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PharmAla Signs Drug Donation Agreement for MDMA-Assisted Therapy Clinical Trial in Fibromyalgia
Globenewswire· 2026-02-26 13:26
TORONTO, Feb. 26, 2026 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), announced that it has executed an agreement with Spaulding Rehabilitation (“Spaulding Rehabilitation”), a member of the Mass General Brigham healthcare system, for the provision of MDMA for use in a clinical trial investigating MDMA-assisted therapy for the trea ...
PharmAla To Supply Amsterdam UMC with LaNeo™ MDMA, Including Development of New Single-Capsule Stability Data
Globenewswire· 2026-02-23 13:30
TORONTO, Feb. 23, 2026 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), announced that it has executed a binding supply agreement with Amsterdam University Medical Center (“Amsterdam UMC”) in the Netherlands for the provision of LaNeo™ 40mg MDMA capsules for use in a proposed clinical trial. Under the terms of the agreement, PharmAl ...
PharmAla Announces Changes to Board of Directors
Globenewswire· 2026-02-10 21:40
Core Viewpoint - PharmAla Biotech Holdings Inc. announces changes to its Board of Directors, including the resignation of Dr. Malik Slassi and the appointment of Mr. Lennie Ryer, aiming to enhance the board's expertise as the company progresses in its development [1][2][3]. Company Overview - PharmAla Biotech Holdings Inc. is focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, with a dual focus on alleviating the backlog of clinical-grade MDMA for trials and commercial sales, as well as developing novel drugs [4]. - The company is currently the only provider of clinical-grade MDMA for patient treatments outside of clinical trials and has completed proof-of-concept research into several intellectual property families, including its lead drug candidate ALA-002 [4]. Board Changes - Dr. Malik Slassi has resigned from the board effective February 9, 2026, after four years of support and insight during the company's early stages [2][3]. - Mr. Lennie Ryer, a seasoned financial executive with extensive experience in corporate finance and governance, has been appointed to the board, bringing valuable expertise as the company enters a new phase of development [3].
PharmAla To Supply Østfold Hospital Trust with LaNeo™ MDMA for Clinical Research
Globenewswire· 2026-01-08 13:30
Core Viewpoint - PharmAla Biotech Holdings Inc. has entered into an agreement with Østfold Hospital Trust of Norway to supply LaNeo™ MDMA for research into its potential as a treatment for Major Depressive Disorder [1][2] Group 1: Agreement Details - The agreement includes financial and data-sharing provisions, with PharmAla aiming to ship LaNeo MDMA Clinical Research Materials to Østfold Hospital Trust as soon as regulatory approvals are obtained [2][3] - Østfold Hospital Trust selected PharmAla after a competitive review, citing the company's professionalism and understanding of regulatory and scientific requirements for clinical research [3] Group 2: Company Background - PharmAla is focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, and aims to alleviate the global backlog of clinical-grade MDMA for trials and commercial sales [5] - The company is the only provider of clinical-grade MDMA for patient treatments outside of clinical trials and has completed proof-of-concept research into several drug candidates [5]
PharmAla Issues Audited Year End 2025 and Unaudited Q1 Fiscal 2026 Financial Statements
Globenewswire· 2025-12-24 13:30
Core Viewpoint - PharmAla Biotech Holdings Inc. is advancing its development of LaNeo™ MDMA and aims to initiate Phase 2a/b clinical trials in Australia, driven by increasing demand and reimbursement approvals for medical treatments using LaNeo MDMA [2]. Financial Highlights - The company has reported an increase in customer deposits, with a total of $276,000 as of August 31, 2025, up from $209,000 in 2024, and $433,000 as of November 30, 2025, up from $276,000 [7]. - Recognized revenue for the year-end 2025 was $83,000, and for Q1 2026, it was $68,000, indicating ongoing revenue generation alongside growing deposits [7]. Development and Strategy - The company has filed a short-form prospectus and secured a lending partner in Australia, which will support its clinical trial and development efforts [4]. - PharmAla is focused on alleviating the global backlog of generic, clinical-grade MDMA and developing novel drugs within the MDXX class [4].
PharmAla Biotech Australia Contracts with UK-based CDMO for Manufacture of ALA-002 Drug Substance
Globenewswire· 2025-12-15 13:30
TORONTO, Dec. 15, 2025 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is pleased to announce that its wholly-owned subsidiary, PharmAla Biotech Australia, has contracted with a UK-based CDMO to execute manufacture of its ALA-002 drug substance. “PharmAla Australia worked diligently, executing a global RFP search ...
PharmAla Files Final Base Shelf Prospectus and Signs Term Sheet with Radium Capital
Globenewswire· 2025-11-03 13:30
Core Viewpoint - PharmAla Biotech Holdings Inc. has filed a final short form base shelf prospectus to provide flexibility for financing opportunities over a 25-month effective period, allowing the company to issue various securities as needed [1][2][4] Group 1: Prospectus Details - The prospectus has been filed in all provinces and territories in Canada, enabling the company to offer common shares, warrants, units, subscription receipts, debt securities, or any combination of these securities [2] - The company may utilize the prospectus for "at-the-market distribution," allowing securities to be sold through the Canadian Securities Exchange or other trading markets [3] - Currently, there are no immediate plans to issue any securities under the prospectus, and specific terms will be outlined in a prospectus supplement if the company decides to proceed [4] Group 2: Loan Facility with Radium Capital - PharmAla's subsidiary, PharmAla Biotech Australia, has signed a term sheet with Radium Capital for a loan facility based on expected Research and Development Tax Incentive refunds [5] - The loan facility allows for up to 80% of the expected RDTI refund to be advanced once qualifying expenses are incurred, with each tranche secured by the related RDTI refund [5] - The CEO emphasized that this loan facility presents an opportunity to develop intellectual property without exposing it to securitization risk, aligning with the company's clinical trial strategy in Australia [6] Group 3: Strategic Goals - The CFO highlighted that securing efficient, low-risk debt funding will help optimize future tax incentives and drive cost efficiency in planned clinical trials [7] - PharmAla aims to alleviate the global backlog of generic, clinical-grade MDMA for clinical trials and commercial sales while developing novel drugs in the same class [7]
PharmAla Launches Nexus Portal for MDMA Prescribers and Therapists
Globenewswire· 2025-10-08 12:55
Core Insights - PharmAla Biotech Holdings Inc. has launched NEXUS, a new tool aimed at connecting prescribers, therapists, and clinic managers involved in MDMA-assisted therapy, enhancing the care delivery process [1][2][3] Group 1: NEXUS Tool - NEXUS is designed to facilitate communication and data sharing among the entire MDMA-assisted therapy team, including prescribers, therapists, and clinic managers [2][3] - The tool aims to address the challenges faced by prescribers and other stakeholders in navigating regulatory pathways and improving patient care [2][3] Group 2: Leadership Changes - Farnoud Kazemzadeh has been appointed as the Chief Operating Officer of PharmAla, bringing extensive experience in scaling businesses [3] - Dr. Harriet De Wit has resigned from PharmAla's Board of Directors, with the company expressing gratitude for her contributions [4] Group 3: Company Overview - PharmAla focuses on the research, development, and manufacturing of MDXX class molecules, including MDMA, and is the only company providing clinical-grade MDMA for patient treatments outside of clinical trials [5] - The company aims to alleviate the backlog of clinical-grade MDMA for trials and commercial sales while developing novel drugs in the same class [5]
PharmAla Completes Shipment of LaNeo™ MDMA to Johns Hopkins
Globenewswire· 2025-10-02 13:15
Core Insights - PharmAla Biotech Holdings Inc. has successfully shipped its LaNeo™ MDMA to Johns Hopkins University, marking a significant advancement in MDMA research in the United States [1][2] - The CEO of PharmAla emphasizes the importance of this delivery for clinical trials, which have faced challenges in sourcing investigational medical products [2] - LaNeo™ MDMA is now approved for use in the continental US and is already utilized in clinical trials globally [2] Company Overview - PharmAla Biotech is focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, with a dual aim of alleviating the backlog of clinical-grade MDMA and developing novel drugs [4] - The company is currently the only provider of clinical-grade MDMA for patient treatments outside of clinical trials [4] - PharmAla's research unit has completed proof-of-concept research for several drug candidates, including ALA-002, its lead candidate [4] Financial Activities - The company has settled $150,000 in debt by issuing 1,666,667 common shares at a deemed price of $0.09 per share [3]
PharmAla Partners with Veridion Group as Exclusive Distributor in New Zealand
Globenewswire· 2025-09-25 13:30
Core Insights - PharmAla Biotech Holdings Inc. has signed a distribution agreement with Veridion Group to act as the exclusive distributor for its LaNeo MDMA in the Netherlands market [1] - The partnership aims to ensure safe and controlled access to MDMA treatments for New Zealand clinicians [2][3] - Dr. Kiyan Afzali has been appointed as a director for PharmAla Australia, bringing nearly a decade of experience in translational research and drug discovery [4][5] Company Overview - PharmAla is focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, and aims to alleviate the backlog of clinical-grade MDMA for trials and commercial sales [6] - The company is the only provider of clinical-grade MDMA for patient treatments outside of clinical trials and has completed proof-of-concept research into several drug candidates [6] Strategic Developments - The distribution agreement with Veridion includes an annual purchase minimum, waived for the first year, and restrictions on re-export [2] - Dr. Afzali's appointment is effective October 1, 2025, and is expected to enhance PharmAla's research and development efforts in Australia [5]