Fortress Biotech's majority-owned Cyprium gets NDA resubmission for CUTX-101 to FDA

Fortress Biotech, Inc.

Sentynl resubmitted NDA for CUTX-101 to FDA on Nov 14, 2025.
Prior Complete Response Letter on Oct 1, 2025.
Cyprium retains ownership of any Priority Review Voucher upon approval.
Cyprium eligible for up to $129M in development and sales milestones plus royalties.

item 8.01

Fortress Biotech, Inc. filing history →

Source: SEC EDGAR

accession 0001104659-25-112945

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