Rocket Pharmaceuticals: KRESLADI PDUFA itinakda sa Marso 28, 2026

Tinanggap ng FDA ang muling pagsusumite ng BLA para sa KRESLADI (marnetegragene autotemcel) sa malubhang LAD-I at nagtalaga ng target na petsa ng aksyon ng PDUFA na Marso 28, 2026. Karapat-dapat ang kumpanya sa Rare Pediatric Disease Priority Review Voucher kapag naaprubahan. Nagtatatag ito ng malapit na regulatory milestone para sa lentiviral hematology program.

Mahahalagang fact

Na-file: Peb 26, 2026, 09:21 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: RCKTRocket Pharmaceuticals
Asset: marnetegragene autotemcel
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Mar 28, 2026 · Walang naitalang resulta

Sipi mula sa source

EX-99.1 2 ef20066645_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Rocket Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Highlights Recent Progress Pivotal Phase 2 trial of RP-A501 for Danon disease to resume in 1H 2026 KRESLADI™ for severe LAD-I on track for March 28, 2026 PDUFA date Dosing of first patient in Phase 1 study of RP-A701 for BAG3-related dilated cardiomyopathy anticipated in mid-2026 Cash, cash equivalents and investments of approximately $188.9M; expected operational runway into the second quarter of 2027 CRANBURY, NJ – February 26, 2026 – Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today report

SEC 8-K