Lipocine Inc Stock Price, News & Analysis

Lipocine Inc. (Nasdaq: LPCN) announced FDA clearance for its Investigational New Drug Application to begin a Phase 2 study of LPCN 1154, an oral neuro-steroid for treating postpartum depression (PPD). The pharmacokinetic study is set to start in July 2021, with results expected by Q3 2021, followed by a proof-of-concept study later in Q4 2021. PPD affects 1 in 7 women post-birth, and LPCN 1154 aims to provide a non-invasive treatment option, likely benefiting breastfeeding mothers.

Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced its participation in the Lytham Partners Summer 2021 Investor Conference from June 14-16, 2021. The company will present on June 14, starting at 3:30 PM ET. Interested parties can access the webcast here. Lipocine focuses on metabolic and endocrine disorders, with notable products in its pipeline including TLANDO and LPCN 1144, aimed at treating testosterone deficiencies and non-cirrhotic NASH, respectively.

On May 26, 2021, Lipocine (NASDAQ: LPCN) announced the U.S. District Court for Delaware granted Clarus Therapeutics' motion for Summary Judgment, invalidating Lipocine's patents 9,034,858; 9,205,057; 9,480,690; and 9,757,390 due to inadequate written description. Despite this setback, Lipocine continues to affirm the strength of its intellectual property and is evaluating further actions. The company’s pipeline includes TLANDO and LPCN 1144, with various clinical studies underway for treating metabolic and endocrine disorders.

Clarus Therapeutics achieved a significant legal victory as Federal Circuit Judge William C. Bryson ruled in favor of Clarus, invalidating all patent claims asserted by Lipocine, Inc. (NASDAQ: LPCN). The court found Lipocine's claims lacked adequate written description. The lawsuit stemmed from Lipocine's 2019 infringement allegations related to Clarus's FDA-approved testosterone product, JATENZO. Clarus's Chairman, Dr. Robert Dudley, expressed satisfaction with the ruling and indicated the company would continue to focus on expanding its product pipeline.

Lipocine Inc. (NASDAQ: LPCN) reported its first-quarter financial results for 2021, showcasing positive developments in its clinical programs. The company achieved significant results in the Phase 2 LiFT clinical study for LPCN 1144, successfully meeting primary endpoints in male NASH subjects. They raised approximately $28.7 million in a public offering and reported a reduced net loss of $3.4 million, improving from $5.8 million year-over-year. Research and administrative expenses also declined, while unrestricted cash reached $50 million, a notable increase from the previous quarter.

Lipocine Inc. (NASDAQ: LPCN) has announced its participation in two upcoming virtual investor conferences. The M Vest LLC and Maxim Group Emerging Growth Virtual Conference will take place on March 18-19, 2021, with Lipocine presenting on March 17 at 9:00 AM ET. The Lytham Partners Spring 2021 Investor Conference is scheduled for March 30-April 1, 2021, with a presentation on March 30 at 5:00 PM ET. Details and webcasts of the presentations will be available on Lipocine's corporate website.

Lipocine Inc. (NASDAQ: LPCN) announced its financial results for the year ending December 31, 2020, reporting a net loss of $21.0 million, or ($0.38) per diluted share, compared to a loss of $13.0 million in 2019. The company received tentative FDA approval for TLANDO, its oral testosterone product, and reported positive results from the Phase 2 LiFT study for LPCN 1144. Research and development expenses increased to $9.7 million, while general and administrative expenses rose to $8.2 million. As of December 31, 2020, Lipocine had $19.7 million in unrestricted cash.

Lipocine Inc. (NASDAQ: LPCN) announced the publication of preclinical results supporting LPCN 1144's potential in treating non-alcoholic steatohepatitis (NASH) and hepatic fibrosis. The study, featured in the Journal of Endocrinological Investigation, demonstrated LPCN 1144's effectiveness in a high-fat diet-induced NASH rabbit model. Lipocine is advancing LPCN 1144 through clinical trials, with a Phase 2 study ongoing. The company focuses on metabolic and endocrine disorders, with an FDA-approved product pipeline including TLANDO and TLANDO XR.

Lipocine Inc. (Nasdaq: LPCN) announced that clinical data on its lead candidate, TLANDO™, will be presented at the ENDO 2021 Conference from March 20-23, 2021. TLANDO is an oral testosterone replacement therapy for adult males with hypogonadism. Key presentations include assessments on liver health interventions and efficacy/safety of TLANDO. The FDA has given tentative approval for TLANDO to treat testosterone deficiency. Lipocine's pipeline also includes LPCN 1144, TLANDO XR, LPCN 1148, and LPCN 1107.