Clinical Trials

GeoVax's Multi-Antigen COVID-19 Vaccine Shows Strong Immune Response in Immunocompromised Patients
GeoVax Labs' GEO-CM04S1 vaccine demonstrates robust immunity in high-risk patients with blood cancers, potentially addressing a multi-billion dollar market where current vaccines have limited effectiveness.

Spark Biomedical Secures Wellcome Leap Funding to Advance Women's Health Neurostimulation Technology
Spark Biomedical's recent funding from Wellcome Leap will enable FDA-style clinical trials for its OhmBody wearable neurostimulation device, which has shown promising results in reducing menstrual bleeding and symptoms, representing a significant advancement in addressing long-neglected women's health needs.

Cybin Executives to Present at TD Cowen Neuropsychiatry Summit Amid Phase 3 Depression Treatment Development
Cybin Inc. executives will present at the TD Cowen Neuropsychiatry & Epilepsy Summit, highlighting the company's late-stage development of novel mental health treatments including CYB003, which has received FDA Breakthrough Therapy Designation for major depressive disorder.

Kairos Pharma to Host Key Opinion Leader Event on Phase 2 Prostate Cancer Trial Results
Kairos Pharma will present interim efficacy results from its Phase 2 trial of ENV105 in advanced prostate cancer, potentially addressing critical drug resistance challenges in oncology treatment.

Sigyn Therapeutics Appoints Dr. Christoph Zaba to Scientific Advisory Board to Advance Dialysis-Like Cardiovascular Therapy
Sigyn Therapeutics has appointed Dr. Christoph Zaba, an expert in extracorporeal therapies, to its Scientific Advisory Board to support the development of Sigyn Therapy™, a novel treatment designed to reduce cardiovascular disease risk factors using existing dialysis infrastructure.

Oncotelic Therapeutics Engages IBN to Lead Corporate Communications Strategy
Oncotelic Therapeutics has selected IBN to manage its corporate communications as the company advances its RNA-based immunotherapy pipeline, including a Phase 3 pancreatic cancer treatment, highlighting strategic positioning for future clinical and regulatory milestones.

Helix BioPharma to Present Clinical Trial Progress and NASDAQ Uplisting Plans at Investor Summit
Helix BioPharma will present its Phase Ib/II clinical study for non-small cell lung cancer treatment and planned NASDAQ uplisting at the Q3 2025 Investor Summit, highlighting strategic moves to advance oncology therapies and access global capital markets.

Clene Inc. Advances Toward NDA Submission for ALS Therapy CNM-Au8®
Clene Inc. is progressing toward submitting a New Drug Application for its ALS treatment CNM-Au8® by late 2025, potentially offering new hope for patients with this devastating neurodegenerative disease.

VolitionRx Partners with Werfen to Advance Diagnostic Testing for Antiphospholipid Syndrome
VolitionRx has signed an agreement with Werfen to evaluate its Nu.Q NETs assay for improved detection and monitoring of antiphospholipid syndrome, potentially transforming diagnosis and management for millions of patients worldwide.

Gyre Therapeutics Advances Hydronidone Toward China Approval and Expands Clinical Pipeline
Gyre Therapeutics has submitted Hydronidone for approval in China and initiated a U.S. Phase 2 trial, positioning the company for significant growth in liver fibrosis treatment markets.

OS Therapies Advances Toward 2026 Osteosarcoma Drug Launch with FDA RMAT Designation
OS Therapies Inc. achieves critical regulatory milestones for its OST-HER2 immunotherapy, positioning for potential accelerated approval and U.S. commercial launch in 2026 to address a 40-year treatment gap in osteosarcoma.

GeoVax's Multi-Antigen COVID-19 Vaccine Shows Promise for Immunocompromised Patients
GeoVax Labs will present clinical data demonstrating that its GEO-CM04S1 vaccine generates cross-variant antibody and robust cellular immune responses in immunocompromised patients with hematologic malignancies, potentially addressing a critical gap in COVID-19 protection for vulnerable populations.

New Medication Baxdrostat Shows Promise in Lowering Blood Pressure and Slowing Kidney Disease Progression
The novel medication baxdrostat demonstrated significant reductions in systolic blood pressure and urine albumin levels in patients with chronic kidney disease and uncontrolled hypertension, potentially offering new treatment options for this high-risk population.

Soligenix Receives FDA Orphan Drug Designation for Dusquetide in Behçet's Disease Treatment
Soligenix Inc. has secured FDA orphan drug designation for its investigational therapy dusquetide, marking a significant advancement in treating Behçet's disease following promising phase 2a clinical trial results.

Nutriband Secures $5.3 Million Through Warrant Exercises to Advance Abuse-Deterrent Fentanyl Patch Development
Nutriband Inc. has raised $5.3 million from warrant exercises to fund the clinical development and FDA submission of AVERSA Fentanyl, potentially the world's first abuse-deterrent opioid patch with estimated peak annual U.S. sales of $80-200 million.

Cybin Inc. to Present at H.C. Wainwright Global Investment Conference
Cybin Inc. will present at the H.C. Wainwright 27th Annual Global Investment Conference, highlighting its late-stage neuropsychiatry developments including breakthrough therapy-designated treatments for major depressive disorder and generalized anxiety disorder.

Lantern Pharma Receives FDA Guidance for Pediatric CNS Cancer Trial, Advancing AI-Driven Oncology Treatment
Lantern Pharma has completed a Type C meeting with the FDA, gaining regulatory guidance for its planned pediatric trial targeting CNS cancers including ATRT, which could accelerate development of its AI-driven oncology therapy LP-184/STAR-001.

Kairos Pharma to Present Initial Phase 1 Data for ENV105 Lung Cancer Treatment at World Conference
Kairos Pharma Ltd. will present initial Phase 1 data for its ENV105 combination therapy targeting drug-resistant non-small cell lung cancer at the World Lung Cancer Conference, potentially addressing significant unmet medical needs in oncology treatment.

Cybin Inc. to Present at Cantor Global Healthcare Conference, Highlighting Progress in Neuropsychiatric Treatments
Cybin Inc.'s participation in the Cantor Global Healthcare Conference underscores the company's advancing clinical programs for mental health disorders, including its Phase 3 CYB003 for major depressive disorder and Phase 2 CYB004 for generalized anxiety disorder, both of which hold significant potential to address unmet medical needs.

GeoVax to Present Pipeline Updates at H.C. Wainwright Investment Conference
GeoVax Labs will showcase progress on its Mpox/smallpox, COVID-19, and cancer immunotherapy programs at the upcoming H.C. Wainwright conference, highlighting advancements in vaccine development and manufacturing capabilities.

Sigyn Therapeutics Expands Cardiovascular Disease Study to Target Lipoprotein Reduction
Sigyn Therapeutics plans a clinical feasibility study of its blood purification technology that could address cardiovascular disease in high-risk patients while potentially extending lives of end-stage renal disease patients and generating significant economic impact.

Clene Inc. to Present at H.C. Wainwright Global Investment Conference
Clene Inc. will present at the H.C. Wainwright 27th Annual Global Investment Conference, highlighting its late-stage clinical developments in neurodegenerative disease treatments.

Study Links Head Injuries to Increased Brain Cancer Risk, Driving Treatment Research
A Mass General Brigham study of 75,000 patients reveals traumatic brain injuries elevate malignant brain tumor risk, highlighting the importance of ongoing treatment development by companies like CNS Pharmaceuticals Inc.

Calidi Biotherapeutics to Present RedTail Platform at H.C. Wainwright Global Investment Conference
Calidi Biotherapeutics will showcase its innovative RedTail platform at the H.C. Wainwright conference, highlighting its potential to revolutionize cancer treatment through systemic delivery of genetic medicines to metastatic sites.

Clene Inc. Advances Neurodegenerative Disease Treatment CNM-Au8® Toward Potential FDA Accelerated Approval
Clene Inc. is progressing its oral treatment CNM-Au8® for ALS and multiple sclerosis through late-stage clinical development, with key FDA meetings and regulatory catalysts potentially accelerating commercialization for patients with limited treatment options.

Oncotelic Therapeutics Highlights Robust Oncology Pipeline and CEO's Patent Portfolio
Oncotelic Therapeutics showcases its clinical-stage oncology and immunotherapy pipeline, including multiple late-stage candidates and rare disease programs, while emphasizing CEO Dr. Vuong Trieu's extensive intellectual property contributions that underpin the company's competitive strategy.

CNS Pharmaceuticals CEO Outlines Glioblastoma Treatment Strategy and Market Opportunities in Podcast Interview
CNS Pharmaceuticals CEO John Climaco discussed the company's progress in developing novel brain cancer treatments and expanding into aggressive cancers like triple-negative breast cancer with brain metastases during a recent BioMedWire podcast appearance.

Soligenix Advances Rare Disease Pipeline with Key Clinical Milestones Expected Through 2026
Soligenix Inc. reports significant progress in its late-stage rare disease treatments, including pivotal Phase 3 cancer trial results due in 2026 and multiple fast-tracked therapies that could transform care for underserved patient populations.

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.