Jan. 03, 2022 8:46 AM ET
Immix Biopharma, Inc. (IMMX)
By: Dulan Lokuwithana, SA News Editor
– Immix Biopharma (NASDAQ:IMMX) has jumped ~56.7% in the pre-market on above average volume after the company announced that the FDA granted the Rare Pediatric Disease (RPD) designation for IMX-110, a cancer candidate targeted at children.
– FDA’s RPD for IMX-110 relates to rhabdomyosarcoma, a potentially fatal form of pediatric cancer in children, and the experimental therapy is currently undergoing a Phase 1b/2a clinical trial.
– In awarding RPD, the federal agency picks drug candidates targeted at serious and life-threatening diseases affecting less than 200K individuals in the U.S. with a primary impact on children aged 18 years or younger.
– If the drugs with the RPD wins approval from the FDA, the sponsor of its marketing application is entitled to receive a Priority Review Voucher (PRV) from the regulator. The PRV can be redeemed to receive priority review for any subsequent marketing application, or it can be sold or transferred.
– The latest regulatory triumph for Immix (IMMX) comes less than a month since its IPO.