On September 29, 2025, CorMedix announced the completion of enrollment in its global Phase III REZPECT trial for REZZAYO, a once‑weekly echinocandin being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic bone‑marrow transplantation.
The multicenter, randomized, double‑blind study enrolls patients across the United States and Europe, administering a 400 mg loading dose in week 1 followed by 200 mg weekly for 13 weeks. The primary endpoint is fungal‑free survival at day 90, with secondary endpoints including incidence of invasive fungal disease, discontinuation due to toxicity, and mortality adjusted for comorbidities.
REZZAYO’s potential market is estimated at over $2 billion in the United States, based on an addressable population of roughly 130,000 patients. The drug enjoys orphan drug exclusivity through 2035 and patent protection through 2038, positioning it for a lucrative commercial opportunity once FDA approval is obtained.
This enrollment milestone reinforces CorMedix’s ability to advance a high‑potential product within its expanded portfolio, which now includes the Melinta Therapeutics acquisition. The completion of the REZPECT trial brings the company closer to a pivotal regulatory decision that could unlock significant revenue streams and enhance the overall value of CorMedix’s specialty‑pharma platform.
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