Key preclinical milestone for novel, non-opioid extended-release pain therapeutic SARASOTA, FL, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced the initiation of a pharmacokinetic (PK) and tolerability study in partnership... Read more
Agreement Supports Phase IIb and Future Phase III Trial Development, Addressing Critical Needs in Palliative Care Using Optimi's Natural Psilocybin Extract Vancouver, British Columbia--(Newsfile Corp. - December 17, 2024) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian manufacturer of GMP-certified, naturally-derived psilocybin and MDMA, has entered into binding agreements with Psyence Biomedical Ltd. (Nasdaq: PBM)... Read more
The term sheet is non-binding, subject to the execution of a definitive agreement Vancouver, Canada, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced that it has signed a non-binding term sheet with Dr. Glitter... Read more
Voyage is the first-ever Phase 3 study of lysergide D-tartrate (LSD) with the primary endpoint measuring the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) score at week 12 for MM120 Orally Disintegrating Tablet (ODT) 100 µg vs placebo Study builds on positive Phase 2b study results presented at the American Psychiatric Association’s Annual Meeting in May 2024 Topline data from the 12-week double-blind period anticipated in the first... Read more
The import was conducted in collaboration with the government of Peru Magdalena Biosciences is focused on developing novel, natural prescription medicines derived from plants for mental health indications VANCOUVER, BC, Dec. 16, 2024 /CNW/ -Filament Health Corp. (OTCQB: FLHLF) (Cboe CA: FH) (FSE: 7QS) ("Filament" or "Filament Health"), a clinical-stage natural psychedelic drug development company, today announced that Magdalena Biosciences ("Magdalena"), a joint venture... Read more
NEW YORK / Dec 11, 2024 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that it presented encore data from its Phase 2b study of MM120 (lysergide D-tartrate or LSD), the Company’s lead product candidate in generalized anxiety disorder, at the ACNP 2024 Congress taking place December 8 – 11 in Phoenix,... Read more
TORONTO, ON / ACCESSWIRE / December 10, 2024 / Quantum BioPharma Ltd. (NASDAQ:QNTM) (CSE:QNTM) (FRA:0K91) ("Quantum BioPharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, HUGE Biopharma Australia Pty Ltd., that the safety review committee recommends commencing dosing of the second cohort in its trial entitled "A Phase 1, Randomised, Double-Blind, Pla... Read more
Poster presentations highlight clinical data across Cybin’s CYB003 deuterated psilocin and DMT programs TORONTO / Dec 10, 2024 / Business Wire / Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today announced the presentation of two posters at the American College... Read more
CORAL GABLES, Fla., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that in light of the recent data monitoring committee (DMC) evaluation of the full dataset from the Reliance II Phase 3 study of the Company's REL-1017 program, the Company will discontinue the Reliance II and Relight Phase 3 studies.... Read more
Innovation Passport Designation Aims to Accelerate Time to Market and Facilitate Patient Access to Innovative Medicines NEW YORK / Dec 05, 2024 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD), has been granted an... Read more
TORONTO, ON / ACCESSWIRE / December 5, 2024 / Quantum BioPharma Ltd. (NASDAQ:QNTM) (CSE:QNTM) (FRA:0K91) ("Quantum BioPharma" or the "Company"), is pleased to announce that it intends to complete a non-brokered private placement offering (the "Offering") of up to 5,000 convertible debenture units of the Company (the "Debenture Units") at a price of $1,000 per Debenture Unit (the "Issue Price"). Each Debenture Unit will consist of (i) one secured convertible debenture having... Read more
The DMC did not identify any new safety concerns Relmada to evaluate potential next steps for the REL-1017 program Relmada to continue to focus on the development of REL-P11 for metabolic disease Relmada is well capitalized with approximately $54.1 million in cash and cash equivalents as of September 30, 2024 CORAL GABLES, Fla., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a late-stage biotechnology... Read more
New patents provide additional composition of matter and methods of use claims for Enveric’s EVM301 series neuroplastogenic molecules, and recently out-licensed tryptamine-derived prodrugs, including EB-002, a new chemical entity psilocin prodrug CAMBRIDGE, Mass. / Dec 02, 2024 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics... Read more
Prototype development and feasibility testing underway for optimized subcutaneous delivery SARASOTA, FL, Nov. 29, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced a collaboration agreement with Kymanox for specialized design and development... Read more
FDA provided preliminary responses to questions contained in the clarification only post-CRL meeting scheduled for December 2, 2024 PharmaTher has decided to cancel the meeting as the FDA preliminary responses were satisfactory and do not require further discussion PharmaTher initiated activities to address the MINOR deficiencies cited in the CRL TORONTO, Nov. 26, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF)... Read more
Dose-proportional oral bioavailability without clinical signs, including those associated with hallucinogenic compounds, was demonstrated in rat and dog pharmacokinetic (PK) studies while significant brain penetration was observed in rat CAMBRIDGE, Mass. / Nov 25, 2024 / Business Wire / Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogen small molecule therapeutics... Read more
NRx-developed training and monitoring methodology in recently completed phase 2b/3 clinical trial of NRX-101 documents higher interrater reliability (IRR) on primary endpoint (MADRS depression scale) than previously reported industry standards Positive implications for conduct of future registration trials for NRX-101 and similar medications. Published in the peer reviewed American Journal of Clinical Psychopharmacology WILMINGTON, Del., Nov. 25, 2024 /PRNewswire/... Read more
VANCOUVER, British Columbia, Nov. 25, 2024 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech company focused on the development of BETR-001, a non-hallucinogenic derivative of lysergic acid diethylamide (“LSD”), announced it has completed one of its IND-enabling cardiac safety studies of BETR-001. These GLP in vitro studies demonstrated that BETR-001 has minimal impact... Read more
Poster presentations on BMB-101 will focus on 5-HT2C functional selectivity and Phase 1 clinical data NEW YORK, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (NASDAQ: DRUG), a pioneering company focused on developing highly selective 5-HT2 agonists for the treatment of drug-resistant epilepsy, depression, and other central nervous system (CNS) disorders, is proud to announce two upcoming presentations at the American Epilepsy Society 2024 Annual... Read more
CORAL GABLES, Fla., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that Sergio Traversa, Chief Executive Officer (CEO), will present at the Jefferies London Healthcare Conference on Wednesday, November 20, 2024. Jefferies London Healthcare Conference details: Presentation: Wednesday, November... Read more
FDA granted a post-complete letter clarification meeting scheduled for December 2, 2024 Company initiated activities to address the deficiencies cited in the CRL TORONTO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the FDA granted a post-complete letter clarification meeting (the “Meeting”) scheduled for December 2, 2024. As... Read more
U.S. Patent Office issues notice of allowance for a second patent for Conjugated Psilocin™ Once issued, this patent will provide additional coverage for psilocin mucate compositions VANCOUVER, British Columbia & STUART, Fla. / Nov 18, 2024 / Business Wire / Lobe Sciences, Ltd. ("Lobe Sciences" or the "Company") (CSE: LOBE), (OTCQB: LOBEF) and Alera Pharma, Inc. (“Alera” or “Alera Pharma”), biopharmaceutical companies focused on developing products to treat... Read more
Dual-action approach combining 5-HT4R Agonist (SPC-15) and NMDAR antagonist demonstrates enhanced efficacy in preclinical study for managing severe conditions The Company is currently developing SPC-15 as an intranasal treatment for PTSD SARASOTA, FL, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems... Read more
100% of participants were responsive to treatment and 71% of participants were in remission at 12 months after just two 16 mg doses of CYB003 Robust, long-term efficacy with ~23-point reduction in Montgomery-Asberg Depression Rating Scale (“MADRS”) score compared to baseline at 12 months after two 16 mg doses of CYB003 Findings validate dosing regimen and confirm that CYB003’s effects are highly durable and offer sustained relief for MDD patients&nb... Read more
Toronto, Ontario--(Newsfile Corp. - November 18, 2024) - Braxia Scientific Corp. (CSE: BRAX) (OTC Pink: BRAXF) (FSE: 4960) ("Braxia", or the "Company") announced that Jerry Habuda has resigned as a director effective November 12, 2024. Peter Rizakos was appointed on the same date by the remaining directors. Roger McIntyre resigned as a director and CEO effective November 13, 2024. The current directors of the Company are Ahmed Shehata and Peter Rizakos. About Braxia Scientific... Read more
Definitive agreement includes the sale of U.S. wellness clinics and a partnership to launch a technology-driven clinic management solution for mental health care providers. Executed a definitive agreement with Stella for the sale of Numinus Wellness clinics for US$3.53 million Focusing on business units and product development ("Numinus Network") to facilitate clinic efficiency and care reimbursement for mental health practitioners Stella will partner w... Read more
VANCOUVER, BC, Nov. 14, 2024 /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (Cboe CA: FH) (FSE: 7QS) ("Filament" or the "Company"), a clinical-stage natural psychedelic drug development company, released its third quarter financial results and operational highlights for the period ended September 30, 2024. "This quarter we continued to grow our position as the premier global supplier of cGMP botanical psilocybin," said Benjamin Lightburn, Chief Executive Officer... Read more
TORONTO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), has signed a Letter of Intent with a research institution to provide its LaNeo MDMA in exchange for a full and perpetual license to the efficacy and safety data generated by the trial. “One... Read more
Company to host conference call and webcast at 8:00 a.m. ET on Monday, November 18, 2024 Presentation will also include discussion of its recently initiated Phase 3 PARADIGM program for CYB003 TORONTO / Nov 14, 2024 / Business Wire / Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry platform company committed to revolutionizing mental healthcare by developing new and innovative... Read more
REL-P11 is a proprietary, low-dose, modified-release psilocybin formulation Single-Ascending Dosing (SAD) study to evaluate safety and pharmacokinetics in obese and normal weight subjects With positive results, Phase 2a proof-of-concept study expected to begin in H1 2025 CORAL GABLES, Fla., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a late-stage biotechnology company addressing diseases of the central... Read more
Phase 2b clinical trial of GH001 in patients with treatment-resistant depression completed enrolment of the double-blind phase in Q3 2024 Phase 1 clinical trial to evaluate proprietary aerosol delivery device in healthy volunteers is ongoing in the UK Cash, cash equivalents, other financial assets and marketable securities of $193.8 million DUBLIN, Nov. 14, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated... Read more
NEW YORK and MELBOURNE, Australia, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with chronic diseases and significant unmet medical needs, today reported fiscal first quarter financial results and provided business highlights for the quarter ended September 30, 2024. “The first quarter reflects ongoing progress for Incannex, building on the... Read more
On track to file New Drug Applications (NDAs) for NRX-100 (IV Ketamine) in treating suicidal ideation in depression, including bipolar depression and NRX-101 (Oral D-Cycloserine/Lurasidone) for Accelerated Approval in bipolar depression with suicidality or akathisia by year end 2024 with 2025 PDUFA date forecast. HOPE Therapeutics acquiring Interventional Psychiatry Clinics; key to developing a best-in-class network of care to prevent suicide, continues to expect first... Read more
Advanced pre-IND activities and research for lead candidate, EB-003, a novel neuroplastogenic molecule designed to treat severe mental health disorders Announced the expansion of patent protection for a broad range of molecules in its EVM301 portfolio, including five previously unannounced US patents Out-licensed patented radiation dermatitis topical product to Aries Science & Technology Out-licensed EVM201 Program including EB-002 Candidate to MycoMedica Life S... Read more
TORONTO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the Company requested a post-complete letter clarification meeting (the “Meeting”) in response to the FDA issuing a complete response letter (CRL), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments... Read more
PARADIGM ™ program comprises two 12-week randomized, placebo-controlled studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND) APPROACH ™: A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans with Major Depressive Disorder has been initiated and will enroll 220 patients at 36 clinical sites across the U.S. and Europe; topline results expected in 2026 EMBRACE... Read more
Agreement includes development and sales milestones payments potentially totaling up to $62 million as well as tiered single digit royalties on future sales CAMBRIDGE, Mass. / Nov 12, 2024 / Business Wire / Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogen small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced... Read more
On track to initiate the Phase 3 Voyage study of MM120 Orally Disintegrating Tablet (ODT) in Generalized Anxiety Disorder (GAD) in the fourth quarter of 2024; 12-week topline data anticipated in the first half of 2026 On track to initiate the Phase 3 Panorama study of MM120 ODT in GAD and the Phase 3 Emerge study of MM120 ODT in Major Depressive Disorder (MDD) in the first half of 2025 Cash and cash equivalents of $295.3 million as of September 30, 2024, expected to fund... Read more
TORONTO, Nov. 07, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is proud to announce that it has been contracted as a supplier of MDMA to a clinical trial at Yale University. “Requests for clinical trial material – LaNeo™ MDMA – for research... Read more
Pre-planned Phase 3 Reliance II interim analysis, anticipated by YE 2024, could represent an important de-risking event for REL-1017 and the Company Phase 1 study for REL-P11 for metabolic disease expected to begin by YE 2024 Cash position of $54.1 million provides runway through key near-term milestones, into 2025 Management hosting conference call and webcast today at 4:30 PM ET CORAL GABLES, Fla., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq:... Read more
VANCOUVER, British Columbia, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (CSE: DRUG) (NASDAQ: DRUG) (“Bright Minds” or the “Company”) announces that further to its news release of October 18, 2024, the Company has closed a non-brokered private placement of 1,612,902 common shares in the capital of the Company (“Shares”) at a price of USD$21.70 per Share for aggregate gross proceeds of USD$35,000,000 (the “Offering”). The Company is pleased... Read more
PsyLabs develops and produces certified pharmaceutical-grade nature-derived psychedelics for applications in mental health and well-being Psyence Biomedical has issued common shares to Psyence Group pursuant to a debt-for-equity swap agreement NEW YORK, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Psyence Group Inc. ("Psyence Group") (CSE: PSYG) today announced the successful closing of its previously announced disposal of its 11.13% stake in privately... Read more
The implant demonstrates stability and consistent drug release, supporting further analytical testing and development SARASOTA, FL, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced promising results from recent sterilization and... Read more
Top-line COMP005 data for COMP360 phase 3 pivotal program in treatment-resistant depression now expected in second quarter 2025 COMP006 data will now be announced after 26-week time point, expected in the second half of 2026 Strategic reorganization to focus all efforts on COMP360 program resulting in reduction of workforce of approximately 30% Cash position of $207 million Conference call October 31 at 8:00 am ET (12:00 pm UK) LONDON & NEW YORK / Oct 31, 2024... Read more
The clinics are located in favorable locations, are revenue generating and EBITDA positive Clinics offer a comprehensive range of mental health services Acquisition is expected to be immediately accretive to revenue and EBITDA for HOPE and NRx MIAMI, Oct. 30, 2024 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), a medical and technology driven company, and a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq: NRXP), today announced... Read more
Six months post cessation of treatment with MB22001, the antidepressant response is sustained with an impressive 72% overall reduction in severity of depression with 58% of patients in complete remission from their depression. Vancouver, British Columbia – TheNewswire - 29 October, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), is a leading clinical stage biopharmaceutical company in psychiatric medicine... Read more
TORONTO, ON / ACCESSWIRE / October 29, 2024 / Quantum BioPharma Ltd. (NASDAQ:QNTM)(CSE:QNTM)(FRA:0K91) ("Quantum BioPharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, HUGE Biopharma Australia Pty Ltd., that sentinel dosing has started for its trial entitled "A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate... Read more
The Company is evaluating non-hallucinogenic dosing of CYB005 preclinical candidate molecules for the treatment of CNS disorders Cybin’s sector-leading intellectual property portfolio now includes over 70 granted patents and more than 220 patent applications pending TORONTO / Oct 24, 2024 / Business Wire / Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry platform company committed... Read more
One of two Phase 2B trials currently dosing and underway: Phase 2B trialing MB22001 in patients with Major Depressive Disorder, and; Phase 2B trialing MB22001 in patients with Advanced Stage Cancer Vancouver, British Columbia – October 24, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a leading biopharmaceutical company in psychiatric medicine development, targeting depressive disorders... Read more
TORONTO, Oct. 23, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. The deficiencies... Read more
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