On Monday, Fortress Biotech (NASDAQ:FBIO), Inc. (market cap: $61.56 million), whose stock has gained 10.12% year-to-date, announced that its majority-owned subsidiary, Cyprium Therapeutics, Inc., has reached a significant milestone with the U.S. Food and Drug Administration (FDA) accepting its New Drug Application (NDA) for CUTX-101 (Copper Histidinate). The FDA has granted the application priority review status and set a target action date of June 30, 2025.
This development follows the December 2023 agreement in which Sentynl Therapeutics, Inc., a subsidiary of Zydus Lifesciences Ltd., took over the responsibilities for the development and commercialization of CUTX-101 from Cyprium. Sentynl completed the NDA submission and will oversee the drug's commercial launch upon approval. According to InvestingPro analysis, Fortress Biotech is currently burning through cash rapidly, making strategic partnerships particularly crucial for its development pipeline.
Cyprium, founded by Fortress in 2017, retains ownership of any Priority Review Voucher that might be granted at the NDA's approval. Additionally, Cyprium is entitled to royalties and could receive up to $129 million in development and sales milestones. Fortress Biotech currently holds approximately 76% ownership of Cyprium.
The acceptance of the NDA by the FDA marks a critical step forward for Cyprium and its parent company, Fortress Biotech. The information for this news article is based on a press release statement.
In other recent news, significant developments have been made by Fortress Biotech and its subsidiaries. The FDA is reviewing CUTX-101, a potential treatment for Menkes disease developed by Fortress Biotech and Cyprium. If approved, it would be the first FDA-sanctioned therapy for this disease. Meanwhile, Checkpoint Therapeutics (NASDAQ:CKPT), another subsidiary of Fortress Biotech, has received FDA approval for UNLOXCYT™, a new drug designed to treat advanced stages of cutaneous squamous cell carcinoma.
Fortress Biotech reported a GAAP EPS of ($0.76) for the third quarter, notably better than the analysts' estimate of ($1.49), although revenue for the quarter fell short of the estimated $16.28 million. H.C. Wainwright maintained a Buy rating on the stock and increased the price target from $24 to $26.
In addition, Mustang Bio (NASDAQ:MBIO), a subsidiary of Fortress Biotech, has been granted an extension by the Nasdaq Hearings Panel to meet the exchange's continued listing requirements. Mustang Bio also received FDA Orphan Drug Status for its glioma treatment, MB-108. On the financial front, Fortress Biotech secured approximately $8 million from stock sales and private placements and entered into a $50 million loan agreement with Oaktree Capital Management. The company reported a second-quarter revenue of $14.9 million. These are the recent developments from Fortress Biotech and its subsidiaries.
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