一次情報の記録
重要申請受理
Biofrontera: FDA、sBCC向けAmeluz PDTのsNDAを受理; PDUFAは2026年9月
プレスリリースによると、FDAは提出審査を完了し、表在性基底細胞癌に対するAmeluz PDTのsNDAを受理した。この受理により、2026年9月のPDUFA目標アクション日が設定され、この新適応症の規制経路が前進する。
主要事実
出典の抜粋
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