 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 in vitro preclinical data generated by Eurofins supporti...
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18.06.2025
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MIRA Pharmaceuticals' Lead Drug Candidate Ketamir-2 First Manuscript Accepted for Publication in the Peer-Reviewed Journal Frontiers in Pharmacology
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MIAMI, FL / ACCESS Newswire / June 18, 2025 / 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 that the first manuscript describing its lead drug candidate Ketamir-2,...
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28.05.2025
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MIRA Pharmaceuticals to Participate in BIO 2025 in Boston and Highlights Ongoing Progress Across Clinical Program
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The company will engage in BIO One-on-One Partnering™ meetings as it advances Phase 1 for Ketamir-2, prepares Phase IIa study in neuropathic pain, and finalizes filings for SKNY acquisition. MIAMI, FL / ACCESS Newswire / May 28, 2025 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a clinical-stage pha...
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08.05.2025
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MIRA Pharmaceuticals Announces Board Approval of SKNY Acquisition Reflecting $60+ Million in Combined Enterprise Value Based on Independent Review
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With valuations confirmed by the board, MIRA advances strategic acquisition targeting obesity and nicotine dependence, which includes a $5 million contribution in cash or assets from SKNY to be transferred at closing. MIAMI, FLORIDA / ACCESS Newswire / May 8, 2025 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company&quo...
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06.05.2025
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MIRA Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked Neurotoxicity
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Preclinical data supports the advancement of oral Ketamir-2 as a safe, next-generation alternative to ketamine, with ongoing momentum in Phase I clinical trial enrollment MIAMI, FL / ACCESS Newswire / May 6, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused...
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23.04.2025
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MIRA Pharmaceuticals Reports Positive In Vitro Drug Release Data for Topical Ketamir-2, Targeting $11B+ U.S. Topical Pain Relief Market and Exploring FDA Fast Track Designation
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MIAMI, FLORIDA / ACCESS Newswire / April 23, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), or MIRA, a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic and neuropsychiatric disorders, today announced the completion of in vitro release testing (IVRT) for its topical formulation of Ketamir-2. The formula...
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16.04.2025
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MIRA Pharmaceuticals Announces Positive Results for Ketamir-2 in Diabetic Neuropathy Animal Model, Reinforcing Confidence Ahead of Phase I Completion
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Ketamir-2 Demonstrates Strong Efficacy in Diabetic Neuropathy Model, with Some Subjects Achieving Complete Symptom Reversal MIAMI, FLORIDA / ACCESS Newswire / April 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), or MIRA, a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic and neuropsychiatric disord...
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01.04.2025
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MIRA Pharmaceuticals Enrolls First Subjects in Phase 1 Clinical Trial of Ketamir-2 for Neuropathic Pain
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MIAMI, FLORIDA / ACCESS Newswire / April 1, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company developing breakthrough therapeutics for neurologic and neuropsychiatric disorders, today announced the enrollment of the first subjects in its Phase 1 clinical trial of Ketamir-2, a novel oral ketamine analog in deve...
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24.03.2025
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MIRA Pharmaceuticals Signs Binding Letter of Intent to Acquire SKNY Pharmaceuticals, Securing a $5 Million Capital Infusion to Advance Weight Loss and Smoking Cessation Drug Development
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Strategic acquisition expands MIRA's pipeline with SKNY-1, a next-generation oral therapeutic targeting the two leading causes of preventable death-obesity and smoking. MIAMI, FL / ACCESS Newswire / March 24, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA"), a clinical-stage pharmaceutical company developing breakthrough therapeut...
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13.03.2025
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MIRA Pharmaceuticals Expands Ketamir-2 Development with Topical Treatment for Localized Neuropathic and Inflammatory Pain
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MIAMI, FL / ACCESS Newswire / March 13, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced the successful formulation of Ketamir-2 into a topical treatment for localized neuropathic and inflammatory pain. This advan...
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04.03.2025
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MIRA Pharmaceuticals Announces Approval and Initiation of Phase 1 Clinical Trial for Ketamir-2 in Neuropathic Pain
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MIAMI, FL / ACCESS Newswire / March 4, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), 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...
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19.12.2024
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MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline Development
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MIAMI, FLORIDA / ACCESSWIRE / December 19, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), 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...
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10.12.2024
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MIRA Pharmaceuticals Validates Ketamir-2's Safety Profile With No Adverse Findings, Paving the Way for IND Submission by Year-End
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Strong Safety Profile Validated Across Studies, Setting the Stage for Clinical Trials in Neuropathic Pain MIAMI, FL / ACCESSWIRE / December 10, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, proudly announces the successful completion of its current Good Laboratory Practice (GLP) preclinical safety prog...
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20.11.2024
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MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site
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Backed by a Strong Balance Sheet, MIRA Accelerates Toward Becoming a Clinical-Stage Company and Advancing Breakthroughs in Pain and Depression Treatment MIAMI, FL / ACCESSWIRE / November 20, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, is pleased to announce the selection of The Centre for Human Drug...
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28.10.2024
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MIRA Pharmaceuticals' Ketamir-2 Shows 60% Greater Efficacy Than FDA-Approved Gabapentin in Reversing Chemotherapy-Induced Neuropathic Pain
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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 BostonMIAMI, FL / ACCESSWIRE / October 28, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a leading pre-clinical-stage pharmaceutical development company, announces...
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21.10.2024
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MIRA Pharmaceuticals Announces Ketamir-2 Outperforms Current FDA-Approved Neuropathic Pain Treatments, Gabapentin and Pregabalin, in Preclinical Study
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MIAMI, FL / ACCESSWIRE / October 21, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), 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 n...
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27.09.2024
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MIRA Pharmaceuticals Announces New Preclinical Data for Ketamir-2 to Be Presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024
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Conference presentation delivers preclinical results demonstrating Ketamir-2 achieves 100% reversal of neuropathic painMIAMI, FL / ACCESSWIRE / September 27, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company developing innovative therapies for neurologic and neuropsychiatric disorders, today announced that...
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18.09.2024
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MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025
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MIAMI, FL / ACCESSWIRE / September 18, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), 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 stra...
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