Lipocine Inc Stock Price, News & Analysis

Lipocine (NASDAQ: LPCN) presented Phase 2 clinical data for oral LPCN 2401 at ObesityWeek® (Nov 4–7, 2025). The poster reports 20‑ and 36‑week results showing increases in lean mass, reductions in fat mass and improved FM/LM ratio versus placebo. LPCN 2401 and LPCN 2401+vitamin E produced rapid liver benefits (ALT/AST reductions starting at 4–8 weeks) and significant MRI‑PDFF liver fat reductions by 12 weeks that were maintained through week 36. LPCN 2401 was reported as well tolerated with no concerning safety signals through 72 weeks.

Lipocine (NASDAQ: LPCN) reported progress in its pivotal Phase 3 clinical trial for LPCN 1154, an oral brexanolone treatment for postpartum depression (PPD). The trial has reached a significant milestone with one-third of planned patients randomized, and topline results are expected in Q2 2026.

The company plans to provide a safety update in Q4 2025 following a Data Safety Monitoring Board (DSMB) review. The trial is being conducted in an outpatient setting without required medical monitoring, following FDA feedback. LPCN 1154 features a 48-hour dosing schedule and aims to provide rapid, meaningful clinical benefits. Lipocine plans to submit a 505(b)(2) NDA in 2026.

Lipocine (NASDAQ: LPCN), a biopharmaceutical company focused on innovative oral drug delivery, will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025. The company's presentation will be available starting September 5, 2025, at 7:00 a.m. EDT.

The conference will be held in both in-person and virtual formats. Investors interested in one-on-one meetings with Lipocine management should coordinate through their H.C. Wainwright representatives.

Lipocine (NASDAQ: LPCN) has announced that two abstracts for their drug candidate LPCN 2101, being developed for epilepsy treatment, have been accepted for poster presentation at the 2025 American Epilepsy Society (AES) annual meeting in Atlanta, Georgia, December 5-9.

The presentations will focus on the oral toxicokinetics and clinical pharmacokinetics of LPCN 2101, a GABA A receptor modulating neuroactive steroid. The first presentation is scheduled for December 7, and the second for December 8, 2025. The abstracts are currently under embargo until November 24, 2025.

Lipocine (NASDAQ: LPCN) reported Q2 2025 financial results, highlighting a net loss of $2.2 million ($0.41 per share) and cash position of $17.9 million. The company's key developments include progress in their LPCN 1154 Phase 3 trial for postpartum depression treatment and plans to initiate a Phase 2 study for LPCN 2401 in obesity management.

Revenue for Q2 2025 included $123,000 in TLANDO royalties and $500,000 in license revenue. The company expanded TLANDO's global reach through partnerships with Aché Laboratórios for Brazil and Verity Pharma's NDS filing in Canada. Operating expenses showed improved efficiency with reduced G&A costs of $0.9 million, down from $1.5 million in Q2 2024.

Lipocine (NASDAQ: LPCN) has initiated dosing in its pivotal Phase 3 clinical trial for LPCN 1154, an oral brexanolone treatment for postpartum depression (PPD). The trial is being conducted in an outpatient setting without required medical monitoring, following FDA feedback.

The two-arm, randomized, blinded study will evaluate LPCN 1154 against placebo in women aged 15+ with severe PPD, featuring a 48-hour dosing period. The primary endpoint measures changes in the Hamilton Depression Rating Scale (HAM-D). The company expects top-line results in Q2 2026 and plans an NDA submission by mid-2026.

Lipocine Inc. (NASDAQ: LPCN) announced a virtual R&D investor event scheduled for July 9, 2025, focusing on LPCN 1154 (BRLIZIO™) for postpartum depression (PPD) treatment. The event will feature Dr. Kristina M. Deligiannidis from Zucker Hillside Hospital and company management discussing PPD treatment landscape and unmet needs. LPCN 1154, a bioidentical neuroactive steroid, is being developed as a potential first-line treatment for PPD with rapid symptom relief. The drug aims to provide a 48-hour treatment duration through oral administration in an outpatient setting. The event will include updates on clinical programs, regulatory status, and development progress, including details on an ongoing Phase 3 registrational study with expected results in Q2-2026.

Lipocine (NASDAQ: LPCN) announced that its licensing partner Verity Pharma has filed a New Drug Submission (NDS) for TLANDO in Canada. TLANDO is the first FDA-approved oral testosterone replacement therapy (TRT) that doesn't require dose titration. The Canadian market presents a significant opportunity with over 700,000 annual TRT prescriptions, with approximately 50% of patients covered by private insurance. The limited promotional activities for existing TRTs in Canada could provide TLANDO an opportunity to capture substantial market share. This submission follows a January 2024 exclusive licensing agreement between Lipocine and Verity Pharma for TLANDO's commercial rights in the US and Canada.

Lipocine's (NASDAQ: LPCN) development candidate LPCN 1148 for treating men with cirrhosis has been featured in the June 2025 edition of Hepatology's "Highlights" section. The article discusses Phase 2 trial results for this "First in Class" product candidate, which targets overt hepatic encephalopathy and sarcopenia indications. The trial involved a 24-week randomized study comparing oral LPCN 1148 to placebo.

The FDA has granted fast track designation to LPCN 1148 for treating sarcopenia in patients with decompensated cirrhosis. The company is currently seeking partnership opportunities for LPCN 1148. The treatment represents a novel approach, as current sarcopenia treatment in cirrhosis is limited to diet and exercise.