In a significant development for the pharmaceutical industry, Fortress Biotech, Inc. (NASDAQ:FBIO), currently trading at $1.85 per share with a market capitalization of $51.57 million, announced that its majority-controlled subsidiary, Checkpoint Therapeutics (NASDAQ:CKPT), has received approval from the U.S. Food and Drug Administration (FDA) for its new drug UNLOXCYT™ (cosibelimab-ipdl).
The approval, announced on Sunday, December 13, 2024, marks a milestone as UNLOXCYT becomes the first and only programmed death ligand-1 (PD-L1) blocking antibody approved for treating adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are ineligible for curative surgery or radiation.
The FDA's decision was based on positive results from the clinical trial Study CK-301-101, which evaluated the efficacy of UNLOXCYT in adults with various advanced solid tumor cancers, including cSCC. The study demonstrated clinically meaningful objective response rates and duration of response, which were assessed by an independent central review committee.
The approval represents a significant advancement in the treatment options available for patients with this type of skin cancer, which until now had limited therapies for those with advanced stages of the disease. This news could potentially impact the share value of Fortress Biotech, Inc., which trades under the ticker NASDAQ:FBIO, and its preferred stock NASDAQ:FBIOP.
According to InvestingPro, the stock has experienced a 13.78% decline over the past week, with analysts maintaining a strong buy consensus. InvestingPro analysis suggests the stock is currently undervalued.
As a Delaware-incorporated entity with headquarters in Bay Harbor Islands, FL, Fortress Biotech operates within the pharmaceutical preparations industry under the standard industrial classification code 2834. The company, formerly known as Coronado Biosciences Inc., underwent a name change on March 10, 2008.
The information regarding this FDA approval and its implications for Fortress Biotech and Checkpoint Therapeutics is based on a press release statement filed with the SEC. This announcement is expected to be closely watched by investors and industry analysts as it may influence the company's market position.
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In other recent news, Fortress Biotech saw a boost in stock target following an impressive third-quarter earnings report. The company reported a GAAP EPS of ($0.76), notably better than the analysts' estimate of ($1.49).
However, the company's revenue for the quarter, reported at $14.63 million, fell short of the estimated $16.28 million. Despite this, H.C. Wainwright maintained a Buy rating on the stock, increasing 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. The company also received FDA Orphan Drug Status for its glioma treatment, MB-108. Concurrently, Fortress Biotech, Mustang Bio's parent company, secured FDA approval for its rosacea treatment, Emrosi™, developed in partnership with Dr. Reddy’s Laboratories.
Mustang Bio also generated around $4 million from warrant exercises and announced a stock offering and private placement expected to yield approximately $2.5 million. 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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