Mira Pharmaceuticals

MIRA (Nasdaq: MIRA) Developing next-generation FDA-approved pharmaceutical marijuana and oral ketamine analogs for advanced treatment solutions $MIRA

[Mira Pharmaceuticals @PharmaMira]

Positive 7-day toxicokinetic findings for $MIRA’s SKNY-1 demonstrated rapid absorption and dose-dependent systemic exposure.

These findings support our advancement toward GLP toxicology and IND-enabling development for our investigational oral obesity candidate, being developed to promote weight loss while preserving lean body mass.

Read more: https://t.co/8GNmjUiHiy

#SKNY1 #Obesity

[Mira Pharmaceuticals @PharmaMira]

$MIRA: Three differentiated drug candidates. Three therapeutic areas.

🔹 MIRA-55 – Preclinical, currently being investigated for chronic inflammatory pain and progressing toward an IND.

🔹 SKNY-1 – Preclinical, currently being investigated for obesity and addiction-related disorders and progressing toward an IND.

🔹 Ketamir-2 – Preparing for a Phase 2a clinical study in chemotherapy-induced peripheral neuropathy (CIPN).

We remain focused on advancing innovative oral therapies to address significant unmet medical needs.

Learn more: https://t.co/cx637Qctdl

$MIRA #Biotech #DrugDevelopment #ClinicalResearch

[Mira Pharmaceuticals @PharmaMira]

$MIRA MIRA Pharmaceuticals (NASDAQ: $MIRA) announced successful preclinical oral formulation results for MIRA-55, our investigational non-opioid oral drug candidate for chronic inflammatory pain.

These findings support the continued development of MIRA-55 and build upon our previously reported preclinical efficacy, behavioral, mechanistic, and pharmacokinetic studies.

Full press release: https://t.co/ICbB0B1Uv9

#Biotech #DrugDevelopment #PainResearch #NonOpioid

[Mira Pharmaceuticals @PharmaMira]

MIRA Pharmaceuticals (NASDAQ: $MIRA) announced successful preclinical oral formulation results for SKNY-1, our investigational oral drug candidate for obesity and addiction-related disorders.

We believe the next generation of obesity therapies should strive not only to support weight loss but also to preserve lean body mass, all in the convenience of an oral therapy.

Read the full press release: https://t.co/nIBjwztsQx

$MIRA #Biotech #Obesity #DrugDevelopment

[Mira Pharmaceuticals @PharmaMira]

$MIRA | Advancing Ketamir-2 Toward Phase 2a

MIRA Pharmaceuticals has submitted its Phase 2a clinical study plan to the FDA for Ketamir-2, our investigational therapy being developed for chemotherapy-induced peripheral neuropathy (CIPN).

CIPN affects an estimated 30–40% of patients receiving chemotherapy and can significantly impact quality of life. Despite its prevalence, there are currently no FDA-approved therapies specifically developed for this condition.

Ketamir-2 has completed Phase 1 clinical development with no serious adverse events.

The submission of the Phase 2a study plan represents an important step in the clinical development process as we continue working to address a significant unmet medical need in oncology supportive care.
This post contains forward-looking statements. See our SEC filings for risk factors.

#CIPN #Ketamir2 #Oncology #DrugDevelopment #Biotech

[Mira Pharmaceuticals @PharmaMira]

$MIRA | MIRA Pharmaceuticals will be attending BIO International Convention in San Diego, June 22–25.

Ketamir-2 has successfully completed Phase 1 clinical development and is advancing toward Phase 2a evaluation in chemotherapy-induced peripheral neuropathy (CIPN), an area of significant unmet medical need with no FDA-approved therapies.

Program highlights:
• Once-daily oral administration
• DEA non-scheduled
• Patent-protected across major pharmaceutical markets
• Supported by completed Phase 1 clinical data

MIRA Pharmaceuticals is a NASDAQ-listed biotechnology company with a clean capital structure and is available for licensing, co-development, and strategic partnership discussions.

To schedule a meeting, please submit a request through the BIO Partnering Portal.

#BIO2026 #CIPN #DrugDevelopment #Biotech #Partnering

[Mira Pharmaceuticals @PharmaMira]

$MIRA Prescribing gabapentin for CIPN is not a treatment decision. It is a concession that no better option exists.

For oncology patients dealing with chemo-induced nerve damage, the pharmacologic fallback is a drug approved for epilepsy and a drug approved for diabetic neuropathy. Neither was tested in CIPN at approval. Neither is FDA-approved for CIPN today. Patients are not getting care tailored to their condition.

They are getting the closest approximation medicine could find. Ketamir-2 is being built specifically for this population, from the ground up, with a mechanism designed for the biology of chemotherapy-induced nerve injury.

#MIRA $MIRA #CIPN #Ketamir2 #StandardOfCare #CancerPain #Oncology

[Mira Pharmaceuticals @PharmaMira]

$MIRA | MIRA Pharmaceuticals will be attending the BIO International Convention in San Diego (June 22–25, 2026) and is actively scheduling partnering meetings through the BIO One-on-One Partnering™ portal.

Ketamir-2 continues advancing toward Phase 2a development in chemotherapy-induced peripheral neuropathy (CIPN) following positive Phase 1 clinical results across 56 healthy volunteers.

Ketamir-2 is a proprietary oral NMDA receptor modulator designed with:
• Favorable safety and tolerability
• Dose-proportional PK
• Once-daily oral administration potential
• DEA non-scheduled status

CIPN remains a significant unmet medical need with no FDA-approved therapies currently available.

MIRA believes Ketamir-2’s expanding clinical and intellectual property position may support future strategic licensing, co-development, and broader partnership opportunities.

Partnering meetings are now available through the BIO International partnering platform. Search “MIRA Pharmaceuticals” to request a meeting.

#BIO2026 #Biotech #Partnering #Oncology #DrugDevelopment #NASDAQ

[Mira Pharmaceuticals @PharmaMira]

$MIRA | SKNY-1 Weight Loss Data — What's Different About This One

With weight loss drugs dominating headlines, one question keeps coming up: what about lean muscle mass?

GLP-1 drugs — the current standard — are highly effective at reducing weight, but a growing body of clinical evidence shows they also reduce lean muscle mass, which has real implications for long-term metabolic health.

MIRA Pharmaceuticals' SKNY-1 preclinical data showed something worth noting:
• ~30% body weight reduction at the higher dose
• Reduction in total cholesterol and LDL
• Reduction in liver fat accumulation
• No significant reduction in whole-body density

That fourth point — no lean mass signal — is what makes this dataset worth paying attention to, even at this early preclinical stage.

SKNY-1 is an oral compound working through a completely different mechanism than GLP-1 drugs. More studies are needed before any clinical decisions. But the profile is differentiated — and it's asking the right questions.

📄 Full publication: https://t.co/YMme6vVuaC

$MIRA $NASDAQ #Obesity #WeightLoss #Biotech

[Mira Pharmaceuticals @PharmaMira]

$MIRA | MIRA Pharmaceuticals — Peer-Reviewed Publication for SKNY-1
MIRA Pharmaceuticals today announced that preclinical data for SKNY-1 — its oral drug candidate for obesity and nicotine addiction — has been published in the International Journal of Molecular Sciences.

• ~30% dose-dependent body weight reduction over six days of oral administration

• Reductions in total cholesterol, LDL, and hepatic triglyceride accumulation

• Attenuation of compulsive feeding and nicotine-seeking behaviors across multiple behavioral paradigms

• Normalization of appetite-regulatory leptin and ghrelin gene expression toward wild-type levels

• No significant reduction in whole-body density — relevant to the growing clinical focus on lean mass preservation during weight loss treatment

What makes SKNY-1 different: it targets both the metabolic side of obesity and the behavioral side — cravings, compulsive eating, addiction — in one oral compound.
This is early-stage science with more studies ahead, but peer-reviewed publication is an important step.
📄 Full publication: https://t.co/YMme6vW20a
📋 Full PR: https://t.co/MOI3Y6RP1f

$MIRA $NASDAQ #Obesity #Biotech #WeightLoss

[Mira Pharmaceuticals @PharmaMira]

$MIRA Proud to share the publication of our peer-reviewed SKNY-1 manuscript in the International Journal of Molecular Sciences @MDPIOpenAccess, representing an important milestone for the program and the continued advancement of our investigational oral therapeutic approach for obesity and nicotine addiction.

Publication:
https://t.co/Rm5Wtln2gf
#biotech #obesity #drugdevelopment

[Mira Pharmaceuticals @PharmaMira]

Three programs. One team. Each one addressing a condition where patients have been waiting too long.

Ketamir-2 leads the pipeline in CIPN with an established safety profile. SKNY-1 targets weight loss and nicotine addiction, engineered to avoid the CNS side effects that buried prior CB1 antagonists. MIRA-55 is an oral small molecule that has showcased comparable pain reversal to injected morphine in preclinical inflammatory pain models.

Pipeline breadth at this stage is how you protect against single-asset binary risk while building long-term enterprise value.

We invite you to follow along as we progress all three programs!

#MIRA #$MIRA #SKNY1 #MIRA55 #Pipeline #DrugDevelopment#BiotechInvesting

[Mira Pharmaceuticals @PharmaMira]

The next chapter for Ketamir-2 begins with a proof-of-concept study in patients with moderate to severe Chemotherapy-induced Peripheral Neuropathy (CIPN).

MIRA is finalizing the design of its Phase 2a clinical trial, which will enroll patients with CIPN and evaluate Ketamir-2 using validated neuropathic pain assessment tools.

The study is being designed with appropriate statistical powering to generate clinically meaningful safety and preliminary efficacy data. Subject to regulatory feedback, the Company anticipates initiating Phase 2a in the second quarter of 2026.

Follow MIRA Pharmaceuticals for trial initiation updates!

#Phase2a #CIPN #ProofOfConcept #Ketamir2 #ClinicalDevelopment #BiotechRoadmap

[Mira Pharmaceuticals @PharmaMira]

MIRA Pharmaceuticals (Nasdaq: MIRA) is proud to announce our presentation at the AACR Annual Meeting 2026 in San Diego, CA.

We shared our Phase 1 multiple ascending dose (SAD + MAD) clinical data on Ketamir-2, our lead oral NMDA receptor antagonist being developed for chemotherapy-induced peripheral neuropathy (CIPN).

To date, 56 healthy volunteers have been dosed. Based on safety data reviewed to date, no serious adverse events and no clinically significant ketamine-like CNS effects have been observed, supporting advancement into patient studies.

We are currently advancing our Phase 1 data package and preparing our Phase 2a clinical protocol for FDA submission

This is a meaningful milestone in our mission to improve quality of life for cancer patients suffering from treatment-related neurological complications.

We appreciate engaging with the oncology research community and sharing our progress.

#AACR2026 #Ketamir2 #CIPN #ClinicalStagePharmaceuticals #Oncology$MIRA

[Mira Pharmaceuticals @PharmaMira]

MIRA Pharmaceuticals intends to pursue FDA Fast Track designation for Ketamir-2 in chemotherapy-induced peripheral neuropathy.

Fast Track designation is available for therapies that address serious or life-threatening conditions with unmet medical need. CIPN meets both criteria. There are no FDA-approved treatments, and the condition directly impacts the ability of cancer patients to tolerate and complete chemotherapy.

If granted, Fast Track provides more frequent FDA interactions, eligibility for rolling review, and the potential for priority review. MIRA plans to submit the Phase 2a protocol to the FDA under its active IND in the first half of 2026.

Stay current with MIRA's regulatory milestones at https://t.co/TK7c05v7w3

#FastTrack #FDA #Ketamir2 #CIPN #RegulatoryStrategy #DrugDevelopment

[Mira Pharmaceuticals @PharmaMira]

MIRA Pharmaceuticals just released new data on their drug candidate Mira-55, a next-generation cannabinoid-based compound designed to treat inflammatory pain.

Here's what's exciting: Unlike THC (the psychoactive ingredient in cannabis) or rimonabant (a weight-loss drug pulled off the market due to serious psychiatric side effects), Mira-55 showed none of those harmful CNS side effects in preclinical testing.

On top of that, it previously demonstrated pain relief comparable to morphine, without the addiction and sedation risks that come with opioids.

For the millions suffering from chronic inflammatory pain with few good options, this kind of research could be a game changer. Mira-55 is now advancing toward an IND (investigational new drug) submission with the FDA.

Read the full press release: https://t.co/ajqwchN0kg

#PainRelief #DrugDevelopment #NonOpioid #Biotech #MIRAPharmaceuticals

[Mira Pharmaceuticals @PharmaMira]

56 subjects. Doses up to 600 mg. No serious adverse events.

The Phase 1 program for Ketamir-2 was conducted as a randomized, double-blind, placebo-controlled study at Hadassah Medical Center in Jerusalem. The single ascending dose arm enrolled 32 participants across four cohorts (50 mg to 600 mg).

The multiple ascending dose arm enrolled 24 participants across three cohorts (150 mg, 300 mg, and 600 mg daily for five days). Dose-proportional pharmacokinetics with rapid absorption and a favorable half-life support once-daily oral dosing. Final audited analyses are underway.

Full Phase 1 data to be presented at AACR 2026. Follow for updates.

#Ketamir2 #Phase1Data #ClinicalTrial #SafetyProfile #Pharmacokinetics #BiotechInvestor

[Mira Pharmaceuticals @PharmaMira]

$MIRA Can you unlock cannabinoid efficacy—without the CNS side effects?

New preclinical data: Mira-55 showed no THC- or rimonabant-associated CNS effects.

Previously demonstrated morphine-comparable pain relief—without opioid risks.

Advancing toward IND.

https://t.co/iJZDgWneE3

#biotech #drugdevelopment #painmanagement