UPDATE 2-Fennec does not expect U.S. approval for hearing loss drug, shares slump [Reuters]
Fennec Pharmaceuticals Inc. (FENC)
Last fennec pharmaceuticals inc. earnings: 11/12 06:00 am
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Source: Reuters
Nov 29 (Reuters) - Fennec Pharmaceuticals Inc (FENC.O) said on Monday it expects the U.S. health regulator to again decline the marketing application for its drug to prevent chemotherapy-induced hearing loss in children, sending its shares tumbling 45%. The Food and Drug Administration (FDA) indicated that deficiencies have been identified following an inspection of the drug's manufacturing facility, the company said, without providing further details. This is the second potential setback for Pedmark, the only clinical drug candidate in Fennec's pipeline. The FDA had declined to approve the drug last year, citing similar reasons. The company resubmitted its application earlier this year, which the regulator accepted for review and set a target action date of Nov. 27 to give its decision. Administered intravenously, Pedmark is intended for children between one month and 18 years, who have received platinum-based chemotherapy, which uses an agent called cisplatin. Such therapies are com
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News
- Those who invested in Fennec Pharmaceuticals (NASDAQ:FENC) five years ago are up 136% [Yahoo! Finance]Yahoo! Finance
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- Fennec Pharmaceuticals Inc. (NASDAQ:FENC) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- Fennec Pharmaceuticals Reports Full Year and Fourth Quarter 2023 Financial Results and Provides Business Update [Financial Post (Toronto, Ontario, Canada)]Financial Post
- Fennec Pharmaceuticals Reports Full Year and Fourth Quarter 2023 Financial Results and Provides Business Update [Yahoo! Finance]Yahoo! Finance
FENC
Earnings
- 3/21/24 - Miss
FENC
Sec Filings
- 4/22/24 - Form 4
- 4/22/24 - Form 144
- 4/19/24 - Form 144
- FENC's page on the SEC website