Clinical Trial News

Iterum Therapeutics' NDA resubmission for oral sulopenem to treat uncomplicated urinary tract infections in adult women is accepted by the FDA, with a PDUFA action date of October 25, 2024.

Astellas' resubmission of the Biologics License Application (BLA) for zolbetuximab, a CLDN18.2-targeted monoclonal antibody for first-line treatment of HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, has been acknowledged by the U.S. FDA, setting a new action date of November 9, 2024.

Milestone Pharmaceuticals announced the FDA accepted their New Drug Application for Cardamyst (etripamil) nasal spray, intended for paroxysmal supraventricular tachycardia (PSVT) management. The PDUFA target date is set for 10 months after the acceptance date. Cardamyst aims to provide a new, convenient treatment option for PSVT patients, potentially allowing self-management without medical supervision.

FDA grants Priority Review to Roche's inavolisib for advanced HR+/HER2- breast cancer with PIK3CA mutation, based on Phase III INAVO120 results showing significant progression-free survival benefits.

Atara Biotherapeutics submits a Biologics License Application to the FDA for tabelecleucel (tab-cel®) as monotherapy for EBV+ PTLD patients who have received at least one prior therapy, with no FDA approved therapies in this setting. Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells, supported by pivotal data from over 430 patients. The therapy has Breakthrough Therapy and orphan drug designations, and has received marketing authorization in Europe, UK, and Switzerland under the brand name Ebvallo™.

Yorvipath (palopegteriparatide) is FDA approved for hypoparathyroidism. Ascendis Pharma's review period for TransCon PTH extended to August 14, 2024.

Eton Pharmaceuticals submits New Drug Application to FDA for ET-400 (hydrocortisone oral solution), expecting a 10-month review for potential approval in Q1 2025.

Iterum Therapeutics resubmits NDA to FDA for oral sulopenem to treat uncomplicated urinary tract infections in adult women, with data from phase 3 clinical trials demonstrating its efficacy and safety.

Abeona Therapeutics receives a Complete Response Letter from the FDA for its Biologics License Application for prademagene zamikeracel (pz-cel) due to unresolved Chemistry Manufacturing and Controls (CMC) requirements, with no deficiencies identified in clinical efficacy or safety data. The company plans to resubmit the BLA in the third quarter of 2024.

Supernus receives a Complete Response Letter from FDA for SPN-830, an apomorphine infusion device for Parkinson’s disease, citing product quality and infusion device master file issues. No clinical safety or efficacy issues identified. Company remains committed to addressing the CRL and resubmitting the NDA.