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Lipocine Announces Second Quarter 2019 Financial and Operational Results
SALT LAKE CITY, Aug. 7, 2019 /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, Aug. 7, 2019 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the second quarter and six months ended June 30, 2019 and provided a corporate update.\n\n \nSecond Quarter and Recent Corporate Highlights\nFiled a New Drug Application (\"NDA\") for TLANDO™ as testosterone replacement therapy (\"TRT\") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The FDA has assigned November 9, 2019 as the Prescription Drug User Fee Act (\"PDUFA\") goal date.Received clearance from the U.S. Food and Drug Administration (\"FDA\") to clinically investigate LPCN 1144 in an expanded target population of adult male non-alcoholic steatohepatitis (\"NASH\") patients. FDA has waived the limitation of only testing in NASH subjects with total testosterone levels below 300 ng/dL (threshold for hypogonadism).Initiated the LiFT (\"Liver Fat intervention with oral Testosterone\") LPCN 1144 Phase 2 clinical study, a paired-biopsy study in confirmed pre-cirrhotic NASH subjects. Filed suit against Clarus Therapeutics, Inc. (\"Clarus\") in the United States District Court (\"Delaware\") alleging that Clarus's JATENZO® product infringes six of Lipocine's U.S. patents. Joined the Russell Microcap® Index effective July 1, 2019 as a result of the Russell indexes annual reconstitution.\"During the second quarter, we continued to advance our pipeline, with important milestones achieved for both TLANDO and LPCN 1144,\" said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. \"The acceptance of the NDA for TLANDO for treating hypogonadism in males puts us on track for potential approval of this product in the fourth quarter of 2019. TLANDO is designed as a fixed dose oral TRT. For LPCN 1144, we were excited to initiate the LiFT study in biopsy confirmed NASH subjects, and based on our observed meaningful liver fat reduction in hypogonadal males, receive FDA clearance to expand our target patient population in adult NASH males regardless of their hypogonadal status. We believe this increases LPCN 1144's potential utility in a broader NASH population who reportedly have low testosterone.\"\nSecond Quarter Ended June 30, 2019 Financial Result...