- The U.S. Food and Drug Administration (FDA) granted orphan drug designation to Moleculin Biotech's ( NASDAQ: MBRX ) WP1122 to treat Glioblastoma Multiforme (GBM), a type of brain cancer.
- "Given the progress of our Phase 1 clinical trial in healthy volunteers, the strong preclinical data supporting GBM as one of many potential indications and the recent clearance by the FDA of IND status for WP1122 in GBM, we believe this designation further supports the potential of WP1122 and is another step forward in further validating our deep pipeline," said Moleculin Chairman and CEO Walter Klemp.
- The FDA grants orphan drug status to therapies which treat or prevent rare diseases that affect fewer than 200K people in the U.S. The designation provides certain incentives, including seven years of market exclusivity, if approved.
For further details see:
Moleculin brain cancer therapy WP1122 gets FDA orphan drug status