By Sam Boughedda
Investing.com — Immix Biopharma Inc (NASDAQ:IMMX) shares have more than doubled, up 116% to $7.70 on Monday, after the Food and Drug Administration granted the company's treatment for pediatric cancer in children Rare Pediatric Disease (RPD) designation.
The drug, IMX-110, is used to treat a life-threatening form of pediatric cancer in children and is currently in phase 1b/2a clinical trial.
Rare Pediatric Disease designation is granted for serious and life-threatening diseases that affect children aged 18 and younger and less than 200,000 people in the U.S.
The designation allows Immix Biopharma to receive a fast-track review and a priority review voucher once they have marketing approval.
According to the company, priority review voucher holders can benefit from an expedited six-month review of a new drug application for any disease by the FDA. In addition, they said that the vouchers are transferable to other companies and have historically sold for $67 to $350 million.
Immix's Chief Executive Officer Ilya Rachman said the company is "pleased by FDA's acknowledgment of the urgent need for a safe and effective treatment for children with this devastating disease."
Immix started life as a public company in mid-December, with its shares opening up at $5 apiece.