Avenue Therapeutics is a pre-revenue specialty pharmaceutical company developing two drug candidates. Avenue's lead asset is IV tramadol, an intravenous formulation of the well-known Schedule IV opioid tramadol, targeting post-operative acute pain in hospital settings where patients cannot yet tolerate oral medication. No IV formulation of tramadol is currently approved in the U.S. Avenue's second asset is ATX-04 (clenbuterol), an oral small molecule being developed as an add-on therapy to enzyme replacement therapy for Pompe disease, a rare inherited muscle-wasting disorder. ATX-04 is designed to enhance the uptake of enzyme replacement therapy into muscle cells. Both programs are early-stage and neither has been approved. Avenue's business model is to in-license drug candidates, advance them through clinical development, and commercialize them independently or via partnership. Avenue has just one full-time employee and relies on outside advisors and consultants. Avenue is a majority-controlled subsidiary of Fortress Biotech. IV tramadol has had a difficult regulatory history, including two FDA Complete Response Letters and a negative FDA advisory committee vote. Avenue recently agreed with the FDA on a new Phase 3 safety study protocol, but has not yet initiated the study, which is contingent on securing financing or a partnership. ATX-04 is even earlier in development, with a pre-IND meeting with the FDA still pending. Avenue is entirely dependent on external financing until products are approved and commercialized.