Welcome to our dedicated page for Pharmala Biotech news (Ticker: MDXXF), a resource for investors and traders seeking the latest updates and insights on Pharmala Biotech stock.
PharmAla Biotech Holdings Inc. (OTCQB: MDXXF) is a biotechnology company in the healthcare sector that focuses on the research, development, and manufacturing of MDXX class molecules, including MDMA. Its news flow centers on clinical-grade MDMA supply agreements, progress in its ALA-002 development program, and updates on its role in MDMA-assisted therapy research.
Company announcements frequently highlight contracts to supply LaNeo MDMA for investigator-sponsored and other clinical trials at leading institutions. Recent releases describe shipments or supply agreements involving the University of Washington, Yale University, Johns Hopkins University, Mt. Sinai Health System, Østfold Hospital Trust in Norway, and the STRONG STAR Consortium led by UT Health San Antonio and Emory University. These updates often explain how LaNeo MDMA will be used in studies of conditions such as PTSD and personality disorders.
PharmAla’s news also covers developments in its pipeline, particularly ALA-002, a patented, novel, non-racemic MDMA formulation. The company has reported the issuance of a US patent for ALA-002 and has announced manufacturing arrangements for ALA-002 drug substance through its subsidiary PharmAla Biotech Australia and a UK-based CDMO.
Operational and regulatory milestones are another recurring theme, including new distribution and logistics partnerships, the launch of a clinical trial tool that provides researchers with access to CMC data and the Investigator’s Brochure, and corporate governance items such as option grants and advisory agreements. Investors and researchers following MDXX class drug development, MDMA-assisted therapy, and clinical trial supply can use this news page to review PharmAla’s disclosed contracts, research collaborations, and corporate updates over time.
PharmAla (OTCQB: MDXXF) executed a binding letter of intent with Aluvaris to form a special purpose vehicle (SPV) to develop patented novel MDXX molecule APA-01. Key terms include a conditional global exclusive IP license, Aluvaris seed capital commitment (the Funding Threshold), a one-time license fee upon closing, and a 3% perpetual royalty on net sales. The SPV retained CRO Diteba for GLP/GMP clinical and analytical work. Parties target execution of a definitive agreement by June 8, 2026, subject to approvals and due diligence.
PharmAla Biotech (OTCQB: MDXXF) says it is operationally ready to supply the U.S. Expanded Access pathway created by the April 18, 2026 Executive Order directing FDA and DEA action. The company reports LaNeo MDMA is already supplied into multiple U.S. trials, including VA and DHA programs.
PharmAla has initiated GMP manufacturing of its patented ALA-002 API and expects patient dosing in 2026. Through Cortexa Australia, PharmAla claims unique commercial MDMA market insight.
Cortexa (MDXXF) confirms commercial progress for MDMA supply in Australia, having committed the majority of its first GMP batch and securing supply arrangements with authorised providers. Sales value related to these activities will exceed AUD$1.0 million. PharmAla has begun producing a second GMP 20mg capsule batch expected to be available in Q2 2026. The three-year licence with annual $250,000 payments concludes in FY2026, while the joint venture retains rights including first refusal on PharmAla innovations and royalty provisions.
PharmAla Biotech (CSE: MDMA; OTCQB: MDXXF) executed an agreement to supply LaNeo™ MDMA clinical research materials to Østfold Hospital Trust in Norway. The agreement includes financial and data-sharing provisions and delivery is planned subject to customary regulatory approvals. PharmAla highlighted its existing European value chain and said it can help convert trial registrations and IRB approvals to the LaNeo MDMA Chemistry, Manufacturing and Control package. The company offers an online tool for researchers to access drug product quality information and may offer discounts in exchange for data sharing. Qualified researchers may contact sales@pharmala.ca for inquiries.
PharmAla Biotech (OTC:MDXXF) announced that its subsidiary PharmAla Biotech Australia has contracted a UK-based CDMO to manufacture the ALA-002 drug substance, a patented non-racemic MDMA formulation. The company said this manufacturing contract is a key step toward executing an ALA-002 Phase 2a/2b clinical trial in 2026. The CDMO name is not being disclosed due to the controlled-substance nature of ALA-002. PharmAla also completed one of two contracted shipments of LaNeo MDMA to the Parsons Research Center for Psychedelic Healing at Mount Sinai for use in clinical research.
PharmAla Biotech (OTCQB:MDXXF) has successfully delivered its LaNeo™ MDMA to Johns Hopkins University from its new U.S. distribution site. This marks a significant milestone for MDMA research in the United States, particularly benefiting investigator-sponsored clinical trials.
The company's LaNeo™ MDMA, which is already being used in clinical trials globally and in commercial medical applications in several countries, is now imported and approved for use in the continental US by state and federal regulators. Additionally, PharmAla has settled a $150,000 debt through the issuance of 1,666,667 common shares at $0.09 per share.
PharmAla Biotech Holdings (CSE: MDMA) (OTC:MDXXF) has secured a contract with an unnamed third-party logistics company to serve as its US clinical trial distribution partner. This strategic move aims to address increasing US-Canada cross-border shipping uncertainties and potential tariff barriers.
The agreement enables GMP-compliant storage and distribution of PharmAla's LaNeo™ MDMA for clinical trials in the United States. The non-exclusive partnership will streamline warehousing operations for current and future clients, providing enhanced certainty against import/export risks. The agreement specifically excludes sales provisions of LaNeo™ MDMA, limiting the partner's role to storage and directed distribution.
This development follows PharmAla's recent permanent and exclusive licensed distribution agreement with Duchefa Farma in the Netherlands.
PharmAla Biotech Holdings (OTC:MDXXF) has announced advancement of its contract with UT Health San Antonio for the STRONG STAR Consortium study, funded through the Defense Appropriations Act. The company will develop a new 20mg clinical drug product dose of its LaNeo™ MDMA, complementing its existing 40mg capsules.
The Department of Defense-funded project, valued at $10M, will examine MDMA-Assisted Therapy (MDMA-AT) effects on active-duty military personnel with PTSD. The study will be conducted at two sites: UT Health San Antonio and Emory University. This development will allow greater dosing flexibility for clinical trials and eventual patient treatment in jurisdictions where permitted.
PharmAla Biotech Holdings (CSE: MDMA) (OTC: MDXXF), a biotechnology company specializing in LaNeo™ MDMA and MDXX class molecules research and manufacturing, has announced signing an advisory agreement with shareholder Matthew Azrieli.
The agreement includes up to 1 million Performance Share Units, contingent on achieving pre-set corporate goals in three major categories: media advisory, market development, and investment advisory. CEO Nick Kadysh expressed confidence in Azrieli's ability to assist PharmAla's growing Clinical Trials business in the United States and other growth markets.
The company has scheduled an investor webinar for February 6, 2025, at 4:30 PM ET, where CEO Nicholas Kadysh and CFO Will Avery will discuss financial results and future plans.