SELLAS Says FDA Grants Rare Pediatric Disease Designation For SLS009 To Treat Pediatric ALL
(RTTNews) - Biopharmaceutical company SELLAS Life Sciences Group, Inc. (SLS) announced Monday that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to SLS009, a highly selective CDK9 inhibitor, for the treatment of pediatric acute lymphoblastic leukemia (ALL).
In clinical trials, SLS009 has demonstrated a very favorable safety profile with complete absence, to date, of any non-hematologic clinical higher-grade toxicities.
If, in the future, a New Drug Application (NDA) for SLS009 for the treatment of pediatric AML is approved by the FDA, SELLAS might be eligible to receive a Priority Review Voucher (PRV) that could be redeemed to receive a priority review for any subsequent marketing application.
PRVs may be used by the sponsor or sold to another sponsor for their use and have recently sold for approximately $100 million.
SELLAS Life Sciences Reports Positive Topline Data In Lymphoma Cohort From SLS009 Phase 1 Trial
Malaysia Stock Market Tipped To Open In The Green
Hang Seng Tipped To Open To The Upside On Thursday
Japan Stock Market Has Positive Lead For Thursday
Additional Support Anticipated For South Korea Shares
South Korea Export Prices Climb 1.0% In July
Australia Unemployment Data Due On Thursday
