Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
MIRA Catalyst Timeline
Dated clinical, regulatory and corporate events for MIRA Pharmaceuticals, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for MIRA Pharmaceuticals, Inc.
Upcoming catalysts 2
Event history 9
Past FDA Catalysts and PDUFA Decisions
How MIRA actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-10-05 | Ketamir-2 | Phase 1 data presentation | Phase 1 |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ketamir-2 Small moleculeCompletedNCT07791303 | Undisclosed | Phase 1 | COMPLETED | 57 | Mar 5, 2026 |
Clinical Trial Results
Readouts, endpoints and source filings for every MIRA program
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Aminov ErezDirector, Officer (Chief Executive Officer) | Grant/Award | 83,500 83,500 held | $0.00 | 03/30/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in MIRA
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in MIRA for Q2 2026. | ||||
MIRA Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How MIRA ranks across every disease it competes in
MIRA News
MIRA Pharmaceuticals Advances Ketamir-2 to Phase 2a in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Following FDA Review
MIRA Pharmaceuticals has announced the advancement of Ketamir-2 to Phase 2a for chemotherapy-induced peripheral neuropathy (CIPN) after incorporating FDA feedback. The study will evaluate the drug's efficacy and safety in patients with moderate-to-severe CIPN. This marks a critical transition from initial safety assessments in healthy volunteers to testing in patients.
Read more →MIRA Pharmaceuticals Advances Non-Opioid Oral MIRA-55 for Inflammatory Pain Toward IND
MIRA Pharmaceuticals has reported positive outcomes from its recent toxicology studies of MIRA-55, an oral non-opioid drug candidate aimed at treating inflammatory pain. The studies, conducted over a 7-day period in rats and dogs, support the drug's advancement towards an Investigational New Drug (IND) application. This development marks a significant step in MIRA's clinical pipeline.
Read more →MIRA Reports Positive 7-Day Dog Study Results for SKNY-1
MIRA Pharmaceuticals has reported positive results from a 7-day repeated-dose study of its obesity treatment candidate, SKNY-1, in Beagle dogs. The findings indicate favorable toxicokinetic profiles that aid in dose selection and bolster the company's regulatory pathway towards an Investigational New Drug (IND) application. This advancement marks a significant step for MIRA in developing novel therapeutics.
Read more →MIRA Pharmaceuticals Progresses MIRA-55 and SKNY-1 Toward IND-Enabling Studies
MIRA Pharmaceuticals is advancing its lead preclinical programs, MIRA-55 and SKNY-1, toward IND-enabling studies. Recent development activities include formulation optimization and exploratory toxicology studies in animal models. Both drug candidates have shown promising preclinical results, indicating potential for treating chronic inflammatory pain and obesity-related disorders. The company emphasizes a disciplined approach to drug development.
Read more →MIRA Pharmaceuticals Reports Successful Formulation Results Supporting Development of MIRA-55 as a Non-Opioid Oral Therapy for Chronic Inflammatory Pain
MIRA Pharmaceuticals has reported positive preclinical results for its oral drug candidate MIRA-55, aimed at treating chronic inflammatory pain without opioids. The optimized formulation showed favorable oral bioavailability and effective distribution in the brain and liver. This development supports the potential of MIRA-55 as a non-opioid therapy.
Read more →MIRA Pharmaceuticals Reports Successful Formulation Results for SKNY-1, Its Oral Drug Candidate for Obesity and Addiction
MIRA Pharmaceuticals has reported positive preclinical results for SKNY-1, its oral drug candidate targeting obesity and addiction. The studies show favorable oral bioavailability, significant brain penetration, and liver exposure, suggesting a potential for once-daily dosing. These findings mark a significant advancement in the development of SKNY-1.
Read more →MIRA Pharmaceuticals Reports New Preclinical Data Demonstrating Mira-55’s Differentiated Mechanism of Action and Anxiolytic Activity Relative to THC
MIRA Pharmaceuticals has reported new preclinical data for Mira-55, highlighting its unique pharmacological mechanism that does not induce central nervous system effects like THC. The data also indicate that Mira-55 exhibits anxiolytic activity, a benefit not associated with THC, reinforcing its potential for treating chronic inflammatory pain. This development supports ongoing research and clinical trials.
Read more →MIRA Pharmaceuticals Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral Neuropathy
MIRA Pharmaceuticals has submitted a Phase 2a clinical trial protocol to the FDA for its investigational drug Ketamir-2, targeting chemotherapy-induced peripheral neuropathy. The study will be randomized, double-blind, and placebo-controlled, focusing on the safety, tolerability, and efficacy of oral Ketamir-2. This trial will take place at a leading cancer center in the U.S.
Read more →MIRA Pharmaceuticals Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral Neuropathy Randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and do
MIRA Pharmaceuticals has submitted a Phase 2a clinical trial protocol to the FDA for its oral NMDA receptor modulator, Ketamir-2, targeting chemotherapy-induced peripheral neuropathy (CIPN). This condition affects a significant proportion of cancer survivors, and current treatments do not specifically address their symptoms. The study aims to evaluate the safety and tolerability of Ketamir-2, building on positive results from a prior Phase 1 study. Despite its promise, Ketamir-2 has not yet been approved by the FDA, and its effectiveness is still unproven.
Read more →MIRA Pharmaceuticals Secures Worldwide Exclusive Rights to MIRA-55 and SKNY-1
MIRA Pharmaceuticals has announced the acquisition of worldwide exclusive rights to MIRA-55 and SKNY-1, enhancing its strategic flexibility for future licensing and partnership opportunities. This agreement solidifies MIRA's position in the development of therapeutics targeting neurologic, neuropsychiatric, inflammatory, and metabolic disorders. The move is expected to strengthen MIRA's core therapeutic pipeline significantly.
Read more →MIRA Pharmaceuticals Secures Worldwide Exclusive Rights to MIRA-55 and SKNY-1 Establishes Global Exclusivity Across MIRA's Core Therapeutic Pipeline and Enhances Strategic Flexibility for Future Licensing
MIRA Pharmaceuticals, Inc. has announced that it has secured worldwide exclusive rights to MIRA-55 and SKNY-1 through an amended license agreement with MIRALOGX LLC. This move enhances MIRA's strategic flexibility for future licensing and commercialization efforts, providing them with a unified rights structure across their core therapeutic pipeline. MIRA-55 is currently being developed for chronic inflammatory pain, while SKNY-1 targets obesity and addiction-related disorders. The agreement strengthens MIRA's position with partners and investors as they advance the development of their investigational drug candidates.
Read more →MIRA Pharmaceuticals Secures Worldwide Rights for Ketamir-2, Expanding Global IP Portfolio Across 10 Major Markets Ahead of Phase 2a in CIPN
MIRA Pharmaceuticals has secured worldwide rights for Ketamir-2, enhancing its intellectual property portfolio across 10 major markets. This move is expected to provide the company with increased strategic flexibility and potential long-term value. The announcement comes ahead of the Phase 2a clinical trial for the treatment of chemotherapy-induced peripheral neuropathy (CIPN).
Read more →MIRA Pharmaceuticals Secures Worldwide Rights for Ketamir-2, Expanding Global IP Portfolio Across 10 Major Markets Ahead of Phase 2a in CIPN global intellectual property portfolio enhances strategic flexibility and long-term value potential for Ketamir-2
MIRA Pharmaceuticals has announced the acquisition of worldwide rights for its investigational drug Ketamir-2. This expansion enhances the company's intellectual property portfolio across ten major markets ahead of the planned Phase 2a development for chemotherapy-induced peripheral neuropathy (CIPN). The move is expected to significantly strengthen MIRA's strategic flexibility and long-term commercial prospects for Ketamir-2, particularly after positive Phase 1 clinical results were reported. The company is now advancing toward the submission of its Phase 2a protocol documentation to the FDA.
Read more →MIRA Pharmaceuticals Reports Positive Unblinded Phase 1 Data for Ketamir-2
MIRA Pharmaceuticals has reported positive unblinded results from its Phase 1 clinical trial of Ketamir-2, a selective oral NMDA receptor modulator. The trial demonstrated a favorable safety and tolerability profile, which supports the company's plans for Phase 2a development targeting chemotherapy-induced peripheral neuropathy. This advancement marks a significant step for MIRA in its drug development pipeline.
Read more →MIRA Pharmaceuticals Announces Acceptance of Peer-Reviewed SKNY-1 Manuscript Highlighting Oral Obesity and Nicotine Addiction Drug Candidate
MIRA Pharmaceuticals has announced the acceptance of a peer-reviewed manuscript detailing the preclinical findings of its drug candidate SKNY-1. The study highlights significant results, including weight loss, lipid normalization, and a decrease in compulsive feeding and nicotine-seeking behaviors. This publication is expected to bolster the company's position in the market.
Read more →MIRA Pharmaceuticals Reports Mira-55 Shows No THC- or Rimonabant-Associated CNS Side Effects in Preclinical Studies
MIRA Pharmaceuticals has reported promising preclinical data for Mira-55, indicating it does not cause CNS side effects linked to THC or Rimonabant. The compound has previously shown the ability to provide pain relief comparable to morphine without the associated risks of opioids. This data supports the company's upcoming IND submission for treating inflammatory pain.
Read more →MIRA Pharmaceuticals Completes Phase 1 Dosing of Ketamir-2
MIRA Pharmaceuticals has completed Phase 1 dosing of Ketamir-2, a selective oral NMDA receptor modulator, with favorable safety and tolerability outcomes. The study involved 56 healthy volunteers, and no serious adverse events were reported. MIRA plans to submit documentation for a Phase 2a trial targeting chemotherapy-induced peripheral neuropathy, a condition lacking FDA-approved therapies.
Read more →MIRA Pharmaceuticals Initiates Final Cohort of Ketamir-2 Phase 1 Clinical Study as Company Prepares for Phase 2a Study
MIRA Pharmaceuticals has commenced dosing in the final cohort of its Phase 1 clinical trial for Ketamir-2, an oral NMDA receptor antagonist. The trial aims to evaluate the safety and pharmacokinetics of the drug, with no serious adverse events reported thus far. MIRA plans to submit a Phase 2a protocol to the FDA following the completion of Phase 1, targeting chemotherapy-induced peripheral neuropathy, a condition with no approved treatments.
Read more →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 has launched a multiple ascending dose Phase 1 study for its oral Ketamir-2, targeting chemotherapy-induced neuropathic pain. This condition currently lacks approved treatments, highlighting the significance of the study. The company is also considering FDA Fast Track designation to expedite development.
Read more →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 announced promising preclinical data indicating that oral Mira-55 effectively normalized pain and significantly reduced inflammation, outperforming injected morphine. This development supports the company's plans for an Investigational New Drug (IND) application targeting chronic inflammatory pain. The findings bolster MIRA's competitive stance in the growing non-opioid pain management market.
Read more →