Record mula sa primary source
Decision-gradeTopline na resulta
CorMedix nag-ulat ng positibong Phase III ReSPECT topline para sa rezafungin prophylaxis
Natugunan ng ReSPECT Phase III trial ang pangunahing endpoint nito ng non-inferior fungal-free survival sa Day 90 kumpara sa standard antimicrobial regimen. Ipinakita ng mga secondary endpoints ang paborableng safety differentiation sa toxicity-related discontinuations at drug-drug interactions. Plano ng kumpanya ang pre-NDA meeting na sinundan ng sNDA submission sa 2H26 para sa expanded prophylaxis indication.
Mahahalagang fact
- Na-file
- Abr 27, 2026, 12:05 PM
- Kaganapan
- Topline na resulta
- Direksyon
- Positibo
- Kumpanya
CRMDCorMedix- Asset
- rezafungin
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Pangunahing layunin
- naabot ang hindi-pagkamababa
- Kaligtasang walang impeksyong fungal sa Araw 90
- 60.7% kumpara sa 59.0%
Sipi mula sa source
EX-99.1 2 ea028764001ex99-1.htm PRESS RELEASE DATED APRIL 27, 2026 Exhibit 99.1 CORMEDIX Therapeutics AnnounceS POSITIVE Topline Results from PHASE III respect TriaL assessing Rezzayo® for the PROPHYLAXIS of invasive fungal diseases in ALLOGENEIC Haematopoietic Stem Cell Transplantation PATIENTS – The study primary endpoint was met, showing non-inferiority vs. standard antimicrobial regimen in fungal free survival at Day 90 – – Study showed favorable benefit for toxicity related discontinuations and drug-drug interactions – – Rezafungin was well tolerated, with a safety profile comparable to standard antimicrobial regimens – Parsippany, NJ – April 27, 2026 – CorMedix Therapeutics (Nasdaq: CRMD) today announced positive Phase III topline results from the global ReSPECT clinical trial