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Monday, 12/17/2018 6:50:03 AM

Monday, December 17, 2018 6:50:03 AM

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EVFM PM going 21%% Evofem: Phase 3 Amphora Study for Prevention of Pregnancy Met Primary Endpoint >EVFM
6:21 am ET December 17, 2018 (Dow Jones) Print


By Colin Kellaher

Evofem Biosciences Inc. (EVFM) on Monday said its phase 3 study of the contraceptive gel Amphora for the prevention of pregnancy met its primary endpoint.
The San Diego clinical-stage biopharmaceutical company said Amphora showed 86% efficacy in the study, and 98.7% efficacy when used as directed.
Evofem said it expects to file a new-drug application for Amphora with the U.S. Food and Drug Administration in the second quarter of 2019 and to commercialize the product, if approved, in January 2020.

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

(END) Dow Jones Newswires
December 17, 2018 06:21 ET (11:21 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.

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