Biofrontera: FDA define 28 de set de 2026 PDUFA para sNDA do Ameluz em sBCC

A FDA aceitou a sNDA para o Ameluz PDT no carcinoma basocelular superficial e atribuiu a data-alvo de ação PDUFA de 28 de setembro de 2026. Isso estabelece um ponto de decisão regulatória de curto prazo que poderia expandir as indicações aprovadas para a plataforma Ameluz PDT.

Fatos principais

Arquivado: 14 de mai. de 2026, 12:00
Evento: Data PDUFA definida
Direção: Positivo
Empresa: BFRIBiofrontera Inc.
Ativo: Ameluz
Fonte: SEC 8-K
Confiança: Com fonte
Calendário: Decisão da FDA (PDUFA) · 28 de set. de 2026 · Aprovado

Trecho da fonte

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