प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णसलाहकार समिति निर्धारित
Relmada ने NMIBC में NDV-01 के लिए दो Phase 3 मार्गों पर FDA की सहमति हासिल की
FDA Type B meeting confirmed two independent registrational paths: a single-arm study in high-risk BCG-unresponsive NMIBC and a randomized adjuvant study in intermediate-risk NMIBC. No additional non-clinical studies are required for a 505(b)(2) NDA. Phase 3 trials are expected to start in H1 2026.
मुख्य तथ्य
- फाइल किया गया
- 13 नव॰ 2025, 09:58 pm
- घटना
- सलाहकार समिति निर्धारित
- दिशा
- सकारात्मक
- कंपनी
RLMDRelmada- संपत्ति
- NDV-01
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- कैलेंडर
- ट्रायल परिणाम · 1 जन॰ 2026 · परिणाम दर्ज नहीं
- ग्रेड 3 टीआरएई
- 0%
- वित्तपोषण सकल
- $100M
- पूर्ण प्रतिक्रिया 3मो
- 84% (21/25)
- पूर्ण प्रतिक्रिया 6मो
- 87% (20/23)
- पूर्ण प्रतिक्रिया 9मो
- 85% (17/20)
- बीसीजी अनुत्तरदायी कभी भी
- 91% (10/11)
- पूर्ण प्रतिक्रिया कभी भी
- 92% (23/25)
स्रोत का अंश
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