Mira Pharmaceuticals, INC 8-K filings
NASDAQ
MIRA Pharmaceuticals announced compelling animal study results for SKNY-1, a drug candidate under acquisition, demonstrating up to 30% weight loss and reversal of high-calorie and nicotine cravings.
NASDAQ
MIRA Pharmaceuticals, Inc. announced new preclinical data for SKNY-1, a drug candidate for weight loss and smoking cessation, highlighting a unique profile designed to avoid central nervous system side effects.
NASDAQ
MIRA Pharmaceuticals announced its lead drug candidate, Ketamir-2, was accepted for publication in a peer-reviewed journal, while its Phase 1 trial progresses with no safety concerns, and the SKNY Pharmaceuticals acquisition remains on track.
NASDAQ
MIRA Pharmaceuticals, Inc. announced significant progress in its Ketamir-2 clinical trials, including the successful completion of a Phase 1 dosing cohort, and is finalizing regulatory filings for the SKNY Pharmaceuticals acquisition, while preparing for strategic collaborations at the BIO International Convention 2025.
NASDAQ
MIRA Pharmaceuticals announced the appointment of Alan Weichselbaum as Chief Financial Officer, effective May 15, 2025, following the mutual separation of Michelle Yanez from the same role.
NASDAQ
MIRA Pharmaceuticals announces a definitive agreement to acquire SKNY Pharmaceuticals for approximately $60 million, aiming to expand its pipeline and address obesity and nicotine dependence.
NASDAQ
MIRA Pharmaceuticals reports that Ketamir-2, its novel oral NMDA receptor antagonist, did not induce neurotoxic changes in a regulatory-required study, confirming the absence of ketamine-linked neurotoxicity.
NASDAQ
MIRA Pharmaceuticals announces successful dose-proportional drug release of its topical Ketamir-2 formulation in a validated laboratory study, marking a significant step towards clinical testing.
NASDAQ
MIRA Pharmaceuticals reports positive preclinical study results for its oral ketamine analog, Ketamir-2, showing significant reduction in neuropathic pain symptoms in a rat model of diabetic neuropathy.
NASDAQ
8-K: MIRA Pharmaceuticals Faces Nasdaq Compliance Issue but Plans Acquisition and Clinical Trial Progress
MIRA Pharmaceuticals received a Nasdaq notification regarding stockholders' equity but is pursuing a plan to regain compliance, including a planned acquisition and ongoing clinical trials.
NASDAQ
8-K: MIRA Pharmaceuticals Announces Enrollment of First Subjects in Phase 1 Clinical Trial for Ketamir-2
MIRA Pharmaceuticals has initiated its Phase 1 clinical trial for Ketamir-2, a novel oral ketamine analog targeting neuropathic pain.
NASDAQ
MIRA Pharmaceuticals plans to acquire SKNY Pharmaceuticals in a stock exchange transaction, gaining access to SKNY-1, a novel drug candidate targeting weight loss and smoking cessation, and securing a $5 million capital infusion.
NASDAQ
Mira Pharmaceuticals has successfully formulated Ketamir-2 into a topical treatment for localized neuropathic and inflammatory pain, expanding its pain management pipeline.
NASDAQ
MIRA Pharmaceuticals has received approval to begin a Phase 1 clinical trial in Israel for its oral ketamine analog, Ketamir-2, targeting neuropathic pain.
NASDAQ
MIRA Pharmaceuticals has announced the resignation of Cherry Bekaert LLP as its independent auditor and the appointment of Salberg & Company P.A. as its new auditor.
NASDAQ
MIRA Pharmaceuticals has submitted an Investigational New Drug application to the FDA for Ketamir-2, a novel oral ketamine analog aimed at treating neuropathic pain.
NASDAQ
MIRA Pharmaceuticals has successfully completed preclinical safety studies for its novel oral ketamine analog, Ketamir-2, with no adverse findings, paving the way for an Investigational New Drug (IND) application submission by the end of 2024.
NASDAQ
MIRA Pharmaceuticals has announced the resignation of a director and the appointment of a new director and Audit Committee Chair, effective November 18, 2024.
NASDAQ
MIRA Pharmaceuticals has selected The Centre for Human Drug Research in the Netherlands for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog, with recruitment starting in Q1 2025.
NASDAQ
MIRA Pharmaceuticals' Ketamir-2 demonstrated 60% greater efficacy than gabapentin in a preclinical study for chemotherapy-induced neuropathic pain.
NASDAQ
MIRA Pharmaceuticals' oral ketamine analog, Ketamir-2, has demonstrated greater efficacy than existing FDA-approved treatments for neuropathic pain in preclinical studies.
NASDAQ
MIRA Pharmaceuticals successfully held its 2024 Annual Meeting, electing five directors and approving amendments to its 2022 Omnibus Incentive Plan.
NASDAQ
Mira Pharmaceuticals has chosen neuropathic pain as the primary indication for its Ketamir-2 drug and has submitted a pre-IND meeting request to the FDA.
NASDAQ
MIRA Pharmaceuticals announced that its novel oral ketamine analog, Ketamir-2, achieved a 100% reversal of neuropathic pain in a pre-clinical rat study.
NASDAQ
MIRA Pharmaceuticals reports promising preclinical data for Ketamir-2 and its metabolite Nor-Ketamir-2, including enhanced oral bioavailability and brain penetration.
NASDAQ
MIRA Pharmaceuticals has received notification from Nasdaq that it has regained compliance with the minimum bid price requirement, resolving all issues cited by the exchange.
NASDAQ
Mira Pharmaceuticals has released new preclinical data showing its drug candidate, Ketamir-2, has a selective binding mechanism to the NMDA receptor, potentially reducing side effects compared to traditional ketamine.
NASDAQ
8-K: MIRA Pharmaceuticals Announces Positive Preclinical Results for Novel Ketamine Analog Ketamir-2
MIRA Pharmaceuticals reports promising preclinical data for its oral ketamine analog, Ketamir-2, showing potential for improved brain penetration and reduced side effects compared to traditional ketamine.
NASDAQ
Mira Pharmaceuticals has received a delisting notice from Nasdaq due to its stock price falling below $1.00, but the company is working to regain compliance while also reporting positive preclinical results for its MIRA-55 compound.
NASDAQ
MIRA Pharmaceuticals has amended its employment agreement with CFO Michelle Yanez, reducing her annual base salary to $137,500 and setting a minimum 30-hour work week.