Eisai Begins Submission of Biologics License Application to US FDA for LEQEMBI® (lecanemab-irmb) Subcutaneous Maintenance Dosing in Early Alzheimer's, Fast Track Status.
PTC Therapeutics, Inc. revealed today that the FDA has officially received the Biologics License Application for Upstaza™ (eladocagene exuparvovec), a gene therapy aimed at treating AADC deficiency.
The data reveal that the experimental AZR-MD-001 has shown lasting effects in enhancing the ocular symptoms of Meibomian Gland Dysfunction (MGD) after a six-month treatment period.
The proceeds from this offering will fund Stoke's R&D activities, especially for their Dravet syndrome candidate STK-001, preclinical development of ophthalmology candidate STK-002, and other pipeline projects.
The study combines InnoCare's SHP2 allosteric inhibitor, ICP-189, with ArriVent's furmonertinib, an EGFR inhibitor, for patients with advanced or metastatic NSCLC.