MIRA Pharmaceuticals Secures Worldwide Rights for Ketamir-2, Expanding Global IP Portfolio Across 10 Major Markets Ahead of Phase 2a in CIPN
Rhea-AI Summary
MIRA Pharmaceuticals (NASDAQ:MIRA) amended its Ketamir-2 license, expanding from North America to worldwide rights wherever patent protection exists.
The updated portfolio now includes the US, Europe, China, Japan, Canada, Australia, India, Israel, Mexico, and South Korea.
Ketamir-2, an oral NMDA modulator, showed favorable Phase 1 safety in 56 volunteers and is progressing toward planned Phase 2a in chemotherapy-induced peripheral neuropathy (CIPN) under an active FDA IND.
Positive
- Ketamir-2 license expanded to worldwide rights in all patent countries
- Patents now cover US, Europe, China, Japan, Canada, Australia, India, Israel, Mexico, South Korea
- Phase 1 in 56 healthy volunteers showed favorable safety and pharmacokinetics
- No serious adverse events or discontinuations reported in Phase 1 trial
- Preparing Phase 2a CIPN protocol for FDA submission under active IND
- Amendment does not materially change core economic license terms
Negative
- None.
News Market Reaction – MIRA
In the May 27 session, MIRA gained 18.58%, reflecting a significant positive market reaction. Argus tracked a peak move of +17.1% during that session. Our momentum scanner triggered 22 alerts that day, indicating elevated trading interest and price volatility. Trading volume was very high at 4.2x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 14 | Phase 1 results | Positive | +0.4% | Positive unblinded Phase 1 Ketamir-2 data in healthy volunteers. |
| May 13 | Preclinical update | Positive | -4.8% | Peer-reviewed acceptance of SKNY-1 obesity and nicotine data. |
| Mar 23 | Preclinical update | Positive | +22.3% | Mira-55 pain data showing strong analgesia without THC-like effects. |
| Mar 4 | Trial completion | Positive | -1.6% | Completion of Ketamir-2 Phase 1 dosing with no serious adverse events. |
| Feb 3 | Trial progress | Positive | -1.6% | Initiation of final Ketamir-2 Phase 1 cohort and Phase 2a planning. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent MIRA news has produced mixed reactions, with several positive R&D updates met by flat or negative price moves.
Over recent months, MIRA has repeatedly highlighted progress across its pipeline. Ketamir-2 advanced through Phase 1 dosing and reported positive safety data in 56–57 healthy volunteers, with plans for a Phase 2a CIPN study. SKNY-1 showed promising obesity and nicotine-addiction signals in preclinical work, and Mira-55 delivered non-opioid analgesia with favorable CNS findings. Despite generally constructive updates, share reactions have ranged from modest gains to notable selloffs, suggesting investor caution around execution and financing.
Key Terms
nmda receptor modulator medical
chemotherapy-induced peripheral neuropathy medical
pharmacokinetic medical
phase 2a medical
investigational new drug (ind) regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Expanded Global Intellectual Property Portfolio Enhances Strategic Flexibility and Long-Term Value Potential for Ketamir-2
MIAMI, FL / ACCESS Newswire / May 27, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on the development of proprietary therapeutics for neurologic, neuropsychiatric, inflammatory, and metabolic disorders, today announced the execution of Amendment No. 1 to its exclusive Ketamir-2 license agreement with MIRALOGX LLC, expanding the Company's licensed territory from the United States, Canada, and Mexico to worldwide rights across all countries in which patent rights exist.
The amended agreement incorporates an expanded international patent portfolio now covering filings in the United States, Europe, China, Japan, Canada, Australia, India, Israel, Mexico, and South Korea, representing the world's largest pharmaceutical markets.
Ketamir-2 is MIRA's proprietary oral NMDA receptor modulator currently advancing toward planned Phase 2a development in chemotherapy-induced peripheral neuropathy ("CIPN"), an indication with significant unmet medical need. The Company recently announced positive Phase 1 clinical results across 56 healthy volunteers, demonstrating favorable safety, tolerability, and pharmacokinetic findings, with no serious adverse events or study discontinuations reported.
Management Commentary
Erez Aminov, Chairman and CEO of MIRA, stated: "Securing worldwide rights for Ketamir-2 represents an important strategic milestone for MIRA and significantly strengthens the long-term global commercial potential of the program. As we advance toward planned Phase 2a development in CIPN, this expanded intellectual property position strengthens our ability to pursue global licensing, co-development or commercialization discussions with potential strategic partners.
The amendment does not materially modify the previously disclosed core economic terms of the original license agreement.
With worldwide IP rights secured and a completed Phase 1 data package in hand, MIRA is advancing Phase 2a protocol documentation for submission to the FDA under its active Investigational New Drug (IND) application.
About Ketamir-2
Ketamir-2 is a proprietary, orally bioavailable investigational new molecular entity designed to selectively modulate the NMDA receptor (PCP binding site) with low binding affinity and limited off-target receptor activity.
In validated preclinical models of neuropathic pain, including paclitaxel-induced neuropathy and sciatic nerve ligation, Ketamir-2 demonstrated improved efficacy compared with ketamine and established neuropathic pain agents, including pregabalin and gabapentin.
Following scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Ketamir-2 is not classified as a controlled substance.
Ketamir-2 has not been approved by the U.S. Food and Drug Administration for any indication, and its safety and efficacy have not been established.
About MIRA Pharmaceuticals, Inc.
MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of investigational therapeutics for neurologic, neuropsychiatric, inflammatory, and metabolic disorders. The Company's pipeline includes oral drug candidates being evaluated for neuropathic pain (CIPN), inflammatory pain, obesity, addiction-related disorders, anxiety, and cognitive impairment.
For more information, please visit MIRA Pharmaceuticals.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "can," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project," "guidance," "potential," "intend," "seek," "target" and other words of similar meaning, although not all forward-looking statements include these words. Forward-looking statements may include, but are not limited to, statements regarding the therapeutic potential, mechanism of action, development plans, regulatory pathway, safety profile, clinical utility, market opportunity, and future development of SKNY-1 and the Company's other product candidates. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management's beliefs and assumptions, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to preclinical and clinical development, the ability to obtain regulatory approvals, the outcome of future studies, reliance on third parties, intellectual property protection, financing needs, market conditions, and the other risks identified in the Company's under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K and the Company's other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update or revise such statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.
We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at SEC website and in the "Investors" section of our website at MIRA Investors, for a discussion of these and other risks and uncertainties.
Contact:
Krystina Quintana
info@mirapharma.com
(786) 432-9792
SOURCE: MIRA Pharmaceuticals, Inc.
View the original press release on ACCESS Newswire