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. (NASDAQ: LPCN) is a biopharmaceutical company that publicly describes itself as leveraging a proprietary technology platform to develop therapeutics with effective oral delivery. News about Lipocine often centers on clinical trial milestones, regulatory interactions, and partnering activity related to its oral drug candidates.
A key focus of recent news is LPCN 1154, an oral formulation of brexanolone in development for the potential treatment of postpartum depression (PPD). Company press releases highlight the initiation of a pivotal Phase 3 trial, first patient dosing, enrollment progress, interim safety reviews by an independent Data Safety Monitoring Board, and plans to use Phase 3 data to support a 505(b)(2) NDA submission. Updates also describe the outpatient design of the trial and its target population of women with severe PPD.
News flow also covers LPCN 2401, an oral proprietary anabolic androgen receptor agonist being evaluated in obesity‑related settings. Lipocine has reported Phase 2 clinical data showing changes in body composition and liver‑related measures in men with obesity and metabolic dysfunction associated steatohepatitis, and has presented these data at the ObesityWeek meeting. Additional releases discuss regulatory status and development plans for proof‑of‑concept studies.
Other recurring topics include LPCN 2101 for the potential treatment of epilepsy, with announcements about abstract acceptances and poster presentations at the American Epilepsy Society annual meeting, as well as corporate updates on financial results, TLANDO licensing and royalty revenue, and participation in investor conferences. Investors and observers can use the LPCN news stream to follow clinical progress, safety updates, licensing developments, and strategic communications that the company files or references in its SEC reports.
Lipocine Inc. (NASDAQ: LPCN) announced positive FDA guidance regarding its drug LPCN 1144, aimed at treating nonalcoholic steatohepatitis (NASH) in non-cirrhotic men. The FDA confirmed that LPCN 1144 can be submitted via the 505(b)(2) pathway and that no additional nonclinical studies are necessary. Improvements were noted in NASH histopathology in phase 2 studies. The FDA suggested a phase 3 study duration of 72 weeks and requested updated protocols for review. CEO Dr. Mahesh Patel expressed satisfaction with the alignment on LPCN 1144's development plan.
Lipocine Inc. (NASDAQ: LPCN) announced that Antares Pharma has received FDA acceptance for the NDA resubmission of TLANDO®, a testosterone replacement therapy. The FDA classified the resubmission as Class 1, with a review period of two months, leading to a target action date of March 28, 2022. TLANDO® is an oral treatment for hypogonadism, previously granted tentative approval by the FDA. This resubmission could enable Lipocine to market TLANDO® in the U.S. after the exclusivity period for JATENZO® expires.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced the peer-reviewed publication of positive Phase 3 clinical data for TLANDO, an oral testosterone treatment for hypogonadism. The Dosing Validation study met its primary endpoint, successfully restoring testosterone levels in hypogonadal males. TLANDO is noted for its ease of use, with no titration required. The FDA has granted tentative approval for TLANDO for conditions related to testosterone deficiency. The results are published in Andrology and indicate potential advantages for both patients and physicians.
Lipocine Inc. (NASDAQ: LPCN) announced that at the upcoming 2022 NASH-TAG Conference in Park City, Utah, it will present one abstract as a podium presentation and three additional abstracts as poster presentations. The podium presentation titled 'LPCN 1144 Therapy Demonstrates Histologic Benefits in the Phase 2 LiFT Study in Nonalcoholic Steatohepatitis (NASH) Subjects' is scheduled for January 7, 2022. The poster presentations will include LPCN 1144’s effects on body composition and its safety and tolerability in NASH subjects. This showcases progress in LPCN's pipeline focused on metabolic disorders.
Lipocine Inc. (Nasdaq: LPCN) has initiated a Phase 2 clinical study (NCT04874350) for LPCN 1148, targeting liver cirrhosis management. The multi-center, randomized trial will assess skeletal muscle index changes in patients on the liver transplant list over 52 weeks. Key secondary endpoints include frailty, hospital admissions, and mortality rates. Primary results are anticipated in the latter half of 2022. The company aims to apply for Orphan Drug Designation to address significant unmet needs in cirrhosis treatment, impacting an estimated 630,000 Americans.
Lipocine Inc. (NASDAQ: LPCN) reported its financial results for Q3 and the first nine months of 2021, highlighting a net loss of $3.1 million, or ($0.03) per diluted share, compared to $4.3 million in Q3 2020. The company entered a licensing agreement with Antares Pharma for TLANDO, potentially earning up to $21 million. LPCN 1144 received FDA Fast Track Designation for NASH treatment, and Phase 2 results showed significant liver fat reduction. As of Sept 30, 2021, Lipocine had $38.7 million in cash and equivalents, up from $19.7 million at year-end 2020.
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.