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LPCN

Lipocine

$4.52

0.03 (0.67%)

08:23
08/09/17
08/09
08:23
08/09/17
08:23

Lipocine resubmits NDA for LPCN 1021

Lipocine announced the resubmission of a New Drug Application, or NDA, for LPCN 1021, its oral testosterone product candidate for testosterone replacement therapy, or TRT, in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. Lipocine had previously submitted an NDA for LPCN 1021 and received a Complete Response Letter, or CRL, from the FDA in June 2016. The CRL identified a deficiency related to the dosing algorithm for the proposed label. With the goal of addressing this deficiency, the company successfully completed a dosing validation study, which confirmed the validity of a fixed dose approach without the need for dose titration to orally administer LPCN 1021. The efficacy results of the DV study, as well as an integrated safety set from all previously conducted clinical trials, including 52-week safety results from the Phase 3 Study of Androgen Replacement clinical study, form the basis for the NDA resubmission.

  • 09

    Aug

  • 26

    Sep

LPCN Lipocine
$4.52

0.03 (0.67%)

06/20/17
ADAM
06/20/17
NO CHANGE
Target $11
ADAM
Buy
Lipocine data sets path toward FDA submission, says Canaccord
Canaccord analyst Dewey Steadman noted Lipocine reported positive top-line data for its dosing validation and dosing flexibility studies, which were required for the resubmission of its oral testosterone NDA. The analyst sees a resubmission in Q3 and believes the company has sufficient capital to meet near-term needs while the company plans to partner the drug. Steadman reiterated his Buy rating and raised his price target to $11 from $10 on Lipocine shares.
02/21/17
ROTH
02/21/17
NO CHANGE
Target $38
ROTH
Buy
Lipocine price target raised to $38 from $30 at Roth Capital
Roth Capital analyst Michael Higgins raised his price target for Lipocine to $38 from $30 following clarity on LPCN-1107's pivotal trial design. The analyst reiterates a Buy rating on the shares.
12/20/16
ADAM
12/20/16
INITIATION
Target $15
ADAM
Buy
Lipocine assumed with a Buy at Canaccord
Canaccord analyst Dewey Steadman assumed Lipocine with Buy and $15 price target citing its status as one of the leading companies developing oral testosterone replacement therapies to treat hypogonadism.
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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