1차 출처 기록
결정급탑라인 결과
Lipocine LPCN 1154 3상 톱라인 결과, 2026년 4월 초 발표 예정
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.
핵심 사실
- 제출
- 2026년 3월 10일 AM 10:13
- 이벤트
- 탑라인 결과
- 방향
- 중립
- 출처
- SEC 8-K
- 신뢰도
- 출처 확인
- 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
출처 발췌
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