Lipocine Inc. (NASDAQ:LPCN)
Lipocine Inc. (NASDAQ:LPCN) has reported positive efficacy results regarding its Dosing Validation and Dosing Flexibility studies for oral testosterone candidate 1021. According to Lipocine, the study results validate a fixed dose approach without the need for dose titration.
Topline LCPN 1021 Results
Study results indicate that LPCN 1021 achieved all of the predetermined FDA primary efficacy guidelines. 70% of the subject’s average testosterone levels were restored and 81% of the subjects achieved average testosterone levels. The trial also confirmed that twice-daily dosing would be the appropriate dosing regimen.
“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,” said Lipocine Inc. (NASDAQ:LPCN) CEO, Dr. Mahesh Patel.
Lipocine Inc. (NASDAQ:LPCN) is developing LCPN 1021 as an oral testosterone replacement therapy designed to help restore normal testosterone levels in hypogonadal men. Current treatment options rely on short acting injectable products. The company wants to do away with these treatment options given that they carry an FDA ‘black box’ warning.
In addition to LCPN 1021 DF study, Lipocine Inc. (NASDAQ:LPCN) is currently undertaking preclinical toxicology tests for LCPN 111. Trials should be complete by midyear paving way for an end-of-phase 2 meeting with the FDA. The company expects approval sometime in 2019 with the drug set to go on sale in 2020.
LCPN 1107 is another candidate drug that Lipocine is working on as a novel prevention option for recurrent preterm birth. Lipocine Inc. (NASDAQ:LPCN) expects LCPN to become the first oral HPC product for prevention of preterm birth in women with a prior history. Its potential benefits, when compared to injectable products, include the elimination of pain and site reactions associated with injections.
Separately, law firm, Robinson Arroyo LLP, has lodged a class action complaint against Lipocine. The law firm alleges that the company misled investors on Phase 3 clinical results for its candidate drug 1021. The company officials are accused of using a different dosing scheme compared to the one described in the New Drug application.
Lipocine Inc. (NASDAQ:LPCN) stock was up by 5.47% in Tuesday’s trading session to end the day at $4.24 a share.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.