Pharmala Biotech - MDXXF STOCK NEWS

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.

PharmAla Biotech Holdings (CSE: MDMA) (OTC:MDXXF) has entered into an agreement with Merhavim Mental Health Centre of Beer Yaakov, Israel, to supply clinical trial materials for MDMA-assisted psychotherapy research. The study, focusing on PTSD treatment for early sexual trauma compared to adult trauma, will provide PharmAla with full data licensing rights in exchange for free clinical trial materials.

The partnership, which includes MAPS Israel, comes at a significant time following the announcement of a cease-fire in Gaza. The trial marks a unique investigation into MDMA's effectiveness in treating recent versus historical trauma. PharmAla will provide its LaNeo MDMA Clinical Research Materials, pending regulatory approvals.

Researchers can access drug product quality information through PharmAla's website tool, and the company offers support for converting clinical trial registrations to the LaNeo MDMA Chemistry, Manufacturing and Control package. Additional research collaborations with MAPS Israel are anticipated.

PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) has been contracted to supply its GMP LaNeo™ MDMA to a clinical trial at Mt. Sinai Health System. The company, focused on MDMA research and manufacturing, will support Mt. Sinai's researchers with high-quality clinical trial drug product. PharmAla has launched a new tool on their website for researchers to access drug product quality information.

Additionally, PharmAla announced the termination of its supply agreement with CCrest Labs, which was previously contracted to distribute PharmAla's MDMA to doctors under the Special Access Program. The company will now rely on other contracted distributors for this purpose.

PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) has launched a new MDMA Clinical Trial Tool for researchers. This tool provides direct access to Chemistry, Manufacturing and Control (CMC) data and the company's investigator's brochure to qualified researchers. The initiative comes in response to a surge in requests for MDMA research materials following the FDA's decision on Lykos' New Drug Application for MDMA.

The tool, available at pharmala.ca/clinical-trials, aims to streamline the process for researchers applying for trials with MDMA and boost PharmAla's sales pipeline for clinical trials using LaNeo MDMA. Additionally, PharmAla announced the appointment of William Avery, CPA, CA, as the new Chief Financial Officer, effective October 1st, replacing outgoing CFO Carmelo Marelli.

PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) has responded to the USFDA's decision to request a third confirmatory Phase 3 trial for MDMA-assisted therapy in treating PTSD. While disappointed, PharmAla's CEO Nicholas Kadysh emphasized the company's US operations and commitment to ongoing research. PharmAla currently supplies LaNeo™ MDMA for patient treatments in Canada and Australia under special access programs.

Additionally, PharmAla announced the USPTO issuance of patent No. 12,053,452 for ALA-002, its novel non-racemic mixture of MDMA enantiomers. This patent is seen as a valuable asset in PharmAla's R&D program, addressing safety concerns associated with racemic MDMA and potentially positioning ALA-002 favorably for regulatory approval.

PharmAla Biotech Holdings Inc. announces the commencement of batch manufacturing of GMP LaNeo® MDMA 40mg capsules by its joint venture, Cortexa Pty. , marking a significant milestone in the Australian psychedelic landscape. The exclusive arrangement with Optima Ovest for domestic manufacturing strengthens Cortexa's position as a leader in the field and signals commitment to the growing Australian market for LaNeo™ MDMA.

PharmAla Biotech Holdings Inc. receives USPTO allowance for ALA-002 patent, a novel mixture of MDMA enantiomers with improved therapeutic potential. The patent provides strong IP protection for the company's lead investigational MDXX NCE, showing reduced hyperthermia incidence and enhanced pro-social effects in preclinical testing.

PharmAla Biotech Holdings Inc. has received a patent for its PharmAla-1 molecule, now known as APA-001, which shows promising therapeutic features in proof-of-concept rodent models. The molecule has a strong pro-social signal, induces neuroplasticity, and has a low abuse liability. The company is evaluating potential applications in treating psychological trauma, neurological damage, Traumatic Brain Injury (TBI), stroke, and fear disorders.

PharmAla becomes the first company to supply both MDMA and Psilocybin into the Australian Market, establishing a significant presence in the psychedelic medicine sector.