PDUFA Target Action Date Set for September 14, 2025
HENDERSON, Nev.--(BUSINESS WIRE)--#corstasistherapeutics--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.
About Bumetanide Nasal Spray
Bumetanide Nasal Spray is an investigational new drug designed to enable patients to self-administer non-oral loop diuretic therapy through the nasal mucosa in an outpatient setting.
About Corstasis Therapeutics Inc.
Corstasis Therapeutics Inc. is a clinical-stage MedTech pharmaceutical company focused on maximizing the potential of proven therapeutics. Our mission is to develop and deliver pragmatic, innovative therapies that enhance patient care and reduce healthcare costs. For more information, please visit www.corstasis.com.
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the development, regulatory progress, and potential benefits of Bumetanide Nasal Spray. These statements involve risks and uncertainties, such as the possibility that the FDA may not approve Bumetanide Nasal Spray by the expected date—or at all—and that additional data or analyses may be required. Actual results may differ materially from those expressed or implied by these forward-looking statements. Corstasis Therapeutics Inc. disclaims any obligation to update these statements except as required by law.
Contacts
Media Contact
Ben Esque, CEO
Corstasis Therapeutics Inc.
Phone: 702-541-9222
Email: Info@corstasis.com
