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. (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.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced its participation in two upcoming virtual investor conferences: the Raymond James 42nd Annual Institutional Investors Conference from March 1-3, 2021, and the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. Lipocine will present at the Raymond James conference on March 1 at 11:40 AM EST, with a webcast available. The H.C. Wainwright session will begin on March 9 at 7:00 AM EST. The presentations will also be archived for 90 days on the company's website.
Lipocine Inc. (NASDAQ:LPCN) announced the closing of an underwritten public offering of 16,428,571 shares at $1.75 each, generating approximately $28.7 million in gross proceeds. This offering included the full exercise of underwriters' options for 2,142,857 additional shares. The shares were issued under an effective shelf registration statement and the transaction was managed by Raymond James & Associates, Inc. and Ladenburg Thalmann & Co. Inc. Lipocine focuses on metabolic and endocrine disorders and has several drug candidates in its clinical pipeline.
Lipocine (NASDAQ:LPCN) priced a public offering of 14,285,714 shares at $1.75 each, expected to close around January 28, 2021. The offering could generate approximately $25 million in gross proceeds. Underwriters hold a 30-day option for an additional 2,142,857 shares. Proceeds will primarily support general corporate purposes, including working capital. Raymond James is the sole book-running manager, with Ladenburg Thalmann as co-manager. The offering is conducted under an effective registration statement with the SEC.
Lipocine Inc. (NASDAQ: LPCN) announced plans for an underwritten public offering of its common stock. The offering will also allow underwriters a 30-day option to purchase an additional 15% of the shares offered. The net proceeds are intended for general corporate purposes, including working capital and capital expenditures. This offering is made under an effective shelf registration statement previously filed with the SEC. There’s no assurance regarding the completion or specific terms of the offering due to market conditions.
Lipocine Inc. (NASDAQ: LPCN) announced that the USPTO's Patent Trial and Appeal Board declared Interference No. 106,128 involving Lipocine's patent application against Clarus Therapeutics' application. The USPTO withdrew the Clarus application as part of this process. This decision continues a trend of favorable outcomes for Lipocine, following previous interferences that resulted in the cancellation of Clarus patents. Lipocine's CEO, Dr. Mahesh Patel, expressed satisfaction with the PTAB's ruling, which reinforces the strength of Lipocine's patent portfolio.
Lipocine Inc. (NASDAQ: LPCN) reported positive topline results from its Phase 2 LiFT study of LPCN 1144, an oral testosterone prodrug, in male subjects with biopsy-confirmed non-cirrhotic NASH. The study, involving 56 subjects, showed robust liver fat reduction and improved liver injury markers at 12 weeks, with no tolerability issues. LPCN 1144 demonstrated a significant average reduction in liver fat of up to 46.9% and over 63% of patients achieving a >30% reduction. An open label extension study is set to collect additional data up to 72 weeks.
Lipocine Inc. (NASDAQ: LPCN) announced its participation in the H.C. Wainwright BioConnect 2021 Conference, scheduled virtually from January 11-14, 2021. A webcast of their presentation will be accessible on-demand starting 6:00 am ET, January 11, for 90 days.
Lipocine is focused on metabolic and endocrine disorders and has several products in its pipeline, including TLANDO, which has received tentative FDA approval for hypogonadism. Other products under development address conditions like non-cirrhotic NASH and recurrent preterm birth.