Biofrontera：FDA 受理 Ameluz PDT 用於 sBCC 的 sNDA；PDUFA 目標日期為 2026 年 9 月

新聞稿指出，FDA 已完成申報審查並受理 Ameluz PDT 用於表淺性基底細胞癌的 sNDA。此受理將 PDUFA 目標行動日期定為 2026 年 9 月，推進此新適應症的監管程序。

關鍵事實

申報時間: 2026年3月19日下午01:35
事件: 申請已受理
方向: 正面
公司: BFRIBiofrontera Inc.
資產: Ameluz
來源: SEC 8-K
可信度: 有出處
行事曆: FDA 審查決定 (PDUFA) · 2026年9月28日 · 已核准

來源摘錄

EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Biofrontera Inc. Reports Record Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update Conference call will be held today, Thursday, March 19 at 10:00 am ET Woburn, MA (March 19, 2026) (GLOBE NEWSWIRE) — Biofrontera Inc. (NASDAQ:BFRI) (the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the three and twelve months ended December 31, 2025 and provided a business update. Fourth Quarter Financial Highlights ● Revenues for 4Q25 were a record $17.1 million, a 36% increase compared to $12.6 million for the same period in 2024. ● Gross margins were 82.4%, a roughly 2,400 basis point year over y

SEC 8-K