Biofrontera: FDA tetapkan PDUFA 28 Sep 2026 untuk sNDA Ameluz pada sBCC

FDA menerima sNDA untuk Ameluz PDT pada karsinoma sel basal superfisial dan menetapkan tanggal aksi target PDUFA 28 September 2026. Hal ini menetapkan titik keputusan regulasi jangka pendek yang berpotensi memperluas indikasi yang disetujui untuk platform Ameluz PDT.

Fakta utama

Diajukan: 14 Mei 2026, 12.00
Peristiwa: Tanggal PDUFA ditetapkan
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 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