Psychedelics
Silo Pharma Announces Strategic Focus on Psychedelic and Traditional Therapeutics for 2024
LOS ANGELES- Silo Pharma, Inc., a developmental stage biopharmaceutical company, has outlined a strategic focus for its clinical pipeline in 2024, emphasizing the advancement of novel formulations and drug delivery systems for both traditional therapeutics and psychedelic treatments. The company is set to prioritize the development of four innovative drugs targeting critical health areas: mental health, chronic pain, and neurology. Eric Weisblum, CEO of Silo, announced the company's intent to submit a Pre-Investigational New Drug Application (IND) for its post-traumatic stress disorder (PTSD) therapeutic, SPC-15, to the U.S. Food and Drug Administration (FDA) by the end of the second fiscal quarter in 2024. This move is in collaboration with Columbia ...
Filament Health Corp. Gains FDA Approval for Psilocybin Clinical Trials
LOS ANGELES- The U.S. Food and Drug Administration (FDA) has recently granted an investigational new drug application to Vancouver-based Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) for its botanical psilocybin substance, PEX010. This approval marks a significant stride for Filament, enabling the firm to conduct clinical trials in the United States aimed at treating substance use disorders. The green light from the FDA follows Filament's ongoing research efforts in Canada, where PEX010 is currently under investigation for its potential in treating opioid use disorder (OUD). Benjamin Lightburn, CEO of Filament Health, expressed optimism about the development, stating, “We believe that botanical PEX010 could offer a solution.” He emphasized the importance ...
Psyence Biomedical Merges with Newcourt, Listing and Raising US$10 Million for Clinical Trials
LOS ANGELES- Psyence Biomedical Ltd. a subsidiary of Psyence Group Inc, has successfully completed a merger with Newcourt Acquisition Corp (“Newcourt”), a special purpose acquisition company. This business combination, which received approval from Newcourt’s stockholders on January 18, 2024, will introduce Psyence Biomed to the NASDAQ stock exchange under the new ticker symbols “PBM” for common stock and “PBMWW” for warrants, starting January 26, 2024. Concurrent with the merger, Psyence Biomed has entered into a securities purchase agreement, aiming to raise up to US$10 million. This capital will be raised through the issuance of up to four senior secured convertible notes in a deal with a US-based investment firm. These ...
Broad Support in Canada for Psilocybin Use in Palliative Care, New Study Reveals
LOS ANGELES — A recent Canadian study, published in the medical journal Palliative Medicine, has revealed significant public support for the use of psilocybin, a psychedelic compound, in treating existential dread among end-of-life patients. Conducted by a team led by Michel Dorval, a researcher at CHU de Québec-Université Laval Research Center and a professor at Université Laval’s Faculty of Pharmacy, the study highlights a growing acceptance of psychedelic-assisted therapy in palliative care. The study, carried out between November and December 2022, surveyed 2,800 Canadians, including 1,000 residents of Québec and 1,800 from Ontario, Alberta, and British Columbia. It probed public opinion on the administration of psilocybin without Health Canada's approval, its ...
PharmAla Launches “MDXXF” Ticker Amid MDMA Research
LOS ANGELES- PharmAla Biotech Holdings Inc., a biotechnology company specializing in the research, development, and manufacturing of novel MDMA derivatives (MDXX class molecules), has announced the introduction of its new OTC ticker symbol, "MDXXF." This change, effective from January 24th, signifies a strategic alignment with the company's core business focus. The announcement was made by Nick Kadysh, CEO of PharmAla Biotech, who expressed heightened anticipation for the upcoming period. This anticipation is particularly driven by the impending decision of the U.S. Food and Drug Administration (FDA) on its approach to assessing MDMA as a therapeutic molecule. Kadysh highlighted PharmAla's leading global position in the development of MDMA and MDXX class ...
Red Light Holland Advances in Psilocybin Microdosing Capsules for Australasian Market
NEW YORK – Red Light Holland Corp., a leader in the production and distribution of functional mushrooms and psilocybin truffles, has announced significant progress in the development and distribution of its natural psilocybin microdosing capsules. The company, in a strategic collaboration with CCrest Laboratories, has completed a crucial Product Specification report, paving the way for NUBU Pharmaceuticals to seek an import license in Australia and New Zealand. Red Light Holland's microdosing capsules, developed from psilocybin truffles grown in the Netherlands, have previously cleared stringent quality checks, including a Certificate Of Analysis and stability testing. These tests confirmed the absence of pesticides, bio-contaminants, or heavy metals in the capsules, ensuring they ...
AlphaFold: AI’s Role in the Future of Psychedelic Drug Development
LOS ANGELES- In the realm of pharmaceutical research, a groundbreaking approach is being adopted in the United Kingdom, where researchers are utilizing AlphaFold, an advanced artificial intelligence tool, to develop new psychedelic drugs potentially useful as antidepressants. The latest research, which awaits peer review, suggests that AlphaFold's AI-generated protein structures could rival traditional experimental methods like X-ray crystallography, which often require years of investigation. AlphaFold, developed by DeepMind in London, is a public database comprising structure predictions for nearly every known protein. This AI tool is poised to revolutionize biological research by enabling pharmaceutical companies to more efficiently identify and refine drugs targeting disease-related molecules. Jens Carlsson, a computational chemist ...
FDA’s ‘Breakthrough’ Nod to MM120, An LSD-Derivative, for Anxiety Relief
LOS ANGELES- In a significant development within the field of psychedelic therapy, the Food and Drug Administration (FDA) has recognized the LSD-analog substance MM120, also known as lysergide d-tartrate, with a 'breakthrough therapy' designation for its potential in treating generalized anxiety disorder (GAD). This status is aimed at accelerating the development and review process for drugs that demonstrate substantial improvement over existing therapies for conditions with considerable unmet medical needs. MM120, developed by Mind Medicine Inc. (MindMed), joins a growing list of psychedelic substances, including MDMA, esketamine, and psilocybin, that have garnered attention for their transformative potential in mental health treatment. Described as a tartrate salt form of lysergide, MM120 ...
Optimi Health Corp Expands Psychedelic Substance Manufacturing Capabilities with Health Canada License Amendment
LOS ANGELES- Optimi Health Corp. a Health Canada licensed entity engaged in psychedelic substance research and formulation, has achieved a significant milestone in its operational growth. The company announced on January 16, 2024, an amendment to its Controlled Drugs and Substances Licence by Health Canada. This amendment marks a substantial increase in the permitted quantities of several controlled substances, including MDMA, MDA, and 2C-B. The specific changes under the amendment include an increase in the permissible amount of N-Methyl-3,4-methylenedioxyamphetamine (MDMA) from 2kg to 20kg, 3,4-Methylenedioxyamphetamine (MDA) from 1kg to 2kg, and 4-Bromo-2,5-Dimethoxybenzene Ethanamine (2C-B) from 400g to 4kg. These adjustments reflect a significant expansion in Optimi's manufacturing capabilities for these ...
Filament Health Achieves Milestone with First Botanical Psilocybin Export to Australia
NEW YORK – Filament Health Corp. (OTCQB: FLHLF) (Cboe CA: FH) (FSE: 7QS), a trailblazer in the realm of natural psychedelic drug development, announced a significant milestone in its global expansion with the successful export of PEX010, its botanical psilocybin drug candidate, to Perth, Western Australia. This shipment, received by Reset Mind Sciences Ltd., a subsidiary of Little Green Pharma, marks a historic first in the Australian psilocybin industry. Lisa Ranken, Chief Operating Officer at Filament Health, highlighted the achievement as a testament to the company's robust regulatory capabilities. She noted, "This is the first legal shipment of a botanical psilocybin drug candidate to arrive in Australia, and we are pleased ...
DEA Proposes Increased Production Quotas for Cannabis and Psychedelics
LOS ANGELES- In a significant policy shift, the Drug Enforcement Administration (DEA) has proposed substantial increases in the production quotas for cannabis and various psychedelics for 2024. This move reflects a growing recognition of the potential therapeutic benefits of these substances and underscores the federal agency's commitment to facilitating more comprehensive research. The DEA's initial proposal, outlined in the Federal Register in November 2023, included notable increases in the aggregate production quotas (APQ) for substances such as THC, psilocybin, and dimethyltryptamine (DMT), all of which have garnered attention for their possible therapeutic effects. The latest update for the 2024 quotas suggests even larger increases. For instance, the APQ for d-9-THC ...
Numinus Wellness Inc. Announces First Quarter Fiscal 2024
NEW YORK – Numinus Wellness Inc. a mental health care emphasizing psychedelic-assisted therapies, has released its financial figures for the first quarter of fiscal year 2024, ending November 30, 2023. The results reveal a nuanced financial picture, marked by both gains in gross profit and challenges in revenue generation. The company reported a gross profit of $2.1 million, indicating an 18.8% increase from the fourth quarter of 2023. However, revenues saw a 3.0% decline in the same period, totaling $5.9 million. Notably, operating expenses were reduced by 19.9% over the previous quarter, reflecting the company’s strategic focus on cost containment. The cash position as of November 30, 2023, stood at ...
Rhode Island Explores Psilocybin Reform with a New Legislative Proposal
NEW TORK- In a significant legislative move, Rhode Island Representative Brandon Potter (D) has introduced a bill aimed at reforming the state's approach to psilocybin, the active compound in "magic mushrooms." The bill, H 7047, proposes a temporary allowance for the cultivation, possession, and sharing of up to one ounce of psilocybin, with its provisions set to expire in July 2026. This initiative comes as several U.S. states actively pursue reforms in their psilocybin policies, primarily focusing on decriminalizing possession and cultivation while exploring therapeutic applications. Rhode Island's proposal stands out for its nuanced approach, not aiming to establish a retail system but rather providing a decriminalization model that prioritizes ...
PSYC Corporation CEO Addresses Company Challenges and Future in Detailed Podcast Update
NEW YORK — PSYC Corporation , the parent company of Spotlight Media Corporation (SMC), a leader in media for emerging sectors like medicinal psychedelics, recently released a video podcast featuring CEO David Flores. The podcast, recorded on January 2, 2024, aimed to provide shareholders and interested parties with a comprehensive update on the company's current business status. In the podcast, moderated by Psychedelic Spotlight Director and Producer Matthew Dunehoo, Flores openly discussed the various challenges and uncertainties PSYC faces as it navigates its role in the rapidly evolving psychedelics industry. The conversation, lasting over 30 minutes, was intended to offer insight into the difficulties confronting the company. Flores acknowledged the ...
VA to Explore Psychedelics for PTSD and Depression
LOS ANGELES- In a groundbreaking move, the Department of Veterans Affairs (VA) is funding research into the therapeutic potential of psychedelics for treating mental health conditions like post-traumatic stress disorder (PTSD) and depression in veterans. This initiative, a first in decades, signals a significant shift in the VA's approach to mental health treatment. The VA's request for applications (RFA) calls on its pool of researchers to explore the effectiveness of methylenedioxymethamphetamine (MDMA) and psilocybin, the active compound in magic mushrooms, for these conditions. The last time the VA funded similar research was in 1963, focusing on psychedelics for alcoholism and mental disorders. This new research endeavor seeks definitive scientific evidence ...
DEA Clarifies Legality of Psychedelic Mushroom Spores, Highlighting Regulatory Complexities
WASHINGTON, D.C. — The U.S. Drug Enforcement Administration (DEA) recently provided a crucial clarification on the legal status of psychedelic mushroom spores. According to a statement from Terrence Boos, Chief of the DEA's Drug and Chemical Evaluation Section, these spores are not considered controlled substances under the Controlled Substances Act (CSA) as long as they do not contain the Schedule I substances psilocybin or psilocin. This announcement comes at a time when many U.S. states are reconsidering their stance on the therapeutic use of psilocybin, despite its classification as a Schedule I drug under the CSA, which implies a lack of accepted medical use and a high potential for abuse. ...
MAPS Public Benefit Corporation Secures Over $100 Million for Groundbreaking PTSD Therapy
LOS ANGELES- MAPS Public Benefit Corporation a key player in mental healthcare innovation, has announced an oversubscribed Series A financing round, raising over $100 million. This significant funding milestone, which includes conversion of previously issued convertible notes, marks a substantial step forward in the development and potential commercialization of MDMA-assisted therapy for post-traumatic stress disorder (PTSD). The financing was spearheaded by Helena, a globally recognized problem-solving organization, with contributions from a diverse group of mission-aligned and institutional investors. These include the Steven & Alexandra Cohen Foundation, Eir Therapeutics, Vine Ventures, and several others, each contributing to the ambitious vision of transforming mental healthcare. Concurrent with the financing, MAPS PBC has ...
Incannex Healthcare Concludes Phase 2 Trial of Psilocybin Therapy for Anxiety Disorder, Awaiting FDA IND Application
LOS ANGELES- Incannex Healthcare Inc., a pharmaceutical company in the development of medicinal cannabinoid and psychedelic medicine therapies, has recently completed a significant milestone in its PsiGAD-1 clinical trial. This Phase 2 study, focused on evaluating the company’s proprietary psilocybin treatment for generalized anxiety disorder (GAD), successfully completed dosing and treatment protocols for all 72 participants. Conducted at Monash University in Melbourne, Australia, the PsiGAD-1 trial is a randomized, triple-blind, active-placebo-controlled study. Its primary goal is to determine the efficacy of a 7-week psilocybin-assisted psychotherapy program in reducing GAD symptoms, measured by changes in the Hamilton Anxiety Rating Scale (HAM-A). The trial's comprehensive approach included safety and tolerability assessments, along ...
Lykos Therapeutics Secures Over $100 Million in Series A Financing
LOS ANGELES- Lykos Therapeutics, previously known as MAPS Public Benefit Corporation, has achieved a significant milestone in its journey to revolutionize mental healthcare. The company announced an oversubscribed Series A financing, raising over $100 million, including the conversion of previously issued convertible notes. This funding is a crucial step in supporting regulatory and pre-launch activities for its investigational MDMA-assisted therapy for post-traumatic stress disorder (PTSD). The financing round was led by Helena, a global problem-solving organization, with contributions from a diverse group of mission-aligned and institutional investors. These include the Steven & Alexandra Cohen Foundation, Eir Therapeutics, Vine Ventures, True Ventures, and several others. Amy Emerson, CEO of Lykos, expressed ...
Cybin Inc. Advances Psychedelic Therapy with Promising Phase 2 Results and Upcoming Trials
LOS ANGELES- Cybin Inc., a clinical-stage biopharmaceutical company at the forefront of psychedelic-based mental health treatments, recently announced encouraging results from its Phase 2 study of CYB003 for Major Depressive Disorder (MDD) and outlined key milestones for its upcoming clinical trials. The company's Phase 2 findings revealed a significant breakthrough in treating MDD. The study observed that 79% of patients achieved remission from depression symptoms six weeks after receiving two doses of CYB003 (12mg). These results are especially notable when compared to the efficacy of current standard antidepressants like selective serotonin reuptake inhibitors (SSRIs). CYB003 showed a mean -13.75 point difference in the Montgomery–Asberg Depression Rating Scale (MADRS) score compared ...
AMA Introduces Psychedelic Therapy Codes Amidst FDA Review of Prescription MDMA
-LOS ANGELES The American Medical Association (AMA) has taken a significant step in the realm of psychedelic therapy by introducing specific codes for these treatments. This development aligns with the Food and Drug Administration's (FDA) ongoing evaluation of MDMA as a potential prescription medication for post-traumatic stress disorder (PTSD). In July, the AMA, in collaboration with the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS) and COMPASS Pathways, established Current Procedural Terminology (CPT) III codes. These codes aim to standardize psychedelic treatments, paving the way for insurance coverage and reimbursement, contingent on FDA approval. This initiative follows the publication of MAPS' latest Phase 3 Trial findings in the esteemed ...
Silo Pharma Advances in Development of Ketamine-Loaded Implant for Chronic Pain Treatment
LOS ANGELES- In a significant step towards innovating chronic pain management, developmental-stage biopharmaceutical company Silo Pharma, Inc. (Nasdaq: SILO) has reported notable progress in the development of SP-26, a ketamine-loaded implant designed for home treatment of fibromyalgia and other chronic pain conditions. Working collaboratively with Sever Pharma Solutions, Silo Pharma is conducting analytical testing and pre-clinical trials to ascertain the drug release and stability of the implant. This phase is crucial for evaluating the potential effectiveness and safety of the treatment. Eric Weisblum, CEO of Silo Pharma, emphasized the company’s commitment to addressing the urgent need for non-opioid pain relief options. “Based on our current findings, SP-26 stands a chance ...
Copy of BetterLife Pharma Secures Funding to Advance Innovative Mental Health Treatment
LOS ANGELES — BetterLife Pharma Inc. ("BetterLife"), a biotech company at the forefront of mental disorder treatments, has announced the successful closing of $300,000 in convertible debentures. This funding is a strategic step towards the development of their lead compound, BETR-001, a non-hallucinogenic derivative of LSD, poised to revolutionize the treatment of psychiatric disorders. BETR-001, BetterLife's proprietary version of 2-bromo-LSD, stands out in the field of mental health for its potential in treating psychiatric disorders without causing hallucinations. The company plans to utilize the newly acquired funds to complete necessary IND-enabling studies as mandated by the FDA, and to produce Good Manufacturing Practice (GMP) drug substances for future clinical trials. Ahmad ...
A Psychedelics Deep Dive: Capital Flow in the Psychedelics Industry: Part 4 of 4
TORONTO– Some people are surprised to learn about the very existence of a publicly traded psychedelics market. We’ve been conditioned for generations, after all, to conflate benign psychedelic substances with dangerous narcotic drugs. Regardless of our preconceptions, the truth remains that the global psychedelics industry is thriving even if it’s taking some time to find its wings. In this fourth and final part of our series investigating the psychedelics market, we’ll cover how money enters the psychedelics industry and what investors want it to do once it gets there. How is the psychedelics industry funded? The psychedelics market remains highly speculative, but there’s a lot more to it than mere ...
Psychedelics Deep Dive: Psychedelic Medicines in Development: Part 3 of 4
LOS ANGELES- Human beings have used psychedelic substances for thousands of years. It's only recently, though, that these mind-altering compounds have made their way back into the realm of mainstream medical science. Out of all the psychedelics discovered and popularized during the 20th century, ketamine was the only substance to retain its therapeutic classification. Now, though, drugs like MDMA and LSD, originally produced for psychotherapy, are regaining their rightful places within the modern pharmacological pantheon. The modern psychedelic movement is being propelled by unprecedented levels of capital influx. Many psychedelic companies are publicly traded—even within American markets. Global capital clearly favors the advent of prescription psychedelic therapies. It’s now up ...
