Research analysts covering MIRA PHARMACEUTICALS.
Recent press releases and 8-K filings for MIRA.
MIRA Pharmaceuticals Initiates Final Dosing for Ketamir-2 Phase 1 Trial
MIRA
New Projects/Investments
- MIRA Pharmaceuticals, Inc. announced on February 2, 2026, that it has initiated dosing in the final cohort of its Phase 1 multiple ascending dose (MAD) clinical trial for Ketamir-2, with 50 healthy volunteers already dosed and 6 subjects remaining.
- The company expects to complete the Phase 1 clinical program by the end of the first quarter of 2026 and anticipates initiating the Phase 2a study in the second quarter of 2026, aiming for FDA Fast Track designation for Ketamir-2.
- MIRA Pharmaceuticals plans to present Phase 1 data on Ketamir-2 at the American Association for Cancer Research (AACR) Annual Meeting in April 2026.
- The company also provided an update on its preclinical pipeline programs, SKNY-1 (for weight loss and nicotine addiction) and MIRA-55 (for inflammatory pain), with the objective of advancing both to IND-enabling status by year-end 2026.
4 days ago
MIRA Pharmaceuticals Announces Positive Preclinical Data for Mira-55
MIRA
Product Launch
New Projects/Investments
- On October 15, 2025, MIRA Pharmaceuticals, Inc. announced new preclinical data for its proprietary non-psychotropic marijuana analog, Mira-55.
- The study demonstrated that oral administration of Mira-55 normalized pain and significantly reduced inflammation, outperforming injected morphine in an established animal model of chronic inflammatory pain.
- This marks the first time inflammation was directly measured in the Mira-55 program, showing superior pain normalization and direct anti-inflammatory effects compared to morphine's partial and indirect reduction.
- These findings support MIRA's plan to pursue an Investigational New Drug (IND) application for chronic inflammatory pain, reinforcing its position in the $70 billion non-opioid pain market.
Oct 15, 2025, 8:01 PM
MIRA Pharmaceuticals Completes Acquisition of SKNY Pharmaceuticals
MIRA
M&A
New Projects/Investments
Delisting/Listing Issues
- MIRA Pharmaceuticals, Inc. completed the acquisition of SKNY Pharmaceuticals, Inc. on September 29, 2025, acquiring 100% of SKNY in exchange for restricted shares of MIRA's common stock.
- As a condition to closing, SKNY contributed $5 million in marketable securities to MIRA, strengthening the Company’s balance sheet.
- The acquisition expands MIRA's pipeline, positioning it as a multi-program biopharmaceutical developer with programs addressing high-value therapeutic areas, including Ketamir-2 (Phase 1 for neuropathic pain), MIRA-55 (oral THC analog for inflammatory pain), and SKNY-1 (oral therapeutic for obesity and smoking cessation).
- MIRA believes it has regained compliance with Nasdaq's minimum $2,500,000 stockholders' equity rule as of the date of the report, following the acquisition and other stock sales.
Sep 30, 2025, 11:00 AM
MIRA Pharmaceuticals Reports Positive PTSD Data for Ketamir-2
MIRA
New Projects/Investments
- MIRA Pharmaceuticals, Inc. announced positive results from a proof-of-concept validation study for its oral drug candidate, Ketamir-2, in an animal model of post-traumatic stress disorder (PTSD) on September 15, 2025.
- The study demonstrated that Ketamir-2 treatment was associated with a reversal of PTSD-like behaviors (such as increased despair and immobility) in stressed animals, returning them to levels observed in non-stressed animals.
- Ketamir-2 is a proprietary, orally bioavailable new molecular entity designed to provide the therapeutic efficacy of ketamine while minimizing dissociative and central nervous system side effects, and it has been determined not to be a controlled substance by the U.S. Drug Enforcement Administration.
- A larger follow-on PTSD study is currently ongoing, and Ketamir-2 is also being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a favorable safety profile to date.
Sep 15, 2025, 8:02 PM
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