Clinical Trials
Cybin Receives Australian Approval for Phase 3 Study of Psychedelic-Based Depression Treatment
Cybin Inc. has secured Australian regulatory approval to conduct its EMBRACE Phase 3 clinical trial of CYB003, a novel deuterated psilocin analog, marking a significant advancement in developing next-generation treatments for major depressive disorder.
NRx Pharmaceuticals' Depression Treatment Receives FDA Fast Track Designation
NRx Pharmaceuticals' NRX-100 received FDA Fast Track designation for treating suicidal ideation, potentially expanding its market to 13 million U.S. adults and offering a novel approach targeting neuroplasticity in depression treatment.
Boone Heart Institute to Host Summit Conference 2025 Focused on Preventive Cardiology Advancements
The Boone Heart Institute's Summit Conference 2025 in Denver will bring together healthcare professionals to address atherosclerosis, the world's leading cause of death, through cutting-edge research and clinical innovations in preventive cardiology.
Incannex Healthcare's IHL-42X Shows Promising Phase 2 Results for Sleep Apnea Treatment
Incannex Healthcare Inc. reports significant progress with its IHL-42X treatment for obstructive sleep apnea, achieving up to 83% reduction in apnea events with strong patient-reported outcomes, positioning the company for potential market entry while strengthening its financial position.
Branded Legacy Subsidiary Partners with McMaster University to Evaluate Addiction Treatment Solutions
Branded Legacy's subsidiary Bio-Legacy Evaluative Group has formed a strategic partnership with McMaster University to advance rigorous evaluations and clinical trials for addiction interventions, aiming to reduce overdose deaths and promote recovery.
LabConnect Launches LabConnector to Standardize Clinical Trial Lab Data Exchange
LabConnect's new LabConnector technology standardizes laboratory data into HL7 format, enabling faster and more accurate data exchange for clinical trials, which could accelerate drug development timelines.
Cybin Inc. Reports Strong Shareholder Participation in 2025 Annual Meeting
Cybin Inc. announced robust shareholder engagement with nearly 49% of outstanding shares represented at its annual meeting, demonstrating significant investor confidence in the company's late-stage neuropsychiatry treatments for major depressive disorder and generalized anxiety disorder.
Ascentage Pharma Advances Global Phase III Trial for Lisaftoclax in Higher-Risk MDS Treatment
Ascentage Pharma's GLORA-4 Phase III trial of lisaftoclax, a potential breakthrough for higher-risk myelodysplastic syndrome (MDS), receives FDA and EMA clearance, marking a significant step towards addressing a critical unmet medical need in oncology.
Soligenix Inc. Receives FDA Orphan Drug Designation for Dusquetide in Behçet’s Disease
Soligenix Inc. has been granted FDA orphan drug designation for dusquetide, a significant step forward in treating Behçet’s Disease, highlighting the potential for new therapies in rare diseases.
Annovis Bio Inc. Advances Phase 3 Alzheimer’s Trial and Reports Q2 2025 Financial Results
Annovis Bio Inc. (NYSE: ANVS) makes significant progress in its Phase 3 Alzheimer’s trial and reports improved financial results for Q2 2025, highlighting the potential impact of its neurodegenerative disease therapies.
Lantern Pharma Reports Significant Q2 2025 Achievements and Expands AI Platform
Lantern Pharma announces Q2 2025 results with complete responses in oncology trials and advancements in its AI platform, marking a pivotal step in cancer treatment innovation.
Cybin Inc. Advances Mental Health Treatments with Q1 2025 Results and Key Program Updates
Cybin Inc. reports significant progress in its Phase 3 depression program and Phase 2 anxiety study, highlighting advancements in next-generation mental health treatments.
Clene Inc. Advances Toward FDA Submission for ALS Therapy with Promising Q2 2025 Results
Clene Inc. reports significant progress in its Q2 2025 results, targeting a year-end NDA submission for its ALS therapy, CNM-Au8, with sufficient cash runway into Q1 2026.
CNS Pharmaceuticals Inc. Advances TPI 287 Toward Phase 2 GBM Trial Amid Improved Financials
CNS Pharmaceuticals Inc. reports a slight improvement in Q2 2025 financials, with reduced net losses and increased R&D expenses as it prepares for a Phase 2 trial of TPI 287 for glioblastoma multiforme, highlighting the drug's potential to cross the blood-brain barrier and treat CNS tumors.
The Strategic Advantages of Collaborating with Established Clinical Research Teams
Exploring the multifaceted benefits organizations gain by partnering with experienced clinical research teams, from ensuring high-quality, ethical studies to fostering innovation and compliance with regulations.
Oragenics Inc. Advances Toward Phase IIa Concussion Trial with ONP-002
Oragenics Inc. (NYSE American: OGEN) is making significant progress with its lead candidate, ONP-002, aiming to become the first FDA-approved pharmacological treatment for concussion, highlighting the potential of its intranasal delivery technology in transforming neurological care.
New Study Offers Hope for Pediatric Glioma Treatment
A collaborative study between the Broad Institute and the Dana-Farber Cancer Institute has identified a promising treatment approach for pediatric gliomas using FDA-approved inhibitors.
Quantum BioPharma Ltd. Advances MS Treatment with CDMO Agreement for Lucid-MS
Quantum BioPharma Ltd. has taken a significant step towards clinical trials for its oral Lucid-MS treatment for multiple sclerosis by partnering with a leading contract development and manufacturing organization.
Nutriband Inc. Advances Toward FDA Approval for AVERSA(TM) Fentanyl Abuse-Deterrent Patch
Nutriband Inc. has secured a Type C Meeting with the FDA for its AVERSA(TM) Fentanyl patch, a significant step towards introducing the world's first abuse-deterrent opioid patch to the market.
Quantum BioPharma's PET Tracer Shows Promise in Monitoring Myelin Integrity in Multiple Sclerosis
Quantum BioPharma Ltd.'s collaboration with Massachusetts General Hospital has yielded a PET tracer capable of detecting MS lesions invisible to conventional MRI, marking a significant advancement in the monitoring and treatment of multiple sclerosis.
Lantern Pharma Inc. Completes Japanese Enrollment for LP-300 Phase 2 HARMONIC(TM) Trial Ahead of Schedule
Lantern Pharma Inc. has successfully completed patient enrollment in Japan for its Phase 2 HARMONIC(TM) trial targeting never-smoker non-small cell lung cancer patients, a significant step towards addressing a critical unmet medical need.
Soligenix Inc. Highlighted for Innovation in Rare Disease Treatment
Soligenix Inc.'s inclusion in a NetworkNewsWire editorial highlights its HyBryte(TM) platform's potential to address the urgent need for effective therapies in rare diseases, particularly cutaneous T-cell lymphoma, showcasing a commitment to domestic innovation and support for underserved patient populations.
Cybin Inc. Receives EU Approval for Phase 3 MDD Study, Marking a Significant Step in Mental Health Treatment
Cybin Inc. has secured European approval to commence its EMBRACE Phase 3 study for CYB003, a potential breakthrough in treating Major Depressive Disorder, highlighting a pivotal moment in neuropsychiatry.
Lantern Pharma's Starlight Therapeutics Receives FDA Clearance for GBM Combination Trial
Starlight Therapeutics, a subsidiary of Lantern Pharma, has been cleared by the FDA to begin a Phase Ib/2a clinical trial for a novel combination therapy targeting glioblastoma multiforme, a move that could significantly impact treatment options for this aggressive brain cancer.
Soligenix Inc. Advances Rare Disease Treatment with HyBryte Platform, Highlighting Growing Need in Aging Population
Soligenix Inc. is making strides in treating cutaneous T-cell lymphoma, a rare skin cancer affecting older adults, underscoring the urgent need for innovative treatments in the face of an aging population and the prevalence of rare diseases.
ABVC BioPharma Secures $2.5 Million in International Investments to Fuel Growth
ABVC BioPharma's recent $2.5 million investment from international backers underscores confidence in its innovative therapies and strategic direction, marking a significant step forward in its clinical and commercial endeavors.
Quantum BioPharma Ltd. Reports Positive Phase 1 Safety Results for Lucid-MS
Quantum BioPharma Ltd. announces positive Phase 1 safety results for Lucid-MS, a potential treatment for multiple sclerosis, marking a significant step towards efficacy trials and FDA application.
Soligenix Inc. Advances in Rare Disease Therapeutics with HyBryte(TM) Platform
Soligenix Inc. (NASDAQ: SNGX) is making significant strides in the development of treatments for rare diseases, particularly with its HyBryte(TM) platform for cutaneous T-cell lymphoma, addressing a critical need for FDA-approved therapies in an underserved market.
Epic Medical Research Joins hyperCORE International's Global Network, Expanding Clinical Trial Capabilities
Epic Medical Research's inclusion in hyperCORE International's global partner site network signifies a strategic expansion in clinical research capabilities, enhancing the delivery of innovative and efficient clinical trial solutions across a wide range of therapeutic areas.
Clene Inc. to Showcase Neurodegenerative Disease Treatments at Canaccord 45th Annual Growth Conference
Clene Inc. will present its innovative treatments for neurodegenerative diseases at the Canaccord 45th Annual Growth Conference, highlighting potential advancements in ALS and MS therapy.