Current Report Filing (8-k)
August 27 2021 - 5:21PM
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2021-08-26
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2021-08-26
2021-08-26
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fbio:Sec9.375SeriesCumulativeRedeemablePerpetualPreferredStockMember
2021-08-26
2021-08-26
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UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d) of the
Securities Exchange
Act of 1934
Date of report (Date of
earliest event reported): August 26, 2021
Fortress Biotech, Inc.
(Exact Name of Registrant
as Specified in Charter)
Delaware
(State or Other Jurisdiction
of Incorporation)
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001-35366
(Commission File Number)
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20-5157386
(IRS Employer
Identification No.)
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2 Gansevoort Street, 9th Floor
New York, New York 10014
(Address of Principal
Executive Offices)
(781) 652-4500
(Registrant’s
telephone number, including area code)
Check the appropriate
box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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¨
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Written communications pursuant to Rule 425 under the Securities Act.
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act.
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¨
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Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act.
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
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Securities registered pursuant to Section
12(b) of the Act:
Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock
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FBIO
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Nasdaq Capital Market
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9.375% Series A Cumulative Redeemable Perpetual Preferred Stock
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FBIOP
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Nasdaq Capital Market
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Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
On August 26, 2021,
Avenue Therapeutics, Inc. (“Avenue”) a Fortress Biotech, Inc. partner company, received an Appeal Denied Letter from the
Office of Neuroscience of the Food and Drug Administration (“FDA”) in response to its Formal Dispute Resolution Request
(“FDRR”) submitted in July 2021 with respect to the Complete Response Letters previously issued by the FDA to Avenue
related to its intravenous (“IV”) tramadol New Drug Application (“NDA”). The regulatory history of the NDA
for IV tramadol, the anticipated FDRR process and other pertinent information regarding these topics were previously disclosed.
Avenue currently intends
to continue to pursue regulatory approval for IV tramadol.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
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Fortress Biotech, Inc.
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(Registrant)
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Date: August 27, 2021
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By:
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/s/ Lindsay A. Rosenwald, M.D.
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Lindsay A. Rosenwald, M.D.
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President and Chief Executive Officer
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