Drug Development
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.
Clene Inc. to Share Corporate Update at Emerging Growth Conference
Clene Inc. is set to present a corporate update at the Emerging Growth Conference, highlighting its progress in developing treatments for neurodegenerative diseases.
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.
Intensity Therapeutics Pioneers New Cancer Treatment with Minimal Side Effects
Intensity Therapeutics is advancing a novel cancer treatment that directly targets tumors with minimal side effects, offering hope for patients with refractory solid tumors.
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.
Creative Biolabs Introduces AI-Powered Solution to Revolutionize Drug Discovery
Creative Biolabs has launched an AI-powered end-to-end drug discovery solution aimed at addressing the challenges of high costs, failure rates, and lengthy timelines in drug R&D.
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.
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.
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.
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.
Lantern Pharma Introduces AI Tool PredictBBB.ai(TM) with 94% Accuracy in Predicting Blood-Brain Barrier Permeability
Lantern Pharma's new AI module, predictBBB.ai(TM), significantly enhances the prediction of small molecules' ability to cross the blood-brain barrier, addressing a major challenge in drug development.
Intensity Therapeutics Secures $6.6 Million to Advance Cancer Treatment Research
Intensity Therapeutics raises $6.6 million through an At-the-Market offering to fund clinical trials for its innovative cancer therapy, INT230-6, marking a significant step forward in the fight against cancer.
Soligenix Inc. Advances in Treating Rare Skin Cancer with HyBryte Platform
Soligenix Inc.'s progress with its HyBryte platform for treating cutaneous T-cell lymphoma highlights the critical need for innovative therapies in addressing rare diseases among the aging population.
OncoX and ABVC BioPharma Strengthen Collaboration to Advance Oncology Treatments
OncoX BioPharma's deepened alliance with ABVC BioPharma signifies a strategic move to enhance its oncology pipeline, leveraging ABVC's IND-stage programs to develop innovative cancer therapies.
Oragenics Inc. Advances ONP-002 Phase IIa Trial with Southern Star Research for Concussion Treatment
Oragenics Inc. partners with Southern Star Research to conduct a Phase IIa trial for ONP-002, an intranasal therapy aimed at treating mild traumatic brain injuries, highlighting a significant step towards addressing the unmet needs in concussion care.
Calidi Biotherapeutics Inc. Receives FDA Fast Track Designation for CLD-201 in Soft Tissue Sarcoma
Calidi Biotherapeutics Inc. has been granted FDA Fast Track designation for its CLD-201 treatment, marking a significant step forward in the development of therapies for soft tissue sarcoma and other cancers.
Creative Biolabs to Showcase Tumoroid-on-a-Chip Technology in Upcoming Webinar
Creative Biolabs is set to host a webinar on tumoroid-on-a-chip technology, highlighting its potential to revolutionize cancer research and drug development by offering more physiologically relevant conditions for preclinical testing.
Soligenix Inc. Advances Treatment for Rare Behçet’s Disease with SGX945
Soligenix Inc. is developing SGX945, a promising treatment for Behçet’s disease, addressing the critical need for more effective therapies for this rare condition.
Clene Inc. Advances Neurodegenerative Disease Treatment with FDA-Backed Biomarker Analysis
Clene Inc. is set to initiate neurofilament biomarker analyses for its drug CNM-Au8 in ALS patients, marking a significant step towards innovative treatments for neurodegenerative diseases.
Candel Therapeutics' CAN-2409 Receives European Orphan Designation for Pancreatic Cancer Treatment
The European Medicines Agency grants Orphan Designation to Candel Therapeutics' CAN-2409, highlighting its potential to address the significant unmet medical need in pancreatic cancer treatment across Europe.
GeoVax Shifts Gedeptin® Strategy to Neoadjuvant Combination Trial After KEYNOTE-689 Success
GeoVax Labs, Inc. announces a strategic pivot in its Gedeptin® clinical development program towards a neoadjuvant therapy combination with pembrolizumab for head and neck squamous cell carcinoma, following promising KEYNOTE-689 Phase 3 trial results.
ReAlta’s Pegtarazimod Demonstrates Potential in Reducing Brain Inflammation in Newborns with HIE
A preclinical study reveals pegtarazimod's ability to significantly reduce brain inflammation in newborns with hypoxic ischemic encephalopathy (HIE), offering hope for a new treatment approach.
Lantern Pharma Secures EU Patent for AI-Designed Cancer Drug LP-284
Lantern Pharma's EU patent for LP-284, an AI-designed cancer drug, marks a significant step in global commercialization and treatment for non-Hodgkin’s lymphoma.
NanoViricides Announces Promising Results for Measles Treatment in Humanized Animal Study
NanoViricides, Inc. reports a significant breakthrough with its lead drug candidate, NV-387, showing increased survival rates in a lethal measles infection model, highlighting the potential for the first therapeutic option amid rising global measles cases.
GeoVax Advances Toward European Approval for Mpox Vaccine Following EMA Guidance
GeoVax Labs, Inc. has received positive Scientific Advice from the European Medicines Agency, paving the way for expedited approval of its GEO-MVA Mpox vaccine in the EU, potentially accelerating revenue generation.
Soligenix Inc. Reports Promising Results in HyBryte(TM) Trial for Early-Stage Cutaneous T-Cell Lymphoma
Soligenix Inc.'s HyBryte(TM) shows promising treatment success in early-stage cutaneous T-cell lymphoma, offering hope for patients with limited options.