Welcome to our dedicated page for Mira Pharma news (Ticker: MIRA), a resource for investors and traders seeking the latest updates and insights on Mira Pharma stock.
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) generates a steady flow of news as a clinical-stage biopharmaceutical company advancing oral and topical therapies for neurologic, neuropsychiatric, metabolic, and pain-related disorders. Company press releases and Form 8-K filings highlight progress across its pipeline, including Ketamir-2 for neuropathic pain and CNS indications, MIRA-55 for chronic inflammatory and nociceptive pain, and SKNY-1 for obesity and nicotine addiction following the acquisition of SKNY Pharmaceuticals.
On this news page, readers can follow updates on clinical trial milestones for Ketamir-2, such as completion of the single ascending dose Phase 1 study, initiation of the multiple ascending dose phase, and plans for Phase 2a evaluation in chemotherapy-induced peripheral neuropathy. News items also cover preclinical data releases, including peer-reviewed publications and conference presentations describing Ketamir-2’s performance versus ketamine, gabapentin, and pregabalin in validated neuropathic pain models, as well as topical Ketamir-2 data showing effects comparable to injected morphine in acute and inflammatory pain models.
MIRA’s news flow further includes pipeline expansion and transaction announcements, such as the closing of the SKNY Pharmaceuticals acquisition and new preclinical results for MIRA-55 demonstrating oral pain normalization and inflammation reduction relative to morphine. Corporate and financing updates, including at-the-market equity offerings and Nasdaq listing compliance developments, are also reported through current reports and press releases.
Investors, clinicians, and researchers can use this page to monitor how MIRA’s programs evolve from preclinical studies into human trials, track regulatory milestones like FDA IND clearance, and review strategic decisions that shape the company’s multi-program portfolio in neuropathic pain, chronic inflammatory pain, obesity, addiction, PTSD, and related areas.
MIRA Pharmaceuticals announced positive preclinical results for Ketamir-2, an oral ketamine analog, suggesting it as a potential superior alternative to traditional ketamine for treating depression and treatment-resistant depression (TRD). The study conducted by Pharmaseed revealed that Ketamir-2 showed higher efficacy and safety compared to oral ketamine in male mice, with significant improvements in locomotor activity, reduced anxiety, and antidepressant effects. Unlike ketamine, Ketamir-2 can be administered orally, promising better patient compliance and is not a controlled substance under DEA rules. MIRA plans to submit an Investigational New Drug Application (IND) to the FDA later this year to initiate human trials.
Mira Pharmaceuticals announced that its novel drug MIRA-55 has been ruled by the DEA as not being a controlled substance. This decision eliminates regulatory barriers for manufacturing, research, and commercialization. MIRA-55, aimed at treating neuropathic pain, anxiety, and cognitive decline, shows promise in enhancing memory and cognitive performance without the adverse effects associated with THC in marijuana. The drug also demonstrates stable anti-anxiety effects and reduced intoxicating effects, providing a significant advantage over traditional cannabis. With access to large neurological and cannabis markets, MIRA-55 represents a promising value for the company.
MIRA Pharmaceuticals (NASDAQ: MIRA) is in advanced talks with Memorial Sloan Kettering Cancer Center (MSK) to evaluate MIRA's novel oral ketamine analog, Ketamir-2, for cancer-related pain and depression. This collaboration could validate Ketamir-2's potential and expand its application beyond depression and PTSD. MSK currently treats refractory cancer pain with intravenous ketamine, but Ketamir-2 may offer a more convenient oral alternative with higher bioavailability and a better safety profile. The study will compare Ketamir-2's efficacy to traditional ketamine in rodent models. MIRA also collaborates with Pharmaseed to explore Ketamir-2's effects on neuropathic pain. Successful preclinical results could accelerate FDA approval and create non-dilutive funding opportunities. Cancer pain affects 44% of patients, with 31% experiencing moderate to severe pain, and 25% suffering from depression.
Mira Pharmaceuticals has announced significant advancements in preclinical trials for Ketamir-2, an oral ketamine analog aimed at treating PTSD, depression, and neuropathic pain, including cancer pain. The company plans to submit an Investigational New Drug (IND) application to the FDA by year-end, aiming for human trials in 2025.
In collaboration with Pharmaseed, MIRA is testing Ketamir-2's efficacy in severe PTSD using rat models. Another study with Biotrial will evaluate the drug's locomotor effects in mice. MIRA has also initiated toxicological studies with Frontage Laboratories and improved the manufacturing process to reduce costs.
The potential market for Ketamir-2 is substantial, with PTSD affecting 8 million adults annually in the U.S. and the market for PTSD treatments projected to reach $26 billion by 2031.
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