PDUFA Target Action Date Set for September 14, 2025
Corstasis Therapeutics Inc. (www.corstasis.com), a clinical-stage MedTech pharmaceutical company developing innovative, practical therapies for fluid overload, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its novel Bumetanide Nasal Spray (RSQ-777). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 14, 2025.
This NDA acceptance represents a pivotal milestone for Corstasis Therapeutics, signifying the FDA’s determination that the application is sufficiently complete to move forward with a comprehensive review. Bumetanide Nasal Spray (RSQ-777) is being developed as a convenient, outpatient-focused therapy for edema associated with congestive heart failure, as well as liver and kidney disease.
“We are pleased the FDA has accepted our NDA for Bumetanide Nasal Spray,” said Benjamin Esque, CEO of Corstasis Therapeutics Inc. “This milestone brings us closer to providing a simple, easy-to-use outpatient therapy for patients with fluid overload. We look forward to working closely with the FDA throughout the review process.”
“Our aim is to reduce the burden on both patients and the healthcare system by offering treatment options outside the hospital setting—potentially lowering costs and improving quality of life,” added Dr. Brian Kolski, Chief Medical Officer of Corstasis Therapeutics Inc.
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