Published on 22 Mar 2024 on Zacks via Yahoo Finance

Lisata's (LSTA) LSTA1 Gets FDA's RPDD Tag for Osteosarcoma

Lisata Therapeutics, Inc. LSTA announced that the FDA has granted a Rare Pediatric Disease Designation (“RPDD”) to its lead pipeline candidate, LSTA1, for the treatment of osteosarcoma, a rare type of bone cancer that affects children, adolescents and young adults. Shares of the company were up 8.4% on Mar 21, following the announcement of the news.

The RPDD designation is granted by the FDA to medicines that treat serious or life-threatening diseases, usually affecting less than 200,000 children in the United States of all ages. Upon potential approval for LSTA1 by the FDA, the company may become eligible to receive a priority review voucher (“PRV”). This PRV can be used either by LSTA in a subsequent marketing application filed with the FDA for a different product or may even be sold to any other third party to boost cash reserves.

LSTA1 is an investigational drug that allows co-administered or tethered anti-cancer drugs to better penetrate solid tumors by activating a novel uptake pathway. The candidate has exhibited the potential to improve the tumor environment, thereby making tumors more responsive to immunotherapy.