Catatan sumber primer
MaterialInspeksi manufaktur
Scholar Rock menyelesaikan pertemuan Type A FDA untuk BLA apitegromab
Scholar Rock mengadakan pertemuan Type A yang konstruktif dengan FDA pada 12 November 2025, untuk BLA apitegromab pada SMA. Catalent Indiana (Novo Nordisk) mengonfirmasi bahwa remediasi fasilitas fill-finish sedang berjalan sesuai rencana untuk kesiapan reinspeksi pada akhir tahun. Pengajuan ulang BLA dan peluncuran di AS kini diperkirakan pada 2026.
Fakta utama
- Diajukan
- 14 Nov 2025, 12.10
- Peristiwa
- Inspeksi manufaktur
- Arah
- Positif
- Perusahaan
SRRKScholar Rock- Aset
- apitegromab
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
EX-99.1 2 srrk-20251114xex99d1.htm EX-99.1 Exhibit 99.1 Scholar Rock Reports Third Quarter 2025 Financial Results and Recent Business Highlights • Completed constructive and collaborative in-person Type A meeting with U.S. Food and Drug Administration (FDA) on November 12th for apitegromab biologics license application (BLA) for the treatment of children and adults with spinal muscular atrophy (SMA) • Catalent Indiana, LLC (part of Novo Nordisk) participated in the Type A meeting in person and presented the progress made in implementing the remediation plan; confirmed to FDA that the site is on-track to be reinspection ready by the end of this year • Resubmission of BLA and U.S. launch following approval of apitegromab for children and adults with SMA anticipated in 2026 • Timelines accel
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