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. (NASDAQ: LPCN) announced that the FDA is working towards action on TLANDO's New Drug Application (NDA) during the week of December 7, 2020, but cannot guarantee timely action. TLANDO is an oral testosterone product candidate for testosterone replacement therapy in adult males with hypogonadism. The company has also resubmitted its NDA for TLANDO, which is currently under review. Lipocine's pipeline includes several product candidates aimed at metabolic and endocrine disorders.
Lipocine Inc. (NASDAQ: LPCN) reported its Q3 2020 financial results, revealing a net loss of $4.3 million, up from $3.1 million in Q3 2019. R&D expenses increased to $2.5 million, primarily due to clinical study costs related to LPCN 1144. The company completed patient enrollment for the LPCN 1144 Phase 2 study, with top-line results due in January 2021. Cash resources grew to $18.8 million from $14.1 million at the end of 2019. Additionally, general and administrative expenses rose to $1.9 million, influenced by increased legal and personnel costs.
Lipocine Inc. (NASDAQ: LPCN) announced that the FDA is expected to take action on its TLANDO New Drug Application (NDA) around November 30, 2020. TLANDO is an oral testosterone product aimed at treating hypogonadism in adult males. The company has resubmitted its NDA, which is currently under FDA review. Lipocine's pipeline also includes other drug candidates like LPCN 1144 and TLANDO XR. However, the company warns that the FDA may not meet the expected timeline and that approval is not guaranteed.
Lipocine Inc. (NASDAQ: LPCN) announced it will present results from a preclinical study on LPCN 1144, targeting hepatic fibrosis and NASH, at The Liver Meeting Digital Experience™ on November 13, 2020. The study showed that LPCN 1144 significantly improved histological scores and reduced fibrosis in a high fat diet-induced model. Additionally, Lipocine completed enrollment for its Phase 2 clinical study, LiFT, with top-line results expected in January 2021. The positive preclinical data suggest potential therapeutic benefits of LPCN 1144 for patients with NASH.
Lipocine Inc. (NASDAQ: LPCN) announced its upcoming presentations at the 21st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America on November 9, 2020. The presentations will cover research indicating low testosterone levels may adversely affect COVID-19 outcomes in men and the safety and efficacy of TLANDO™, an oral testosterone therapy requiring no dose titration. Recent studies highlight that 80% of men who died from COVID-19 had low testosterone levels. TLANDO demonstrated effectiveness in restoring testosterone without dose adjustments in a prior clinical study.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, will present an update on its product LPCN 1144 at the virtual H.C. Wainwright 4th Annual NASH Investor Conference on October 5, 2020, from 3:30 PM to 4:00 PM Eastern Time. LPCN 1144, an oral bioidentical testosterone, is being evaluated for treating non-cirrhotic NASH. The presentation will discuss recent clinical findings and future development plans. The company is also advancing other products in its pipeline, including TLANDO and LPCN 1107.
Lipocine Inc. (NASDAQ: LPCN) announced enrollment completion of its Phase 2 LiFT study, investigating LPCN 1144 for non-cirrhotic NASH. The study involved 56 male patients and aims to evaluate liver fat reductions. Initial results are expected in January 2021, with further data in mid-2021. LPCN 1144 has previously shown promise in reducing liver fat without major tolerability issues in over 700 hypogonadal subjects. The company expresses optimism regarding the study amidst the COVID-19 pandemic.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, has announced its participation in the 22nd HC Wainwright Annual Global Investment Conference from September 14-16, 2020. A corporate update will be presented on September 14 at 12 noon Eastern Time. Interested parties can view the presentation via webcast and register at hcwevents.com. Lipocine is focused on metabolic and endocrine disorders, with products like TLANDO aimed at restoring testosterone levels in men.
Lipocine Inc. (NASDAQ: LPCN) has announced that the FDA requires more time to review TLANDO's NDA, extending the anticipated PDUFA goal date of August 28, 2020. The FDA has not requested additional data and expects to finish its review in the coming weeks. TLANDO is an oral testosterone product for adult males with testosterone deficiency. Lipocine's pipeline also includes LPCN 1144, TLANDO XR, LPCN 1148, and LPCN 1107, focusing on metabolic and endocrine disorders.
Lipocine Inc. (NASDAQ: LPCN) reported financial results for Q2 2020, highlighting a net loss of $6.4 million, or ($0.13) per share, up from a $3.4 million loss in Q2 2019. R&D expenses rose to $2.3 million, driven by costs for LPCN 1144's Phase 2 study. General administrative costs increased to $2.0 million, largely due to legal fees from ongoing lawsuits. The company has $18.3 million in unrestricted cash as of June 30, 2020. Upcoming milestones include a PDUFA target date of August 28, 2020, for TLANDO's NDA and the initiation of the LPCN 1144 Phase 2 LiFT study.