Rocket Pharmaceuticals: KRESLADI™ PDUFA itinakda sa Marso 28, 2026

Tinanggap ng FDA ang muling pagsumite ng BLA para sa KRESLADI™ (marnetegragene autotemcel) at itinalaga ang target na petsa ng aksyon ng PDUFA na Marso 28, 2026. Karapat-dapat din ang Rocket para sa Rare Pediatric Disease Priority Review Voucher kapag naaprubahan. Sinabi ng kumpanya na ang asset ay nasa tamang landas para sa petsang ito.

Mahahalagang fact

Na-file: Nob 6, 2025, 09:04 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 ef20058531_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Rocket Pharmaceuticals Reports Third Quarter 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 Leadership updates with the appointments of Dr. Syed Rizvi, Chief Medical Officer, Christopher Stevens, Chief Operating Officer, and Sarbani Chaudhuri, Chief Commercial & Medical Affairs Officer Cash, cash equivalents and investments of approximately $222.8M; expected operational runway into the second quarter of 2027 CRANBURY, NJ – November 6, 2025 – Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic

SEC 8-K