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Fortress Biotech Stock Plummets After FDA Rejection
FDA rejected Fortress Biotech's Menkes drug, CUTX-101, due to factory issues, but the drug's safety and efficacy data were fine.
FDA rejected Fortress Biotech's Menkes drug, CUTX-101, due to factory issues, but the drug's safety and efficacy data were fine.
Despite the massive demand boost, analysts remain cautious, citing the company’s $4.9 billion net loss last year and concerns over valuation.
The delay is due to manufacturing issues at a third-party facility, with no safety or clinical data concerns.
Ardelyx shares fell after losing a court case on Xphozah Medicare coverage, moving drug into bundled payments, hurting revenue outlook.