The Fly | MDXXF

Yesterday

Psychedelic: Compass Pathways reports six-month data for psilocybin drug

Yesterday, 9:48 AM

Over a week ago

Psychedelic: Enveric, NRx, Bright Minds report quarterly earnings

May 21, 11:26 AM

Psychedelic: Compass Pathways, AtaiBeckley, GH Research report earnings

May 14, 11:09 AM

Psychedelic: FDA awards Compass Pathways priority review voucher

Apr 30, 10:18 AM

PharmAla positioned to supply U.S. expanded access pathway for MDMA

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Apr 20, 8:31 AM

Psychedelic: Compass Pathways, NRx Pharma report earnings results

Mar 26, 10:57 AM

Psychedelic: Helus Pharma reports HLP004 Phase 2 signal detection study results

Mar 5, 10:14 AM

PharmAla signs supply, data agreement with Nautilus Sanctuary

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Mar 3, 9:06 AM

Psychedelic: AtaiBeckley reports EMP-01 met primary objective in Phase 2a trial

Feb 26, 10:15 AM

PharmAla signs drug donation agreement with Spaulding Rehabilitation

MDXXF

Feb 26, 8:28 AM

PharmAla to supply Amsterdam UMC with LaNeo MDMA

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Feb 23, 8:45 AM

Psychedelic: Bright Minds reports results from Phase 2 BMB-101 trial

Jan 8, 10:57 AM

PharmAla to supply Ostfold Hospital Trust with LaNeo MDMA

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Jan 8, 8:50 AM

PharmAla reports Q1 customer deposits C$433,000 vs. C$276,000 last quarter

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Dec 24, 8:38 AM

PharmAla reports FY25 customer deposits C$276,000 vs. C$209,000 last year

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Dec 24, 8:37 AM

Psychedelic: Clearmind completes second cohort enrollment for CMND-100 trial

Dec 18, 10:32 AM

PharmAla contracts with UK-based CMO for ALA-002 manufacturing

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Dec 15, 8:43 AM

Psychedelic: Atai Beckley granted U.S. patent for EMP-01

Dec 11, 11:00 AM

PharmAla completes release testing on LaNeo capsules

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Dec 10, 8:37 AM

PharmAla signs term sheet with Radium Capital

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Nov 3, 8:43 AM

Psychedelic: PharmAla launches portal for MDMA prescribers, therapists

Oct 9, 10:52 AM

PharmAla director Harriet De Wit resigns

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Oct 8, 8:57 AM

PharmAla appoints Farnoud Kazemzadeh as COO

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Oct 8, 8:56 AM

PharmAla launches NEXUS portal for MDMA prescribers, therapists

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Oct 8, 8:56 AM

Psychedelic: Enveric announces EB-003 manufacturing milestones

Oct 2, 11:09 AM

GMP Manufacturing Control: PharmAla directly controls the manufacturing of its pharmaceutical-grade MDMA, ensuring purity, consistency, and compliance with Good Manufacturing Practice (GMP) standards critical for clinical trials and commercialization.

Proprietary MDMA Analogues and IP: The company develops and holds intellectual property for novel MDMA analogues and derivatives, offering potential improvements in efficacy, safety profile, or therapeutic applications beyond traditional MDMA.

Focused Regulatory Strategy: PharmAla has a strategic focus on navigating the complex regulatory landscape for psychedelic compounds, aiming for Health Canada and FDA approval through established pharmaceutical development processes.

Clinical Trial & Approval Risk: The success of PharmAla's drug candidates, including MDMA, relies heavily on favorable outcomes from ongoing and future clinical trials and subsequent regulatory approvals from health authorities like the FDA and Health Canada, which are uncertain and may be lengthy or unsuccessful.

Regulatory & Legal Framework Risk: The psychedelic drug industry operates within a complex and evolving regulatory and legal framework, particularly concerning controlled substances like MDMA, which could change unfavorably, restrict operations, or prevent market access.

Competition & Market Saturation Risk: PharmAla faces significant competition from other biotech and pharmaceutical companies developing psychedelic-assisted therapies, as well as academic institutions, which could lead to market saturation, pricing pressures, or loss of market share.