Immix Shares Rally On FDA Rare Pediatric Disease Tag For Cancer Program In Children

The FDA has granted Rare Pediatric Disease (RPD) designation to newly listed Immix Biopharma Inc's IMMX IMX-110 for rhabdomyosarcoma, a form of pediatric cancer.

• IMX-110 is currently being evaluated in Phase 1b/2a clinical trial.
• If IMX-110 is approved in the U.S., ImmixBio may be eligible to receive a Priority Review Voucher (PRV) from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application, or maybe sold or transferred.
• Also See: Benzinga's Full FDA Calendar.
• PRV holders can benefit from an expedited six-month review of a new drug application for any disease by the FDA.
• Rhabdomyosarcoma is a high-grade, malignant neoplasm, the most common soft tissue sarcoma in pediatric and adolescent populations and rarely occurs in adults.
• IMX-110 is the first clinical-stage product of ImmixBio's SMARxT Tissue-Specific Platform, which produces Tissue-Specific Therapeutics that accumulate at intended therapeutic sites at 3 to 5 times the rate of conventional medicines. 
• The FDA has already granted orphan drug designation to IMX-110 to treat soft tissue sarcoma.
• Price Action: IMMX shares 77.8% at $6.33 during the premarket session on the last check Monday.