Mira Pharma Stock Price, News & Analysis

MIRA Pharmaceuticals (NASDAQ:MIRA) has signed a binding letter of intent to acquire SKNY Pharmaceuticals, securing a $5 million capital infusion. The acquisition includes SKNY-1, a preclinical-stage oral drug candidate targeting weight loss and smoking cessation.

The transaction will be executed through a stock exchange, with SKNY shareholders receiving MIRA common stock at a valuation determined by an independent third-party firm. The deal positions MIRA in two significant markets: the weight loss drug market, projected to exceed $150 billion by early 2030s, and the smoking cessation market, expected to reach $51 billion by 2030.

SKNY-1 is being developed to interact with cannabinoid receptors CB1 and CB2 pathways for appetite, metabolism, and energy balance regulation. The drug aims to address limitations of current treatments, including severe side effects and the need for lifelong injections in existing weight loss medications.

The transaction is subject to a 90-day due diligence period, regulatory approvals, and board approvals.

MIRA Pharmaceuticals (NASDAQ:MIRA) has successfully developed a topical formulation of Ketamir-2 for localized neuropathic and inflammatory pain treatment, expanding beyond its existing oral formulation. The topical treatment is designed for slow release, providing targeted pain relief while minimizing systemic exposure and side effects.

The new formulation targets multiple conditions including:

• Neuropathic pain conditions (diabetic neuropathy, postherpetic neuralgia)
• Inflammatory pain conditions (osteoarthritis, rheumatoid arthritis)
• Nerve compression & musculoskeletal pain

MIRA's clinical progress includes:

• Ongoing Phase 1 trial for oral Ketamir-2
• Preclinical PTSD studies
• Planned Phase 2a study for diabetic neuropathy by year-end
• Animal study for topical Ketamir-2
• MIRA-55 preclinical studies for memory enhancement

MIRA Pharmaceuticals (NASDAQ:MIRA) has received approval to initiate Phase 1 clinical trials for Ketamir-2, their novel oral ketamine analog for neuropathic pain treatment. The trial, authorized by the Israeli Ministry of Health, will be conducted at Hadassah Medical Center in Jerusalem.

The study includes two parts: a Single Ascending Dose (SAD) with 32 participants and Multiple Ascending Dose (MAD) with 24 participants. The trial aims to evaluate safety, tolerability, and pharmacokinetics, with completion expected by Q4 2025.

Preclinical studies showed Ketamir-2's superior efficacy compared to existing treatments:

• Full pain reversal in nerve ligation models
• 60% more effective than gabapentin in chemotherapy-induced neuropathy
• Enhanced bioavailability through Pamoate salt formulation
• Improved safety profile with no cardiovascular concerns

The neuropathic pain market is projected to reach $5.2 billion in North America by 2030. The company plans to initiate Phase 2a studies in Q4 2025.

MIRA Pharmaceuticals (NASDAQ:MIRA) has submitted an Investigational New Drug (IND) application to the FDA for Ketamir-2, its novel oral ketamine analog for treating neuropathic pain. The submission includes comprehensive data on pharmacology, pharmacokinetics, and toxicology, along with in vitro and in vivo study results.

The North American neuropathic pain market is valued at $3.1 billion with expected growth to $4.5 billion by 2030. Ketamir-2 addresses limitations of existing treatments through selective NMDA receptor targeting, showing 100% pain reversal in preclinical studies without psychotropic effects. The company plans to initiate Phase I Clinical Trials in Q1 2025, followed by Phase IIa trials in late 2025.

MIRA Pharmaceuticals (NASDAQ:MIRA) announces successful completion of Good Laboratory Practice preclinical safety program for Ketamir-2, their novel oral ketamine analog. The studies showed no adverse findings across multiple safety assessments, including cardiovascular safety in dogs, CNS assessment in rats, and respiratory safety tests.

The company plans to submit an Investigational New Drug (IND) application by end of 2024, with Phase I clinical trials scheduled to begin in Q1 2025. The trial design includes pain tests to evaluate effects on neuropathic pain and psychosis, with data expected by Q2 2025. A Phase IIa proof-of-concept study is planned for Q4 2025, with results anticipated by year-end.

MIRA Pharmaceuticals (NASDAQ:MIRA) has selected The Centre for Human Drug Research (CHDR) in Leiden, Netherlands, for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. The trial will begin recruitment in Q1 2025, with Phase I results expected in H2 2025 and Phase IIa results in H1 2026. The study will utilize CHDR's proprietary PainCart technology to measure pain response in healthy subjects during Phase I, followed by testing in diabetic neuropathy patients in Phase IIa. The trial is designed as a randomized, double-blind, placebo-controlled study. Ketamir-2 has shown superior efficacy compared to pregabalin and gabapentin in preclinical studies, with no reported side effects to date.

MIRA Pharmaceuticals (NASDAQ:MIRA) announces that its novel oral ketamine analog Ketamir-2 shows 60% greater efficacy than FDA-approved gabapentin in treating chemotherapy-induced neuropathic pain in preclinical studies. Using the paclitaxel model, Ketamir-2 achieved near-complete pain normalization at 300 mg/kg dose. The company plans to submit an IND application by end of 2024 and begin Phase I trials in Q1 2025. MIRA is also evaluating Ketamir-2 for diabetic neuropathy, PTSD, and other conditions. The drug could potentially qualify for FDA breakthrough therapy designation, fast track, and priority review for treating rare cancer-related neuropathic pain.

MIRA Pharmaceuticals (NASDAQ:MIRA) announces that its novel oral ketamine analog, Ketamir-2, outperforms FDA-approved neuropathic pain treatments Gabapentin and Pregabalin in preclinical studies. Key findings show Ketamir-2 provided up to 112% more effective results than Pregabalin and 70% greater relief than Gabapentin at higher doses by Day 22 in female rats.

Ketamir-2 offers advantages over current treatments, including being non-habit forming and potentially avoiding sedation and cognitive impairment. MIRA is preparing to submit an Investigational New Drug (IND) application by year-end, with Phase 1 clinical trials scheduled for Q1 2025 and Phase 2 trials in Q4 2025. The company is also exploring Ketamir-2's potential for PTSD treatment and pursuing government grants to accelerate development.

MIRA Pharmaceuticals (NASDAQ:MIRA) announced new preclinical data on Ketamir-2, its lead development product, will be presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024. The presentation, titled "Selective NMDA Receptor Modulation: The Superior Efficacy of Ketamir-2 in Neuropathic Pain Treatment," will showcase breakthrough findings where Ketamir-2 achieved 100% reversal of neuropathic pain in preclinical models.

Ketamir-2, a novel oral Ketamine analog, selectively targets the PCP site of the NMDA receptor, offering enhanced efficacy with fewer side effects compared to ketamine. In preclinical studies using the Chung model of neuropathic pain, Ketamir-2 demonstrated superior efficacy to ketamine, achieving full normalization of pain response. MIRA plans to submit an Investigational New Drug (IND) application to the U.S. FDA by December 2024, with aims to demonstrate efficacy in humans as early as 2025.