Precigen: PAPZIMEOS (zopapogene imadenovec-drba) ได้รับการอนุมัติเต็มรูปแบบจาก FDA สำหรับ RRP

The FDA granted full approval of PAPZIMEOS in August 2025 with a broad label and no confirmatory trial requirement, making it the first and only approved therapy for adults with RRP. The product is now commercially available and shipping to prescribers in the US, with over 100 patients registered in the Patient Hub and >100 million lives covered by private insurance plus Medicare/Medicaid access.

ข้อเท็จจริงสำคัญ

ยื่นเมื่อ: 13 พ.ย. 2568 21:18
เหตุการณ์: การอนุมัติของ FDA
ทิศทาง: เชิงบวก
บริษัท: PGENPrecigen
สินทรัพย์: zopapogene imadenovec-drba
แหล่งที่มา: SEC 8-K
ความเชื่อมั่น: มีแหล่งอ้างอิง

ข้อความจากแหล่งที่มา

EX-99.1 2 dp237316_ex9901.htm EXHIBIT 99.1 Exhibit 99.1 Precigen Reports Third Quarter 2025 Financial Results and Business Updates · PAPZIMEOS (zopapogene imadenovec-drba) received full approval by the FDA in August · PAPZIMEOS launched with a broad label in the US as the first and only FDA-approved treatment for adults with RRP · PAPZIMEOS is now available and shipping to prescribers in the US for the treatment of adults with RRP · To date, over 100 patients have been registered in the PAPZIMEOS Patient Hub · The Company has made significant progress with private health insurance coverage, with more than 100 million lives covered to date; PAPZIMEOS is now available through Medicare and Medicaid · Rapid commercial launch execution underway with full deployment of the sales team in

SEC 8-K