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MIRA Pharmaceuticals, Inc.

MIRA
Richly ValuedPharma · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$0.75
▲ +0.04 · +6.05%

Financials

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Total Assets
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52W LOW $0.6052W HIGH $2.45
Volume
52.43 K
Value Traded
89.18 K
Short % Float
1.16%
+1.36%Week
-0.94%1 Month
-18.05%3 Month
-27.62%6 Month
-85.83%5 Year
-85.83%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
31.33 M
EPS (TTM)
-0.23
P/E Ratio
-
Ent. Value
23.21 M
Total Shares
42.00 M
Float Shares
38.69 M
Insiders
7.92%
Institutions
5.51%

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 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

MIRA Catalyst Timeline

Dated clinical, regulatory and corporate events for MIRA Pharmaceuticals, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for MIRA Pharmaceuticals, Inc.

14Total events
4Upcoming
1Tier-1 (high impact)
2026 to 2027Coverage

Upcoming catalysts 2

T2Abstract
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Ketamir-2
T2Timing Guidance
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Event history 9

●FDA Feedback ReceivedKetamir-2FDA Meeting
FDA review and comments received on Ketamir-2 Phase 2a CIPN protocol
chemotherapy-induced peripheral neuropathy (CIPN)source ↗
●Ethics Committee ApprovalKetamir-2Trial
Phase 2a CIPN protocol submitted for IRB review
chemotherapy-induced peripheral neuropathy (CIPN)source ↗
▲Preclinical PoCMIRA-55Preclinical
Positive results from completed 7-day dose-range finding toxicology and toxicokinetic studies of MIRA-55 in rats and dogs
inflammatory painsource ↗
▲Preclinical PoCSKNY-1Preclinical
Positive 7-day repeated-dose toxicokinetic study of SKNY-1 in Beagle dogs
obesitysource ↗
●IND Enabling CompleteMIRA-55Preclinical
Completed in-life dosing of exploratory 7-day repeated-dose toxicology and toxicokinetic studies
chronic inflammatory painsource ↗
●IND Enabling CompleteSKNY-1Preclinical
Completed in-life dosing of exploratory 7-day repeated-dose toxicology and toxicokinetic studies
obesity and addiction-related disorderssource ↗
▲IND Enabling CompleteKetamir-2Preclinical
DEA determined Ketamir-2 is not a controlled substance
chemotherapy-induced peripheral neuropathysource ↗
▲Preclinical PoCMIRA-55Preclinical
Positive preclinical formulation results for MIRA-55
chronic inflammatory painsource ↗
▲Preclinical PoCSKNY-1Preclinical
Positive preclinical formulation results for SKNY-1
obesity and addictionsource ↗
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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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 %
2026-10-05Ketamir-2 Phase 1 data presentation Phase 1
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

F18 / 100
Pipeline Score
$0M
Pipeline Value
Richly Valued
Valuation Signal
1
Drugs Scored
0.0x
rNPV / MCap
Top 95%
Micro Cap
(rank 624 of 657)
Percentile Rank
MIRA Pharmaceuticals, Inc. has significant pipeline risk (18/100), led by Ketamir-2 in Undisclosed (Phase 1).
Showing 1 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Ketamir-2 Small moleculeCompletedNCT07791303UndisclosedPhase 1 COMPLETED 57Mar 5, 2026
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Clinical Trial Results

Readouts, endpoints and source filings for every MIRA program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
SKNY-1 obesity2026-08-06positive toxicokinetic findingsRead MoreMIRA Reports Positive 7-Day Dog Study Results for SKNY-1Read More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Aminov ErezDirector, Officer (Chief Executive Officer)Grant/Award 83,500 83,500 held$0.00 03/30/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in MIRA for Q2 2026.
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

MIRA Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
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Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
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Calls vs Puts by Expiry

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Competitive positioning

How MIRA ranks across every disease it competes in

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See how MIRA ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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MIRA News

MIRA
Sep 17, 2026
MIRAPhases
▲ +5.5%on this news· ran to +26% by day 3

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
Sep 1, 2026
MIRAFDA Updates
▲ +11.7%on this news

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.

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MIRA
Aug 6, 2026
MIRAPhases

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.

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MIRA
Jul 30, 2026
MIRAPhases

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.

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MIRA
Jul 10, 2026
MIRAPhases

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.

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MIRA
Jul 6, 2026
MIRAPhases

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.

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MIRA
Jun 25, 2026
MIRAPhases

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.

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MIRA
Jun 17, 2026
MIRAPhases

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.

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MIRA
Jun 17, 2026
MIRAPhases

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.

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MIRA
Jun 4, 2026
MIRAGeneral

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.

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MIRA
Jun 4, 2026
MIRAGeneral

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.

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MIRA
May 27, 2026
MIRAPhases
▲ +18.6%on this news

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).

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MIRA
May 27, 2026
MIRAPhases
▲ +18.6%on this newsshared move

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.

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MIRA
May 14, 2026
MIRAPhases

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.

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MIRA
May 13, 2026
MIRAGeneral

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.

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MIRA
Mar 23, 2026
MIRAPhases
▲ +22.3%on this news

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.

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MIRA
Mar 4, 2026
MIRAPhases

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.

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MIRA
Feb 3, 2026
MIRAPhases

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.

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MIRA
Oct 24, 2025
MIRAPhases

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.

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MIRA
Oct 16, 2025
MIRAGeneral
▲ +36.4%on this news

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.

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About MIRA Pharmaceuticals, Inc.

Miami, FL 2 employees mirapharmaceuticals.com
Headquarters1200 BRICKELL AVENUE, MIAMI, FL, 33131
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