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EVFM

Evofem

$6.14

0.48 (8.48%)

07:38
11/26/19
11/26
07:38
11/26/19
07:38

Evofem resubmits NDA to FDA for Amphora

Evofem Biosciences announced that it has resubmitted its New Drug Application, or NDA, to the FDA for Amphora, a Multipurpose Vaginal pH Regulator, or MVP-R, for the prevention of pregnancy. The company said, "We have submitted a comprehensive and compelling package that we believe addresses the Agency's outstanding questions, and we look forward to the potential opportunity to provide millions of women with an innovative new hormone-free, on-demand, prescription contraceptive option that gives them control over their sexual and reproductive health." The Amphora NDA resubmission includes full results from the Phase 3 AMPOWER study, a confirmatory single-arm, open-label Phase 3 trial evaluating the safety and efficacy of Amphora in approximately 1,400 healthy women aged 18-35 years. The trial was designed with guidance and input from the FDA to address questions raised in the Complete Response Letter received by Evofem in April 2016.

EVFM Evofem
$6.14

0.48 (8.48%)

01/07/19
HCWC
01/07/19
NO CHANGE
Target $12.5
HCWC
Buy
Evofem price target raised to $12.50 from $11 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju raised his price target for Evofem Biosciences to $12.50 after the Ampower pivotal trial met its primary endpoint. The results demonstrate that when Amphora is used as directed, the efficacy in which women can have confidence is similar to other frequently-used contraceptive methods, says the analyst. He reiterates a Buy rating on Evofem.
04/12/19
OPCO
04/12/19
NO CHANGE
Target $11
OPCO
Outperform
Evofem price target raised to $11 from $9 at Oppenheimer
Oppenheimer analyst Leland Gershell raised his price target for Evofem Biosciences (EVFM) to $11 from $9 following yesterday's announcement of the securities purchase agreement with PDL BioPharma (PDLI), which he says cures a significant financing overhang on favorable terms, mitigates uncertainty around U.S. commercial economics, and provides validation by a well-regarded strategic healthcare investor. He maintains an Outperform rating.
04/12/19
CANT
04/12/19
NO CHANGE
Target $9
CANT
Overweight
Evofem financing removes near-term capital concerns, says Cantor Fitzgerald
Cantor Fitzgerald analyst Matthew Lillis believes Evofem Biosciences' (EVFM) financing agreement for up to $80M, including a strategic investment from PDL BioPharma (PDLI), removes near-term capital concerns. Further, it positions Evofem well to execute other pieces of its long-term financing strategy, which may involve sources of non-dilutive capital that could further benefit shareholders, Lillis tells investors in a research note. He reiterates an Overweight rating on the shares with a $9 price target.
10/16/19
CANT
10/16/19
INITIATION
Target $9
CANT
Overweight
Evofem assumed with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Louise Chen assumed coverage of Evofem with an Overweight rating and $9 price target. The market opportunity for the company's Amphora is underappreciated, Chen tells investors in a research note. Amphora could be: a first-in-class hormone-free birth control that also improves sexual satisfaction, says the analyst. She believes now is a good time to take another look at Evofem shares ahead of the Phase 2b trial results in November.

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