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. develops biopharmaceutical products using a proprietary technology platform for effective oral drug delivery. News about LPCN centers on clinical development of LPCN 1154, an oral brexanolone product candidate for postpartum depression, including trial progress, safety reviews and reported efficacy results.
Company updates also cover TLANDO, Lipocine’s oral testosterone replacement therapy, and related license, supply and distribution arrangements in multiple territories. Recurring financial news includes research and development spending, royalty revenue from TLANDO sales, pipeline prioritization and corporate presentations tied to the company’s oral-delivery programs.
Lipocine (Nasdaq:LPCN) will host a virtual KOL webinar on June 12, 2026 at 11:00 AM ET to highlight unmet needs in postpartum depression (PPD) and the clinical profile of LPCN 1154 (BRLIZIO™), its investigational oral brexanolone.
The event features expert presentations, Phase 3 topline data review, and a Q&A session.
Lipocine (NASDAQ:LPCN) announced that Phase 3 clinical data for LPCN 1154, an oral brexanolone for postpartum depression, were accepted for oral and poster presentation at the 2026 ASCP Annual Meeting in Miami.
The oral talk is scheduled for May 26, 2026, with a poster on May 27, 2026.
Lipocine (NASDAQ:LPCN), a biopharmaceutical company focused on oral drug delivery, announced that management will participate in a fireside chat at A.G.P.'s Annual Virtual Healthcare Company Showcase on bWednesday, May 20, 2026 at 3:00 PM ET
Investors can register online and view the fireside chat.
Lipocine (NASDAQ: LPCN) reported Q1 2026 results and a corporate update on May 7, 2026. The company had $24.7M in unrestricted cash and marketable securities at March 31, 2026, versus $14.9M at December 31, 2025. Net loss was $3.7M ($0.52/share).
In April 2026, Phase 3 topline results for oral brexanolone LPCN 1154 in postpartum depression did not meet the primary endpoint; the product was well tolerated and showed positive post hoc results in participants with a psychiatric history. Lipocine applied for breakthrough and fast track designations and is evaluating development and strategic options. TLANDO licensing and distribution agreements remain in place.
Lipocine (NASDAQ: LPCN) reported topline Phase 3 results for LPCN 1154 in postpartum depression (PPD) on April 2, 2026. In the full analysis set (N=90) the primary endpoint at hour 60 was not met. LPCN 1154 was well tolerated with no treatment-related SAEs and no excessive sedation.
In a post hoc subset (n=54) with a history of psychiatric conditions, nominally significant and clinically meaningful HAM-D reductions appeared as early as hour 12 and persisted through day 30. The company has applied for FDA breakthrough and fast track designations and will evaluate next steps.
Lipocine (NASDAQ: LPCN) reported full-year 2025 results and a corporate update on March 10, 2026. Key financials: $14.9M cash at Dec 31, 2025, $2.0M revenue, and a $9.6M net loss for 2025. Cash later increased to $24.7M as of March 6, 2026 due to an ATM offering.
Clinical highlights include completion of Last Patient/Last Visit for the confirmatory Phase 3 study of LPCN 1154 in PPD in Feb 2026, topline results expected early April 2026, and potential 505(b)(2) NDA submission mid-2026 if successful. Development continues across LPCN 2201, 2101 and 2401.
Lipocine (NASDAQ: LPCN) announced completion of Last Patient Last Visit in its pivotal Phase 3 trial of LPCN 1154 (oral brexanolone) for postpartum depression on Feb 18, 2026. The randomized, double-blind, placebo-controlled study enrolled 90 patients with severe PPD (average baseline HAM-D 28.3).
The company reported a positive safety profile: all nervous system adverse events were mild-to-moderate, with no drug discontinuations, excessive sedation, loss of consciousness, or drug-related serious adverse events. LPCN 1154 achieved bio-equivalent systemic exposure to intravenous brexanolone; efficacy results are pending.
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.