Biofrontera：FDA为Ameluz sNDA在sBCC的PDUFA日期定于2026年9月28日

FDA已受理Ameluz PDT用于浅表基底细胞癌的sNDA，并指定2026年9月28日为PDUFA目标行动日期。这确立了一个近期监管决策点，可能扩大Ameluz PDT平台的获批适应症。

关键事实

申报时间: 2026年5月14日 12:00
事件: PDUFA 日期确定
方向: 积极
公司: BFRIBiofrontera Inc.
资产: Ameluz
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年9月28日 · 已批准

来源摘录

EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Biofrontera Inc. Reports First Quarter 2026 Financial Results and Provides a Business Update Woburn, MA (May 14, 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 months ended March 31, 2026 and provided a business update. First Quarter Financial Highlights ● Revenues for Q1 2026 were $10.1 million, a ~17% increase compared to $8.6 million for the same period in 2025. ● Gross margins were about 80%, an 18 percentage points increase compared to approximately 62% in Q1 2025, reflecting the first full quarter under the new earnout structure following

SEC 8-K