Latest news with #FabioChianelli
Ottawa Citizen
14-05-2025
- Business
- Ottawa Citizen
PharmaTher Unveils KetaVault™: A First-of-Its-Kind Portal to Accelerate Ketamine Research and Commercialization
Article content KetaVault™ to Provide Partners Unprecedented Access to PharmaTher's Extensive Regulatory, Manufacturing, and Clinical Ketamine Data, Aiming to Expedite New Therapies and Market Entry Article content Article content TORONTO, May 14, 2025 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the 'Company' or 'PharmaTher') (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on the research and commercialization of ketamine for unmet medical needs, today announced the launch of KetaVault™. This innovative, world-first portal offers pharmaceutical and biotech companies, academic and clinical researchers, and government agencies to partner with PharmaTher for direct access to its comprehensive proprietary data on ketamine. KetaVault™ is strategically designed to streamline and accelerate clinical trials, regulatory submissions, and commercialization initiatives for ketamine-based therapies. Article content Article content The launch of KetaVault™ is strategically timed with the Company's anticipated FDA approval for its ketamine product, which has an approval goal date of June 4, 2025. This dual milestone underscores PharmaTher's commitment to leading innovation in the ketamine space. KetaVault™ is positioned to be a pivotal catalyst, empowering partners to leverage PharmaTher's deep expertise and data to unlock new therapeutic avenues for ketamine in areas of high unmet medical need and for emergency use applications, potentially revolutionizing treatment paradigms. Article content Fabio Chianelli, Chairman and CEO of PharmaTher, commented: 'PharmaTher is committed to revolutionizing patient care through ketamine. With KetaVault™, PharmaTher isn't just sharing data; we're igniting a new era of collaborative ketamine innovation. This platform is a bold step toward unlocking the full potential of ketamine, empowering our partners with unprecedented access to our years of dedicated work, rich proprietary insights, and collectively accelerating the journey towards novel treatments for patients in critical need. As we near our FDA approval goal date for ketamine, KetaVault™ will serve as a critical tool to expand ketamine's therapeutic reach and solidify PharmaTher's leadership in the market for ketamine, creating significant value for our partners and shareholders.' Article content Article content Expedited Regulatory Pathways: Leverage existing data to potentially streamline investigational new drug applications and emergency use authorizations. De-risked Clinical Development: Inform trial design, safety and efficacy data, and identify promising indications based on robust existing research. Enhanced Commercial Strategy: Gain insights into manufacturing, control, and product development for market readiness. Article content Regulatory Filings: Investigational New Drug (IND) Applications. Comprehensive Drug Information: Investigator's Brochures. Manufacturing Insights: Chemistry, Manufacturing, and Control (CMC) data. Clinical Research & Data: In-depth clinical study protocols and research data for indications including Parkinson's disease. Orphan Drug Designations: Access to information supporting FDA Orphan Drug Approvals for Amyotrophic Lateral Sclerosis, Rett Syndrome, Complex Regional Pain Syndrome, Status Epilepticus, and ischemia/reperfusion injury during solid organ transplantation. Novel Delivery Systems: Product development programs and regulatory filings for PharmaTher's ketamine microneedle patch and subcutaneous wearable pump.
Associated Press
03-03-2025
- Business
- Associated Press
PharmaTher Provides Complete Response Amendment for US FDA New Drug Application for Ketamine
Expecting FDA approval of Ketamine in Q2-2025 Solving the shortage problem of Ketamine and unlocking its pharmaceutical potential Toronto, Ontario--(Newsfile Corp. - March 3, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the 'Company' or 'PharmaTher'), a specialty pharmaceutical company, is pleased to announce today that the Company has provided its resubmission to the complete response amendment for its U.S. Food and Drug Administration ('FDA') new drug application for Ketamine, which addresses the deficiencies classified as MINOR in the complete response letter ('CRL') provided by the FDA dated October 22, 2024. Fabio Chianelli, Chairman and CEO of PharmaTher, commented: 'I am very pleased that we have addressed all the minor deficiencies detailed in the FDA complete response letter and completed the resubmission response to support our FDA new drug application for Ketamine. This submission is a significant step towards obtaining FDA approval. I look forward to sharing our revised FDA approval goal date, which is expected to be in Q2-2025, with our shareholders and the medical community.' Expecting FDA approval of Ketamine in Q2-2025 PharmaTher has addressed the deficiencies in the CRL and expects to receive a new approval date for a Q2-2025 FDA approval. As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the Ketamine submission batches and no new preclinical and clinical studies were requested. Solving the Ketamine shortage problem in the U.S. PharmaTher is committed to its overall goal of solving the Ketamine shortage problem in the United States of America and adhering to the FDA's strict manufacturing guidelines. Ketamine has been on the FDA's drug shortage list since February 2018, which is believed to have encouraged the widespread availability of compounded Ketamine products. On October 10, 2023, the FDA published a compounding risk alert describing the potential risks associated with compounded Ketamine products for psychiatric disorders, specifically from telehealth providers that provide in-home Ketamine services. The outcome with resolving Ketamine's drug shortage issue would be similar to the recent news of Wegovy and Ozempic being removed from the FDA shortage list and compounders have a 60- to 90-day grace period to stop supplying them ( see FDA letter). Unlocking the pharmaceutical potential of Ketamine With pending FDA approval for Ketamine on the horizon, the Company remains focused on its mission to be a leading innovator and provider of Ketamine to treat unmet medical needs. It is well-known that Ketamine is an essential medicine used for anesthesia and analgesia (pain relief), listed on the WHO Essential Medicines List, and has been used as a sedative and painkiller in hospital settings. Outside of the FDA and Health Canada approved indications, Ketamine is also being administered in hospitals and clinics to treat various pain, neurological, and mental health disorders. A published peer-reviewed study on the real-world effectiveness of Ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation. The potential of Ketamine to make a significant impact on patient lives is immense. PharmaTher, with its innovative approaches and commitment to patient care, is poised to play a pivotal role in making Ketamine available to millions of people globally. About PharmaTher Holdings Ltd. PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of KETARX™ (Ketamine) to fill the unmet medical needs for surgery, pain, mental health, neurological, and medical countermeasures indications. Learn more at For more information about PharmaTher, please contact: Fabio Chianelli Chief Executive Officer PharmaTher Holdings Ltd. Tel: 1-888-846-3171 Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words 'closer', 'could', 'confident', 'would', 'intend', 'expect', 'believe', 'will', 'projected', 'estimated', 'potential', 'aim', 'may', 'plan', 'proposed', 'lead', 'toward', 'anticipate', 'provide', and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the 'Company') current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption 'Risk Factors' in Company's management's discussion and analysis for the three and six months ended November 30, 2024 dated January 21, 2025, which is available on the Company's profile at
Associated Press
03-03-2025
- Business
- Associated Press
DiagnaMed Granted FDA Orphan Drug Designation for Molecular Hydrogen to Treat Amyotrophic Lateral Sclerosis
Toronto, Ontario--(Newsfile Corp. - March 3, 2025) - DiagnaMed Holdings Corp. (CSE: DMED) (OTCQB: DGNMF) ('DiagnaMed', 'DMED', or the 'Company'), a leading provider of cutting-edge technology solutions for the hydrogen and life sciences industries, today announced in a significant advancement for rare disease research, the Company has been granted Orphan Drug Designation (ODD) for molecular hydrogen in the treatment of amyotrophic lateral sclerosis (ALS) by the U.S. Food and Drug Administration (FDA). This designation underscores the potential of molecular hydrogen as a novel therapeutic option for ALS patients and highlights ongoing efforts to address unmet medical needs in rare disease communities. ALS is a progressive neuromuscular disease that attacks nerve cells responsible for controlling voluntary muscle movement, leading to paralysis and, ultimately, respiratory failure, and has a life expectancy of only two to six years after diagnosis. Currently, there is no known cure for ALS. ALS affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases diagnosed annually. With limited treatment options available, the FDA's recognition of molecular hydrogen as an orphan drug offers hope to patients and families impacted by this debilitating illness. Molecular hydrogen, a small molecule with antioxidant and anti-inflammatory properties, has shown early promise in preclinical studies for its ability to mitigate oxidative stress and inflammation-key factors implicated in ALS progression. The FDA's decision paves the way for DiagnaMed to accelerate its discovery and development programs with molecular hydrogen. One of DiagnaMed's strategic initiatives regarding hydrogen is to unlock the medical potential of molecular hydrogen for neurodegenerative diseases and brain health conditions ( press release). The Company's commercialization strategy involves partnering with specialty pharmaceutical companies to fund the development of its medical programs involving molecular hydrogen. Letter of Intent with Revive Therapeutics Ltd (CSE: RVV) (OTCQB: RVVTF) ('Revive') DiagnaMed and Revive have entered into a non-binding letter of intent (LOI), dated February 28, 2025, with Revive to acquire the full rights to DiagnaMed's intellectual property (the 'Acquired Assets') pertaining to molecular hydrogen for ALS (the 'Acquisition'). The final terms of the Acquisition will be agreed to by the parties after the completion of due diligence by Revive. The Acquisition is expected to close on or before March 31, 2025, subject to customary closing conditions, including but not limited to, the negotiation and execution of a definitive agreement. Fabio Chianelli, Chairman and CEO of DiagnaMed, commented: 'Receiving orphan drug designation from the FDA is a significant milestone for DiagnaMed and validates the promise of molecular hydrogen as a potential treatment for ALS. We are excited to partner with Revive Therapeutics to advance this program and meet the urgent needs of the ALS community.' The Orphan Drug Designation provides DiagnaMed with key incentives, including tax credits for clinical trial costs, exemption from certain FDA fees, and the potential for seven years of market exclusivity upon approval. These benefits are designed to encourage the development of therapies for rare diseases that might otherwise lack sufficient commercial interest. About DiagnaMed DiagnaMed Holdings Corp. (CSE: DMED) (OTCQB: DGNMF) delivers innovative technology solutions for the cleantech and life sciences industries, with a focus on hydrogen production and AI-driven drug discovery and diagnostics. Visit For more information, please contact: Fabio Chianelli Chairman and CEO DiagnaMed Holdings Corp. Tel: 416-800-2684 Email: [email protected] Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Cautionary Statement Certain statements in this news release are forward-looking statements, including with respect to future plans, and other matters. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such information can generally be identified by the use of forwarding-looking wording such as 'will', 'may', 'expect', 'could', 'can', 'estimate', 'anticipate', 'intend', 'believe', 'projected', 'aims', and 'continue' or the negative thereof or similar variations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including but not limited to, business, economic and capital market conditions, the ability to manage operating expenses, and dependence on key personnel. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, anticipated costs, and the ability to achieve goals. Factors that could cause the actual results to differ materially from those in forward-looking statements include, the continued availability of capital and financing, litigation, failure of counterparties to perform their contractual obligations, loss of key employees and consultants, and general economic, market or business conditions. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption 'Risk Factors' in Company's management's discussion and analysis for the three-months ended December 31, 2024 ('MD&A'), dated February 24, 2025, which is available on the Company's profile at Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The reader is cautioned not to place undue reliance on any forward-looking information. The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
