Record mula sa primary source
Decision-gradeTopline na resulta
Inaasahan ang topline readout ng Phase 3 ng Lipocine LPCN 1154 sa unang bahagi ng Abril 2026
The last patient completed the final study visit in the confirmatory Phase 3 safety and efficacy trial of LPCN 1154 for postpartum depression in February 2026. Topline results are now expected early April 2026. If positive, the data are intended to support a 505(b)(2) NDA submission in mid-2026.
Mahahalagang fact
- Na-file
- Mar 10, 2026, 10:13 AM
- Kaganapan
- Topline na resulta
- Direksyon
- Neutral
- Kumpanya
LPCNLipocine Inc.- Asset
- LPCN 1154
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- N
- 90
- phase
- 3
- post hoc N
- 54
- primary result
- not met
- post hoc day 30
- -5.3 (P < 0.05)
- post hoc hour 12
- -7.2 (P < 0.001)
- post hoc hour 60
- -6.1 (P < 0.01)
- primary endpoint
- HAM-D17 total score at hour 60
Sipi mula sa source
EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Lipocine Announces Financial Results for the Full Year Ended December 31, 2025 SALT LAKE CITY, March 10, 2026 — 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 full year ended December 31, 2025 and provided a corporate update. “We believe 2025 was a pivotal year for Lipocine as we continue to advance our pipeline and expand our market presence. The progress we’ve made, especially with our postpartum depression therapeutic, LPCN 1154, demonstrates the strength of our science and our team’s commitment to delivering more effective treatments for patients in need,” said Dr Mahesh Patel, Lipocine
Higit pa tungkol sa asset na ito
Kapansin-pansin
Set 14, 2026
10:15 AM
LPCNLipocine Inc.Sinimulan ng Lipocine ang pag-aaral ng BLOOM Phase 3 ng LPCN 1154 sa PPD