Lipocine Inc Stock Price, News & Analysis

Lipocine Inc. (NASDAQ: LPCN) announced positive results from its Open Label Extension (OLE) study for LPCN 1144, an oral testosterone prodrug. The study, involving 25 subjects over 72 weeks, showed LPCN 1144 was well tolerated, with no safety signals reported. Key liver injury markers like ALT and AST were significantly reduced and maintained during treatment. Additionally, liver histology improvements support further development of LPCN 1144 as a treatment for Nonalcoholic Steatohepatitis (NASH). The company plans to discuss pivotal study design with the FDA.

Lipocine Inc. (NASDAQ: LPCN) announced its Q1 2022 financial results with a net loss of $3.5 million, consistent with the previous year. R&D expenses rose to $1.9 million due to ongoing clinical studies for LPCN 1148 and related projects. General and administrative costs decreased to $1.2 million. The company maintains $42 million in cash and equivalents, down from $46.6 million at the end of 2021. TLANDO™ received FDA approval with a commercial launch expected in Q2 2022, while Phase 2 studies for LPCN 1148 and LPCN 1144 are progressing.

Lipocine Inc. (NASDAQ: LPCN) announced the appointment of Jill M. Jene, Ph.D. and Spyros Papapetropoulos, M.D., Ph.D. to its board of directors on April 11, 2022. Dr. Jene brings over 20 years of biopharmaceutical experience, having facilitated over $6 billion in transactions. Dr. Papapetropoulos has a strong background in neuroscience and biopharmaceutical development. The company focuses on neuroendocrine and metabolic disorders, with a pipeline that includes products like TLANDO and LPCN 1148, targeting various conditions associated with testosterone deficiency and liver cirrhosis.

On March 29, 2022, Lipocine announced that its partner, Antares Pharma, received FDA approval for TLANDO™ (testosterone undecanoate), an oral testosterone replacement therapy for adult males with hypogonadism. This approval marks a significant milestone for Lipocine, which licensed the U.S. commercialization rights for TLANDO. The commercial launch is anticipated in Q2 2022, providing patients with a new, convenient treatment option. Lipocine continues to focus on developing innovative therapies for neuroendocrine and metabolic disorders while expanding its pipeline of drug candidates.

Lipocine Inc. (NASDAQ: LPCN) reported significant financial updates for the year ending December 31, 2021, including a net loss of $634,399, a reduction from a previous loss of $21 million. The company recognized $16.1 million in revenue, primarily from licensing fees related to TLANDO. R&D expenses decreased to $7.7 million, while general and administrative expenses fell to $5.3 million, mainly due to reduced legal and personnel costs. Lipocine also highlighted advancements in its clinical programs, including the initiation of a Phase 2 study for LPCN 1148 and an FDA-approved study for LPCN 1154.

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.