Welcome to our dedicated page for Lipocine news (Ticker: LPCN), a resource for investors and traders seeking the latest updates and insights on Lipocine stock.
Lipocine Inc. develops biopharmaceutical products using a proprietary technology platform for effective oral drug delivery. News about LPCN centers on clinical development of LPCN 1154, an oral brexanolone product candidate for postpartum depression, including trial progress, safety reviews and reported efficacy results.
Company updates also cover TLANDO, Lipocine’s oral testosterone replacement therapy, and related license, supply and distribution arrangements in multiple territories. Recurring financial news includes research and development spending, royalty revenue from TLANDO sales, pipeline prioritization and corporate presentations tied to the company’s oral-delivery programs.
Lipocine Inc. (LPCN) announced that the FDA has granted Fast Track Designation to LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis (NASH). LPCN 1144, an oral prodrug of bioidentical testosterone, showed significant liver fat reduction and improved liver injury markers in the Phase 2 clinical study. The Fast Track Designation allows for more frequent communication with the FDA, potential Accelerated Approval, and Rolling Review of the New Drug Application. NASH affects a significant portion of the U.S. population, with no approved treatments available currently.
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Lipocine has entered an exclusive licensing agreement with Antares Pharma to commercialize TLANDO in the U.S., bringing Lipocine up to $21 million in licensing fees. This includes an immediate payment of $11 million and potential future payments of $10 million based on conditions. Commercial milestone payments can reach $160 million along with tiered royalties on net sales. TLANDO is a testosterone replacement therapy that has received tentative FDA approval, with final approval expected after March 27, 2022.
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.