Lipocine Announces Financial Results for the Full Year Ended December 31, 2024 [Yahoo! Finance]
Lipocine Inc. (LPCN)
Last lipocine inc. earnings: 11/12 04:00 pm
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Source: Yahoo! Finance
to augment therapeutics through effective oral delivery, today announced financial results for the year ended December 31, 2024 , and provided a corporate update. (PRNewsfoto/Lipocine Inc.) Oral Brexanolone LPCN 1154 is an oral formulation of the neuroactive steroid brexanolone that Lipocine is developing for the rapid treatment of postpartum depression (PPD). Lipocine held a meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2025 to discuss the NDA submission package for LPCN 1154 (oral brexanolone) as a treatment for PPD. In the meeting, Lipocine was advised that the FDA believes that, in addition to the previously completed PK bridge data, a safety and efficacy study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission. Based on observed comparable exposure of LPCN 1154 and the reference drug in the PK bridge study, the company is initiating a phase 3 safety and efficacy study with expected first patient dose
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News
- Lipocine's PPD Phase 3 Study (LPCN 1154) Hits 80% Enrollment Milestone [Yahoo! Finance]Yahoo! Finance
- Lipocine's PPD Phase 3 Study (LPCN 1154) Hits 80% Enrollment MilestonePR Newswire
- Lipocine (NASDAQ:LPCN) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Lipocine (NASDAQ:LPCN) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Lipocine Highlights Promising Interim Safety Profile in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD) [Yahoo! Finance]Yahoo! Finance
LPCN
Sec Filings
- 12/16/25 - Form 8-K
- 12/15/25 - Form 8-K
- 12/11/25 - Form 8-K
- LPCN's page on the SEC website