Biofrontera: FDA menerima sNDA untuk Ameluz PDT pada sBCC; PDUFA September 2026

Siaran pers menyatakan bahwa FDA telah menyelesaikan tinjauan pengajuan dan menerima sNDA untuk Ameluz PDT pada karsinoma sel basal superfisial. Penerimaan ini menetapkan tanggal aksi target PDUFA pada September 2026, memajukan jalur regulasi untuk indikasi baru ini.

Fakta utama

Diajukan: 19 Mar 2026, 13.35
Peristiwa: Permohonan diterima
Arah: Positif
Perusahaan: BFRIBiofrontera Inc.
Aset: Ameluz
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 28 Sep 2026 · Disetujui

Kutipan sumber

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