- Jasper Therapeutics ( NASDAQ: JSPR ) on Thursday said it had got a fast track designation from the U.S. FDA for its monoclonal antibody JSP191 for the treatment of patients with immune disorders undergoing stem cell transplant.
- Shares of the micro-cap U.S. biotech jumped 12% to $1.49 in premarket trading.
- The FDA's Fast Track approval is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
- The exact indication for JSP191's fast track designation was for the treatment of patients with severe combined immunodeficiency (SCID) undergoing allogenic hematopoietic stem cell transplant.
- JSPR said, to date, JSP191 had been evaluated in 14 SCID patients in an ongoing multicenter clinical trial.
- JSP191 had previously received a orphan drug designation and a rare pediatric disease designation from the FDA.
For further details see:
FDA grants fast track nod to Jasper's monoclonal antibody, shares rise 12% premarket