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 (NASDAQ: LPCN) announced on January 20, 2026 that enrollment and dosing are complete in its pivotal Phase 3 trial of LPCN 1154 (oral brexanolone) for postpartum depression. A total of 90 patients were randomized. The company reported a favorable safety profile to date with no drug discontinuations, excessive sedation, loss of consciousness, or drug-related serious adverse events. Topline safety and efficacy results are expected early in Q2 2026, and data are planned to support a 505(b)(2) NDA submission in 2026. The trial is outpatient and does not require medical monitoring for dosing.
Lipocine (NASDAQ: LPCN) completed a second independent Data Safety Monitoring Board review of its ongoing Phase 3 trial of LPCN 1154 (oral brexanolone) for postpartum depression. The DSMB reviewed safety from 82 randomized participants (74 completed dosing) and recommended the trial continue without modification. There have been no treatment discontinuations, no drug-related serious adverse events reported, and no cases of excessive sedation or loss of consciousness to date. The study has stopped screening new participants but continues to enroll eligible, already-consented subjects. The company is on track to report topline safety and efficacy results early in Q2 2026.
Lipocine (NASDAQ: LPCN) announced that its Phase 3 trial of LPCN 1154 for postpartum depression has reached 80% enrollment, with 66 of 80 planned participants randomized as of Dec. 16, 2025. The company said topline results remain on track for Q2 2026.
The release notes a prior Data Safety Monitoring Board review that recommended the trial continue without modification and that a second DSMB meeting is planned for early January 2026.
Lipocine (NASDAQ:LPCN) reported third-quarter 2025 results and clinical program updates on November 6, 2025. The company had $15.1 million in unrestricted cash and marketable securities as of September 30, 2025 versus $21.6 million at year-end 2024.
Q3 results: net loss $3.2M (−$0.59/share); R&D expenses $2.7M; TLANDO royalty revenue $115k. Nine-month results: net loss $7.3M; revenue $831k (license revenue $500k; TLANDO royalties $331k).
Clinical: Phase 3 trial of LPCN 1154 for postpartum depression is enrolling; DSMB safety review and a safety update are planned in November 2025; top-line data expected Q2 2026 and a 505(b)(2) NDA submission is expected in 2026. The company is exploring partnerships for commercialization across programs.
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.
FAQ
What is the current stock price of Lipocine (LPCN)?
What is the market cap of Lipocine (LPCN)?
