Orphan Drug Designation for Immix Biopharma NXC-201 as Treatment for Multiple Myeloma

 FDA Orphan Drug Designation (“ODD”) qualifies NXC-201 for:

• 7 years of U.S. market exclusivity after approval

• Tax credits for qualified clinical testing

• Waiver of the Prescription Drug User Fee (currently at almost $3 million for a new drug)

• The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according to Wilcock, et al. Nature Reviews

 Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the “Company”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) designation for NXC-201 for the treatment of a life-threatening form of blood cancer, multiple myeloma. NXC-201, a next generation CAR-T cell therapy, is currently being evaluated in a Phase 1b/2a clinical trial NEXICART-1 (NCT04720313).

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to 7 years of market exclusivity in the U.S. upon regulatory approval.

https://finance.yahoo.com/news/u-food-drug-administration-approves-123700882.html