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MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a $31.77 million market cap biotech company that has seen its stock surge over 50% in the past six months, announced Tuesday that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for Ketamir-2, an oral NMDA receptor antagonist being developed to treat neuropathic pain.
The company is currently conducting a Phase 1 trial at Hadassah Medical Center in Jerusalem, nearing completion of the single ascending dose portion and preparing to begin the multiple ascending dose segment. MIRA plans to initiate a U.S.-based Phase 2a clinical trial in Q4 2025. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 12.86, providing sufficient resources for its clinical development programs.
According to the company’s press release, preclinical studies showed Ketamir-2 demonstrated no evidence of brain lesions or adverse CNS effects, a distinction from traditional ketamine. The drug candidate also showed efficacy in multiple neuropathic pain models, reportedly outperforming gabapentin and pregabalin in some tests.
"This IND approval validates the strength of our preclinical data and the differentiated pharmacology of Ketamir-2," said Erez Aminov, Chairman and CEO of MIRA.
The company is also exploring potential applications in chemotherapy-induced peripheral neuropathy and diabetic peripheral neuropathy, while advancing formulation development for topical applications.
Neuropathic pain affects millions across North America, with current therapies often providing limited relief and significant side effects. MIRA suggests Ketamir-2’s oral, non-opioid profile could offer advantages over existing treatments.
The company also reported that its planned acquisition of SKNY Pharmaceuticals remains on track, with shareholder approval expected in Q3 2025. SKNY’s lead asset is being developed for obesity and smoking cessation. With the next earnings report due on September 3, 2025, InvestingPro analysts anticipate continued losses this year, though the company’s recent stock momentum suggests growing investor confidence. InvestingPro subscribers have access to 8 additional key insights about MIRA’s financial health and growth prospects.
In other recent news, MIRA Pharmaceuticals, Inc. reported positive preclinical results for its drug candidates SKNY-1 and Mira-55. SKNY-1, developed for obesity and nicotine addiction, showed the ability to reverse anxiety-related behavior in animal models, as evidenced by a zebrafish light-dark preference test. Additionally, Mira-55, a non-opioid pain drug, demonstrated pain relief comparable to morphine without causing inflammation in preclinical studies. These findings were part of a broader announcement that included updates on a definitive agreement for the acquisition of SKNY-1. In financial developments, MIRA Pharmaceuticals raised approximately $2 million through an at-the-market stock sale facilitated by Rodman & Renshaw. The shares were sold at a premium to the prior day’s closing price, with no warrants included in the offering. These developments reflect ongoing progress in MIRA’s research and financial strategies.
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