Biofrontera:FDAがsBCCにおけるAmeluz sNDAのPDUFA日を2026年9月28日に設定

FDA accepted the sNDA for Ameluz PDT in superficial basal cell carcinoma and assigned a PDUFA target action date of September 28, 2026. This establishes a near-term regulatory decision point that could expand the approved indications for the Ameluz PDT platform.

主要事実

提出: 2026年5月14日 12:00
イベント: PDUFA 日設定
方向: ポジティブ
企業: BFRIBiofrontera Inc.
アセット: Ameluz
出典: SEC 8-K
信頼度: 出典あり
カレンダー: FDA 審査決定 (PDUFA) · 2026年9月28日 · 承認

出典の抜粋

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