Fortress Biotech

Fortress Biotech and Cyprium achieve a milestone with FDA's NDA acceptance for CUTX-101, targeting Menkes disease. CUTX-101, a copper histidinate injection, shows promise in clinical trials. Sentynl Therapeutics will commercialize it, with Cyprium eligible for royalties and milestones. Fortress Biotech also sees FDA approval for UNLOXCYT™ and financial advancements.

Sentynl Therapeutics, owned by Zydus Lifesciences and Fortress Biotech, received FDA acceptance for Priority review of CUTX-101, a treatment for Menkes disease, a rare genetic condition affecting 1 in 34,810 to 1 in 8,664 live male births.

CUTX-101, a treatment for Menkes disease, received FDA Priority Review with a PDUFA target action date of June 30, 2025. Cyprium Therapeutics, eligible for royalties and up to $129M in milestones, retains ownership of any Priority Review Voucher. Sentynl Therapeutics, responsible for CUTX-101's development and commercialization, submitted the NDA, supported by positive clinical efficacy results showing significant survival improvement.

CUTX-101, a potential first FDA-approved treatment for Menkes disease, received a six-month priority review with a PDUFA target action date of June 30, 2025. Early treatment showed an 80% reduction in death risk, significantly improving survival rates. Menkes disease, a rare pediatric condition, currently has no FDA-approved treatments.

Fortress Biotech and Cyprium Therapeutics announced FDA's Priority Review for CUTX-101, a treatment for Menkes disease, with a PDUFA target action date of June 30, 2025. Cyprium could receive royalties and up to $129 million in milestones, retaining ownership of any Priority Review Voucher. CUTX-101 showed significant survival improvement in clinical trials.

Rosacea affects 415M globally, impacting self-esteem and social life. cSCC, a common skin cancer, can be fatal. Menkes disease, a copper transport disorder, is lethal without treatment. Post-surgery pain management includes IV Tramadol. CMV poses risks to transplant patients. NHL and GBM are challenging cancers with low survival rates. Gout affects millions, with many unsatisfied with treatment. SBMA, a rare neuromuscular disease, lacks effective treatment.

CUTX-101, a potential first FDA-approved treatment for Menkes disease, received a six-month priority review with a PDUFA target action date of June 30, 2025. It showed an 80% reduction in death risk and improved survival in clinical trials. Menkes disease, a rare pediatric condition, currently has no FDA-approved treatments.

CUTX-101, a potential first FDA-approved treatment for Menkes disease, received a six-month priority review with a PDUFA target action date of June 30, 2025. Early treatment showed an 80% reduction in death risk, improving survival significantly. Menkes disease, a rare pediatric condition, currently has no cure or approved treatments.

CUTX-101, a potential first FDA-approved treatment for Menkes disease, received a six-month priority review with a PDUFA target action date of June 30, 2025. Clinical trials showed significant survival improvement, with an 80% reduction in death risk compared to untreated patients. Menkes disease, a rare pediatric condition, currently has no cure.

Sentynl Therapeutics' NDA for CUTX-101, a Menkes disease treatment, received FDA Priority Review. Fortress Biotech and Cyprium Therapeutics also announced FDA acceptance for CUTX-101, with a PDUFA date of June 30, 2025. Checkpoint Therapeutics' UNLOXCYT™, an anti-PD-L1 treatment for cSCC, was FDA approved. Fortress Biotech reported Q3 2024 results, including FDA approval of Emrosi for rosacea. Avenue Therapeutics anticipates Phase 1b/2a trial data for AJ201 by end of 2024. Checkpoint Therapeutics awaits FDA decision on cosibelimab. Journey Medical Corporation's Emrosi™ for rosacea was FDA approved. Mustang Bio received Nasdaq listing extension and FDA Orphan Drug Designation for MB-108. Highbridge Capital acquired Fortress Biotech shares. Journey Medical presented DFD-29 data. Mustang Bio exercised warrants for $4M. Avenue Therapeutics to participate in Maxim Group’s 2024 Healthcare Virtual Summit.