Highest-materiality recent filing
Fortress Biotech Q1 net income $108.4M; PRV sale for $205M and ZYCUBO approval drive results
Net income $108.4M ($3.44 basic EPS) vs net loss $12.7M in Q1 2025; revenue $16.0M up from $13.1M.
Fortress Biotech reports 2025 results; ZYCUBO approved, PRV sold for $205M
ZYCUBO FDA-approved for Menkes disease; Cyprium sold PRV for $205M gross, with potential $128M in sales milestones.
Fortress Biotech subsidiary Cyprium closes PRV sale for $205M; Fortress expects over $100M
Cyprium sold Rare Pediatric Disease Priority Review Voucher for $205M gross proceeds.
Cyprium (Fortress subsidiary) sells PRV for $205M cash; Oaktree loan covenants eased
Cyprium Therapeutics, 80.4% owned by Fortress, agreed to sell a Rare Pediatric Disease Priority Review Voucher for $205M cash.
FDA approves ZYCUBO for Menkes disease; Cyprium gets PRV, up to $129M milestones
FDA approved ZYCUBO (copper histidinate) as first and only U.S. treatment for Menkes disease in pediatric patients.
FDA accepts CUTX-101 NDA resubmission as Class 1; PDUFA date Jan 14, 2026
FDA accepted NDA resubmission for CUTX-101 (copper histidinate) for Menkes disease; new PDUFA target action date January 14, 2026.
Maturity extended from July 2027 to June 30, 2028; $29.5M outstanding on $35M initial borrowing.
Fortress Biotech's majority-owned Cyprium gets NDA resubmission for CUTX-101 to FDA
Sentynl resubmitted NDA for CUTX-101 to FDA on Nov 14, 2025.
Fortress Biotech Q3 net revenue up 20.5% to $17.6M; net income $3.7M vs prior loss
Net revenue $17.6M (Q3 2025) vs $14.6M (Q3 2024), driven by dermatology product sales.
FDA issues Complete Response Letter for Fortress Biotech's CUTX-101 over manufacturing issues
FDA issued CRL for CUTX-101 NDA to treat Menkes disease; cGMP deficiencies at the manufacturing facility.
Fortress Biotech posts Q2 net income $13.4M; Checkpoint acquisition yields $28M upfront
Checkpoint acquired by Sun Pharma in May; Fortress received ~$28M at close, up to $4.8M CVR, plus 2.5% royalty on UNLOXCYT sales.
Fortress' former asset anselamimab fails primary endpoint in Phase III CARES study
AstraZeneca announced anselamimab did not achieve statistical significance on primary endpoint (ACM + CVH hierarchy) in Mayo stages IIIa/IIIb AL amyloidosis.
Fortress closes sale of Checkpoint to Sun Pharma; receives ~$28M cash plus milestones
Checkpoint merged into Sun Pharma on May 30, 2025; deconsolidated from Fortress.
Fortress Biotech Q1 net loss narrows to $12.7M; Checkpoint acquisition on track
Consolidated net loss $12.7M ($0.48/sh) vs $17.9M ($1.04/sh) in Q1 2024.
Fortress Biotech director Lucy Lu resigns from board, to become Chief Strategy Officer on April 21
Lucy Lu resigned from the Board of Directors effective April 15, 2025, with no disagreement with the Company.
Fortress Biotech posts FY2024 net loss of $55.9M; Checkpoint to be acquired by Sun Pharma
Net loss attributable to common stockholders of $55.9M ($2.69/sh) vs $68.7M ($8.47/sh) in FY2023; net revenue $57.7M, down from $84.5M.
Fortress Biotech subsidiary Checkpoint to be acquired by Sun Pharma for $4.10/share plus CVR
Sun Pharma to acquire Checkpoint at $4.10 per share in cash plus non-tradable CVR for up to $0.70 based on EU regulatory milestones for cosibelimab.
FDA extends PDUFA date for Fortress subsidiary's NDA for CUTX-101 to Sep 30, 2025
FDA extended target action date for CUTX-101 (Copper Histidinate) NDA to September 30, 2025.
FDA accepts Cyprium's NDA for CUTX-101 for priority review; action date June 30, 2025
FDA granted priority review to CUTX-101 (Copper Histidinate) NDA for treating Menkes disease.
FDA approves Fortress subsidiary Checkpoint's UNLOXCYT for advanced cSCC
FDA approved UNLOXCYT (cosibelimab-ipdl) for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in adults not candidates for curative surgery/radiation.
Fortress Biotech Q3 net loss $15M; FDA approved Emrosi on Nov 4; cosibelimab PDUFA Dec 28
Net loss attributable to common stockholders $15.0M ($0.76/shr) vs $7.1M loss in Q3 2023.
FDA approved Emrosi (Minocycline HCL ER 40mg) for inflammatory lesions of rosacea; Journey Medical to market it in U.S.
Fortress Biotech raises $8M in registered direct offering and private placements
Raised $8M gross from sale of 3,939,394 shares at $1.65 and warrants to institutional investors; CEO also purchased shares/warrants.
Fortress Biotech Q2 net loss $13.3M; pauses preferred dividend; two PDUFA dates in Q4 2024
Q2 2024 net revenue $14.9M (dermatology) vs $17.4M Q2 2023; net loss attributable to common $13.3M ($0.73/sh) vs $26.9M ($3.65/sh).
Fortress Biotech's Urica sells gout drug dotinurad to Crystalys for 35% equity and 3% royalty
Urica sold its URAT1 inhibitor dotinurad (gout treatment) and related IP to Crystalys Therapeutics.
Fortress Biotech pauses monthly dividend on Series A Preferred Stock
Dividend of $0.1953125/share on 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock paused effective July 1, 2024; no payment on July 31, 2024.
Fortress Biotech Q1 net loss narrows to $17.7M; FDA accepts DFD-29 NDA for rosacea
Consolidated net revenue $13.0M, all from dermatology products, up 7% YoY driven by Qbrexza and Accutane.
On April 15, 2025, Lucy Lu, M.D., notified Fortress Biotech, Inc. (the “ Company ”) of her resignation from the Board of Directors effective April 15, 2025.
Dr. Lu’s decision to resign from the Board of Directors was made in connection with her accepting an offer to join the Company as Chief Strategy Officer effective April 21, 2025.
Max materiality 0.90 · Median 0.70 · Most common event other_material