Avenue Therapeutics: Two-Step Merger with Cipla, CVR | Value Investing News

Avenue Therapeutics: Two-Step Merger with Cipla, CVR

  • Tramadol is currently only approved in oral/pill form in the U.S., Avenue (via their controlling shareholder Fortress Biotech - FBIO) owns the exclusive license to develop and commercialize an intravenous ("IV") version of Tramadol, IV Tramadol is widely approved and used (~10% of IV painkiller market share in Europe) internationally but hasn't been approved for use in the United States.
  • Currently the company is putting together their new drug application ("NDA") to submit to the FDA for approval.
  • The wildcard might be the Schedule IV classification, we are entering into an election season and opiod litigation is heavily in the news, if the DEA changes Tramadol to a Schedule II drug alongside the conventional opiods, that could blow a hole in the merger agreement.If the merger is completed following FDA approval, Avenue shareholders will get an additional kicker in the form of a CVR tied to the sales of IV Tramadol with a $325MM annual revenue threshold with a favorable graduated tier scale above that.
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