Biofrontera: Tinanggap ng FDA ang sNDA para sa Ameluz PDT sa sBCC; PDUFA Sept 2026

Ayon sa press release, nakumpleto ng FDA ang pagsusuri ng filing at tinanggap ang sNDA para sa Ameluz PDT sa superficial basal cell carcinoma. Itinatakda ng pagtanggap na ito ang target action date ng PDUFA sa Setyembre 2026, na nagpapabuti sa regulatory path para sa bagong indikasyon na ito.

Mahahalagang fact

Na-file: Mar 19, 2026, 01:35 PM
Kaganapan: Tinanggap ang aplikasyon
Direksyon: Positibo
Kumpanya: BFRIBiofrontera Inc.
Asset: Ameluz
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Set 28, 2026 · Inaprubahan

Sipi mula sa source

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