Every 8-K that Lipocine Inc. (LPCN) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow LPCN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full LPCN filings page.
Lipocine Inc. (LPCN) filed a report stating that on September 16, 2026 it presented at the H.C. Wainwright 28th Annual Global Investor Conference in New York City, held September 14–16, 2026. The company furnished its conference presentation as Exhibit 99.1 and incorporated it by reference into this report.
The filing also lists a Cover Page Interactive Data File as Exhibit 104. No financial results, guidance, or transactional events are described; the disclosure centers on making Lipocine’s investor presentation publicly available to the market.
Lipocine Inc. (LPCN) announced the initiation of BLOOM, a Phase 3 outpatient study of LPCN 1154, an oral brexanolone candidate for postpartum depression, with approximately 120 participants and first dosing expected in early Q4 2026. LPCN 1154 is being developed as a 48-hour, at-home treatment aimed at rapid symptom relief.
BLOOM incorporates U.S. FDA feedback and is designed to support a potential New Drug Application under the 505(b)(2) pathway, using the same dosing regimen and a HAM-D17 primary endpoint at 60 hours. The design adds site- and data-quality controls and prespecified sensitivity analyses, following a prior Phase 3 trial that did not meet its primary endpoint but showed exploratory efficacy signals when data from one anomalous high-enrolling site were excluded; those findings are described as exploratory and non-confirmatory. Lipocine reports $23.3 million in unrestricted cash, cash equivalents and marketable securities as of June 30, 2026 and expects existing resources to fund BLOOM, with anticipated average cash use of about $1 million per month during study execution.
Lipocine Inc. (LPCN) reported that on September 8, 2026 it agreed with A.G.P./Alliance Global Partners to modify the compensation terms under their existing Sales Agreement dated April 26, 2024. The Sales Agent’s fee on sales made under this agreement will be up to 3.0%, subject to further adjustment by Lipocine and the Sales Agent.
Lipocine Inc. (LPCN) announced that management 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, in New York City. The company’s presentation is scheduled for September 16, 2026, at 10:00 a.m.
The presentation will be webcast live, with a replay available in the Events section of Lipocine’s website for 90 days. Lipocine describes itself as a specialty biopharmaceutical company developing orally delivered therapeutics, with a pipeline including candidates for postpartum depression, major depressive disorder, epilepsy, essential tremor, obesity management, liver cirrhosis symptoms, and prevention of preterm birth, as well as TLANDO, an FDA‑approved oral testosterone prodrug for hypogonadism.
Lipocine Inc. (LPCN) filed an amendment to report that its Board of Directors appointed Michael Grissinger to serve as a member of the Compensation Committee. The Board made this committee appointment on August 18, 2026, following his earlier appointment to the Board reported on August 3, 2026.
For his additional duties on the Compensation Committee, Mr. Grissinger is eligible to receive an extra $7,500 per year in compensation. The report is signed by President and Chief Executive Officer Mahesh V. Patel on August 21, 2026.
Lipocine Inc. reported Q2 2026 results highlighted by increased liquidity and ongoing investment in its development pipeline. As of June 30, 2026, it held $23.3 million in unrestricted cash, cash equivalents and marketable investment securities, up from $14.9 million at December 31, 2025. For the quarter, net loss was $2.6 million, or ($0.32) per diluted share, compared with a net loss of $2.2 million, or ($0.41) per diluted share, a year earlier. Royalty revenue from TLANDO was $190,099, versus $122,849 in Q2 2025.
For the first half of 2026, total revenue was $309,496, consisting entirely of TLANDO royalties, compared with $716,713 in the prior-year period, which included $500,000 of license revenue. Net loss for the six months was $6.3 million, or ($0.84) per diluted share, versus $4.1 million, or ($0.76) per share, in 2025, reflecting higher research and development expenses of $4.8 million tied primarily to the LPCN 1154 Phase 3 study and increased personnel costs, as well as modestly higher general and administrative expenses. Lipocine continues to advance an oral therapeutics pipeline including LPCN 1154 for postpartum depression and several candidates targeting major depressive disorder, epilepsy, essential tremor, obesity management, liver cirrhosis symptoms and prevention of preterm birth.
Lipocine Inc. expanded its Board of Directors to five members and appointed Michael J. Grissinger as a director, effective August 3, 2026. The board determined that he qualifies as an independent director under Nasdaq listing standards.
Upon joining, Grissinger receives an initial stock option grant to purchase 2,000 shares of Lipocine common stock and an annual non-employee director cash retainer of $55,000. He brings extensive business development and M&A experience from senior roles at Johnson & Johnson and prior work at Ciba-Geigy, and currently serves on several public biotech boards.
Lipocine describes a pipeline of orally delivered drug candidates, including programs in postpartum depression, major depressive disorder, epilepsy, essential tremor, obesity management, liver cirrhosis, and preterm birth, alongside its FDA-approved oral testosterone product TLANDO. The company furnished a press release detailing the appointment and its strategic rationale.
Lipocine Inc. filed a report describing a virtual key opinion leader event held on June 12, 2026. The event focused on unmet medical needs in postpartum depression and reviewed the clinical profile of the company’s investigational product candidate LPCN 1154.
The related slide presentation was furnished as Exhibit 99.1 and is incorporated by reference. Lipocine notes that a link to the presentation is available on its corporate website, giving investors and clinicians access to the detailed discussion from the event.
Lipocine Inc. held its annual shareholder meeting on June 3, 2026 and approved the Sixth Amended and Restated 2014 Stock and Incentive Plan. The amendment raises individual award limits from 25,000 to 100,000 shares and increases available common stock awards by 400,000 shares, so the plan now authorizes up to 1,000,000 shares in total. Shareholders re-elected four directors and ratified Tanner LLC as independent registered public accountants for the fiscal year ending December 31, 2026. They also approved a say‑on‑pay advisory vote on executive compensation, the amended stock and incentive plan, and an adjournment proposal to continue soliciting votes on these matters.
Lipocine Inc. filed an 8-K announcing a virtual Key Opinion Leader event focused on postpartum depression and its investigational oral therapy LPCN 1154 (BRLIZIO™). The webcast will be held on Friday, June 12, 2026 at 11:00 AM Eastern Time and feature leading psychiatrists discussing unmet needs in postpartum depression and Phase 3 topline results for LPCN 1154.
LPCN 1154 is an oral formulation of brexanolone designed to deliver bioequivalent exposure to intravenous ZULRESSO® over 48 hours at home, without medical monitoring. In a Phase 3 trial, a subgroup analysis excluding an epidemiologic outlier site showed clinically meaningful, statistically significant efficacy with 100% dosing-period completion and no treatment-related serious adverse events. LPCN 1154 is not yet FDA approved; BRLIZIO™ is a conditionally approved brand name.
Lipocine Inc. filed a current report describing a scientific presentation rather than a financial event. On May 26, 2026, the company presented Phase 3 clinical data for LPCN 1154, an oral brexanolone candidate for treating postpartum depression, at the American Society of Clinical Psychopharmacology Annual Meeting in Miami Beach.
The presentation and a related scientific poster, which summarize results from a placebo-controlled Phase 3 clinical trial in postpartum depression, are included as Exhibits 99.1 and 99.2 to the report and incorporated by reference for full clinical details.
Lipocine Inc. filed a current report describing a scientific milestone for its postpartum depression program. The company announced that Phase 3 clinical data for its oral brexanolone candidate LPCN 1154 have been selected for both oral and poster presentation at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami.
The oral presentation, titled “Novel Oral Rapid-Acting Neuroactive Steroid for Treatment of Postpartum Depression: A Placebo-Controlled Phase 3 Clinical Trial of LPCN 1154,” is scheduled for May 26, 2026. A related poster will be presented on May 27, 2026. Lipocine highlights LPCN 1154 as a non-SSRI, oral formulation of brexanolone designed as a rapid-acting treatment for postpartum depression with potential at-home use and no intensive monitoring requirement, and notes prior data suggesting improved tolerability and low central nervous system depressant side effects.
Lipocine Inc. filed a current report to note that its management will participate in a fireside chat at A.G.P.’s Annual Virtual Healthcare Company Showcase on Wednesday, May 20, 2026, at 3:00 PM.
The attached press release also highlights Lipocine’s oral drug-delivery focused pipeline, which includes candidates for postpartum depression, major depressive disorder, epilepsy, essential tremor, obesity management, liver cirrhosis symptoms, and prevention of preterm birth, as well as its FDA-approved oral testosterone product TLANDO for hypogonadism.
Lipocine Inc.
Lipocine Inc. reported first quarter 2026 results and a key clinical update. The Phase 3 trial of LPCN 1154, an oral brexanolone for postpartum depression, did not meet its primary endpoint of improving Hamilton Depression Rating Scale scores versus placebo at hour 60 in the full analysis set.
The drug was generally well tolerated with no treatment-related serious adverse events, excessive sedation, loss of consciousness, or treatment-related discontinuations. A post hoc analysis in participants with a history of psychiatric conditions showed statistically significant and clinically meaningful HAM-D improvements versus placebo, and Lipocine has applied for breakthrough therapy and fast track designations while evaluating next steps.
Financially, as of March 31, 2026, Lipocine held $24.7 million in unrestricted cash, cash equivalents and marketable investment securities. The company generated $119,397 in TLANDO royalty revenue and recorded a net loss of $3.7 million, or $(0.54) per diluted share, compared with a net loss of $1.9 million, or $(0.35) per share, a year earlier, largely driven by higher research and development spending on LPCN 1154.
Lipocine Inc. reported that on April 16, 2026, Dr. Spyros Papapetropoulos resigned from its Board of Directors effective immediately. He had served since 2022 as Chairman, Lead Independent Director, and a member of the Board’s compensation committee.
The company stated that Dr. Papapetropoulos resigned due to competing professional commitments and evolving board dynamics arising from differing views on Lipocine’s strategic direction. On April 20, 2026, the Board appointed R. Dana Ono as the new Chairman of the Board and Lead Independent Director, ensuring continuity in independent board leadership.
Lipocine Inc. reported topline Phase 3 results for LPCN 1154, an oral brexanolone, in postpartum depression. The study did not meet its primary endpoint, as LPCN 1154 failed to show a statistically significant improvement in HAM-D total score versus placebo at hour 60 in the full analysis set.
Despite missing the primary endpoint, LPCN 1154 was well tolerated, with a favorable safety profile supporting outpatient use and no treatment-related serious adverse events, excessive sedation, loss of consciousness, or treatment-related discontinuations. A post hoc analysis of patients with a history of psychiatric conditions showed signals that may inform a potential development path. Based on these data, Lipocine has applied for breakthrough therapy and fast track designations and plans to preserve capital while engaging stakeholders to evaluate options, which may include further LPCN 1154 work, other pipeline programs, or strategic transactions.
Lipocine Inc. reported full-year 2025 results with revenue of $2.0 million and a net loss of $9.6 million, compared with revenue of $11.2 million and net income of $8,352 in 2024. The revenue decline mainly reflects lower license revenue, partly offset by higher TLANDO royalty revenue.
Research and development expenses rose to $8.6 million from $7.4 million as the company increased clinical and personnel spending, while general and administrative expenses declined to $3.8 million from $5.0 million due to lower professional, legal, tax and insurance costs. As of December 31, 2025, Lipocine held $14.9 million in unrestricted cash, cash equivalents and marketable investment securities, which increased to approximately $24.7 million as of March 6, 2026, primarily from an at-the-market stock offering.
The company highlighted progress in its pipeline, including candidates for postpartum depression, major depressive disorder, epilepsy, essential tremor, obesity management, liver cirrhosis symptoms and preterm birth prevention, alongside TLANDO, an FDA-approved oral testosterone product.
Lipocine Inc. has activated a stock sales program that lets it issue and sell up to $50,000,000 of common stock through A.G.P./Alliance Global Partners as its sales agent. These shares may be sold from time to time into the market under an existing equity distribution agreement first signed in April 2024.
The company also provided a legal opinion from Dorsey & Whitney LLP confirming the validity of the shares to be issued under this arrangement.
Lipocine Inc. filed a current report to make available an updated corporate presentation used in meetings with investors, analysts and other stakeholders. The updated presentation is included as Exhibit 99.1 to the report. Lipocine’s common stock, par value $0.0001 per share, trades on The NASDAQ Stock Market LLC under the symbol LPCN.
Lipocine Inc. reported preliminary cash and cash equivalents of approximately $19 million as of January 31, 2026, based on unaudited internal estimates. The company also announced that the last patient has completed the final study visit in its pivotal Phase 3 trial of LPCN 1154, an oral brexanolone candidate for treating postpartum depression.
The randomized, double-blind, placebo-controlled study enrolled 90 women with severe postpartum depression, with an average baseline HAM-D score of 28.3. LPCN 1154 showed a favorable safety profile, with only mild to moderate nervous system adverse events and no drug discontinuations, excessive sedation, loss of consciousness, or drug-related serious adverse events.
The single confirmatory outpatient Phase 3 trial is expected to support a planned 505(b)(2) NDA submission in 2026. Lipocine highlights LPCN 1154’s short 48-hour oral treatment regimen and at-home administration as potential advantages over existing postpartum depression therapies.
Lipocine Inc. reported that it has completed enrollment and dosing in its Phase 3 clinical trial of LPCN 1154 for postpartum depression. This means all planned participants have entered the study and received the investigational treatment, marking a key operational milestone for the program. The update was shared through a press release, which is included as an exhibit to this report.
Lipocine Inc. filed a current report stating that it has updated the corporate presentation it uses in meetings with investors, analysts, and other audiences. The updated presentation is included as Exhibit 99.1 to the report, making the materials publicly available through the SEC system. This filing does not announce a specific transaction or financial results, but formally records that new investor presentation materials are now on file.
Lipocine Inc. filed a report describing clinical progress for its investigational drug LPCN 1154 in postpartum depression. On January 12, 2026, the company issued a press release stating there was encouraging progress following the second interim safety review in its Phase 3 trial of LPCN 1154. The press release is provided as an exhibit to the report and is incorporated by reference.
Lipocine Inc. filed a current report to share progress on its clinical development program. On December 16, 2025, the company issued a press release stating that Lipocine’s PPD Phase 3 Study (LPCN 1154) has reached 80% enrollment. This means most of the planned participants for the Phase 3 clinical study have been enrolled, marking a notable step toward completing patient recruitment.
The press release describing this enrollment milestone is furnished as Exhibit 99.1, while a cover page interactive data file is included as Exhibit 104. Lipocine’s common stock, with par value $0.0001 per share, trades on the Nasdaq Stock Market under the symbol LPCN.
Lipocine Inc. reported that board member Jeffrey Fink has informed the Board of Directors that he will resign from the board effective January 1, 2026, for personal reasons. The company states that his resignation is not the result of any disagreement with the company on any matter, which suggests no underlying dispute or conflict is driving the change. The board plans to conduct a search for a new director to fill the upcoming vacancy.
Lipocine Inc. reported that it presented scientific posters on its epilepsy drug candidate LPCN 2101 at the American Epilepsy Society Annual Meeting in Atlanta. The company highlighted clinical pharmacokinetics and tolerability data for this novel oral GABA A receptor positive allosteric modulating candidate for epilepsy, along with oral toxicokinetics data for a bioidentical GABA A receptor modulating neuroactive steroid anti-seizure medication candidate for women with epilepsy.
The posters are furnished as Exhibits 99.1 and 99.2 to the report, giving readers more detail on how LPCN 2101 behaves in the body and how well it was tolerated in the studies described.
Lipocine Inc. (LPCN) filed a current report to announce that it has updated the corporate presentation it uses in meetings with investors, analysts and other stakeholders. The updated materials are being made publicly available as Exhibit 99.1 to this report. By filing the presentation, the company is providing broader market access to the same information it shares in its investor meetings.
Lipocine Inc. (LPCN) reported that it has issued a press release highlighting a promising interim safety profile for its investigational drug LPCN 1154 in a Phase 3 clinical trial for postpartum depression (PPD). The company describes these findings as interim safety results, meaning the study is still ongoing but, so far, the treatment has shown a favorable safety profile in participants.
The press release containing more detail is furnished as Exhibit 99.1 to this report and is incorporated by reference, while no specific efficacy data or numerical safety outcomes are provided in this summary. The update signals continued clinical progress of LPCN 1154 in a late-stage trial targeting postpartum depression, a serious mood disorder affecting women after childbirth.
Lipocine Inc. (LPCN) furnished an 8-K announcing it issued a press release with financial and operational results for the quarter ended September 30, 2025. The release is attached as Exhibit 99.1 and incorporated by reference. The company states the information under Item 2.02, including Exhibit 99.1, is furnished and not deemed “filed” for purposes of Section 18 of the Exchange Act.
Lipocine Inc. filed an 8-K stating it issued a press release announcing presentation of LPCN 2401 clinical data at ObesityWeek in Atlanta, GA, held November 4–7. The company furnished the press release as Exhibit 99.1, incorporating it by reference. This is a disclosure of a scientific presentation and does not detail financial metrics or transactions.
Lipocine Inc. filed a current report describing a new press release about the company’s drug candidate LPCN 1154. The release provides a progress update on the ongoing Phase 3 clinical trial evaluating LPCN 1154 for the treatment of postpartum depression. The report itself does not detail the trial results or timelines but directs readers to the attached press release, which is included as an exhibit and incorporated by reference.
Lipocine Inc. reported that it has updated the corporate presentation it uses with investors, analysts and other audiences. The update reflects the current status of LPCN 2401, a program being developed as an adjunct to GLP-1 therapy.
The company has received IND clearance to proceed with a proof-of-concept study of LPCN 2401, but is first seeking regulatory clarity on the development path, including study endpoints such as functional loss, before moving forward with the study. The revised investor presentation has been filed as Exhibit 99.1 to this report.
Lipocine Inc. filed a current report to announce that the company will present and meet with investors at the H.C. Wainwright 27th Annual Global Investor Conference. The event is scheduled for September 8–10, 2025, in New York City. The company furnished a press release with additional details as Exhibit 99.1 to the report.
Lipocine Inc. filed an 8-K reporting a material event: the company submitted a presentation as Exhibit 99.1 for the H.C. Wainwright 27th Annual Global Investor Conference and included the interactive cover page Exhibit 104 in Inline XBRL format. The filing is signed by Mahesh V. Patel, President and Chief Executive Officer, and is dated September 5, 2025. The filing does not include earnings, financial tables, or other material transaction disclosures; it documents public investor-facing presentation materials being made available.
Lipocine Inc. reported that scientific abstracts related to its program designated LPCN 2101 have been accepted for presentation at the 2025 American Epilepsy Society annual meeting. The conference is scheduled for December 5–9, 2025, in Atlanta, Georgia. Lipocine furnished the related press release as Exhibit 99.1 to this report.
On 9 July 2025 Lipocine Inc. (NASDAQ: LPCN) filed a Form 8-K under Item 8.01 – Other Events. The sole disclosure is that the company hosted a virtual key-opinion-leader (KOL) event focused on LPCN 1154 (BRLIZIO™) as a potential treatment for postpartum depression. A webcast link and slide deck are available on the corporate website, and the materials have been furnished as Exhibit 99.1.
Under Item 9.01 the filing lists Exhibit 104 (Inline XBRL cover page). No financial metrics, clinical trial results, or transactional details accompany the notice. The document is signed by President & CEO Mahesh V. Patel.
This 8-K signals continued development and external engagement around LPCN 1154 but provides no new quantitative data likely to affect near-term valuation.
Lipocine (NASDAQ:LPCN) filed an 8-K announcing that the first patient has been dosed in its Phase 3 clinical trial of LPCN 1154 for postpartum depression. The disclosure, furnished under Item 8.01 with the press release attached as Exhibit 99.1, marks the transition of LPCN 1154 into late-stage development—an essential step toward potential NDA submission and commercialization. No changes to financial guidance, funding, or corporate strategy were reported, and Items 2.02, 5.02 or other sections were not included. While the filing contains no revenue figures, the milestone may accelerate future catalysts such as data read-outs, regulatory meetings and partnership discussions that could materially influence valuation.