CorMedix Inc. (NASDAQ:CRMD) shares are up on Monday following the announcement of positive topline results from the Phase 3 ReSPECT trial assessing REZZAYO (rezafungin) for the prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic blood and marrow transplant.
The company is focused on products in institutional settings of care in the U.S., including hospitals, clinics, and infusion centers.
CorMedix (CRMD) Jumps On Positive Phase 3 ReSPECT Results
The ReSPECT trial met its primary endpoint, demonstrating non-inferiority to standard antimicrobial regimens in fungal-free survival at Day 90, with 60.7% of patients on rezafungin remaining fungal-free compared to 59.0% for the control group.
The Phase 3 study topline results demonstrated comparable efficacy against invasive infections from candida, aspergillus and pneumocystis in both therapeutic arms, as well as comparable mortality.
In addition, results showed a favorable profile in multiple secondary endpoints, most notably treatment-emergent adverse events.
Regulatory Path And Market Opportunity
This positive outcome positions REZZAYO favorably for potential FDA approval, with a supplemental New Drug Application (sNDA) expected to be submitted in the second half of 2026.
CorMedix estimates that the potential U.S. market opportunity for REZZAYO in prophylaxis exceeds $2 billion, based on internal analyses and assumptions.
Rezafungin has orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S.
CRMD Technical Outlook: Key Support, Resistance And Momentum
CorMedix is currently trading within its 52-week range, with a high of $17.43 and a low of $6.13, indicating it is positioned closer to the lower end of this range.
The stock is trading 5.7% above its 20-day simple moving average (SMA) and 9.3% above its 50-day SMA, suggesting a bullish short-term trend, while it remains 8.1% below its 100-day SMA, indicating some resistance in the intermediate term.
The relative strength index (RSI) is at 58.29, suggesting that the stock is in neutral territory, indicating a balanced momentum.
Meanwhile, the moving average convergence divergence (MACD) is above its signal line, which typically suggests bullish momentum, with the histogram also indicating a slight positive momentum.
- Key Resistance: $8.50 — A critical level where selling pressure may emerge.
- Key Support: $6.50 — A level where buying interest may increase.
CRMD Price Action: Cormedix shares were up 3.77% at $7.51 at the time of publication on Monday, according to Benzinga Pro data.
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