Immix Biopharma (NSDQ:IMMX) has announced that the FDA has granted a rare pediatric disease designation related to the potential use of IMX-110 for rhabdomyosarcoma, a rare cancer affecting skeletal muscle. Roughly 400 to 500 cases of rhabdomyosarcoma occur each year in the U.S., according to cancer.org.
IMMX shares jumped 62.36% to $5.78 after the announcement.
Immix had its initial public offering in December 2021. IMMX shares were initially priced at $4.00.
The rare pediatric disease designation opens up the possibility of fast-track review and a priority review voucher, which involves an expedited six-month review of a new drug application. Such vouchers can be redeemed or can be sold or transferred.
Los Angeles-based Immix is currently overseeing a Phase 1b/2a clinical trial of IMX-110.
The rare pediatric disease designation pertains to serious and life-threatening diseases involving less than 200,000 children in the U.S.