Immix Biopharma (NASDAQ:IMMX) stock is taking off on Monday thanks to a Rare Pediatric Disease (RPD) designation from the U.S. Food and Drug Administration (FDA).
This RPD designation covers IMX-110, which is an investigational product for the treatment of rhabdomyosarcoma. Rhabdomyosarcoma is a life-threatening form of pediatric cancer that affects children.
Immix Biopharma’s cancer treatment is currently undergoing a Phase 1b/2a clinical trial. With the RPD designation from the FDA, the company can fast track its treatment for review. That could include a Priority Review Voucher if the FDA approves a New Drug Application for IMX-110.
Ilya Rachman, M.D., PhD., CEO of Immix Biopharma, said the following about the FDA news sending IMMX stock higher today.
‘We are encouraged by our Phase 1b/2a clinical data in soft tissue sarcoma. IMX-110 is a tissue-specific therapeutic that simultaneously attacks all 3 components of the tumor micro-environment, severing the critical lifelines between the tumor and its metabolic and structural support. We believe our SMARxT platform generating Tissue-Specific Therapeutics represents a distinct alternative to the traditional ‘single target, single mutation’ development model.”
The positive FDA news for Monday also has IMMX stock experiencing heavy trading. As of this writing, more than 81 million shares of the company’s stock have changed hands. That’s an impressive jump over the daily average trading volume of 1.2 million shares.
IMMX stock is up 118% as of Monday morning.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
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