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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Shareholders approve Lipocine stock plan amendment; authorized shares raised to 1M
Shareholders approved Sixth Amended and Restated 2014 Stock Plan on June 3, 2026.
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Lipocine to host virtual KOL event on LPCN 1154 for postpartum depression on June 12, 2026
Virtual KOL event focused on unmet needs in postpartum depression and clinical profile of LPCN 1154 (oral brexanolone).
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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 to present at A.G.P. Annual Virtual Healthcare Showcase on May 20
Fireside chat scheduled for 3:00 PM ET on Wednesday, May 20, 2026.
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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 updates corporate presentation; no material new information disclosed
Company updated its corporate presentation, filed as Exhibit 99.1 to this 8-K.
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Lipocine director Spyros Papapetropoulos resigns; R. Dana Ono appointed Chairman
Spyros Papapetropoulos resigned from Lipocine Board effective April 16, 2026, citing competing commitments and differing views on strategic direction.
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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 updates corporate presentation; no material new details disclosed in filing
Company filed an 8-K on April 2, 2026, stating it updated its corporate presentation used with investors.
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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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Lipocine updates corporate presentation; no material new details disclosed
Filed an updated corporate presentation under Item 8.01.
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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 updates corporate presentation; no material details in filing
Lipocine updated its corporate presentation used in investor meetings.
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Lipocine's PPD Phase 3 study hits 80% enrollment; DSMB review in Jan 2026
66 of 80 planned participants randomized in Phase 3 trial of LPCN 1154 for postpartum depression.
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Director Jeffrey Fink resigns from Lipocine Board effective Jan 1, 2026
Jeffrey Fink informed the Board on Dec 12, 2025 of his resignation effective Jan 1, 2026 for personal reasons.
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Lipocine presents LPCN 2101 posters at AES meeting; no specific data disclosed
Posters for LPCN 2101, a GABA A receptor PAM candidate for epilepsy, presented at AES Annual Meeting Dec 5-9, 2025.
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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 files updated corporate presentation; no material facts disclosed in filing
Company filed an updated investor presentation as Exhibit 99.1 to its November 18, 2025 8-K.
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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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In Phase 2 trial, LPCN 2401 increased lean mass, reduced fat mass, and improved fat-to-lean ratio vs placebo at 20 and 36 weeks.
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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 to present at H.C. Wainwright conference; no new material updates filed
Presenting at H.C. Wainwright 27th Annual Global Investor Conference, Sept 8-10, 2025, in NYC.
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Lipocine to Present at H.C. Wainwright Conference Sept 8-10, 2025
Company management will present and hold 1x1 meetings at H.C. Wainwright 27th Annual Global Investment Conference in New York.
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Lipocine announces LPCN 2101 abstracts accepted for AES 2025 annual meeting
Two LPCN 2101 abstracts accepted for poster presentation at AES 2025 (Dec 5-9, Atlanta).
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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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Lipocine hosts KOL event on LPCN 1154 (BRLIZIO™) for postpartum depression
Virtual key opinion leader event held July 9, 2025, for LPCN 1154 (BRLIZIO™).
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Lipocine updates corporate presentation; no material details available
Routine update to investor presentation; no new financial guidance or product data provided.
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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 to host R&D event July 9, 2025 on LPCN 1154 for postpartum depression; Phase 3 data Q2 2026
Virtual R&D investor event on July 9, 2025 at 11 AM ET to discuss LPCN 1154 (BRLIZIO) for postpartum depression (PPD).
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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 shareholders approve reduction in authorized shares from 200M to 75M
Authorized common stock reduced from 200M to 75M shares; Certificate of Amendment filed June 4, 2025.
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Lipocine's LPCN 1148 for cirrhosis highlighted in Hepatology journal
LPCN 1148 for men with cirrhosis featured in 'Hepatology Highlights' in June 2025 edition of Hepatology.
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Lipocine to present at A.G.P. Annual Healthcare Company Showcase on May 21, 2025
Presentation at 4:00 pm ET on May 21, 2025; virtual event hosted by A.G.P.
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Lipocine updates corporate presentation; no financial results or material news disclosed
Corporate presentation filed as Exhibit 99.1; no specific changes quantified.
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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 updates corporate presentation; no material news
Corporate presentation refreshed for investor and analyst meetings.
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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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Lipocine updates corporate presentation; no material new information disclosed
Filed an updated corporate presentation used for investor meetings.
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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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Lipocine updates corporate investor presentation; no specific changes disclosed
Filed updated corporate presentation as Exhibit 99.1 used with investors and analysts.
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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.
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Lipocinc updates corporate presentation for investor meetings
Company filed an updated corporate presentation as Exhibit 99.1 to 8-K.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.50 · Most common event other_material