Psychedelics
Silo Pharma Advances in Ketamine-Based Treatment for Chronic Pain
LOS ANGELES— In a significant stride toward innovative treatment for chronic pain conditions, Silo Pharma, Inc. (Nasdaq: SILO), a biopharmaceutical company in its developmental stage, announced promising developments in its ketamine implant, SP-26. The company, known for its work on novel formulations and drug delivery systems for both traditional therapeutics and psychedelic treatments, is targeting fibromyalgia with this new approach. The SP-26 project has reached a critical milestone in its pre-clinical research phase, focusing on a time-released, dose-controlled formulation of ketamine. The study involves analytical testing services alongside small batch proof-of-concept extrusion trials. These trials are essential for determining the drug's release and stability over time. In a recent series ...
PharmaDrug Inc. Completes Private Placement to Bolster Corporate Initiatives
LOS ANGELES- a specialty pharmaceutical company, announce the successful completion of its previously disclosed non-brokered private placement, raising total gross proceeds of $326,000. In this offering, the company issued 6,520,000 units at a purchase price of $0.05 per unit, resulting in aggregate gross proceeds of up to $326,000. Each unit consists of one common share in the capital of the company and one-half of one common share purchase warrant. Each full warrant entitles the holder to acquire an additional common share at an exercise price of $0.10 until February 8, 2026. The proceeds from this private placement will be allocated towards general corporate purposes, supporting the company's ongoing operations and ...
Clearmind Medicine Secures Patent in China
LOS ANGELES- In a significant advancement for the field of psychedelic-derived therapeutics, Clearmind Medicine, a biotechnology firm with operations in Tel Aviv, Israel, and Vancouver, Canada, has been granted a patent in China for a novel treatment targeting binge behaviors. The treatment is based on a specific chemical compound known as a primary amine aminoindan, expanding the scope of potential therapies in the burgeoning area of psychedelic research. This recent patent approval underscores Clearmind's strategic endeavor to fortify its intellectual property (IP) portfolio in a competitive and rapidly evolving sector. The company, listed on both NASDAQ (CMND) and the Canadian Securities Exchange (CSE: CMND), emphasizes its commitment to pioneering in ...
MindBio Therapeutics Advances in Psychedelic Research
LOS ANGELES- MindBio Therapeutics Corp. is on the brink of completing a pivotal Phase 2a clinical trial, marking a significant milestone in the study of psychedelic substances for therapeutic purposes. The trial focuses on the use of MB22001, MindBio's proprietary titratable form of LSD, in microdoses for the treatment of Major Depressive Disorder (MDD). This trial represents a groundbreaking step in the exploration of psychedelics, with MindBio leading the charge as the only company globally to conduct clinical trials approved for take-home use of LSD in microdoses. The final participant in the trial is expected to complete dosing around February 14, 2024, with top-line results anticipated to be announced in ...
Hawaii Introduces Bill to Regulate Psilocybin Therapy Amid Growing Interest in Psychedelic Medicine
LOS ANGELES- In an innovative step towards mental health treatment, Hawaii lawmakers have introduced legislation aimed at creating a regulatory framework for the therapeutic use of psilocybin. The proposed Senate Bill 3019, introduced by Sen. Chris Lee on January 24, alongside a companion House Bill 2630 by 14 representatives, seeks to protect patients opting for psilocybin therapy for conditions such as post-traumatic stress disorder, end-of-life anxiety, addiction, and more, without fully legalizing the substance. The legislation outlines qualifications for individuals seeking psilocybin therapy, including being 21 or older, holding a high school diploma or equivalent, being a resident of Hawaii, and completing an approved psychedelic integration training program. Eligible conditions ...
Arizona Embarks on Psychedelic Therapy Frontier with Psilocybin Service Center Legislation
LOS ANGELES- In a significant step towards the integration of psychedelic therapy into mainstream healthcare, Arizona is positioning itself at the forefront of a growing movement. Bipartisan lawmakers have introduced groundbreaking legislation aimed at legalizing psilocybin service centers within the state, marking a bold expansion beyond current research efforts into the therapeutic applications of psychedelics. This legislative initiative, spurred by a coalition of nine bipartisan state legislators, seeks to authorize the establishment of licensed facilities where Arizonans can undergo psilocybin therapy under medical supervision. This move is in alignment with a growing trend across the United States, where the medicinal benefits of psychedelics are increasingly recognized and legislated. The proposed ...
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 ...
