Lipocine Inc. - LPCN STOCK NEWS

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.

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.

Lipocine Inc. (Nasdaq: LPCN) announced that the FDA has affirmed the resubmission of its NDA for TLANDO® as a Class 1 resubmission, which entails a two-month review period. TLANDO, an oral testosterone product, received tentative approval in December 2020 for treating hypogonadism in adult males. The final approval and marketing will depend on the expiration of exclusivity for Clarus Therapeutics' Jatenzo®, set for March 27, 2022. The NDA resubmission is anticipated on January 28, 2022, as part of the FDA's regulatory pathway.

Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical firm specializing in metabolic disorders, will present at the Cantor Fitzgerald Virtual Global Healthcare Conference from September 27-30, 2021. The company's presentation is scheduled for September 30, 2021, at 1:20 p.m. EST, available via webcast. Lipocine’s product pipeline includes TLANDO, LPCN 1144, and others aimed at various endocrine disorders, with TLANDO receiving FDA tentative approval for hypogonadism. The webcast will be accessible on Lipocine's website for 90 days post-presentation.