Fortress Biotech Rises After FDA Accepts Application for Menkes Treatment

By Elias Schisgall

Fortress Biotech shares rose after the pharmaceutical company said the Food and Drug Administration accepted a resubmitted New Drug Application for its Menkes disease treatment.

The stock was up 10% to $3.23. Shares have risen 59% this year.

Fortress and its majority-owned subsidiary, Cyprium Therapeutics, said the FDA has accepted an NDA resubmission for CUTX-101, or copper histidinate, a treatment for children who suffer from Menkes disease, a genetic disorder causing copper deficiency.

Sentynl Therapeutics assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium in December 2023. Sentynl submitted a revised NDA last month after the FDA raised questions about the manufacturing site's Current Good Manufacturing Practice compliance.

Upon approval of the drug, Sentnyl will transfer a Rare Pediatric Disease Priority Review Voucher to Cyprium, which will also be entitled to royalties from CUTX-101 and up to $129 million in development and sales milestones from Sentnyl.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

December 15, 2025 11:30 ET (16:30 GMT)