Psychedelics
California Advances Regulated Psychedelic Therapy Bill
LOS ANGELES- California's legislative body has taken a significant step towards the formal integration of psychedelic therapy into medical practice with the Senate Business, Professions and Economic Development Committee's recent approval of Senate Bill 1012. The bill, championed by Senator Scott Wiener of San Francisco, aims to create licensed centers where adults aged 21 and older can use substances such as psilocybin, MDMA, mescaline, and DMT under professional supervision. This legislative move aligns with Governor Gavin Newsom's preference for a measured approach to psychedelic reforms. It marks a notable progression from the previous year when a broader decriminalization bill was vetoed by the governor. Senator Wiener and supporters advocate that ...
Cybin Inc. Secures Patent for Psychedelic-Based Depression Treatment
LOS ANGELES- Cybin Inc., a biopharmaceutical company dedicated to improving mental healthcare through psychedelic-based therapies, has announced the granting of a new U.S. patent for its CYB003 program, aimed at treating Major Depressive Disorder (MDD). The patent, U.S. 11,958,807, is expected to ensure exclusivity for the company's innovative treatments until at least 2041. The patent specifically covers pharmaceutical compositions related to Cybin’s proprietary deuterated psilocybin analog program, CYB003. This development represents a key component of the company's strategy to protect and advance its intellectual property in the burgeoning field of psychedelic medicine. Doug Drysdale, CEO of Cybin, stated that the patent is a crucial step in protecting the company’s innovative ...
Maine Advances Psychedelic Research with Commission Bill Awaiting Governor’s Approval
LOS ANGELES- In a significant move towards exploring the therapeutic potential of psychedelic substances, Maine lawmakers have sent a bill to Governor Janet Mills that aims to establish a commission for studying and recommending regulatory frameworks for psychedelic services. The bill, known as LD 1914, has undergone amendments from its original version, shifting from legalizing psilocybin for therapeutic use to a more cautious approach focusing on research and future regulation. The proposed commission, consisting of 13 members including legislative appointees, health experts, a military veteran, academics, and individuals with experience in psychedelics policy, is tasked with reviewing medical, psychological, and scientific studies on the safety and efficacy of psilocybin in ...
Silo Pharma Licenses Promising Alzheimer’s Disease Therapeutic from Columbia University
NEW YORK- Silo Pharma, Inc. a biopharmaceutical company specializing in novel formulations and drug delivery systems, has announced its decision to license a therapeutic candidate for Alzheimer's disease (AD), known as SPC-14, from Columbia University. This move follows a sponsored research and option agreement established in 2021. Under the terms of the impending license agreement, Silo Pharma will acquire an exclusive global license to further develop, manufacture, and commercialize SPC-14. The company anticipates finalizing and entering into this exclusive license agreement in the first half of 2024. Eric Weisblum, CEO of Silo Pharma, expressed optimism about the potential of SPC-14, stating, "Columbia University has discovered a therapeutic candidate that could ...
Filament Health Reports Revenue Gains and Progress in Psychedelic Drug Development
LOS ANGELES- Filament Health Corp., a psychedelic drug developer, has reported its financial results for the fourth quarter and the full year ending December 31, 2023. The company showed notable revenue gains and a significant reduction in net loss compared to the previous year. For the full year, Filament reported total revenues of $2.1 million, a substantial increase from $364,500 in 2022. The net loss for the year was $5.3 million, which represents a 103% improvement from the $16.5 million net loss in 2022. The company ended the year with $1.8 million in cash and cash equivalents and $1.1 million in working capital. CEO Benjamin Lightburn highlighted the company's progress, ...
California Proposes Supervised Psychedelic Therapy Bill
LOS ANGELES- In an innovative legislative move, California lawmakers have introduced a bipartisan bill that aims to permit individuals over the age of 21 to consume psychedelic mushrooms under professional supervision. This proposal seeks to address the state's pressing mental health and substance use issues. The introduction of this bill follows Governor Gavin Newsom's veto last year of a measure that would have decriminalized the possession and personal use of certain plant-based hallucinogens, including psychedelic mushrooms. The governor had emphasized the need for therapeutic guidelines and regulations at the time. The newly proposed Senate Bill 1012, spearheaded by Democratic Sen. Scott Wiener and Republican Assemblymember Marie Waldron, advocates for the ...
Alberta Leads in Psychedelic-Assisted Therapy Coverage
NEW YORK- Alberta Blue Cross's recent endorsement of insurance coverage for Psychedelic-Assisted Therapy signifies a pioneering move in Canadian healthcare, positioning Alberta as the first province to officially support and regulate such treatments. This development reflects a broader shift in the perception of psychedelic substances, including psilocybin, MDMA, LSD, and DMT, for their therapeutic potential in mental health care. Psychedelic-Assisted Therapy has been under the spotlight for its promising outcomes in treating severe mental health disorders, offering a new avenue for patients who have not found relief through traditional methods. This step by Alberta Blue Cross not only enhances access to these innovative treatments but also sets a precedent for ...
University of Calgary Studies Psychedelic Treatment for Alcohol Use Disorder
LOS ANGELES- The University of Calgary, through its Hotchkiss Brain Institute, has embarked on a study to examine the potential of psychedelics, specifically psilocybin, in treating Alcohol Use Disorder (AUD). With plans to recruit 128 participants, this research integrates specialized therapy sessions with psychedelic treatments to evaluate whether this novel approach can outperform conventional treatment methods. Dr. Leah Mayo, leading the study, explains that the trial will build on the foundational benefits of psychotherapy for AUD, with psilocybin introduced to enhance treatment outcomes. This strategy aims to disrupt persistent negative behaviors by leveraging a brief but intensive treatment period, combining controlled psilocybin doses with psychotherapy over five weeks. The study's ...
ICER Raises Concerns Over MDMA-Assisted Psychotherapy for PTSD
LOS ANGELES- The Institute for Clinical and Economic Review (ICER) has recently highlighted significant concerns regarding the clinical evidence behind MDMA-assisted psychotherapy (MDMA-AP) for post-traumatic stress disorder (PTSD), according to a draft evidence report. This report marks the halfway point of an eight-month evaluation process conducted by ICER, a nonprofit organization known for its rigorous analysis of the value of health interventions. While the findings are preliminary, they shed light on potential issues within the clinical trials conducted by Lykos for its MDMA therapy. David Rind, ICER’s Chief Medical Officer, acknowledged the profound impact of PTSD and the current gaps in effective treatments. However, the draft report outlines serious concerns ...
PharmAla Biotech and Cortexa Supply GMP Psilocybin for Therapeutic Use in Australia
LOS ANGELES- PharmAla Biotech Holdings Inc., in collaboration with Cortexa Pty. Ltd., has achieved supplying Good Manufacturing Practice (GMP) Psilocybin for therapeutic use to a patient under the Australian authorized prescriber scheme, marking what the company believes to be a global first. This groundbreaking development allows for the treatment of patients with treatment-resistant depression outside of clinical trials. The partnership between PharmAla and Australian-based digital health company Vitura Health Ltd. led to the creation of Cortexa, a joint venture established in May 2023. Cortexa has rapidly positioned itself as the sole provider in Australia capable of immediately supplying both GMP MDMA and Psilocybin for clinical trials and prescriptions through the ...
Utah to Launch Psilocybin and MDMA Pilot Program for Behavioral Health Treatment
NEW YORK-Utah is set to introduce a pioneering pilot program that will allow select hospitals to administer psilocybin and MDMA to patients for behavioral health treatment starting in May, after Governor Spencer Cox opted to let the authorizing bill become law without his signature. This decision marks a significant step forward in the exploration of psychedelic substances for medical use within the state. The program, which is scheduled to run for three years until 2027, is open to any privately owned nonprofit Utah hospital system that operates at least 15 hospitals, as well as any higher education medical program. This initiative is designed to explore the potential benefits of psilocybin ...
Clinical Trial Explores Psychedelic Treatment for Depression
LOS ANGELES- In a move within the field of psychiatric treatment, MindBio Therapeutics Corp. has announced the launch of its Phase 2B clinical trial, investigating the potential of psychedelics in treating Major Depressive Disorder (MDD). This trial aims to assess the effectiveness of MB22001, a proprietary formulation of Lysergic Acid Diethylamide (LSD), uniquely designed for self-administration by patients outside clinical environments. The study, characterized by its randomized, triple-blind, and active placebo-controlled design, is set to enroll 90 patients in an 8-week regimen. This innovative trial structure allows participants to self-administer MB22001, demonstrating MindBio's commitment to developing scalable, user-friendly treatments. The trial participants are evenly divided, with one group receiving an ...
Indiana’s Pioneering Psilocybin Research Bill Awaits Governor’s Approval
LOS ANGELES- In a groundbreaking legislative move, Indiana stands on the precipice of advancing psilocybin research, following the final approval of a bill aimed at exploring the substance's potential in treating various medical conditions. The bill, now awaiting Governor Eric Holcomb's signature, could usher in a new era of mental health treatment options, particularly benefiting veterans and first responders. Senate Bill 139, championed by Senator Ed Charbonneau, successfully navigated the complexities of legislative procedures, integrating its objectives into House Enrolled Act 1259. The proposed legislation seeks to establish a therapeutic psilocybin research fund under the Indiana Department of Health, providing financial backing for scientific inquiries into the use of psilocybin ...
Cybin Eyes $150 Million Boost Through Private Placement to Propel Psychedelic Drug Development
Cybin Inc., a firm at the forefront of psychedelic drug development, announced its plan on Wednesday to secure approximately $150 million in funding through the private placement of over 348 million common shares. This strategic financial maneuver aims to bolster the company's operations and expedite clinical trials for its promising drug candidate, CYB003. In a press release, Cybin revealed that the funds would be allocated to support "certain Phase 3 drug development activities for CYB003, working capital, and general corporate purposes." The company, still navigating the pre-revenue phase, focuses on the development of CYB003, a psilocybin-based drug currently undergoing testing for the treatment of major depressive disorder (MDD). Despite its ...
atai Life Sciences Advances VLS-01, A Novel DMT-Based Treatment
LOS ANGELES- atai Life Sciences a biotechnology company specializing in mental health treatments, is making strides in the development of a groundbreaking approach to treating treatment-resistant depression. Dr. Srinivas Rao, the Chief Scientific Officer, recently shed light on the company's promising development candidate, VLS-01, in a discussion with Proactive’s Stephen Gunnion. VLS-01 is a novel formulation of DMT, the psychoactive molecule in ayahuasca, tailored to address the challenges of treatment-resistant depression. Rao emphasized the innovative delivery mechanism of VLS-01 — an oral transmucosal film, similar to a dissolvable strip akin to Listerine, designed to dissolve in the mouth over 20 minutes. This method represents a significant leap forward, offering a ...
New Mexico Advances Psilocybin Research with Memorial Legislation
-LOS ANGELES- In a significant move toward exploring alternative therapeutic treatments, New Mexico Governor Michelle Lujan Grisham has signed Senate Memorial 12 (SM-12), initiating a comprehensive study on the therapeutic potential of psilocybin, the psychoactive compound found in certain mushrooms. The memorial, distinct from typical bill proposals, mandates the New Mexico Department of Health and the University of New Mexico to investigate psilocybin's efficacy and outline regulatory frameworks for a potential therapeutic program. This legislative action stems from an acknowledgment of the state's escalating mental health crisis, marked by a troubling rise in suicides, particularly among veterans and first responders, and the nation-leading rates of drug overdoses and alcohol-related deaths. ...
Numinus Wellness Secures $6 Million in Public Offering to Fuel Psychedelic-Assisted Therapy Initiatives
LOS ANGELES- Numinus Wellness, a Vancouver-based healthcare company specializing in the innovative field of psychedelic-assisted therapies, has announced the successful completion of a significant financial milestone. Through a "bought deal" public offering, the company has raised $6 million, a move that positions it strongly within the burgeoning sector of mental health care. Financial Details and Strategic Impact The transaction saw the sale of 50,000,000 units at $0.12 each, precisely matching the stock's current market price. Each unit comprises a common share and a warrant, the latter offering the option to purchase an additional common share at $0.18 within the next 24 months. This infusion of capital is earmarked for supporting ...
FSD Pharma Announces Market Offering Agreement to Fund Research and Development
NEW YORK- FSD Pharma a biopharmaceutical company focused on developing a diverse portfolio of innovative assets and biotechnological solutions, has unveiled a strategic market offering agreement with H.C. Wainwright & Co. LLC. This collaborative effort paves the way for FSD Pharma to potentially offer and sell up to $11,154,232 in Class B subordinate voting shares at its discretion, marking a significant step in the company's financial and developmental strategy. Under the terms of the agreement, sales of the Class B shares are set to occur at prevailing market prices, providing FSD Pharma with a flexible mechanism to raise capital as needed. H.C. Wainwright & Co. LLC is set to receive ...
Clearmind Medicine Inc. Advances Psychedelic Therapeutics with New Patent Applications
NEW YORK– Clearmind Medicine Inc. a biotech firm dedicated to the discovery and development of novel psychedelic-derived therapeutics, has taken significant steps to enhance its intellectual property (IP) portfolio through the submission of three patent applications under the international Patent Cooperation Treaty (PCT). This strategic move, in collaboration with SciSparc Ltd. (Nasdaq: SPRC), a clinical-stage pharmaceutical company specializing in central nervous system disorders, underscores the companies' commitment to advancing the field of psychedelic medicine. The patent applications encompass innovative proprietary combinations of lysergic acid diethylamide (LSD), psilocybin, N,N-dimethyltryptamine (DMT), and Palmitoylethanolamide (PEA), the active ingredient in SciSparc’s proprietary CannAmide™. Initially filed as provisional patents with the United States Patent and ...
MindBio Therapeutics Announces Completion of Groundbreaking Phase 2a LSD Microdose Trial
LOS ANGELES- In a significant advancement for psychiatric medicine, MindBio Therapeutics Corp., a pioneering biopharmaceutical company, has announced the successful completion of its Phase 2a clinical trial, marking a pivotal moment in the development of treatments for Major Depressive Disorder (MDD). This trial is notably the world's first to receive regulatory approval for the take-home use of a psychedelic medicine, specifically a titratable form of Lysergic Acid Diethylamide (LSD) known as MB22001, designed for microdosing. The open-label trial aimed to identify clinically significant changes in depression severity, utilizing the globally recognized Montgomery Asberg Depression Rating Scale (MADRS). The primary endpoint for MB22001’s success in treating depression was marked by improvements ...
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 ...
