Immix Biopharma Inc
(Get Free Alerts for IMMX) stock is soaring Monday after the U.S. Food and Drug Administration granted Rare Pediatric Disease designation for IMX-110 for the treatment of rhabdomyosarcoma, a life-threatening form of pediatric cancer in children.
"This clearly provides additional opportunities for us and represents tremendous value for us as a company in addition to the validation of this technology," Immix CEO Ilya Rachman said Monday on "Benzinga Live."
It has been historically difficult to motivate companies to develop therapies for smaller pediatric populations, so there have been regulatory pathways developed to help incentivize companies, the CEO said.
Companies are now incentivized through vouchers, which can be worth $65 million to $300 million, Rachman said.
"The RPD designation puts us in a position of eligibility to receive the PRV (Priority Review Voucher)."
The voucher's value is dependent upon overall market conditions, the industry's development and investor perceptions, he said.
"We are sticking to the timelines, working hard to meet them," Rachman said.
What's Next For Immix: The capital the company has raised has put it in a "fantastic position," the CEO said. He told Benzinga he does not expect that the company will need to raise additional funds in 2022.
IMX-110 is in Phase 1b trials. Rachman told Benzinga that investors can anticipate quarterly readouts as the trials progress, as well as pre-clinical data from other downstream candidates.
Commenting on the stock's price action today, Rachman said the move isn't "insane."
"We think that this is the beginning of the validation where markets ... begin to understand the potential, the technology and what we represent."
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