- Qualigen Therapeutics ( NASDAQ: QLGN ) stock rose ~15% on Tuesday after the company said that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to QN-302 to treat pancreatic cancer.
- "Receiving Orphan Drug Designation for our lead cancer therapeutic, QN-302, for treating pancreatic cancer, is an important accomplishment as we prepare to submit our IND application in the first half of 2023 for our Phase I clinical trial," said Qualigen Chairman and CEO Michael Poirier.
- 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.
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Qualigen stock soars 15% on FDA orphan drug status for pancreatic cancer therapy