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MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage biotech company with a market capitalization of $26.23 million and notably volatile stock performance, announced Tuesday that a manuscript detailing its lead oral drug candidate, Ketamir-2, has been accepted for publication in Frontiers in Pharmacology. InvestingPro analysis indicates the stock has shown strong momentum with a 25.66% gain over the past six months, despite current overvaluation relative to its Fair Value.
The study reports that Ketamir-2 outperformed ketamine, pregabalin, and gabapentin in restoring sensory function and reversing pain behaviors across two rodent models of neuropathic pain. In the Chung model using rats with sciatic nerve ligation, Ketamir-2 restored sensory thresholds toward baseline in males while ketamine showed no measurable benefit. In females, it outperformed both pregabalin and gabapentin.
In a paclitaxel-induced neuropathy model in mice, Ketamir-2 produced more complete normalization of pain sensitivity in both male and female cohorts compared to gabapentin, which provided only partial relief.
Ketamir-2 is described as a new molecular entity that selectively binds to the PCP site of the NMDA receptor with low affinity and shows no significant interaction with over 40 other receptor systems.
"The data clearly demonstrate superior and more consistent pain relief compared to leading neuropathic pain drugs, within the specific models tested," said Erez Aminov, CEO of MIRA, according to the press release.
The company reports that its ongoing Phase 1 trial of Ketamir-2 in Israel is progressing on schedule with no safety concerns reported to date. MIRA plans to submit a Phase 2a clinical trial protocol to the FDA in Q4 2025, with the goal of initiating a study in neuropathic pain by year-end.
According to the company statement, the global neuropathic pain market is valued at approximately $7.97 billion in 2024 and is projected to reach $16.79 billion by 2034, with North America accounting for an estimated $3.7-3.9 billion annually.
In other recent news, MIRA Pharmaceuticals, Inc. announced that its topical Ketamir-2 cream demonstrated pain relief comparable to injected morphine in preclinical animal testing. The U.S. Food and Drug Administration cleared MIRA’s Investigational New Drug application for Ketamir-2, which is being developed to treat neuropathic pain. The company is conducting a Phase 1 trial and plans to initiate a U.S.-based Phase 2a clinical trial in the fourth quarter of 2025. Additionally, MIRA Pharmaceuticals reported preclinical results for its obesity and nicotine addiction drug candidate, SKNY-1, which showed reversal of anxiety-related behavior in animal models. The study used a zebrafish light-dark preference test to measure anxiety responses. In financial developments, MIRA Pharmaceuticals raised $2 million through an at-the-market stock sale to an institutional investor. The shares were sold at an average price of $1.2981 per share, with gross proceeds totaling approximately $2 million before fees and expenses. The transaction was facilitated by Rodman & Renshaw using the StockBlock platform.
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