Mira Pharmaceuticals Inc

06/04/2026

$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.

06/02/2026

$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://loom.ly/pekcFjA
$MIRA $NASDAQ

06/01/2026

MIRA Pharmaceuticals ($MIRA) Secured Worldwide Rights for Ketamir-2!

Last week, MIRA Pharmaceuticals announced the expansion of its exclusive Ketamir-2 license from North American exclusivity to worldwide rights — now covering patent filings across the United States, Europe, China, Japan, Canada, Australia, India, Israel, Mexico, and South Korea.

Here's why it matters beyond the headline:
1. Ketamir-2 is advancing toward Phase 2a in chemotherapy-induced peripheral neuropathy — an indication affecting an estimated 30–40% of chemotherapy patients for which there are currently no FDA-approved treatments. The first approved therapy in CIPN doesn't enter a competitive market. It creates one.
2. Worldwide IP rights mean that commercial opportunity — and any future licensing, co-development, or partnership discussion around it — is now backed by a global patent footprint spanning the world's largest pharmaceutical markets.
3. Phase 1 is complete. 56 healthy volunteers. Zero serious adverse events. Adverse events were higher in the placebo group than in the Ketamir-2-treated group.

Phase 2a protocol submission to the FDA is on deck.
📋 Full PR: https://loom.ly/voWAiIc

$MIRA |

05/28/2026

$MIRA | MIRA Pharmaceuticals — Positive Phase 1 Results for Ketamir-2
MIRA Pharmaceuticals today reported positive unblinded Phase 1 clinical results for Ketamir-2, its oral drug candidate for chemotherapy-induced peripheral neuropathy (CIPN) — nerve damage caused by cancer treatment that affects 30–40% of chemotherapy patients and has zero FDA-approved treatments.

Here's what Phase 1 showed across 56 healthy volunteers:

Safety & Tolerability
• Zero serious adverse events
• Zero dose-limiting toxicities
• Zero withdrawals — all participants completed the study
• Adverse events were predominantly mild — and the incidence was higher in the placebo group than in the Ketamir-2-treated group

Phase 2a in CIPN patients is the next step — submitting the protocol to the FDA under an active IND.
For the millions of cancer patients dealing with lasting nerve damage from chemotherapy and no approved treatment options, this is a program worth watching.

📋 Full PR: https://loom.ly/ZmjC1ME
$MIRA $NASDAQ

05/26/2026

$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 ni****ne 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 ni****ne-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://loom.ly/pekcFjA
📋 Full PR: https://loom.ly/ArA-uAE
$MIRA $NASDAQ

05/05/2026

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 ni****ne 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

05/01/2026

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!

04/22/2026

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.

$MIRA

03/31/2026

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 mirapharmaceuticals.com

03/26/2026

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://loom.ly/9UT8lTg

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