Record mula sa primary source
Decision-gradeNaitakda ang petsa ng PDUFA
Vera Therapeutics: Itinakda ng FDA ang PDUFA na Hulyo 7, 2026 para sa BLA ng atacicept sa IgAN
FDA granted priority review to the atacicept BLA and assigned a PDUFA target action date of July 7, 2026. The company plans a potential U.S. commercial launch in mid-2026 if approved. Positive Phase 3 ORIGIN 3 data were presented at ASN Kidney Week and published in NEJM.
Mahahalagang fact
- Na-file
- Peb 26, 2026, 12:30 PM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Positibo
- Kumpanya
VERAVera Therapeutics- Asset
- atacicept
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Hul 7, 2026 · Inaprubahan
Sipi mula sa source
EX-99.1 2 vera-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Vera Therapeutics Provides Business Update and Reports Full Year 2025 Financial Results • Positive Phase 3 data from ORIGIN 3 study of atacicept in IgA nephropathy (IgAN) presented at American Society of Nephrology (ASN) Kidney Week and published in the New England Journal of Medicine • U.S. Food and Drug Administration (FDA) granted priority review to Biologics License Application (BLA) for atacicept with Prescription Drug User Fee Act (PDUFA) date of July 7, 2026; potential commercial launch of atacicept expected in mid-2026 • Strong balance sheet bolstered by equity and debt financings in 2025 expected to be sufficient to fund company beyond atacicept approval and U.S. commercial launch BRISBANE, Calif., February 26, 2026 – V
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