Lipocine Inc Stock Price, News & Analysis

Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, will present at the H.C. Wainwright 5th Annual NASH Investor Conference on October 12, 2021, at 3:30 pm ET. The company focuses on metabolic and endocrine disorders and has a pipeline that includes TLANDO, LPCN 1144, and LPCN 1107, among others. TLANDO has received FDA tentative approval for treating hypogonadism in adult males. A webcast of the presentation will be available on the company’s website for 90 days.

Lipocine Inc. (Nasdaq: LPCN) announced that the FDA has affirmed the resubmission of its NDA for TLANDO® as a Class 1 resubmission, which entails a two-month review period. TLANDO, an oral testosterone product, received tentative approval in December 2020 for treating hypogonadism in adult males. The final approval and marketing will depend on the expiration of exclusivity for Clarus Therapeutics' Jatenzo®, set for March 27, 2022. The NDA resubmission is anticipated on January 28, 2022, as part of the FDA's regulatory pathway.

Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical firm specializing in metabolic disorders, will present at the Cantor Fitzgerald Virtual Global Healthcare Conference from September 27-30, 2021. The company's presentation is scheduled for September 30, 2021, at 1:20 p.m. EST, available via webcast. Lipocine’s product pipeline includes TLANDO, LPCN 1144, and others aimed at various endocrine disorders, with TLANDO receiving FDA tentative approval for hypogonadism. The webcast will be accessible on Lipocine's website for 90 days post-presentation.

Lipocine Inc. (NASDAQ: LPCN) will present at the H.C. Wainwright 23rd Annual Global Investment Conference virtually from September 13-15, 2021. The presentation is scheduled for September 13, 2021, starting at 7:00 a.m. EST. Investors can access the webcast through the conference portal or Lipocine's website. The presentation will be available on-demand for 90 days. Lipocine focuses on metabolic and endocrine disorders, with products like TLANDO and LPCN 1144 addressing various testosterone-related conditions.

Lipocine Inc. (NASDAQ: LPCN) announced positive topline results from its Phase 2 LiFT clinical study of LPCN 1144 in men with biopsy-confirmed NASH. The study met its primary endpoint, demonstrating a statistically significant reduction in liver fat after 12 weeks, with a mean absolute reduction of 9.2% and a relative reduction of 46.8% compared to placebo. Both treatment arms also showed significant improvements in NASH without worsening fibrosis and favorable safety profiles. The company is planning to discuss potential accelerated approval with the FDA.

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.