Lipocine Receives Updated Regulatory Guidance on LPCN 1154 [Yahoo! Finance]
Lipocine Inc. (LPCN)
Last lipocine inc. earnings: 11/12 04:00 pm
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Source: Yahoo! Finance
In This Article LPCN SALT LAKE CITY Feb. 6, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced receipt of revised regulatory guidance for LPCN 1154 which the Company is developing for postpartum depression (PPD) treatment. As previously disclosed, the Company was scheduled to meet with the U.S. Food and Drug Administration (FDA or the Division) in Q1 2025 to discuss the NDA submission package of LPCN 1154. Following the meeting, the Company was advised that the Division believes, in addition to the previously completed PK bridge data, an efficacy and safety study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission. (PRNewsfoto/Lipocine Inc.) Lipocine remains committed to advancing a rapid relief treatment for postpartum depression. Based on the guidance received and observed comparable exposure
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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