Mira Pharmaceuticals Inc

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MIRA Pharmaceuticals, Inc. operates as a clinical development stage biopharmaceutical company. The company engages in developing its product candidate, MIRA1a, as a synthetic cannabinoid analog for treating anxiety & chronic pain by targeting the cannabinoid type 1 and type 2 (CB1 and CB2) receptors. MIRA Pharmaceuticals was founded by Adam Kaplin on September 3, 2020 and is headquartered in Miami, FL.

MIAMI, FL / 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 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.

MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline Development

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 program for Ketamir-2, a novel oral ketamine analog. The results confirm no adverse findings, clearing a critical milestone as the Company progresses toward submitting its Investigational New Drug (IND) application by year-end 2024.

MIRA Pharmaceuticals Validates Ketamir-2's Safety Profile With No Adverse Findings, Paving the Way for IND Submission by Year-End

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 Research (CHDR) in Leiden, The Netherlands, as the site for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. Recruitment for the trial is set to begin in Q1 2025, with initial safety and efficacy results from the Phase I study in healthy subjects expected in the second half of 2025.

MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site

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 28, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a leading pre-clinical-stage pharmaceutical development company, announces compelling new preclinical findings showing that Ketamir-2, a novel oral ketamine analog, achieves 60% greater efficacy than the FDA-approved neuropathic pain treatment gabapentin in reducing chemotherapy-induced pain. These results build on earlier successes across various pain models, further validating Ketamir-2's potential to set a new standard in pain management.

MIRA Pharmaceuticals' Ketamir-2 Shows 60% Greater Efficacy Than FDA-Approved Gabapentin in Reversing Chemotherapy-Induced Neuropathic Pain

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 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.

MIRA Pharmaceuticals Announces Ketamir-2 Outperforms Current FDA-Approved Neuropathic Pain Treatments, Gabapentin and Pregabalin, in Preclinical Study

Conference presentation delivers preclinical results demonstrating Ketamir-2 achieves 100% reversal of neuropathic pain MIAMI, 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 new preclinical data on its lead development product, Ketamir-2, will be presented at the 18th Annual Pain Therapeutics Summit, taking place on October 28-29, 2024, in Boston, MA (the "Summit"). The presentation, entitled "Selective NMDA Receptor Modulation: The Superior Efficacy of Ketamir-2 in Neuropathic Pain Treatment," will showcase the breakthrough finding that Ketamir-2 achieved a complete reversal of neuropathic pain in preclinical models.

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

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 strategic development plan, MIRA is prioritizing the early demonstration of clinical efficacy, potentially as early as 2025, through innovative Phase I/II study designs.

MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025

MIAMI, FL / ACCESSWIRE / September 11, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), 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.

MIRA Pharmaceuticals Designates Neuropathic Pain as Primary Indication for Ketamir-2 and Submits Pre-IND Meeting Request to FDA

Study Highlights Superior Efficacy of Ketamir-2 Over Oral Ketamine, Achieving Full Normalization of Pain Thresholds MIAMI, FL / ACCESSWIRE / August 26, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a leading pre-clinical-stage pharmaceutical development company, is proud to announce a major breakthrough in the treatment of neuropathic pain. A recent pre-clinical study in rats demonstrated that its novel oral ketamine analog, Ketamir-2, produced a significant reversal of neuropathic pain, induced by nerve ligation, culminating in a 100% normalization of pain thresholds at the highest dose.

MIRA Pharmaceuticals Achieves 100% Reversal of Neuropathic Pain With Oral Ketamir-2 in Breakthrough Study

MIAMI, FL / ACCESSWIRE / August 19, 2024 / MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) "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.

MIRA Pharmaceuticals Showcases Significant Progress and Announces Final Phase of Regulatory Work as It Prepares for IND Submission by Year-End

This breakthrough in bioavailability and formulation showcases the potential for advanced, at home neurological treatments. MIAMI, FL / ACCESSWIRE / August 12, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), or MIRA Pharmaceuticals, a leading pre-clinical-stage pharmaceutical company unveiled new preclinical data providing further insights into the mechanism of action of its innovative drug candidate, Ketamir-2's principal metabolite, Nor-Ketamir-2.

MIRA Pharmaceuticals Unveils Ketamir-2's Principal Metabolite: Nor-Ketamir - a Longer-Acting, Brain Penetrating and Selective Compound Acting on the NMDA PCP Receptor

Latest positive preclinical data provides another step in the path to potential IND submission this year for novel ketamine analog MIAMI, FL / ACCESSWIRE / July 25, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company, today announced new insights garnered from additional, recently received preclinical study data regarding the mechanism of action and toxicology data for its novel oral ketamine analog, Ketamir-2. Ketamir-2 is MIRA's drug candidate being investigated as a potential treatment for neurological and neuropsychiatric disorders.

MIRA Pharmaceuticals Announces Positive Discovery of Ketamir-2's Selective NMDA Binding Mechanism of Action

Mira Pharmaceuticals (NASDAQ: MIRA ) stock is down on Tuesday as the clinical-stage pharmaceutical company's shares come off of a major rally on Monday. Shares of MIRA stock closed out Monday's normal trading hours up 627.4%.

Why Is Mira Pharmaceuticals (MIRA) Stock Down 27% Today?

U.S. stocks traded higher toward the end of trading, with the NASDAQ Composite gaining around 300 points on Monday.

S&P 500 Gains 1%; MIRA Pharmaceuticals Shares Spike Higher

MIRA Pharmaceuticals (NASDAQ: MIRA ) stock is seeing massive gains on Monday after the pre-clinical-stage pharmaceutical company released data from its pre-clinical study of Ketamir-2. Ketamir-2.

Why Is MIRA Pharmaceuticals (MIRA) Stock Up 318% Today?

New findings highlight potential advantages of MIRA's novel oral ketamine analog for treating neurological and neuropsychiatric disorders MIAMI, FL / ACCESSWIRE / July 22, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company, today announced new preclinical study results for its novel oral ketamine analog, Ketamir-2. The additional data announced today continues a string of promising preclinical results announced by MIRA in recent months for Ketamir-2 as MIRA works towards its goal of submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by the end of this year which, if granted, would allow for human testing of Ketamir-2.

MIRA Pharmaceuticals Reveals Preclinical Success: Ketamir-2 Optimized for Brain Delivery, Avoiding Ketamine's Drug Resistance

Testing confirms MIRA's preliminary beliefs regarding potential treatment for neurological and neuropsychiatric disorders MIAMI, FL / ACCESSWIRE / July 15, 2024 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a pre-clinical-stage pharmaceutical development company, today announced promising new findings from recent preclinical studies of its novel oral pharmaceutical marijuana analog, MIRA-55, which is being studied as a potential treatment for anxiety and cognitive decline. The new data confirms MIRA's earlier beliefs regarding MIRA-55's pharmacological profile and potential for potency and efficacy.

Mira Pharmaceuticals Announces Promising Results for MIRA-55 in Multiple Preclinical Tests Compared to THC

New preclinical studies suggest that, unlike traditional ketamine, MIRA's oral ketamine analog Ketamir-2 does not induce hyper-locomotor activity, indicative of psychotic symptoms, offering the potential for safer mental health treatments MIAMI , June 24, 2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, today announced new compelling preclinical results for its investigational compound, Ketamir-2, a novel oral ketamine analog. The new data highlights Ketamir's potential to provide therapeutic benefits without inducing schizophrenia-like behavior or hyper-locomotor activity.

MIRA Pharmaceuticals Announces Ketamir-2 Shows Promising Safety Profile in Comparison to Traditional Ketamine In Preclinical Testing

The company announced that it achieved positive preclinical study results for Ketamir-2, its Novel Oral ketamine Analog.

MIRA Announces Positive Test Results

The positive results from this preclinical study underscore Ketamir-2's potential as a superior alternative to traditional ketamine Unlike ketamine, which requires intravenous or intranasal administration, Ketamir-2's oral formulation promises ease of use and better patient compliance and is not a controlled substance under DEA rules MIAMI , June 10, 2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, today announced positive preclinical study results highlighting the potential efficacy and safety profile of Ketamir-2, MIRA's novel oral ketamine analog designed to treat depression and treatment-resistant depression (TRD). Mira Announces Positive Preclinical Study Results For Its Novel Oral ketamine Analog, Ketamir-2 The highly encouraging study results further MIRA's goal of submitting an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) later this year which, if granted, would allow for human clinical trials of Ketamir-2.

Mira Pharmaceuticals Announces Positive Preclinical Study Results For Its Novel Oral ketamine Analog, Ketamir-2, Paving the Way for IND Submission Later This Year

Ruling removes potential complications for manufacturing, pre-clinical development, IND submission, clinical development, and ultimately commercialization. MIAMI , May 29, 2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, announced that MIRA-55 , has been determined by the U.S. Drug Enforcement Administration (DEA) not to be a controlled substance or listed chemical under the Controlled Substance Act and its governing regulations.

Mira Pharmaceuticals Announces DEA Rules MIRA-55, a Novel Oral Pharmaceutical Marijuana Analog, Is Not Classified as a Controlled Substance

Ketamir-2, the Company's novel oral ketamine analog in development, aims to provide a safe and effective alternative for managing cancer pain and associated depression MIAMI , May 21, 2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, announced it is in advanced discussions with Memorial Sloan Kettering Cancer Center (MSK) to initiate a preclinical study evaluating MIRA's novel oral ketamine analog, Ketamir-2, for the treatment of cancer-related pain and depression. MIRA Pharmaceuticals in Discussions with Memorial Sloan Kettering to Collaborate on Preclinical Cancer Pain Model This collaboration with MSK, one of the top cancer centers in the world, would represent an important validation of the potential for Ketamir-2.

MIRA Pharmaceuticals in Discussions with Memorial Sloan Kettering to Collaborate on Preclinical Cancer Pain Model Utilizing The Company's Novel Oral Ketamine Analog

Investigative studies are underway testing Ketamir-2 as the potential first at home ketamine analog treatment for PTSD, depression, and neuropathic pain, including cancer pain  MIAMI , May 20, 2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, announced that it has advanced new preclinical studies using Ketamir-2, its differentiated oral ketamine analog, towards clinical development for the treatment of severe post-traumatic stress disorder (PTSD) and other leading mental health disorders and neuropathic pain indications.   Mira Pharmaceuticals Advances Preclinical Trials Towards an IND Submission This Year for Ketamir-2 MIRA continues to advance studies of Ketamir-2 in animal studies while improving manufacturing optimization as the company prepares for human testing in 2025.

Mira Pharmaceuticals Advances Preclinical Trials Towards an IND Submission This Year for Ketamir-2, a Differentiated Oral Ketamine Analog

Ketamir-2 is a potential treatment for certain major mental health disorders impacting millions of people in the U.S. MIAMI , April 2, 2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, today shares updates on the ongoing pre-clinical studies of its investigational compound, Ketamir-2, a novel oral ketamine analog which could potentially deliver ultra-rapid antidepressant effects.  MIRA is conducting pre-clinical studies of Ketamir-2 in collaboration with Frontage Laboratories as a potential treatment for individuals battling treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDSI) and post-traumatic stress disorder (PTSD).

Mira Pharmaceuticals Announces Encouraging Preclinical Results Advancing Ketamir-2 Towards Potential Year-End IND Submission

A seasoned pharmaceutical industry executive with over 40 years at the forefront of innovation, including at Synthelabo (acquired by Sanofi-Aventis), Dr. Angel aims to propel MIRA Pharmaceuticals' mission to tackle unmet needs in neurologic and neuropsychiatric disorders MIAMI , March 21, 2024 /PRNewswire/ -- MIRA Pharmaceuticals Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on the development of novel treatments for neurologic and neuropsychiatric disorders, proudly announces the appointment of distinguished pharmaceutical executive Dr. Itzchak Angel as its new Chief Scientific Advisor. Dr. Angel brings over 40 years of preclinical, clinical and regulatory acumen to MIRA.

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