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AVENUE THERAPEUTICS, INC.

(ATXI)
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Avenue Therapeutics' IV Tramadol Gets Negative FDA Response

06/14/2021 | 05:26am EDT

By Matt Grossman

Avenue Therapeutics Inc. said Monday it received a negative response from the Food and Drug Administration in response to its new-drug application seeking approval for intravenous tramadol.

The FDA found that the unpredictable onset of pain relief with use of the drug detracted from its use as a stand-alone drug for patients in acute pain, according to Avenue. There was also insufficient information to support the drug's use in combination with other analgesics as safe and effective for patients.

New York City-based Avenue said it disagrees with the FDA's interpretation of data and it will continue to pursue regulatory approval for the drug.

Avenue's shares were down 4.3% to $4.03 in premarket trade on the Nasdaq exchange after falling 3.4% Friday.

Write to Matt Grossman at matt.grossman@wsj.com

(END) Dow Jones Newswires

06-14-21 0726ET

All news about AVENUE THERAPEUTICS, INC.
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06/25AVENUE THERAPEUTICS, INC.(NASDAQCM : ATXI) dropped from Russell 3000E Index
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06/25AVENUE THERAPEUTICS, INC.(NASDAQCM : ATXI) dropped from Russell 2500 Growth Inde..
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Financials (USD)
Sales 2021 - - -
Net income 2021 -4,08 M - -
Net Debt 2021 - - -
P/E ratio 2021 -6,51x
Yield 2021 -
Capitalization 30,0 M 30,0 M -
Capi. / Sales 2021 -
Capi. / Sales 2022 -
Nbr of Employees 4
Free-Float 39,7%
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Mean consensus OUTPERFORM
Number of Analysts 2
Last Close Price 1,79 
Average target price
Spread / Average Target -
EPS Revisions
Managers and Directors
Lucy Lu President, Chief Executive Officer & Director
Joseph Vazzano Chief Financial Officer & Secretary
Lindsay Allan Rosenwald Executive Chairman
Scott A. Reines Chief Medical Officer
Neil Herskowitz Independent Director
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