Catatan sumber primer
MaterialKomite penasihat dijadwalkan
Relmada memperoleh kesepakatan FDA untuk dua jalur Fase 3 NDV-01 pada NMIBC
Pertemuan Tipe B FDA mengonfirmasi dua jalur registrasi independen: studi single-arm pada NMIBC berisiko tinggi yang tidak responsif terhadap BCG dan studi adjuvan acak pada NMIBC berisiko sedang. Tidak diperlukan studi non-klinis tambahan untuk NDA 505(b)(2). Uji coba Fase 3 diharapkan dimulai pada H1 2026.
Fakta utama
- Diajukan
- 13 Nov 2025, 21.58
- Peristiwa
- Komite penasihat dijadwalkan
- Arah
- Positif
- Perusahaan
RLMDRelmada- Aset
- NDV-01
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Hasil uji klinis · 1 Jan 2026 · Hasil belum tercatat
- TRAE grade 3
- 0%
- pembiayaan kotor
- $100M
- respon lengkap 3mo
- 84% (21/25)
- respon lengkap 6mo
- 87% (20/23)
- respon lengkap 9mo
- 85% (17/20)
- bcg unresponsive kapan saja
- 91% (10/11)
- respon lengkap kapan saja
- 92% (23/25)
Kutipan sumber
EX-99.2 3 ea026563001-8kex99ii_relmada.htm CORPORATE PRESENTATION Exhibit 99.2 EX-99.1 2 ea026563001-8kex99i_relmada.htm PRESS RELEASE Exhibit 99.1 Relmada Therapeutics Reports Third Quarter 2025 Financial Results and Provides Key Clinical, Regulatory, and Corporate Updates Positive 9-month follow-up data for NDV-01 showed a 92% overall response rate at any time in non-muscle invasive bladder cancer (NMIBC), with favorable overall safety Secured FDA alignment on key elements of Phase 3 program with two independent paths for approval in two separate NMIBC indications: High-risk 2 nd line BCG-unresponsive, and Intermediate-risk patients in the adjuvant setting; Studies expected to begin H1 2026 Completed $100M underwritten offering of common stock and pre-funded warrants on November 5