Clinical Trial News

The FDA approved cosibelimab-ipdl for locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) not treatable by surgery or radiation. It's a PD-L1 inhibitor, causing fewer high-grade immune-related adverse effects than PD-1 inhibitors. The approval was based on a clinical trial showing 47-48% response rates with median response durations of 17.7 months for locally advanced disease.

The FDA approved zenocutuzumab-zbco, a HER2/HER3-targeting bispecific antibody, for advanced NSCLC or pancreatic adenocarcinoma with NRG1 gene fusions. It's the first targeted therapy for these conditions. The approval was based on the eNRGy trial, showing responses in 33% of NSCLC and 40% of pancreatic adenocarcinoma patients.

Robbins LLP investigates Applied Therapeutics, Inc. (APLT) for misleading investors about its lead drug candidate, govorestat, during Jan 3, 2024 - Dec 2, 2024. The company received a Complete Response Letter (CRL) from the FDA on Nov 27, 2024, causing a stock decline of over 80%. On Dec 2, 2024, Applied Therapeutics disclosed a 'warning letter' from the FDA regarding clinical trial issues.

PolyPid's SHIELD II Phase 3 trial for D-PLEX100, aiming to prevent surgical site infections, will conclude with 800 patients enrolled, expected in Q1 2025, with top-line results anticipated in Q2 2025. Potential positive data could lead to an NDA submission under Fast Track and Breakthrough Therapy designations. A $14.5 million private placement financing extends the company's cash runway beyond potential NDA approval.

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Adding daratumumab to bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved minimal residual disease (MRD)-negativity and progression-free survival in newly diagnosed multiple myeloma patients ineligible for stem cell transplant, according to the CEPHEUS trial. The MRD-negative CR rate increased by 50% with daratumumab-augmented therapy (D-VRd), leading to superior progression-free survival at 54 months.

FDA approved vibegron (Gemtesa) for men with OAB symptoms on BPH therapy, showing improvements in OAB symptoms in phase 3 trials. It's the first β3 agonist for this group, addressing a prevalent, often undiagnosed condition.

FDA granted Breakthrough Therapy designation to Trodelvy for extensive-stage small cell lung cancer (ES-SCLC) post-platinum chemotherapy. Based on phase 2 TROPiCS-03 study, Trodelvy showed 41.9% overall response rate as second-line treatment. Gilead plans phase 3 trial. Trodelvy, an antibody-drug conjugate targeting TROP2, is also indicated for advanced breast cancers.

Anavex Life Sciences Corp. released its annual Form 10-K report, detailing financial performance with decreased operating expenses and net loss, and business highlights including ongoing clinical trials for Alzheimer's, Parkinson's, and Rett syndrome. The company faces financial and operational risks, regulatory challenges, and a competitive landscape in the biotechnology sector.