Mesoblasts bLA resubmission for remestemcel-L accepted by FDA

Mesoblast Limited (ASX: MSB) announced that it had received approval from the FDA's Office of Therapeutic Products for its resubmission of the Biologics License Application (BLA) for remestemcel-L. It is designed to treat kids with acute graft versus a steroid-refractory host illness. The resubmission has been considered a full response by the FDA, and a Prescription Drug User Fee Act (PDUFA) goal date of 02 August 2023 has been set.

Remestemcel-L has been granted Fast Track designation by the FDA, reserved for drugs that can significantly improve safety or effectiveness over existing treatments of severe conditions. Also, the medicine has been accorded Priority Review status, which is given to medications that have the potential to significantly outperform current therapies for critical illnesses in terms of safety or efficacy.

Customer Notice:

Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.

Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com