Drug Development

NanoViricides to Present at D. Boral Capital Global Conference Amid Progress on Broad-Spectrum Antiviral NV-387
NanoViricides will participate in the D. Boral Capital Global Conference, highlighting its clinical-stage antiviral drug NV-387 and its potential to treat multiple viral infections including RSV, COVID, and Monkeypox.

NanoViricides Gains FDA Orphan Drug Designation for Measles Drug NV-387 Amid Global Outbreaks
NanoViricides received FDA Orphan Drug Designation for its broad-spectrum antiviral NV-387 to treat measles, offering incentives and supporting regulatory advancement as global cases rise.

Telomir Pharmaceuticals Gains FDA Clearance for Telomir-Zn Phase 1/2 Trial in Triple-Negative Breast Cancer
Telomir Pharmaceuticals announced FDA IND clearance for Telomir-Zn to treat advanced triple-negative breast cancer, allowing a Phase 1/2 trial to proceed and marking a key step toward clinical development.

Lexaria Bioscience Extends Material Transfer Agreement with PharmaCO Through 2026
Lexaria Bioscience has extended its Material Transfer Agreement with an undisclosed pharmaceutical company to evaluate its DehydraTECH technology for GLP-1 drugs, allowing for continued collaboration and review of upcoming R&D results.

GeoVax Positions Gedeptin as Immune-Sensitizing Platform Amid Industry Shift to In Vivo Cancer Therapies
GeoVax highlights its gene-directed enzyme prodrug therapy Gedeptin as a potential immune-sensitizing platform that could enhance checkpoint inhibitor efficacy in solid tumors, aligning with rising industry investment in simplified in vivo cancer treatments.

LIXTE Biotechnology Advances Precision Cancer Treatment with Novel PP2A Inhibitor
LIXTE Biotechnology is pioneering a new approach in oncology with its lead compound LB-100, which enhances chemotherapy and radiation efficacy while reducing side effects, potentially improving patient outcomes.

Helus Pharma Appoints Robert Langer and Stephen Brannan to Scientific Advisory Board, Bolstering Neuroscience Pipeline
Helus Pharma adds renowned experts Dr. Robert Langer and Dr. Stephen Brannan to its Scientific Advisory Board, strengthening its drug development capabilities for mental health treatments including major depressive disorder and generalized anxiety disorder.

OS Therapies Advances Key Cancer Treatment Toward Regulatory Filings and Plans Animal Health Spin-off
OS Therapies Inc. is progressing its lead cancer drug OST-HER2 toward U.S. and U.K. regulatory submissions while planning to spin off its animal health division into a separate public company, potentially creating significant value for shareholders.

Soligenix's Platform Approach to Drug Development Offers Efficiency in Biopharmaceutical Innovation
Soligenix Inc. demonstrates how platform-based drug development using synthetic hypericin across multiple dermatologic conditions can streamline clinical impact and reduce redundancy in the biotech industry.

NRx Pharmaceuticals Receives Positive FDA Review for Ketamine ANDA, Targets 2026 Approval
NRx Pharmaceuticals has received a positive FDA review letter for its ketamine ANDA and reported a supportive meeting with FDA leadership, advancing its preservative-free ketamine product toward potential approval in summer 2026 for treating severe mental illness.

Tonix Pharmaceuticals Publishes Pharmacokinetic Study Supporting TONMYA's Mechanism for Fibromyalgia Treatment
Tonix Pharmaceuticals' peer-reviewed study demonstrates TONMYA's superior pharmacokinetic profile compared to oral cyclobenzaprine, supporting its use as the first new fibromyalgia treatment in over 15 years.

Kairos Pharma Recognized for Innovation in Overcoming Cancer Drug Resistance
Kairos Pharma Ltd. has been honored with the 2026 Pinnacle Award for its pioneering work on resistance-modulating treatments that aim to enhance the effectiveness of existing cancer therapies.

Combination Strategies Reshape Precision Oncology as Lixte Advances First-in-Class PP2A Inhibitor
Lixte Biotechnology's LB-100, a first-in-class PP2A inhibitor designed to enhance chemotherapy and immunotherapy, exemplifies the industry shift toward combination regimens to overcome resistance in solid tumors.

Soligenix Gains EU Orphan Drug Designation for SGX945 in Behçet's Disease, Bolstering Rare Disease Pipeline
The European Commission granted orphan drug designation to Soligenix's SGX945 for Behçet's disease, validating the therapy's potential and supporting the company's rare disease strategy.

LIXTE Biotechnology Advances LB-100 as a Novel Cancer Treatment Enhancer
LIXTE Biotechnology's LB-100, a first-in-class PP2A inhibitor, aims to boost the effectiveness of existing chemotherapies and immunotherapies in hard-to-treat cancers, with ongoing clinical trials for ovarian, colon, and soft tissue sarcomas.

Soligenix Reports Encouraging Interim Data and Positive Comparative Results for CTCL Therapy
Soligenix released promising interim analysis from its phase 3 FLASH2 study and positive comparative results for HyBryte versus Valchlor, reinforcing its progress in developing treatments for cutaneous T-cell lymphoma.

Precision Oncology Shifts to Combination Strategies as Resistance Challenges Persist
Cancer treatment is increasingly moving toward multi-drug regimens that combine targeted therapies with immunotherapy and chemotherapy, with Lixte Biotechnology's first-in-class PP2A inhibitor LB-100 designed to enhance existing treatments by disrupting cancer cell repair and boosting immune activity.

Lantern Pharma Seeks FDA Feedback on HARMONIC Trial Protocol Amendments for Lung Cancer Drug
Lantern Pharma has scheduled a Type C meeting with the FDA to discuss proposed changes to its Phase 2 HARMONIC trial for LP-300 in non-small cell lung cancer, focusing on EGFR Exon 21 L858R patients based on promising clinical data.

Oragenics Reports Early Progress in Phase IIa Trial of Intranasal Concussion Therapy
Oragenics Inc. has enrolled two patients and administered eight doses in its Phase IIa trial for ONP-002, a potential first-in-class intranasal treatment for mild traumatic brain injury, addressing a significant unmet medical need in a market with no FDA-approved pharmacological therapies.

Soligenix Gains European Orphan Drug Designation for Behçet's Disease Therapy SGX945
The European Commission granted orphan drug designation to Soligenix's SGX945 for treating Behçet's disease, validating the therapy's potential and providing regulatory and commercial incentives for development in a rare disease area with significant unmet need.

NanoViricides Highlights NV-387 as Potential Measles Treatment Amid Global Outbreak Concerns
NanoViricides announced its antiviral drug candidate NV-387 may address the growing global measles outbreak, potentially complementing vaccination efforts by reducing transmission and treating infected patients.

Soligenix CEO Advocates for Patient-Centric Drug Reformulation to Improve Treatment Access and Adherence
Soligenix CEO Christopher Schaber argues that reformulating therapies to better align with patients' daily lives can enhance treatment access, adherence, and clinical trial success, reflecting a broader industry shift toward patient-centered drug development.

Cybin Reports Strong Q2 2025 Results and Advances Late-Stage Neuropsychiatry Programs
Cybin Inc. has reported strong institutional demand in its second-quarter 2025 results while advancing multiple late-stage clinical programs for mental health treatments, positioning the company for key 2026 data readouts that could significantly impact neuropsychiatry treatment options.

Annovis Bio Advances Alzheimer's Treatment with Phase 3 Trial Progress and Promising Biomarker Data
Annovis Bio reports significant progress in its Phase 3 Alzheimer's trial with full site activation and promising biomarker data showing buntanetap's disease-modifying potential, positioning the company for potential regulatory submission.

March Biosciences Receives FDA RMAT Designation for CAR-T Therapy Targeting Aggressive T-Cell Lymphoma
The FDA granted RMAT designation to March Biosciences' MB-105 CAR-T therapy for relapsed T-cell lymphoma, potentially accelerating treatment development for patients with limited survival options.

NanoViricides Secures $6 Million in Funding to Advance Antiviral Drug Development
NanoViricides has raised $6 million through a registered direct offering and concurrent private placement, providing crucial capital to advance its broad-spectrum antiviral drug candidates including NV-387 for respiratory infections and NV-HHV-1 for shingles treatment.

NanoViricides Receives Regulatory Approval for Phase II MPox Trial in Democratic Republic of Congo
NanoViricides has received regulatory approval to begin Phase II clinical trials for its broad-spectrum antiviral drug NV-387 to treat MPox in the Democratic Republic of Congo, representing a potential breakthrough in antiviral therapy.

PCSK9 Inhibitor Combined with Statin Shows Significant LDL Reduction in Heart Transplant Patients
A clinical trial demonstrates that adding the PCSK9 inhibitor alirocumab to statin therapy reduces LDL cholesterol by more than 50% in heart transplant patients, though it did not prevent the development of cardiac allograft vasculopathy.

Lantern Pharma CEO Details AI Platform's Role in Accelerating Cancer Drug Development
Lantern Pharma is using artificial intelligence to significantly reduce the time and cost of oncology drug development while expanding treatment options for cancer patients.

PCSK9 Inhibitor Shows Significant Cardiovascular Risk Reduction in High-Risk Patients Without Prior Heart Events
The VESALIUS-CV trial demonstrates that evolocumab reduces major cardiovascular events by 25% in patients with atherosclerotic disease or diabetes who haven't had prior heart attacks or strokes, potentially expanding preventive treatment options for millions at risk.