Latest news with #Ketamir-2
Miami Herald
28-05-2025
- Business
- Miami Herald
MIRA Pharmaceuticals to Participate in BIO 2025 in Boston and Highlights Ongoing Progress Across Clinical Program
The company will engage in BIO One-on-One Partnering™ meetings as it advances Phase 1 for Ketamir-2, prepares Phase IIa study in neuropathic pain, and finalizes filings for SKNY acquisition. MIAMI, FL / ACCESS Newswire / May 28, 2025 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that it will participate in the BIO International Convention 2025, taking place in Boston, MA from June 16-19, 2025. The Company has a full schedule of BIO One-on-One Partnering™ meetings planned as it explores potential licensing, strategic partnerships, and M&A opportunities. The Company's lead candidate, Ketamir-2, a next-generation oral ketamine analog, is currently undergoing a Phase 1 clinical trial. With the second dosing cohort completed, the Company is now preparing to initiate the third cohort. Building on this momentum, MIRA anticipates initiating a Phase IIa study in neuropathic pain before the end of the year, advancing the development of what the Company believes could be a safe, effective non-opioid alternative for chronic pain management. In addition, MIRA is advancing a series of preclinical studies with Ketamir-2, including models evaluating its potential in PTSD, as well as a topical formulation aimed at treating localized inflammatory pain. The Company is also finalizing regulatory filings related to its acquisition of SKNY Pharmaceuticals, Inc. ("SKNY"), with submission to the U.S. Securities and Exchange Commission (SEC) expected in the coming weeks. SKNY-1, SKNY's primary pharmaceutical candidate, is being developed as an oral therapeutic targeting smoking cessation and obesity, with activity at CB1, CB2, and MAO-B receptors. "Our pipeline is advancing on all fronts, and we are focused on turning this scientific momentum into long-term value for patients and shareholders," said Erez Aminov, Chief Executive Officer of MIRA. "As we move closer to initiating Phase IIa and completing the SKNY transaction, we're actively exploring strategic opportunities to accelerate growth, including licensing and partnerships-especially in areas like chronic pain where non-opioid alternatives like Ketamir-2 are urgently needed." Dr. Angel, Chief Scientific Advisor at MIRA, added:"We believe Ketamir-2 is paving the way for a new class of non-opioid therapies. The science is compelling, and the progress we have made is truly exciting. I look forward to sharing the depth of our work and the promising data we've generated with potential partners and investors." Cautionary Note Regarding Forward-Looking StatementsThis press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact InformationHelga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
Miami Herald
06-05-2025
- Business
- Miami Herald
MIRA Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked Neurotoxicity
Press Releases MIRA Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked Neurotoxicity Preclinical data supports the advancement of oral Ketamir-2 as a safe, next-generation alternative to ketamine, with ongoing momentum in Phase I clinical trial enrollment MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing breakthrough treatments for neurological and neuropsychiatric conditions, today announced positive results from a neurotoxicity study of Ketamir-2, its novel oral NMDA receptor antagonist. The study was required by the U.S. Food and Drug Administration (FDA) prior to initiating human dosing in the United States. The preclinical study showed no evidence of brain toxicity, including the absence of Olney lesions-vacuolar brain changes historically associated with older NMDA-targeting drugs such as ketamine and MK-801. These results further confirm the favorable safety profile of Ketamir-2 and support its safe continued clinical development. "These results represent a key milestone in the development of Ketamir-2," said Erez Aminov, Chairman and CEO of MIRA. "The absence of NMDA-linked neurotoxicity, along with continued clinical progress, reinforces our confidence in Ketamir-2's potential as a safe next-generation, oral candidate for CNS disorders." Study Overview and Key Findings The neurotoxicity study was conducted in sexually mature Sprague-Dawley rats. High oral doses of Ketamir-2 were administered, while a positive control group received MK-801, a known neurotoxic NMDA receptor antagonist. Brain tissues were examined through detailed histopathological analysis at two time points. Key outcomes: No adverse clinical signs or mortality in any Ketamir-2-treated animals. No microscopic or macroscopic brain lesions detected at any dose. MK-801-treated animals showed clear evidence of brain toxicity, including vacuolation and neuronal necrosis. "These findings eliminate one of the main safety concerns that has historically limited NMDA-targeting therapies," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Ketamir-2's clean neurotoxicity profile strengthens its position as a differentiated and promising therapeutic candidate." Why Ketamir-2 Stands Apart Ketamir-2 is a New Molecular Entity (NME) designed to modulate the NMDA receptor with a reduced affinity for the PCP binding site, which is strongly associated with neurotoxicity and psychotropic effects in legacy compounds like ketamine. In prior preclinical studies, Ketamir-2 has: Demonstrated full reversal of pain thresholds in validated neuropathic pain models. Outperformed FDA-approved treatments such as gabapentin and pregabalin. Shown no sedation or hyperactivity. Demonstrated strong oral bioavailability and brain penetration, as it is not a substrate for P-glycoprotein (P-gp). Ketamir-2 was designed for oral administration, offering a non-invasive alternative to intravenous therapies. In addition, the U.S. Drug Enforcement Administration (DEA) has determined that Ketamir-2 is not classified as a controlled substance, which may streamline development, reduce regulatory burdens, and improve future access if approved. Clinical Progress and What's Next MIRA has already initiated its Phase I clinical trial, with subject recruitment actively underway and progressing smoothly. The Company is preparing to launch a Phase IIa proof-of-concept trial in diabetic patients with neuropathic pain, with the goal of validating clinical efficacy and supporting future regulatory milestones. The newly completed neurotoxicity study results will be submitted to the FDA as part of MIRA's ongoing regulatory and clinical development strategy. Additional information about MIRA Pharmaceuticals is available at Cautionary Note Regarding Forward-Looking Statements This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moya info@ (786) 432-9792 SOURCE: MIRA Pharmaceuticals This story was originally published May 6, 2025 at 8:06 AM.
Globe and Mail
16-04-2025
- Business
- Globe and Mail
Pharmaceutical Stock Jumps After Key Trial Findings
A pharmaceuticals company based out of Maryland is turning heads on Wednesday after the company announced that data demonstrated the potential efficacy of its oral ketamine analog, Ketamir-2, in treating diabetic neuropathy in animal model, according to a press release from this morning. Traders wasted little time buying up shares of MIRA Pharmaceuticals Inc. (Nasdaq:MIRA), thrusting the micro cap up to $1.33/share (+48.24%) at the early session high. This move could indicate a breakout is imminent as this stock fights to breakout of a multi-month downtrend. MIRA Pharmaceuticals, Inc. operates as a clinical development stage biopharmaceutical company. The company focuses on the development and commercialization of a new molecular synthetic tetrahydrocannabinol (THC) analog under investigation for the treatment of adult patients with anxiety and cognitive decline typically associated with early-stage dementia. It is developing MIRA1a, a synthetic cannabinoid analog to treat anxiety and chronic pain by targeting the cannabinoid type 1 and type 2 receptors. The company was formerly known as MIRA1a Therapeutics, Inc. MIRA Pharmaceuticals, Inc. was incorporated in 2020 and is headquartered in Baltimore, Maryland. Copyright © 2025 All rights reserved. Republication or redistribution of content is expressly prohibited without the prior written consent of shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. View more of this article on About Media, Inc.: Founded in 1999, is one of North America's leading platforms for micro-cap insights. Catering to both Canadian and U.S. markets, we provide a wealth of resources and expert content designed for everyone—from beginner investors to seasoned traders. is rapidly gaining recognition as a leading authority in the micro-cap space, with our insightful content prominently featured across numerous top-tier financial platforms, reaching a broad audience of investors and industry professionals. Want to showcase your company's story to a powerful network of investors? We can help you elevate your message and make a lasting impact. Contact us today. Contact: Media, Inc.
Yahoo
24-03-2025
- Business
- Yahoo
EXCLUSIVE: MIRA Pharmaceuticals Signs To Acquire SKNY Pharmaceuticals, Expand Pipeline Into Weight Loss And Smoking Cessation Drug
On Monday, MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) signed a binding letter of intent (LOI) to acquire SKNY Pharmaceuticals, Inc. The transaction includes a $5 million capital infusion of cash or equivalent consideration into MIRA, reinforcing its financial position and supporting the advancement of SKNY-1, a preclinical-stage oral drug candidate for weight loss and smoking cessation. Also Read: Under the terms, MIRA will acquire SKNY through a stock exchange, whereby SKNY shareholders will receive shares of MIRA common stock at a valuation determined by an independent third-party firm. Additionally, SKNY will contribute $5 million in cash or assets to MIRA at closing. Upon completion, SKNY-1 and all related intellectual property assets will be fully integrated into MIRA. The acquisition of SKNY Pharmaceuticals strategically positions MIRA to enter two high-growth pharmaceutical markets with a differentiated, next-generation oral therapy. SKNY-1, in preclinical development, is being investigated as a potential oral therapeutic option for metabolic regulation. The drug candidate is designed to interact with cannabinoid receptors CB1 and CB2 pathways that have been demonstrated for their role in appetite, metabolism, and energy balance regulation. SKNY-1 is being developed as a potential oral therapy that may work by modulating cannabinoid pathways involved in nicotine dependence. If successful, it could provide an alternative to existing treatments by addressing key challenges in smoking cessation. Last week, MIRA Pharmaceuticals announced the formulation of Ketamir-2 as a topical treatment for localized neuropathic and inflammatory pain. The advancement expands the company's pain management portfolio beyond its ongoing Ketamir-2 oral treatment for neuropathic pain. Price Action: MIRA stock is trading lower by 3.12% to $1.24 premarket at the last check on Monday. Read Next:Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article EXCLUSIVE: MIRA Pharmaceuticals Signs To Acquire SKNY Pharmaceuticals, Expand Pipeline Into Weight Loss And Smoking Cessation Drug originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
Yahoo
14-03-2025
- Business
- Yahoo
Psychedelic: atai reports dosing of first patient in Phase 2 VLS-01 trial
In this week's 'Psychedelic,' The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a dosing initiation, a development expansion and a distribution agreement. Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. ATAI DOSES FIRST PATIENT IN PHASE 2 VLS-01 TRIAL: atai Life Sciences (ATAI) announced Tuesday that the first patient has been dosed in the Phase 2 Elumina trial of VLS-01, atai's proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine applied to the buccal surface, in people suffering from treatment-resistant depression. 'Dosing the first patient in the Phase 2 Elumina trial of VLS-01 marks a significant milestone in our commitment to transforming the treatment landscape for mental health disorders,' stated Kevin Craig, CEO. 'Millions worldwide struggle with treatment-resistant depression, often left with few or no viable options. With VLS-01, we see the potential to offer rapid, robust, and durable antidepressant effects that could provide meaningful relief where existing treatments fall short. This trial brings us one step closer to delivering a new and innovative solution to those people who need it most.' Elumina is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, clinical trial to assess the efficacy, safety and tolerability of repeated doses of VLS-01. The trial consists of two treatment periods. In the first treatment period, approximately 142 patients will be randomized 1:1 to receive a 120mg dose of VLS-01 or placebo on Day 1, followed by a second dose of the same intervention at Week 2. The primary endpoint is the change from Baseline in Montgomery-Asberg Depression Rating Scale total score at Week 4. The last double-blind assessment visit will be at Week 14. The first treatment period will provide 12 weeks of blinded durability data following two doses of VLS-01 administered in a placebo-controlled fashion. Topline results from the first treatment period are anticipated in 1Q26. MIRA EXPANDS KETAMIR-2 DEVELOPMENT WITH TOPICAL: On Thursday, MIRA Pharmaceuticals (MIRA) announced the formulation of Ketamir-2 into a topical treatment for localized neuropathic and inflammatory pain. This expands the company's pain management portfolio beyond its ongoing Ketamir-2 oral treatment for neuropathic pain, offering a novel, targeted approach for localized pain relief. The topical treatment of Ketamir-2 is designed for slow release, delivering targeted pain relief directly at the application site while minimizing systemic exposure and side effects. 'The development of both an oral and topical formulation of Ketamir-2 significantly expands our pipeline and enhances the value proposition of MIRA,' stated Erez Aminov, CEO . 'By advancing two distinct formulations, we are positioning Ketamir-2 to address multiple pain conditions and broaden its potential applications. This strategic approach strengthens our presence in the pain management space and underscores our commitment to delivering innovative solutions while creating value for our shareholders.' PHARMALA SIGNS DISTRIBUTOR IN THE NETHERLANDS: PharmAla Biotech Holdings (MDXXF) announced Monday that it has signed a distribution agreement with Duchefa Farma of Haarlem, Netherlands, to act as exclusive distribution agent for its LaNeo MDMA in the Netherlands market. The distribution agreement includes an annual purchase minimum, as well as restrictions on re-export and price controls. It also includes an escalator provision which would significantly increase the minimum purchase amounts in the 24 months following regulatory changes which allow for use of MDMA in the healthcare system. Duchefa will also act as Importer of Record as well as providing Qualified Person Release of PharmAla's products. 'We are confident that this deal will open significant new opportunities for both Duchefa and PharmAla. This is the first new market we have officially opened since entering Australia in late 2023,' said Nick Kadysh, CEO. 'In looking for a partner we can rely on, we were pleased to see that Duchefa has not only an incredible presence in the Netherlands, but exceptional relationships with partners from the Galenos Group across Europe. We are excited to fulfill the demand for clinical trial materials in the Netherlands, and to assist in pushing the Government of the Netherlands towards greater acceptance of MDMA-Assisted Therapy for the treatment of PTSD.' CLEARMIND ANNOUNCES PATENT PUBLICATION: On Monday, Clearmind Medicine (CMND) announced the publication of a patent by the Korean Intellectual Property Office. The patent covers the company's combination therapy of MEAI and N-Acylethanolamines for the treatment of cocaine addiction. The patent is based on preclinical trial results led by Professor Gal Yadid and his team at the Gonda Multidisciplinary Brain Research Center at Bar-Ilan University in Israel. These studies build upon earlier experiments in which animals treated with MEAI exhibited a significant reduction in cocaine-induced cravings. Further research was conducted in rats to assess whether MEAI's effects on drug-seeking behavior extended to natural rewards, given that reward-based reinforcement is a fundamental survival mechanism across species. The study produced positive results, demonstrating that while MEAI reduced cocaine-seeking behavior, it did not impair the rats' response to natural rewards such as sucrose. This finding suggests that MEAI's impact on drug cravings is not tied to the general reward system but is specifically targeted at drug-related compulsions. ANALYST STARTS PSYCHEDELIC FIRMS WITH BUYS: Guggenheim initiated coverage of Cybin (CYBN) on Wednesday with a Buy rating and $35 price target. The firm's investment thesis is based on CYB003's robust and durable antidepressant efficacy in Phase 2 major depressive disorder trials and its potential to replicate those data and deliver best-in-class data in Phase 3, the analyst said. The firm believes upside optionality remains, and with multiple key data readouts expected across the space in the next 6-12 months, it thinks now is the time for investors to start paying attention. Guggenheim initiated coverage of GH Research (GHRS) with a Buy rating and $32 price target. The firm's thesis on GH is based around the belief that rapid-acting psychedelics like 5-MeO-DMT have the potential to transform the treatment resistant depression treatment landscape, the analyst said. The firm added that, with pivotal milestones in the sector coming over the next 6-12 months and an update on the clinical hold anticipated this year, it believes GH is well-positioned for long-term upside. OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Compass Pathways (CMPS), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex Healthcare (IXHL), Mind Medicine (MNMD), Mydecine Innovations (MYCOF), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on ATAI: Questions or Comments about the article? Write to editor@ Largest borrow rate increases among liquid names Atai Life Sciences announces first patient dosed in Elumina Phase 2 trial Psychedelic: MindMed reports Q4 earnings results Atai Life Sciences completes enrollment of Phase 2b trial of BPL-003 Psychedelic: GH Research, Compass Pathways report earnings results Sign in to access your portfolio
