UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

SCHEDULE 13D
Under the Securities Exchange Act of 1934
(Amendment No. 3)*

AVENUE THERAPEUTICS, INC.
(Name of Issuer)

Common Stock, $0.0001 Par Value
(Title of Class of Securities)

05360L205
(CUSIP Number)

A.S. Kumar
General Counsel, Cipla Limited

c/o

InvaGen Pharmaceuticals Inc.
Site B, 7 Oser Ave.
Hauppauge, New York 11788
Tel: +1 (631) 231-3233

with a copy to:

Avner Bengera

Baker Botts L.L.P.

30 Rockefeller Plaza

New York, New York 10112

Tel: +1 (212) 408-2500

(Name, Address and Telephone Number of Person
Authorized to Receive Notices and Communications)

October 11, 2022
(Date of Event which Requires Filing
of this Statement)

If the filing person has previously filed a statement on Schedule 13G to report the acquisition that is the subject of this Schedule 13D, and is filing this schedule because of §§240.13d-1(e), 240.13d-1(f) or 240.13d-1(g), check the following box. ¨

Note: Schedules filed in paper format shall include a signed original and five copies of the schedule, including all exhibits. See §240.13d-7 for other parties to whom copies are to be sent.

* The remainder of this cover page shall be filled out for a reporting person’s initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter disclosures provided in a prior cover page.

The information required on the remainder of this cover page shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934 (“Act”) or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).

This Amendment No. 3 (this “Amendment”) to Schedule 13D (as so amended, “Schedule 13D”) amends the statement on Schedule 13D (the “Original Schedule 13D”) jointly filed on behalf of (i) InvaGen Pharmaceuticals Inc., a New York corporation ("InvaGen"), (ii) Cipla (EU) Limited, a company incorporated in the United Kingdom ("Cipla EU"), and (iii) Cipla Limited, a company incorporated in India ("Cipla Limited") (each of InvaGen, Cipla EU and Cipla Limited, a "Reporting Person", and collectively, the "Reporting Persons") on November 23, 2018, as amended by Amendment No. 1 to the Original Schedule 13D filed on February 11, 2019, as amended by Amendment No. 2 to the Original Schedule 13D filed by the Reporting Persons on July 25, 2022, with respect to shares of common stock (“Shares”) of Avenue Therapeutics, Inc., a Delaware corporation (the “Issuer”). Unless otherwise defined herein, capitalized terms used but not defined in this Amendment have the respective meanings ascribed to them in the Original Schedule 13D. This Amendment is the final amendment to the Schedule 13D and is an exit filing for the Reporting Persons.

Item 4 of the Original Schedule 13D is hereby amended and supplemented by adding the following:

On September 22, 2022, the Issuer completed a 1-for-15 reverse split, resulting in the 5,833,333 Shares previously reported as beneficially owned by the Reporting Persons becoming 388,888 Shares (the “InvaGen Shares”). Pursuant to the terms of the previously announced Stock Repurchase Agreement, dated July 25, 2022, among InvaGen, Fortress Biotech, Inc. and the Issuer, the Issuer repurchased the InvaGen Shares from InvaGen for an aggregate purchase price of $3,000,000 (the "Share Repurchase"). The Share Repurchase closed on October 11, 2022. In addition, as a result of the Share Repurchase and concurrent termination of the Voting and Support Agreement, dated November 12, 2018 (the “Support Agreement”), by and among InvaGen, Madison Pharmaceuticals Inc. and the Issuer, which was disclosed in the Original Schedule 13D, the Reporting Persons no longer have beneficial ownership of the 4,826,89 Shares previously reported as beneficially owned by the Reporting Persons in the Schedule 13D.

Item 5 of the Original Schedule 13D is hereby amended and restated as follows:

SIGNATURE

After reasonable inquiry and to the best of his or her knowledge and belief, the undersigned certifies that the information set forth in this statement is true, complete and correct.

Dated: October 19, 2022

Annex A

Directors and Executive Officers of the Reporting Persons

InvaGen Pharmaceuticals Inc.

The name, business address, present principal occupation and citizenship of each director and executive officer of InvaGen Pharmaceuticals Inc. (“InvaGen”) are set forth below. If no address is given, the business address of each person listed below is 7 Oser Avenue, Hauppauge, New York 11788.

Cipla (EU) Limited

The name, business address, present principal occupation and citizenship of each director and executive officer of Cipla (EU) Limited (“Cipla EU”) are set forth below. If no address is given, the business address of each person listed below is Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom.

Cipla Limited

The name, business address, present principal occupation and citizenship of each director and executive officer of Cipla Limited (“Cipla Limited”) are set forth below. If no address is given, the business address of each person listed below is Cipla House, Peninsula Business Park, Ganapatrao Kadam Marg, Lower Parel West, Mumbai, Maharashtra 400013, India.