Annuncio • Jul 07
PharmAla Biotech Holdings Inc. Completes GMP Manufacturing Of Drug Substance Components For ALA-002 And Provides Corporate Update Regarding ALA-002 Asset PharmAla Biotech Holdings Inc. announced the successful completion of GMP (Good Manufacturing Practice) manufacturing of drug substance necessary for the manufacturing of ALA-002. This milestone marks a significant step forward in the program’s development, providing sufficient material to support upcoming clinical activities. With drug substance manufacturing now complete, the Company is prepared to begin GMP manufacturing of the drug product, the formulated finished form that will be used in clinical activities globally. The successful scale-up and execution of the drug substance batch under GMP conditions demonstrate the maturity and reproducibility of the Company’s manufacturing process and underscore its readiness to advance ALA-002 toward the clinic. PharmAla has been granted an Australian patent, number 2022330718, entitled “Compositions Comprising Non-Racemic Mixtures of (R)- and (S)-3,4-Methylenedioxymethamphetamine or (R) and (S) N-Methyl-1,3-Benzodioxolylbutanamine and Uses Thereof” — the composition-of-matter foundation for its lead drug candidate, ALA-002. Cortexa (the 50/50 joint venture owned by PharmAla Biotech Inc. and Vitura Health Ltd.) has a Right of First Refusal to any new innovation developed by PharmAla. The board of Directors of Cortexa has voted to exercise its rights to commercialize the ALA-002 intellectual property. Cortexa’s option rights relate solely to the Australia territory. Subsequent to Cortexa’s decision to exercise its option for ALA-002, the ALA-002 Drug Product will be known in Australia as LaNeo Gen 2. PharmAla already owns, and sublicenses to Cortexa, the “LaNeo” branding in Australia. LaNeo stand for GMP manufacturing quality, reliability, and safety; LaNeo Gen 2 product represents that, and innovation to improve both Patient safety and Clinic Operator efficiency. Annuncio • May 04
Pharmala Biotech Holdings Inc., Annual General Meeting, Jul 09, 2026 Pharmala Biotech Holdings Inc., Annual General Meeting, Jul 09, 2026. Annuncio • Apr 24
Pharmala Biotech Holdings Inc. Announces Leadership Changes, Effective April 21, 2026 Pharmala Biotech Holdings Inc. announced that Ali Taghva will transition out of his role as Chief Commercial Officer to focus on other projects. Mr. Taghva will leave the role of Chief Commercial Officer effective April 21, 2026, and will fully transition out of the company by July 2026. Annuncio • Feb 11
PharmAla Biotech Holdings Inc. Announces Changes to Board of Directors Effective February 9, 2026 PharmAla Biotech Holdings Inc. announced changes to the makeup of its Board of Directors. Effective February 9, 2026, PharmAla accepted the resignation of Dr. Malik Slassi from the Board of Directors. Also effective February 9, 2026, PharmAla appointed Mr. Lennie Ryer, CPA, CA, of Montreal to its board of directors. Lennie Ryer, CPA, CA is a seasoned financial executive and board director with extensive experience in corporate finance, governance, and strategic leadership. Throughout his career, Mr. Ryer has held numerous senior roles including Chief Financial Officer and Vice President of Finance for companies in the pharmaceutical, biotechnology, and technology sectors. He has also served as Managing Partner of a major public accounting firm, where he specialized in mergers and acquisitions, taxation, and capital markets. Lennie’s background includes guiding companies through transitions to public markets and leading significant equity and debt financings. He holds a Bachelor of Commerce in Finance and a Public Accountancy degree from McGill University and is a Chartered Professional Accountant (CPA, CA). Annuncio • Oct 10
Pharmala Launches Nexus Portal for Efficacy Prescribers and Therapists PharmAla Biotech Holdings Inc. announced the launch of NEXUS, its new and updated tool to bring together and connect Prescribers, Therapists and Clinic managers. NEXUS is designed to be a key tool in connecting the total chain of care for MDMA practitioners, as well as an important mechanism to deliver and share knowledge on the latest advances to regulatory processes, scientific evidence, and best-in-class patient care. Annuncio • Sep 09
Pharmala Biotech Holdings Inc. Announces Resignation of Shane Morris as Chief Operating Officer, Effective September 5 2025 Pharmala Biotech Holdings Inc. announced that Dr. Shane Morris has resigned from his role as Chief Operating Officer of PharmAla Biotech, effective September 5. Dr. Morris’ role will be backfilled; Interested applicants may apply. Annuncio • Sep 03
Pharmala Biotech Holdings Inc. Appoints Evan Lewis to Its Scientific Advisory Board, Effective September 1, 2025 Pharmala Biotech Holdings Inc. appointed Dr. Evan Lewis (MD, FRCPC, CSCN EEG Diplomate, CMLE, C-CAT (P)) to its Scientific Advisory Board, effective September 1, 2025. Dr. Evan Cole Lewis is an adult and pediatric neurologist with specialized training in epilepsy and pediatric neurology. He holds a clinical appointment as Adjunct Assistant Professor in the Department of Pediatrics at the Hospital for Sick Children and the University of Toronto. He founded and led the Neurology Centre of Toronto (2016–2024) and served as Vice President of Psychedelic Neurology at Numinus (2021–2024), where he advanced clinical care and research in medical cannabis and developed and directed a Ketamine-Assisted Therapy program for neurological conditions.His clinical focus includes epilepsy, brain injury, concussion and persistent post-concussion symptoms, functional neurological disorders—especially functional seizures—and the use of cannabis and psychedelics in neurological treatment. Annuncio • Mar 21
Pharmala Announce New Responsibilities to Ali Taghva, Acting as Chief Commercial Officer as Well as Counsel PharmAla is furthermore pleased to announce that Mr. Ali Taghva will take on new responsibilities, acting as Chief Commercial Officer to the Company, as well as Counsel to the Company. Annuncio • Mar 03
PharmAla Completes Shipment of LaNeo MDMA to UCLA for Schizophrenia Study PharmAla Biotech Holdings Inc. announced that it has completed its. The Company believes this is the first such shipment of MDMA capsules to cross the American/Canadian border. PharmAla's LaNeo™? MDMA, which remains the only commercially available MDMA drug product approved by the US Food and Drug Administration (USFDA) for clinical trial use, will be used in this case be used for a clinical trial investigating Schizophrenia. The company is taking steps to address what it sees as a significant unmet need for MDMA in the United States for clinical trial use, which it hopes to announce in the near future. Annuncio • Jan 21
Pharmala Biotech Holdings Inc., Annual General Meeting, Mar 28, 2025 Pharmala Biotech Holdings Inc., Annual General Meeting, Mar 28, 2025. Annuncio • Dec 21
Pharmala Biotech Holdings Inc. announced that it has received CAD 1.56172 million in funding On December 20, 2024, the company has closed the transaction. The company has issued 8,676,221 units for aggregate gross proceeds of CAD 1,561,719.88. The Offering was oversubscribed by 12% with an additional 898,444 units sold. Annuncio • Apr 11
Pharmala Biotech Holdings Inc. announced that it expects to receive CAD 0.75 million in funding Pharmala Biotech Holdings Inc. announced a non-brokered private placement offering of 4,166,666 units at a price of CAD 0.18 per unit for aggregate gross proceeds of up to CAD 749,999.88 on April 10, 2024. It is anticipated that the Offering will be funded solely by a small group of long term shareholders, known to the company. Each unit shall consist of one common share in the share capital of the company and one-half of one common share purchase warrant of the company. Each warrant will entitle the holder thereof to acquire one additional common share at a price of CAD 0.27 per additional share at any time prior to 4:30 pm on the date that is thirty six months following the closing date provided that, if the closing price of the common shares on the Canadian Securities Exchange is CAD 0.38 or greater per common share for a period of ten consecutive trading days at any time after the completion of the Offering, The company may pay finder's fees to eligible finders in connection with the Offering, subject to compliance with applicable securities laws and CSE policies. All securities proposed to be issued in connection with the Offering will be subject to a statutory hold period of four months and one day from the date of issuance. The Offering is expected to close on or about April 18, 2024, subject to customary closing conditions and compliance with CSE policies. Directors and officers of the company may acquire securities under the Offering. Annuncio • Mar 28
Pharmala Biotech Holdings Inc. Allowance Granted for Ala-002 Composition by US Patent and Trademark Office PharmAla Biotech Holdings Inc. announce that the US Patent and Trademark Office (USPTO) has indicated it is issuing an allowance for the granting of a patent for ALA-002, the company’s lead investigational MDXX Novel Chemical Entity. This provides the Company a strong basis for ongoing protection of this intellectual property. ALA-002 is a novel mixture of MDMA enantiomers, consisting of 70-80% R-MDMA and 20-30% S-MDMA. Preclinical testing has shown that the administration of ALA-002 results in significantly lowered incidence of hyperthermia, the major adverse event elicited by racemic generic MDMA. The Composition also showed improved indication of pro-social effect in both C57 (General Population) and BTBR (Autism-Like) mouse models, and a reduced “abuse liability” (addiction) potential. PharmAla’s patent application included in-vivo experimental animal data, which is generally held to be stronger evidence than computational, or in-silico, modeling. ALA-002 is considered by the US Food and Drug Administration (FDA) to be a Novel Chemical Entity (NCE), and in the opinion of the Company it is a different Active Moiety than racemic MDMA. As such, the Company believes that should it be approved by the FDA for use as a treatment for any disorder, it should be granted its own Data Exclusivity period. The Company intends to pursue its own clinical research with the novel composition, either alone or with an out-licensing partner. It has completed a Phase 2 protocol for the research of ALA-002 as a treatment for Social Anxiety symptoms in patients with Autism Spectrum Disorder (ASD) in conjunction with researchers at the University of Sydney. The Company believes that this is an Orphan Indication, in that there are no FDA-approved treatments currently available for social anxiety in autistic patients. However, the Company also believes that ALA-002 could be useful in the treatment of a number of neurological and neuropsychiatric disorders. PharmAla intends to use this landmark USPTO allowance to accelerate allowance in other jurisdictions through all practicable means. Annuncio • Jan 26
PharmAla Biotech Holdings Inc. Receives A Controlled Drugs & Substances Dealer's License by Health Canada PharmAla Biotech Holdings Inc. announced that it has been granted a Controlled Drugs & Substances Dealer's License (CDSL) by Health Canada, Canada's federal health regulator. The CDSL allows PharmAla to offer for sale both 3,4 Methylenedioxymethamphetamine (MDMA) and Psilocybin to those authorized to legally hold these materials. PharmAla's CDSL allows the Company to communicate directly with appropriate individuals about its MDMA and Psilocybin offerings. At this time, PharmAla will not change its business model regarding physically holding these materials, and will continue to rely on licensed partners to physically hold and distribute the materials as required. Annuncio • Jan 25
Pharmala Biotech Holdings Inc. to Report Q1, 2024 Results on Jan 29, 2024 Pharmala Biotech Holdings Inc. announced that they will report Q1, 2024 results on Jan 29, 2024 Annuncio • Jan 09
Pharmala Biotech Holdings Inc.'s PharmAla-1 Molecule Receives US Patent Prosecution Highway Acceptance PharmAla Biotech Holdings Inc. announced that it has received approval to move its PharmAla-1 (P1) molecule through the US Patent and Trademark Office (USPTO) Patent Prosecution Highway pathway based on the positive Patent Cooperation Treaty (PCT) initial office action previously announced by PharmAla. The Patent Prosecution Highway (PPH) speeds up the examination process for corresponding applications filed in participating intellectual property offices. Under PPH, participating patent offices have agreed that when an applicant receives a ruling from a first patent office indicating that at least one claim is allowable, the applicant may request fast track examination of corresponding claims. PharmAla-1 was first discovered through computational in-silico modelling exercises via PharmAla Biotech’s partnership with the University of Windsor, for which PharmAla has also received a grant from the Ontario Centres for Innovation. Proof-of-concept testing for P-1 showed significant efficacy and pro-social effect at dosage levels far lower than MDMA, PharmAla’s primary comparator molecule, as well as excellent safety pharmacology. P-1 is not considered a controlled substance anywhere in the world. Annuncio • Dec 23
Pharmala Biotech Holdings Inc., Annual General Meeting, Feb 27, 2024 Pharmala Biotech Holdings Inc., Annual General Meeting, Feb 27, 2024. Annuncio • Nov 10
PharmAla Biotech Holdings Inc. Announces World's First Observational Trial to Assess Real-World Efficacy of MDMA Treatment PharmAla Biotech Holdings Inc. announced that they have completed a Letter of Intent ("LOI"), and received initial Ethics Board Approval, to initiate an Observational Trial (the "Trial") on patients treated with 3,4 Methylenedioxymethamphetamine ("MDMA") through Health Canada's Special Access Program (SAP). The Parties will each play an important role in the execution of this trial:harmAla a Biotech is currently the only manufacturer of GMP MDMAor clinical use in Canada. PharmAla willll provide drug product to physicians under SAP through its licensed distribution partners, and connect clinicians and patients with UC researchers for voluntary data collection. The University of Calgary, under the direction of Dr. Leah Mayo, Parker Research Chair in Psychedelics, will assess data pertaining to efficacy of MDMA in the treatment of PTSD under real-world circumstances. The University of Calgary will have full rights to publication of data generated by the trial, with no limitation by the Parties. Heroic Hearts Project Canada, a charity supporting veteran mental health by facilitating access to psychedelic-assisted therapy, will offer its future program participants who receive MDMA-assisted therapy via the SAP the option to participate in the Trial and thereby contribute RWE. The announcement of the Trial comes following the release of the Senate of Cana's Subcommittee on Veterarans report, The Time is Now: Granting equitable access to psychedelic-assisted therapies, which urged Veterans Affairs Canada to increase research into the treatment of veterans' "moral injuries" such as Post-Traumatic Stress Disorder with psychedelic molecules, including MDMA. This trial will generate Real World Evidence ("RWE") on the efficacy of MDMA in the treatment the treatment of Post-Traumatic Stress Disorder which may be submitted to Health regulators, including Health Canada and Veterans Affairs Canada. The Parties hope that data collected in the Trial will add to the knowledge base of both regulators and the scientific community on the real-world evidence of efficacy and safety of these treatments. The Parties' initial submission to the Review Ethics Board has been approved, and the parties intend to proceed to data gathering immediately. Subsequent Ethics Review Board submissions are contemplated in the LOI. As the trial is Observational in nature, no patients will be dosed as part of the trial's protocol. The goal of the trial is to gather data on the efficacy of treatment for patients who are already qualified for treatment under the Special Access Program. Annuncio • Sep 26
Pharmala Biotech Holdings Inc. Receives First Office Action for PharmAla-1 Pct Filing PharmAla Biotech Holdings Inc. announced that it has received the first office action from the Patent Cooperation Treaty (PCT) filing for the company's novel PharmAla-1 (P-1) molecule. The filing for P-1 showed the molecule to be novel, with no previous Prior Art shown; It was also found to be inventive, due to the beneficial toxicology of P-1 compared to similar molecules, as shown by preclinical rodent model data generated by the laboratory of Prof. William Fantegrossi at the University of Arkansas for Medical Sciences. PharmAla-1 was first discovered through computational in-silico modelling exercises via PharmAla Biotech's partnership with the University of Windsor, for which PharmAla has also received a grant from the Ontario Centres for Innovation. Proof-of-concept testing for P-1 showed significant efficacy and pro- social effect at dosage levels far lower than MDMA, PharmAla's primary comparator molecule, as well as excellent safety pharmacology. P-1 is not considered a controlled substance anywhere in the world. Annuncio • Aug 01
PharmAla Biotech Holdings Inc. Files Patent for Novel MDXX Molecule PharmAla-1 PharmAla Biotech Holdings Inc. announced that it has filed a patent on the composition of matter of PharmAla-1. The patent filing follows a year of preclinical proof-of-concept research at the University of Arkansas for Medical Sciences in the laboratory of Prof. William Fantegrossi. PharmAla's novel drug development pipeline has been advancing rapidly in 2023, with PharmAla's ALA family moving rapidly into clinical development. The Composition of Matter patent on the Novel Chemical Entity (NCE) PharmAla-1 will further strengthen the company's position as a leading developer of Central Nervous System (CNS) pharmaceutical treatments. PharmAla-1 was first discovered through computational in-silico modelling exercises via PharmAla Biotech's partnership with the University of Windsor, for which PharmAla has also received a grant from the Ontario Centre for Innovation. PharmAla-1 is the first molecule of PharmAla's extensive computational drug development pipeline, which PharmAla is announcing to the market in detail; PharmAla's ALA and ABA patent families were developed via traditional drug discovery. PharmAla is also excited to announce the acceptance of its review article titled "Balancing therapeutic efficacy and safety of MDMA and novel MDXX analogues as novel treatments for autism spectrum disorder" for publication in Psychedelic Medicine. Autism Spectrum Disorder (ASD) affects millions worldwide, presenting challenges in social interactions and impairing daily functioning. Currently, no approved pharmacological treatments specifically target the global symptoms of ASD. In response to this urgent need, PharmAla Biotech's review article addresses the potential of MDMA-like drugs to elicit pro-social effects, potentially alleviating social anxiety and avoidance commonly observed in individuals with ASD. Balancing therapeutic efficacy and safety of MDMA and novel MDXX analogues as treatments for autism spectrum disorder delves into the complex pharmacology of MDMA-like entactogens, exploring their drug-binding sites, metabolic enzymes, and chemical structure-activity relationships. Annuncio • Jul 23
PharmAla Biotech Holdings Inc. Receives Guidance on ALA-002 from MHRA and Launches Clinical Program with University of Sydney PharmAla Biotech Holdings Inc. announced that – following pre-submission meetings held in First Quarter of 2023 – it has received written guidance from the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA). The guidance constitutes, in part, advice that ALA-002 does not require further preclinical data in order for clinical trials to proceed. Following receipt of this guidance, PharmAla is further pleased to announce that it has entered into a clinical development agreement with the University of Sydney, under the leadership of Dr. Adam Guastella, the Michael Crouch Chair in Child and Youth Mental Health at the University.