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
VANCOUVER, British Columbia, Oct. 23, 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 genotoxicity studies of BETR-001. The studies demonstrated that oral BETR-001, even at very high doses, does... Read more
Additional 700 Doses Ordered by Mind Medicine Australia as Demand Surges Vancouver, British Columbia--(Newsfile Corp. - October 23, 2024) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Health Canada-licensed manufacturer of psychedelic pharmaceuticals specializing in botanical psilocybin and MDMA, is proud to announce that the first group of patients with post-traumatic stress disorder (PTSD) in Australia has successfully... Read more
Vancouver, British Columbia – TheNewswire - 22 OCTOBER, 2024 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (the “Company” or “MindBio”), is pleased to report that the final milestone in the Company’s Phase 2A Microdosing Depression Clinical Trial, the 6-month post treatment milestone measuring the “severity of depression” has been completed. The completion of this important milestone comes as the Company progresses more than a third of... Read more
TORONTO, Oct. 21, 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 excited to announce that it has been contracted as a supplier of its GMP LaNeo™ MDMA to a clinical trial at Mt. Sinai Health System. “We’re looking forward to supporting the team... Read more
NEW YORK AND VANCOUVER, British Columbia, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (Bright Minds or the Company) (NASDAQ: DRUG), a biotechnology company focused on developing novel therapies for neurological and neuropsychiatric disorders, today announced that it is once again collaborating with Firefly Neuroscience, Inc. (Firefly) (NASDAQ: AIFF), an Artificial Intelligence (AI) company developing innovative solutions that improve brain health outcomes... Read more
VANCOUVER, British Columbia, Oct. 18, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (CSE: DRUG) (NASDAQ: DRUG) (“Bright Minds” or the “Company”) is pleased to announce a non-brokered private placement of common shares in the capital of the Company (“Shares”) at a price of USD$21.70 per Share (the “Share Offering”). In addition to the Shares issued under the Share Offering, the Company reserves the right to issue pre-funded warrants of the Company... Read more
BMB-201 demonstrated dose-dependent efficacy in pain models BMB-201 demonstrated similar efficacy to morphine in several pain models NEW YORK, Oct. 16, 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 CNS disorders, is excited to announce positive data from the preclinical testing of BMB-201 completed... Read more
TORONTO, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly,” or the “Company”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, today announced collaborating with Bright Minds Biosciences Inc. (CSE:DRUG) (NASDAQ:DRUG) (“Bright Minds” or the “Company”), a biotechnology company focused on developing novel... Read more
In vitro pharmacology studies confirmed EB-003’s ability to target desired serotonergic receptors, supporting the potential of the neuroplastogenic therapeutic candidate to address difficult-to-treat mental health disorders without inducing hallucinations Analysis of off-target interactions indicate ability of EB-003 to minimize potential adverse cardiovascular and CNS events that are common to serotonin-like drug compounds CAMBRIDGE, Mass. / Oct 15, 2024 / Business... Read more
FDA approval for the IND submission to conduct its trial already secured Vancouver, Canada, Oct. 10, 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 it has received Institutional Review Board (IRB) approval from one of its clinical... Read more
TORONTO, Oct. 08, 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 proposed clinical trial at the University of Texas, San Antonio. Pursuant to a submitted grant funding application... Read more
Vancouver, British Columbia – TheNewswire - October 8, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a leading biopharmaceutical company in psychiatric medicine development using microdoses of psychedelic medicines, is delighted to report its microdosing formulation MB22001 has achieved shelf stability at room temperature for 12 months. MB22001 is a proprietary and self-titratable form of Lysergic Acid Diethylamide... Read more
Clinic to serve as the prototype for HOPE's network of Interventional Psychiatric Clinics Nationally recognized founder to become Chief Medical Innovation Officer of HOPE, in order to implement and evolve the Company's standard of care across the HOPE network Acquisition would be immediately accretive to revenue and EBITDA for HOPE and NRx MIAMI, Oct. 3, 2024 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), a medical and technology driven company,... Read more
TORONTO, Oct. 02, 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 Harvard’s Maclean Hospital, the largest neuroscientific and psychiatric private research hospital... Read more
Stability milestone supports submission of FDA New Drug Application by NRx for the use of intravenous ketamine to treat Suicidal Depression Ketamine is currently used off-label for this indication. However, FDA approval is typically required for patients to obtain insurance reimbursement NRX-100 is the first preservative-free formulation of Ketamine, potentially avoiding toxic side effects of preservatives used in current preparations designed for single dose anesthetic... Read more
Announced strategic financing with Arena Investors, providing access to up to $59.0 million USD in gross proceeds to Incannex Announced positive top-line results from our Phase 2 proof-of-concept clinical trial of PSX-001, known as the PsiGAD1 study, in which synthetic psilocybin in combination with psychotherapy was observed to significantly reduce anxiety scores and to be well tolerated in patients with generalised anxiety disorder (GAD) Commenced dosing... Read more
Selection of EB-003 based on research indicating its non-hallucinogenic, anxiolytic and anti-depressant properties CAMBRIDGE, Mass. / Sep 26, 2024 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced that it is presenting research describing the... Read more
TORONTO, ON / ACCESSWIRE / September 25, 2024 / Quantum BioPharma Ltd. (formerly, FSD Pharma Inc.) (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, is pleased to announce that Jason Sawyer, Head of Finance and Mergers and Acquisitions, will present at the ArcStone-Kingswood Growth Summit held on September 26, 2024, in Toronto, ON. The event... Read more
Presentation showcases the profile of EB-003, a non-hallucinogenic, neuroplastogenic DMT analog, which has shown positive outcomes in animal models of anxiety and depression CAMBRIDGE, Mass. / Sep 25, 2024 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders,... Read more
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