Recent 8-K filings for LPCN
Highest-materiality recent filing
Lipocine's LPCN 1154 Phase 3 PPD trial misses primary endpoint; post hoc signals
- Primary endpoint not met: no statistically significant HAM-D17 reduction vs placebo at hour 60 in full population (N=90).
- Post hoc analysis of participants with psychiatric history (n=54) showed nominal significant reductions from hour 12 through day 30.
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Lipocine Presents Phase 3 Data for LPCN 1154 (Oral Brexanolone) for Postpartum Depression at ASCP
May 26, 2026: Company highlighted results from placebo-controlled Phase 3 trial of LPCN 1154 for PPD at ASCP Annual Meeting.
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Lipocine LPCN 1154 Phase 3 data accepted for oral presentation at 2026 ASCP meeting
Phase 3 data for LPCN 1154 (oral brexanolone) for postpartum depression accepted for oral and poster presentation at ASCP Annual Meeting May 26-29, 2026 in Miami, FL.
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Lipocine misses Q1 EPS estimates; LPCN 1154 PPD Phase 3 fails primary endpoint
Net loss of $3.7M ($0.52/share) vs $1.9M loss ($0.35) in Q1 2025; cash $24.7M.
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Lipocine's LPCN 1154 Phase 3 PPD trial misses primary endpoint; post hoc signals
Primary endpoint not met: no statistically significant HAM-D17 reduction vs placebo at hour 60 in full population (N=90).
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Lipocine reports FY2025 net loss of $9.6M; cash $14.9M; PPD Phase 3 topline due April 2026
Net loss of $9.6M ($1.69/diluted) vs $8K net income in FY2024; revenue fell to $2.0M from $11.2M.
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Lipocine files $50M ATM equity facility with A.G.P./Alliance Global Partners
Filed prospectus supplement on Feb 26, 2026 for sale of up to $50M common stock via ATM.
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Lipocine completes last patient last visit in Phase 3 trial of LPCN 1154 for PPD
Last patient completed final visit in pivotal Phase 3 trial of LPCN 1154 (oral brexanolone) for postpartum depression.
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90 patients randomized in double-blind, placebo-controlled Phase 3 trial of LPCN 1154 (oral brexanolone) for PPD.
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Lipocine: Phase 3 PPD trial passes second DSMB safety review; topline data due Q2 2026
DSMB reviewed safety data from 82 randomized patients; recommended trial continue without modification.
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Lipocine reports promising interim safety for LPCN 1154 in Phase 3 PPD trial; topline Q2 2026
DSMB review after one-third of planned 80 participants (n=30) recommended continuation as planned without modification.
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Lipocine Q3 net loss widens to $3.2M; cash drops to $15.1M; PPD trial on track
Net loss of $3.2M ($0.59/sh) vs $2.2M loss ($0.44/sh) in Q3 2024.
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Lipocine LPCN 1154 Phase 3 PPD trial: 1/3 randomized; topline 2Q26; DSMB review 4Q25
One-third of planned patients randomized in LPCN 1154 Phase 3 trial for postpartum depression.
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Lipocine delays LPCN 2401 POC study, seeks FDA clarity on endpoints
Received IND clearance for LPCN 2401 as adjunct to GLP-1 therapy.
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Lipocine Q2 net loss narrows to $2.2M; Phase 3 PPD study underway
Net loss of $2.2M ($0.41/diluted share) vs $3.1M loss year ago; cash $17.9M at quarter end.
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First patient dosed in pivotal Phase 3 trial of LPCN 1154 (oral brexanolone) for postpartum depression; top line data expected Q2 2026.
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Lipocine's partner Verity Pharma files New Drug Submission for TLANDO in Canada
Over 700,000 annual TRT prescriptions in Canada, representing large opportunity.
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Lipocine Q1 net loss $1.9M; starts Phase 3 for PPD drug LPCN 1154
Net loss $1.9M ($0.35 diluted share) vs net income $3.5M ($0.66) in Q1 2024.
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Lipocine licenses TLANDO in Brazil; oral testosterone market grew 34% CAGR 2019-2023
Exclusive license and supply agreement with Aché Laboratórios for TLANDO in Brazil.
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Lipocine initiates Phase 3 outpatient PPD trial of LPCN 1154; dosing expected Q2 2025
Initiation of randomized, blinded, placebo-controlled Phase 3 trial of LPCN 1154 for PPD; first patient dosing expected Q2 2025.
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Lipocine reports near-breakeven 2024; FDA requires Phase 3 for oral brexanolone
Net income of ~$8,400 vs net loss of $16.4M in 2023; revenue of $11.2M from license/royalty fees.
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FDA removes Boxed Warning for testosterone products after TRAVERSE trial benefits Lipocine
FDA removes Boxed Warning on cardiovascular risk for all testosterone products based on TRAVERSE trial.
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FDA requires Phase 3 efficacy/safety study for Lipocine's LPCN 1154 in PPD
FDA advised that an efficacy and safety study in target population is needed for 505(b)(2) NDA submission, beyond prior PK bridge data.
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FDA grants Fast Track Designation to Lipocine for LPCN 1148 in decompensated cirrhosis sarcopenia
FDA Fast Track Designation granted to LPCN 1148 for sarcopenia in decompensated cirrhosis, an unmet medical need.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.50 · Most common event other_material