Fortress Biotech (NASDAQ: FBIO) Receives Notification of Extended FDA Target Action Date for CUTX-101

Fortress Biotech, Inc. recently disclosed in an 8-K filing that its majority-owned subsidiary, Cyprium Therapeutics, Inc., received a notification from Sentynl Therapeutics, Inc. regarding an extension by the U.S. Food and Drug Administration (FDA) of the target action date for the New Drug Application (NDA) for CUTX-101 (Copper Histidinate) to September 30, 2025. This extension was granted after Sentynl assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium back in December 2023.

Under the terms of the agreement between Cyprium and Sentynl, Cyprium will retain ownership of any Priority Review Voucher that may be issued upon NDA approval. Additionally, Cyprium stands to receive royalties and up to $129 million in aggregate development and sales milestones.

Fortress Biotech established Cyprium in 2017 and currently holds approximately 76% ownership of the company. The extension of the FDA target action date signifies a pivotal development in the collaborative efforts between Cyprium and Sentynl in advancing the NDA process for CUTX-101.

While this extension may impact the timeline for the market entry of CUTX-101, it also provides an opportunity for further refinement and potential enhancements to the drug for its eventual commercialization. The announcement underscores Fortress Biotech’s commitment to advancing innovative therapies through strategic partnerships and effective execution of drug development initiatives.

The news about the extended FDA target action date for CUTX-101 comes at a crucial juncture for Fortress Biotech, highlighting the significance of regulatory processes in the pharmaceutical industry and the Company’s dedication to addressing unmet medical needs. Investors and stakeholders will be keenly observing further developments surrounding CUTX-101 as the revised target action date approaches.

Fortress Biotech’s management has not issued any additional comments or statements regarding this development at the time of reporting. Investors are encouraged to monitor future updates and disclosures regarding the progress of CUTX-101 and its potential impact on Fortress Biotech’s pipeline and strategic objectives.

Please note that all information in this article is based on the recent 8-K filing by Fortress Biotech to the Securities and Exchange Commission (SEC) and should be considered as per the official document.

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Please note that all information in this article is directly derived from the recent 8-K SEC filing by Fortress Biotech (NASDAQ:FBIO) and should be treated as per the official document.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Fortress Biotech’s 8K filing here.

About Fortress Biotech

Fortress Biotech, Inc, a biopharmaceutical company, develops dermatology, pharmaceutical, and biotechnology products in the United States. The company markets dermatology products, such as Qbrexza a medicated cloth towelette for the treatment of primary axillary hyperhidrosis; Accutane capsules for severe recalcitrant nodular acne; Amzeeq for severe acne vulgaris; Zilxi, a topical foam; Exelderm cream and solution for topical use; Targadox an oral doxycycline drug for adjunctive therapy for severe acne; Luxamend; sulconazole nitrate cream and solution for tinea cruris and tinea corporis; and doxycycline hyclate tablet.