Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-101 (IL13Ra2-targeted CAR T-cells) to Treat Astrocytomas and Glioblastoma
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jul 07 2025
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Should l Buy FBIO?
Source: Newsfilter
Clinical Trial Results: In a Phase 1 trial, MB-101 (IL13Rα2-targeted CAR-T cell therapy) showed promising results with 50% of patients achieving stable disease or better, including two complete responses lasting over 66 months.
FDA Orphan Drug Designation: The FDA granted Orphan Drug Designation to Mustang Bio for both MB-101 and MB-108, aimed at treating recurrent glioblastoma and high-grade astrocytomas, providing incentives for further development and potential market exclusivity.
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Analyst Views on FBIO
Wall Street analysts forecast FBIO stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 3.490
Low
4.50
Averages
10.75
High
17.00
Current: 3.490
Low
4.50
Averages
10.75
High
17.00
About FBIO
Fortress Biotech, Inc. is a biopharmaceutical company focused on acquiring and advancing assets. The Company has eight marketed prescription pharmaceutical products and over 20 programs in development, with its majority-owned and majority-controlled partners and subsidiaries and partners and subsidiaries it founded and in which it holds significant minority ownership positions. Its portfolio is being commercialized and developed for various therapeutic areas, including oncology, dermatology, and rare diseases. Its dermatology products include Emrosi, Qbrexza, Amzeeq, Zilxi, Exelderm, Targadox, and Luxamend. Its late-stage product candidates include CUTX-101 (copper histidinate injection for Menkes disease), Triplex (cytomegalovirus (CMV) vaccine), and CAEL-101 (monoclonal antibody for AL amyloidosis). Its early and mid-stage product candidates include Dotinurad (urate transporter (URAT1) inhibitor for gout), MB-101 (IL13Rα2 CAR T Cell Program for Glioblastoma), and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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