This development marks a key milestone for Fortress Biotech (NASDAQ:FBIO) and Cyprium in their quest to address the unmet medical needs of patients with Menkes disease. The acceptance of the NDA by the FDA is based on a press release statement from Fortress Biotech, Inc. With a current ratio of 1.23 and revenue growth of 31.5% in the last twelve months, investors can access deeper financial insights and 8 additional ProTips through InvestingPro's comprehensive analysis platform. With a current ratio of 1.23 and revenue growth of 31.5% in the last twelve months, investors can access deeper financial insights and 8 additional ProTips through InvestingPro's comprehensive analysis platform.
Menkes disease, a rare genetic disorder affecting copper levels in the body, leads to severe neurological symptoms and early childhood mortality. CUTX-101, a copper histidinate injection, aims to correct copper imbalances and has shown positive results in clinical trials, with early treatment leading to significantly improved survival rates compared to untreated patients. While the company's gross profit margin stands at -5.12%, InvestingPro analysis suggests the stock is currently trading below its Fair Value, potentially presenting an opportunity for investors interested in biotechnology companies.
Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, has taken full responsibility for the development and future commercialization of CUTX-101, following a transfer of rights from Cyprium in December 2023. If approved, CUTX-101 would be the first FDA-sanctioned therapy for Menkes disease.
In the event of FDA approval, Cyprium stands to receive royalties and could earn up to $129 million in development and sales milestones from Sentynl. Furthermore, Cyprium retains ownership of any Priority Review Voucher that may be awarded, which can be used for future marketing applications or sold to another entity.
The CUTX-101 NDA is bolstered by the drug's previous designations, including FDA Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug Designations, as well as Orphan Drug Designation by the European Medicines Agency.
This development marks a key milestone for Fortress Biotech and Cyprium in their quest to address the unmet medical needs of patients with Menkes disease. The acceptance of the NDA by the FDA is based on a press release statement from Fortress Biotech, Inc.
In other recent news, Fortress Biotech's subsidiary, Checkpoint Therapeutics (NASDAQ:CKPT), has secured FDA approval for its new drug UNLOXCYT™, marking a significant advancement in the treatment options for patients with advanced stages of cutaneous squamous cell carcinoma. This approval was based on positive results from the clinical trial Study CK-301-101. Additionally, 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, increasing the price target from $24 to $26.
In related developments, 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.
Roth/MKM analysts responded to these developments by raising Fortress Biotech's price target from $10.00 to $13.00, maintaining a Buy rating. These are the recent highlights from Fortress Biotech and Mustang Bio.
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