MIRA Pharmaceuticals, Inc.
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- MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage biopharmaceutical company focused on developing novel small-molecule therapeutics for neurologic, neuropsychiatric, metabolic disorders, and pain management; its lead pipeline includes Ketamir-2, a patent-pending oral ketamine analog with exclusive U.S., Canadian, and Mexican rights, under investigation for neuropathic pain, treatment-resistant depression, major depressive disorder with suicidal ideation, post-traumatic stress disorder, and as a topical formulation for localized pain relief; MIRA-55, an oral pharmaceutical marijuana analog targeting anxiety, cognitive decline in early-stage dementia, inflammatory pain, and nociceptive pain; and SKNY-1, an oral therapeutic for obesity and nicotine dependence acquired through the September 2025 completion of the SKNY Pharmaceuticals merger, which added approximately $5 million in cash or assets and expanded the pipeline into high-value metabolic markets. The company, founded in 2020 and headquartered at 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida, primarily serves patients in North America through its neuroscience and pain-focused programs while advancing preclinical and clinical studies without controlled substance classification per U.S. Drug Enforcement Administration review. Recent milestones encompass Investigational New Drug submission for Ketamir-2 in December 2024, Phase 1 single ascending dose completion and multiple ascending dose initiation in August 2025 with plans for Phase 2a in neuropathic pain by year-end, board approval of the SKNY acquisition in May 2025 followed by shareholder approval and closing, and ongoing preclinical work for Ketamir-2 topical and MIRA-55 expansions.
MIRA Pharmaceuticals Reports Successful Formulation Results Supporting Development of MIRA-55 as a Non-Opioid Oral Therapy for Chronic Inflammatory Pain
MIRA Pharmaceuticals Reports Successful Formulation Results for SKNY-1, Its Oral Drug Candidate for Obesity and Addiction
MIRA Pharmaceuticals Reports New Preclinical Data Demonstrating Mira-55's Differentiated Mechanism of Action and Anxiolytic Activity Relative to THC
MIRA Pharmaceuticals Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral Neuropathy
MIRA Pharmaceuticals Secures Worldwide Exclusive Rights to MIRA-55 and SKNY-1
MIRA Pharmaceuticals Secures Worldwide Rights for Ketamir-2, Expanding Global IP Portfolio Across 10 Major Markets Ahead of Phase 2a in CIPN
MIRA Pharmaceuticals Reports Positive Unblinded Phase 1 Data for Ketamir-2
MIRA Pharmaceuticals Announces Acceptance of Peer-Reviewed SKNY-1 Manuscript Highlighting Oral Obesity and Nicotine Addiction Drug Candidate
Visionstate Reports 27% Q2 Revenue Growth as MIRA Platform Gains Traction
MIRA Pharmaceuticals Reports Mira-55 Shows No THC- or Rimonabant-Associated CNS Side Effects in Preclinical Studies
Visionstate Reports Accelerating Subscription Growth and Expansion of MIRA Compliance Platform
MIRA Pharmaceuticals Completes Phase 1 Dosing of Ketamir-2
MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) Short Interest Up 29.4% in February
Visionstate Repositions Under MIRA Compliance Platform and Reports Subscription Growth
MIRA Pharmaceuticals Initiates Final Cohort of Ketamir-2 Phase 1 Clinical Study as Company Prepares for Phase 2a Study
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
MIRA Pharmaceuticals Announces Oral Mira-55 Outperformed Injected Morphine in Normalizing Pain and Reducing Inflammation, Supporting Its Planned IND for Chronic Inflammatory Pain
MIRA Pharmaceuticals Closes Acquisition of SKNY Pharmaceuticals, Expands Pipeline with SKNY-1 for Obesity and Nicotine Addiction
MIRA Pharmaceuticals Announces Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine Analog
MIRA Pharmaceuticals Reports Positive PTSD Data Demonstrating Ketamir-2 Restores Normalized Behavior in Stressed Animals