Record mula sa primary source
MateryalNaiskedyul ang advisory committee
Nakuha ng Relmada ang pagkakahanay ng FDA sa dalawang landas ng Phase 3 para sa NDV-01 sa NMIBC
Ang FDA Type B meeting ay nagkumpirma ng dalawang independiyenteng landas para sa pagpaparehistro: isang single-arm study sa high-risk BCG-unresponsive NMIBC at isang randomized adjuvant study sa intermediate-risk NMIBC. Walang karagdagang non-clinical studies ang kinakailangan para sa 505(b)(2) NDA. Ang Phase 3 trials ay inaasahang magsisimula sa H1 2026.
Mahahalagang fact
- Na-file
- Nob 13, 2025, 09:58 PM
- Kaganapan
- Naiskedyul ang advisory committee
- Direksyon
- Positibo
- Kumpanya
RLMDRelmada- Asset
- NDV-01
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Resulta ng trial · Ene 1, 2026 · Walang naitalang resulta
- Grade 3 TRAE
- 0%
- Kabuuang (gross) na pagpopondo
- $100M
- Kumpletong tugon sa 3 buwan
- 84% (21/25)
- Kumpletong tugon sa 6 buwan
- 87% (20/23)
- Kumpletong tugon sa 9 buwan
- 85% (17/20)
- Hindi tumugon sa BCG, anumang oras
- 91% (10/11)
- Kumpletong tugon, anumang oras
- 92% (23/25)
Sipi mula sa source
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