Lipocine Inc Stock Price, News & Analysis

Lipocine Inc. (NASDAQ: LPCN) announced its financial results for Q2 2021, reporting a net loss of $6.8 million or ($0.08) per diluted share, a reduction from a net loss of $6.4 million in Q2 2020. Research and development expenses decreased to $1.5 million, primarily due to reduced costs in the LPCN 1144 clinical study. Significant corporate highlights include positive topline results from the Phase 2 LiFT study, FDA clearance for LPCN 1154's IND, and an upcoming proof-of-concept study for postpartum depression.

Lipocine Inc. (NASDAQ: LPCN) announced a global settlement with Clarus Therapeutics to resolve ongoing intellectual property litigation. The agreement includes the dismissal of the Lipocine Inc. v Clarus Therapeutics, Inc. case in the U.S. District Court and the interference proceedings in the U.S. Patent and Trademark Office. Although the specific terms remain confidential, this development could allow Lipocine to focus more on its pipeline of drug candidates, including TLANDO and LPCN 1144, which are in various stages of clinical development for metabolic and endocrine disorders.

Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced its participation in the Ladenburg Thalmann Healthcare Conference on July 13, 2021, at 11:00 am ET. The conference will be held virtually, and interested parties can access the webcast here. Lipocine is focused on metabolic and endocrine disorders and has a pipeline including TLANDO, a testosterone treatment that has received FDA tentative approval. For further details, visit www.lipocine.com.

Lipocine Inc. (Nasdaq: LPCN) announced the presentation of clinical data at The International Liver Congress™ 2021 from June 23-26, 2021. The presentations will detail the efficacy of LPCN 1144 in reducing liver fat and improving body composition in non-alcoholic steatohepatitis (NASH) subjects. Key findings include significant reductions in liver injury markers and low testosterone levels in NASH patients. These results may highlight LPCN 1144's potential in treating liver health issues associated with low testosterone, enhancing Lipocine's clinical development pipeline.

Lipocine Inc. (NASDAQ: LPCN) announced its participation in the Raymond James Human Health Innovation Conference from June 21-23, 2021. The presentation is scheduled for June 21 at 12:40 PM ET. Interested parties can access the webcast here. The company focuses on metabolic and endocrine disorders, with key products including TLANDO, LPCN 1144, and others aimed at treating conditions such as hypogonadism and non-cirrhotic NASH.

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.