Fortress Biotech, Inc. (NASDAQ:FBIO), a biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has extended the target action date for the New Drug Application (NDA) of CUTX-101, Copper Histidinate, to September 30, 2025.
The NDA for CUTX-101, developed for treating patients with Menkes disease, is being managed by Sentynl Therapeutics, Inc., which took over full responsibility for the drug's development and commercialization from Cyprium Therapeutics, Inc., a majority-owned subsidiary of Fortress, in December 2023.
Cyprium, founded by Fortress in 2017, retains ownership of any Priority Review Voucher that may be granted upon NDA approval. Additionally, Cyprium is eligible to receive royalties and up to $129 million in potential development and sales milestones payments. Fortress Biotech currently owns approximately 76% of Cyprium.
The extension of the FDA's review period is a critical step in the regulatory process, as CUTX-101 could potentially provide a new treatment option for individuals affected by Menkes disease, a genetic disorder that impacts copper levels in the body.
The information for this article was obtained from a recent 8-K filing with the Securities and Exchange Commission.
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