Fortress Biotech Inc. (FBIO) stock prices were up by 1.64% as of the market closing on October 13th 2021. This brought the price per share up to USD$3.10 at the end of the trading day. Subsequent pre-market fluctuations have seen the stock rise by 7.74%, bringing it up to USD$3.34.
Positive CUTX-101 Trial Data
October 13th, 2021 saw FBIO stock announce positive results from its efficacy and safety analysis of data from the CUTX-101 study. The data was integrated from two completed pivotal studies in patients with Menkes disease who were treated with copper histidinate. Both pre-specified primary and secondary efficacy analyses showed the CUTX-101 treatment, demonstrating a substantially greater median overall survival (OS), as compared to untreated historical control patients. The data is expected to be presented at the 2021 American Academy of Pediatrics National Conference and Exhibition as a virtual poster.
FBIO Stock Builds on Success
The company is keen to address the substantial unmet need for an approved treatment for patients suffering from Menkes disease. The positive data demonstrates the potential of CUTX-101 to be a viable therapy option for patients with the debilitating disease. FBIO stock is keen to collaborate with the United States Food and Drug Administration to begin the rolling submission of a New Drug Application for its proprietary treatment in the fourth quarter of fiscal 2021.
Details of the Study
The trial consisted of two open-label, single-arm, single-site studies, wherein 129 patients with Menkes disease were treated with CUTX-101. The treatment was administered subcutaneously twice a day until 12 months of age and once daily thereafter. The total duration of the treatment lasted up to three years. 66 patients born after 1999 and with severe loss of function ATP7A mutations from the two studies were combined and sorted into an Early Treatment cohort and a Late Treatment cohort. 18 Menkes disease patients were enrolled to comprise a historical control cohort who had not been treated with CUTX-101. 17 of these patients were also included in historical control-late treatment. The efficacy of the treatment was assessed in comparison to untreated HC-ET and untreated HC-LT, with OS serving as the primary and secondary efficacy endpoints, respectively.
Future Outlook for FBIO Stock
The company reported a strong quarter, consolidated by the promising positive data from its CUTX-101 clinical trial. FBIO is poised to push for the accelerated development and commercialization of its flagship treatment. Current and potential investors are hopeful that management will be able to effectively leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value.