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Avenue Therapeutics Receives Notices of Allowance for Patent Applications Covering Methods of Administration for Intravenous Tramadol

New York, NY – March 28, 2018 – Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development and commercialization of intravenous (IV) tramadol, today announced receipt of Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) for two patent applications covering methods of administration for its lead product candidate IV tramadol.

The first patent application is a continuation of issued U.S. patent 8,895,622, titled “Intravenous Administration of Tramadol.”   The patent to be issued from the allowed application (U.S. Application No. 15/407,133) carries a patent term to at least 2032. The second patent application is a continuation of issued U.S. patent 9,693,949, titled “Intravenous Administration of Tramadol.”   The patent to be issued from the allowed application (U.S. Application No. 15/612,665) carries a patent term to at least 2036.

Also, the USPTO has indicated that a Notice of Allowance is being issued for U.S. Application No. 15/622,910 (a continuation-in-part application of U.S. patent 9,693,949). All patents to be issued from these allowed applications contain claims directed to Avenue’s proposed administration of IV tramadol.   Issuance of these patents is expected in the second quarter of 2018.

“The allowance of these patents further expands our patent portfolio and strengthens the protection of the methods of administration for IV tramadol in postoperative pain,” said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer. “We are pleased that the USPTO has allowed these applications during this important stage in IV tramadol’s pivotal development program, as we look forward to reporting topline data from our Phase 3 trial in patients following bunionectomy surgery in the second quarter of 2018, and to initiating a Phase 3 trial in patients following abdominoplasty surgery in the third quarter.”

These patent applications fall under Avenue’s licensing agreement with Revogenex Ireland Ltd.

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Avenue Therapeutics Prices Initial Public Offering of $33,000,000 of Common Stock

New York, NY, June 26, 2017 —- Avenue Therapeutics, Inc. (“Avenue”), a Fortress Biotech, Inc. (NASDAQ: FBIO) company, announced today the pricing of its initial public offering of 5,500,000 shares of common stock at an initial public offering price of $6.00 per share. The gross proceeds to Avenue from the initial public offering are expected to be $33,000,000, before underwriting discounts and commissions and other estimated offering expenses. Avenue has granted the underwriters a 30-day option to purchase up to 825,000 additional shares of common stock, which may be purchased solely for the purpose of covering over-allotments, if any, at the public offering price less the underwriting discounts and commissions.

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Avenue Therapeutics Receives Notice of Allowance for a New Patent Application Covering Methods of Administration for Intravenous Tramadol

New York, NY – May 19, 2017 – Avenue Therapeutics, Inc. (“Avenue”), a Fortress Biotech (NASDAQ: FBIO) Company, today announced that Notice of Allowance has now been received from the U.S. Patent and Trademark Office (USPTO) for a new patent application (U.S. Application No. 15/163,111), entitled “Intravenous Administration of Tramadol.”  The patent application describes and claims a dosing regimen of intravenous (IV) 50 mg tramadol that provides certain pharmacokinetic parameters that are similar to those of 100 mg tramadol HCl administered orally every 6 hours at steady state.

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Avenue Therapeutics Files to Become a Public Reporting Company

New York, NY – December 30, 2015 – Avenue Therapeutics, Inc. (“Avenue”), a Fortress Biotech, Inc.
(NASDAQ: FBIO) Company, announced that it filed a registration statement on Form 10 with the Securities
and Exchange Commission (“SEC”) under the Securities Exchange Act of 1934, as amended, for the
purpose of becoming a reporting company.
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