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WORCESTER, Mass. - The U.S. Food and Drug Administration has granted Orphan Drug Designation to Mustang Bio’s (NASDAQ:MBIO) MB-101, an IL13Ra2-targeted CAR T-cell therapy for treating recurrent diffuse and anaplastic astrocytoma and glioblastoma. According to InvestingPro data, the clinical-stage biotech company, currently valued at $55.6 million, maintains a strong balance sheet with more cash than debt, positioning it well for continued drug development.
The designation, announced Monday, provides incentives including tax credits toward clinical trial costs upon approval and prescription drug user fee waivers. It also confers seven years of market exclusivity for the designated disease if the product receives FDA approval.
MB-101 is being developed as part of a novel combination therapy with MB-108, an HSV-1 oncolytic virus that previously received its own Orphan Drug Designation for malignant glioma treatment. The combination, designated MB-109, aims to improve efficacy by using MB-108 to reshape the tumor microenvironment.
With the stock trading at $1.88 and analyst targets ranging from $4 to $16, InvestingPro analysis suggests the company is currently undervalued. "We are thrilled that MB-101 received Orphan Drug Designation on time and with a designation that is broader than the indication proposed," said Manuel Litchman, President and CEO of Mustang Bio, in a press release statement. Investors can access detailed valuation metrics and 6 additional ProTips with an InvestingPro subscription.
In an ongoing Phase 1 trial published in Nature Medicine, MB-101 demonstrated promising results, with 50% of patients achieving stable disease or better. Two patients with "hot tumors" (high levels of intratumoral CD3+ T cells) achieved complete responses lasting 7.5 and 66+ months.
The therapeutic strategy combines MB-101 CAR-T cell therapy with MB-108 oncolytic virus to potentially make "cold tumors hot," thereby improving treatment efficacy in difficult-to-treat cancers.
Phase 1 clinical trials of MB-101 at City of Hope and MB-108 at The University of Alabama at Birmingham continue to enroll patients. The company noted that further development of the MB-109 program is contingent upon raising additional funding or establishing a strategic partnership. With the next earnings report due on August 12, 2025, investors can access comprehensive financial analysis and Fair Value estimates through InvestingPro’s detailed research reports, available for over 1,400 US stocks.
Orphan Drug Designation applies to drugs and biologics intended for treatment of rare diseases affecting fewer than 200,000 people in the United States.
In other recent news, Fortress Biotech held its annual meeting where shareholders voted on several key proposals. The election of seven directors to serve until the 2026 annual meeting was approved, with each director receiving more votes in favor than against. Shareholders also ratified the appointment of KPMG LLP as the company’s independent registered public accounting firm for the year ending December 31, 2025. An advisory vote to approve the compensation of named executive officers garnered significant support, although there were some votes against and abstentions. Regarding the frequency of future advisory votes on executive compensation, shareholders favored holding these votes every three years, a decision the board has adopted until 2031. Additionally, shareholders approved the Second Amended and Restated Certificate of Incorporation, which includes provisions for officer exculpation. These developments reflect the company’s ongoing governance and operational strategies.
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