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LPCN

Lipocine

$3.80

-0.35 (-8.43%)

08:03
10/17/16
10/17
08:03
10/17/16
08:03

Lipocine completes post action meeting with FDA for LPCN 1021 NDA

Lipocine announced the completion of a Post Action meeting with the FDA regarding its New Drug Application, or NDA, for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The purpose of the meeting was to review the Complete Response Letter, or CRL, and to determine actions needed to achieve approval of LPCN 1021. The CRL, issued June 28, 2016, identified deficiencies related to the dosing algorithm for the label. In response to the CRL, Lipocine proposed a dosing regimen based on analyses of existing data. The FDA noted that while Lipocine's proposed dosing regimen might be acceptable, validation in a clinical trial would be needed prior to resubmission. As a result, Lipocine has submitted the new dosing validation clinical study protocol to the FDA and the FDA has agreed to review the protocol through a Special Protocol Assessment. An SPA is an advanced declaration from the FDA that a planned trial's design, clinical endpoints, and statistical analyses could potentially result in data acceptable for FDA review towards approval for the proposed indication.

LPCN Lipocine
$3.80

-0.35 (-8.43%)

06/30/16
ROTH
06/30/16
NO CHANGE
Target $30
ROTH
Buy
Lipocine price target lowered to $30 from $40 at Roth Capital
Roth Capital analyst Michael Higgins lowered his price target for Lipocine to $30 from $40 after the FDA issued a Complete Response Letter on Lipocine's oral testosterone product, LPCN 1021, citing "deficiencies related to the dosing algorithm." Roth Capital has a Buy rating on the shares.
10/07/16
HCWC
10/07/16
INITIATION
Target $25
HCWC
Buy
Lipocine initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Corey Davis started Lipocine with a Buy rating and $25 price target.
10/11/16
ADAM
10/11/16
NO CHANGE
Target $15
ADAM
Buy
Lipocine price target raised to $15 from $6 at Canaccord
Canaccord analyst John Newman raised his price target on Lipocine to $15 from $6 as he believes its oral testosterone product has better safety and convenience versus currently marketed gels and injectables. The analyst sees rapid market share gains and a 20% market share by 2024. Newman reiterated his Buy rating on Lipocine shares.

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