Relmada Therapeutics Anticipates Key Interim Analysis for REL-1017 in MDD
Relmada Therapeutics is advancing REL-1017 for major depressive disorder (MDD), with interim analysis results expected by the end of 2024.
Hourglass-Shaped Stent Shows Promise in Treating Refractory Angina
A novel hourglass-shaped stent demonstrates potential in alleviating angina for patients with microvascular disease, improving blood flow in small heart vessels.
BridgeBio Reports Positive Pipeline Progress and Q3 2024 Financial Results
BridgeBio's acoramidis shows positive Phase 3 results for ATTR-CM, with an FDA PDUFA date set for November 29, 2024, and potential $500M milestone payment upon approval.
Hoag Family Cancer Institute Advances Glioblastoma Treatment with Novel Clinical Trials
Hoag Family Cancer Institute is participating in the LIBERATE study, which uses Focused Ultrasound to temporarily open the blood-brain barrier for liquid biopsies in glioblastoma patients.
FDA Approves Zanidatamab for HER2-Positive Biliary Tract Cancer
The FDA granted accelerated approval to zanidatamab-hrii (Ziihera) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer.
Gene Therapy for Osteoarthritis Shows Promising Results in Phase 1 Trial
A gene therapy developed at Baylor College of Medicine, PCRX-201, is showing promising results in Phase 1 clinical trials for osteoarthritis.
CorMedix Announces Positive Preliminary Q4 2024 Results and Business Updates
CorMedix reported preliminary unaudited net revenue of approximately $31 million for Q4 2024 and $43 million for FY 2024, exceeding previous guidance.
OcuTerra's Nesvategrast Fails to Meet Primary Endpoint in Phase 2 Diabetic Retinopathy Trial
OcuTerra Therapeutics' Phase 2 DR:EAM trial of nesvategrast eye drops did not meet its primary endpoint of improving DRSS scores in diabetic retinopathy patients.
Werewolf Therapeutics Announces 2025 Milestones for IL-2 and IL-12 INDUKINE Programs
Werewolf Therapeutics anticipates sharing preliminary monotherapy data for WTX-124 in H1 2025, potentially guiding regulatory engagement for accelerated approval.
Tarsus Pharmaceuticals Advances Ocular Rosacea Program and Accelerates XDEMVY Launch
Tarsus Pharmaceuticals is set to initiate a Phase 2 study of TP-04 (lotilaner ophthalmic gel) in the second half of 2025 for treating ocular rosacea.
Libtayo Demonstrates Significant Disease-Free Survival Improvement in High-Risk CSCC
Phase 3 C-POST trial reveals adjuvant Libtayo (cemiplimab) significantly improves disease-free survival (DFS) in high-risk cutaneous squamous cell carcinoma (CSCC) patients after surgery.
Be Bio Secures $92 Million to Advance B Cell Medicines for Hemophilia B and Hypophosphatasia
Be Bio has closed a $92 million Series C financing round to advance its B cell medicine (BCM) programs for hemophilia B and hypophosphatasia.
High-Dose Wegovy Shows Promising Weight Loss, Faces Stiff Competition
A Phase III trial of a higher 7.2 mg dose of Wegovy demonstrated a 20.7% weight loss over 72 weeks, compared to 17.5% with the standard 2.4 mg dose.
Eculizumab Shows Promise in Treating Thymoma-Associated Myasthenia Gravis
A real-world study demonstrates that eculizumab significantly reduces Myasthenia Gravis Activities of Daily Living (MG-ADL) scores in patients with thymoma-associated myasthenia gravis.
AIM ImmunoTech Announces Clinical Milestones and Upcoming Studies for Ampligen
AIM ImmunoTech highlights the continued development of Ampligen (rintatolimod) across multiple clinical programs targeting pancreatic cancer and Long-COVID.
Becton Dickinson Files Patent Infringement Lawsuit Against Baxter Over Infusion Pump Technology
Becton Dickinson & Co. has filed a federal lawsuit against Baxter International Inc., claiming that Baxter's Novum IQ Infusion Platform infringes on six of BD's patents related to infusion-pump technologies.
Phase 3 Trial Success: GTx-104 Shows Promise in Treating Brain Hemorrhage with Reduced Hypotension Risk
Grace Therapeutics' Phase 3 STRIVE-ON trial of GTx-104, an injectable nimodipine formulation, met its primary endpoint with 19% reduction in clinically significant hypotension compared to oral nimodipine in aSAH patients.
AlloStem Cell Therapy Shows 80% Efficacy in One-Year Type 2 Diabetes Trial
Creative Medical Technology's CELZ-201 demonstrated significant reduction in insulin dependency and stable HbA1c levels in late-stage Type 2 diabetes patients over one year of treatment.
FDA Grants Fast Track Designation to BioInvent's BI-1808 for Cutaneous T-cell Lymphoma
BioInvent International has secured FDA Fast Track Designation for BI-1808 in the treatment of relapsed or refractory mycosis fungoides and Sézary syndrome, two subtypes of cutaneous T-cell lymphoma.
Yunu Secures Oversubscribed Funding to Transform Clinical Trial Imaging Workflows
Clinical trials imaging innovator Yunu has secured an oversubscribed investment round led by Spring Mountain Capital to accelerate pharma sponsor and site network growth.