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FENNEC PHARMACEUTICALS INC.

(FENC)
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Fennec Gets Official Notice of FDA Rejection of Pedmark

11/30/2021 | 06:35am EST

By Colin Kellaher

Fennec Pharmaceuticals Inc. on Tuesday confirmed that the U.S. Food and Drug Administration has again rejected the company's application for Pedmark because of issues at the plant where the drug is made.

The Durham, N.C., specialty pharmaceutical company said the FDA issued a complete response letter identifying manufacturing deficiencies that need to be resolved before the agency can approve the application.

Fennec, which is seeking approval of Pedmark for the prevention of hearing loss associated with cisplatin chemotherapy in children, on Monday had warned that it expected the rejection, sending its shares down 50.4%.

The company said it plans to work closely with its current manufacturer and the FDA to address the issues raised in the letter, adding that it continues to advance its second drug-product manufacturing plant.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

11-30-21 0635ET

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Financials (USD)
Sales 2021 25,0 M - -
Net income 2021 6,55 M - -
Net Debt 2021 - - -
P/E ratio 2021 18,3x
Yield 2021 -
Capitalization 120 M 120 M -
Capi. / Sales 2021 4,82x
Capi. / Sales 2022 -
Nbr of Employees 9
Free-Float 83,1%
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Mean consensus BUY
Number of Analysts 5
Last Close Price 4,63 $
Average target price 10,80 $
Spread / Average Target 133%
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Managers and Directors
Rostislav C. Raykov Chief Executive Officer & Director
Robert C. Andrade Chief Financial Officer
Khalid Islam Chairman
Chris A. Rallis Independent Director
Adrian James Haigh Independent Director
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