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LPCN

Lipocine

$4.02

0.15 (3.88%)

16:04
06/19/17
06/19
16:04
06/19/17
16:04

Lipocine says LPCN 1021 achieved primary endpoints in dosing studies

Lipocine announced results from both the Dosing Validation and the Dosing Flexibility studies evaluating efficacy and tolerability of LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The results from these studies confirm the validity of a fixed dose approach without the need for dose titration to orally administering LPCN 1021. LPCN 1021 successfully met the FDA primary efficacy guidelines in the DV study where 81% of the subjects achieved average testosterone levels within the normal range with a lower bound confidence interval of 72%. The DF study restored 70% of the subjects' average testosterone levels within the normal range confirming that twice daily dosing is the appropriate dosing regimen for LPCN 1021 and will be the basis for resubmission. The adverse event profile of LPCN 1021 in both the DV and DF studies was consistent with the previously conducted 52-week Phase 3 Study of Androgen Replacement clinical trial. All drug related adverse events were either mild or moderate in intensity and none were severe, the company said. "We are pleased with the confirmation of LPCN 1021 efficacy, especially with a more practical patient and physician preferred "no titration" dosing regimen. We believe the results should address the label-related deficiency cited by the FDA in our NDA submission. We consider LPCN 1021 to be a differentiated TRT option for treating hypogonadism in men with the potential to both improve patient compliance and eliminate the risk of testosterone transference. We look forward to resubmitting the NDA in the third quarter of 2017," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.

  • 19

    Jun

LPCN Lipocine
$4.02

0.15 (3.88%)

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.
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.
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.

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