← Catalyst calendarFBIO biotech catalysts & pipeline
FORTRESS BIOTECH INC · Data as of 2026-09-08
Upcoming catalysts
Triplex — Topline data
late 2026
● Triplex, a potential vaccine and immunotherapy for prevention and control of cytomegalovirus ("CMV"), is currently being studied in a Phase 2 clinical trial for adults co-infected with HIV and CMV that is now fully enrolled with topline data anticipated in late 2026. The study will also evaluate whether this intervention might reduce chronic inflammation and immune activation, as compared to a placebo, and thus, potentially reduce related mortality and morbidity (NCT05099965).
Source filingATX-04 — FDA meeting
in 2026
● In February 2026, Avenue entered into an exclusive worldwide license agreement with Duke University to acquire patent and know-how rights pertaining to ATX-04 (clenbuterol), a well-characterized small-molecule β2-adrenergic agonist, in clinical development for the treatment of Pompe disease. ATX-04 is a selective β2-adrenergic agonist with human proof-of-concept data demonstrating improved muscle function and enhanced response to enzyme replacement therapy. Avenue anticipates meeting with the FDA in 2026 to discuss and align on the design of a potential single pivotal trial for ATX-04 for Pompe disease.
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