Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
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Fortress Biotech and Cyprium Therapeutics have announced that the FDA has accepted and granted Priority Review for their NDA for CUTX-101, a treatment for Menkes disease. The PDUFA target action date is set for June 30, 2025. Cyprium is eligible for royalties and up to $129 million in milestones.
January 06, 2025 | 1:15 pm
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Fortress Biotech's NDA for CUTX-101 has been accepted by the FDA with Priority Review, indicating potential for accelerated approval. This could lead to significant financial gains through royalties and milestones.
The FDA's acceptance and Priority Review of the NDA for CUTX-101 suggests a higher likelihood of approval, which could positively impact Fortress Biotech's stock price. The potential for royalties and milestone payments further enhances the financial outlook.
CONFIDENCE 95
IMPORTANCE 85
RELEVANCE 90