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 (LPCN) has initiated BLOOM, a Phase 3 outpatient study of oral brexanolone candidate LPCN 1154 for severe postpartum depression, with first participant dosing expected in early Q4 2026.
The trial plans to enroll approximately 120 participants and is designed to support a potential New Drug Application under the 505(b)(2) pathway. BLOOM incorporates U.S. FDA feedback and learnings from a prior Phase 3 study that did not meet its primary endpoint but, in post hoc analyses excluding one anomalous high-enrolling site, suggested rapid and sustained symptom improvement; these findings are described as exploratory and non-confirmatory. The earlier trial reported no treatment-related severe or serious adverse events and no excessive sedation, loss of consciousness, or treatment discontinuations.
Lipocine expects its existing resources to fund BLOOM, with projected average cash use of about $1 million per month and $23.3 million in unrestricted cash, cash equivalents and marketable investment securities as of June 30, 2026.
Lipocine (LPCN)/b) will present and meet with investors at the H.C. Wainwright 28th Annual Global Investment Conference, held in person and virtually from September 14-16, 2026.The company’s presentation is scheduled for Wednesday, September 16, 2026, at 10:00 a.m. ET in New York, NY. A live webcast and replay will be available in the Events section of Lipocine’s website and will remain archived for 90 days. Investors can register for the conference and may request one-on-one meetings through their H.C. Wainwright representative.
Lipocine (NASDAQ: LPCN) reported second quarter 2026 net loss of $2.6 million, or $0.32 per diluted share, versus a $2.2 million loss a year earlier. Total Q2 revenue was $190,099, down from $622,849, reflecting absence of $500,000 in prior-year license revenue, while TLANDO royalty revenue increased to $190,099 from $122,849.
As of June 30, 2026, Lipocine held $23.3 million in unrestricted cash, cash equivalents and marketable securities, up from $14.9 million at year-end 2025. The Phase 3 trial of LPCN 1154 (Brlizio) in postpartum depression did not meet its primary endpoint, but a post hoc analysis excluding one outlier site suggested rapid, sustained symptom improvement. Lipocine has initiated a new placebo-controlled PPD trial, scheduled an FDA guidance meeting for Q3 2026, is planning Phase 2 protocols for LPCN 2201 (MDD) and LPCN 2203 (essential tremor), and reported UAE marketing authorization for TESTYRA (TLANDO) via partner Pharmalink.
Lipocine (NASDAQ: LPCN) appointed Michael J. Grissinger to its Board of Directors, effective August 3, 2026. The company develops therapeutics using a proprietary oral delivery technology platform.
Grissinger previously spent over two decades at Johnson & Johnson in senior roles leading worldwide pharmaceutical licensing, corporate development, and M&A, including heading Immunology business development and licensing. Earlier, he worked 12 years at Ciba-Geigy in finance, marketing, and business development. He currently serves on the boards of Aprea Therapeutics (Nasdaq: APRE) and Adicet Bio (Nasdaq: ACET), and advises several private biotech companies. According to Lipocine, his experience is expected to support advancement of its pipeline and partnership efforts.
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.