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) 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.
Power Metallic (TSXV: PNPN) reported results from its 2025 summer drill campaign and spring Lion zone program, including a total of 17,250 metres drilled across multiple targets and five returned Lion holes.
Key assay highlights: PML-25-015 returned 28.00 m @ 4.28% CuEq (including 1.90 m @ 17.68% CuEq); PML-25-020 returned 22.66 m @ 4.57% CuEq including 6.05 m @ 9.70% CuEq; PML-25-014 intersected 9.44 m @ 1.01–1.46% CuEq in the disseminated zone. All drilled holes hit sulphide-bearing structures and many received BHEM surveys. The company also bid on newly available Quebec lands and expects bid registration within 30–90 days.
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.