Lipocine Inc Stock Price, News & Analysis

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.

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.