Lipocine

LPCN

Market cap $62.5M

Company on track to report topline results early in the second quarter of 2026 Second planned Data and Safety Monitoring Board (DSMB) meeting evaluated all available safety data for the 82 randomized No drug discontinuations, excessive sedation, loss of consciousness, or drug-related SAEs reported Study is no longer screening new participants SALT LAKE CITY, Jan. 12, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD. This was the second of two DSMB reviews planned during the study.

Second Drug Safety Monitoring Board (DSMB) meeting update planned for mid-January 2026 Topline results on track for the second quarter of 2026 SALT LAKE CITY , Dec. 16, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced 80% completion of enrollment in the ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD, with 66 of the 80 planned study participants randomized. In addition, the second of two independent Data Safety Monitoring Board reviews is planned for early-January 2026.

Per the Drug Safety Monitoring Board (DSMB) meeting evaluating one-third of planned participants, study to continue as planned More than half of planned participants have completed dosing with no dose reductions, discontinuations, drug-related SAEs, loss of consciousness, or excessive sedation reported Topline results are on track for the second quarter of 2026 SALT LAKE CITY , Nov. 18, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD. This was the first of two DSMB reviews planned during the study and conducted after approximately one-third of planned 80 participants completed at least the day seven follow-up visit (n=30).

Lipocine (LPCN) came out with a quarterly loss of $0.59 per share versus the Zacks Consensus Estimate of a loss of $0.56. This compares to a loss of $0.44 per share a year ago.

SALT LAKE CITY , Nov. 6, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the third quarter ended September 30, 2025 and provided a corporate update. Neuroactive Steroids (NAS) LPCN 1154 for Postpartum Depression (PPD) LPCN 1154 (oral brexanolone) is a non-invasive, rapid onset, oral formulation of the neuroactive steroid brexanolone that Lipocine is developing for the treatment of PPD.

SALT LAKE CITY , Nov. 4, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced the presentation of a poster Treatment with Oral LPCN 2401, a Physiological Regulator of Myostatin, Rapidly Improves Body Composition in Men with Obesity at the ObesityWeek® annual meeting, taking place in Atlanta, Ga., November 4 to 7.

One-Third of Patients Randomized; Topline Results Expected in 2Q 2026 DSMB Safety Review Update Planned for 4Q 2025 SALT LAKE CITY , Sept. 30, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today provided an update on its ongoing pivotal Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD).

SALT LAKE CITY , Sept. 5, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that Company Management will present and meet with investors at the H.C.

SALT LAKE CITY , Aug. 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that two abstracts related to LPCN 2101 have been accepted for poster presentation at the 2025 American Epilepsy Society (AES) annual meeting to be held December 5-9 in Atlanta, Georgia.  LPCN 2101 is in development for the potential treatment of epilepsy.

SALT LAKE CITY , Aug. 5, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced financial results for the second quarter ended June 30, 2025 and provided a corporate update. Neuroactive Steroids LPCN 1154 (oral brexanolone product candidate) is a non-invasive, 48-hour treatment option targeted for rapid symptom relief of postpartum depression (PPD), a serious unmet medical need.