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Lipocine Announces Financial Results For The Year Ended December 31, 2020
SALT LAKE CITY, March 11, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine
About this update from Lipocine Inc.
[{"type":"text","content":"SALT LAKE CITY, March 11, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the fourth quarter and year ended December 31, 2020, and provided a corporate update.\n\n \n \n \n \n \n \n\n \n\"Lipocine had a number of important accomplishments in 2020, most notably the U.S. Food and Drug Administration (\"FDA\") decision to grant tentative approval to TLANDO, the Company's oral testosterone product for testosterone replacement therapy (\"TRT\") in adult males with hypogonadism. We are committed to taking action to receiving final approval to permit the launch of the product,\" said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. \"We also made excellent progress advancing LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis (\"NASH\"). We were pleased with the top-line results from our Phase 2 LiFT clinical study, announced in January 2021, which showed that treatment with LPCN 1144 resulted in significant liver fat reduction and improvement of key liver injury markers. The trial is on-going and we expect 36-week biopsy data in July/August 2021.\"\nFourth Quarter and Recent Corporate Highlights\nGranted tentative approval by the FDA for TLANDO, Lipocine's oral testosterone product for testosterone replacement therapy (\"TRT\") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone Announced positive topline results from the Phase 2 LiFT (\"Liver Fat intervention with oral Testosterone\") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects Both LPCN 1144 treatment arms met the primary endpoint, change in hepatic fat fraction via magnetic resonance imaging proton density fat fraction (\"MRI-PDFF\"), with statistical significance Statistically significant reduction in markers of liver injury were observed for LPCN 1144 compared to placebo 36-week biopsy data from the LiFT study are expected in July/August 2021 Began enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144 (no placebo arm) The extension will allow the collection of additional data on LPCN 1144 for up to a total of 72 weeks of therapyRaised gross...