FDA Sets October 2025 PDUFA Date for Xspray Pharma's Resubmitted Dasynoc Application
Key Insights
The FDA has acknowledged Xspray Pharma (search)'s resubmitted New Drug Application for Dasynoc, setting a PDUFA decision date of October 7, 2025.
Dasynoc is an amorphous dasatinib formulation developed for treating chronic myeloid leukemia (search) (CML (search)) and acute lymphoblastic leukemia (search) (ALL (search)), with potential advantages over existing treatment options.
The resubmission addresses a Complete Response Letter received in July 2024, with Xspray confirming it has sufficient funding to support the product through approval regardless of FDA review timeline.
The U.S. Food and Drug Administration (FDA) has set October 7, 2025, as the Prescription Drug User Fee Act (PDUFA) date for Xspray Pharma (search)'s resubmitted New Drug Application (NDA) for Dasynoc®, an amorphous dasatinib formulation for leukemia treatment.
The PDUFA date represents the FDA's deadline for communicating its decision on Xspray's application, which was resubmitted following a Complete Response Letter (CRL) received in July 2024 requesting additional information. The acknowledgment from the FDA came approximately one week later than expected, though no specific reason was provided for the delay.
"I am pleased that we now have a PDUFA date, and with that date now set we continue to prepare for a successful launch of Dasynoc® as soon as we receive market approval," said Per Andersson, CEO of Xspray Pharma (search). "At such point we will be ready to offer ALL (search) and CML (search) patients in the US Dasynoc, a dasatinib drug with important advantages compared to today's treatment options."
Clinical Application and Market Potential
Dasynoc is being developed for the treatment of chronic myeloid leukemia (search) (CML (search)) and acute lymphoblastic leukemia (search) (ALL (search)). The company's proprietary HyNap technology platform aims to improve upon existing protein kinase inhibitors (search) (PKIs) for cancer treatment, potentially enhancing efficacy, safety, and patient experience.
The resubmission follows Xspray's plan communicated in January 2025. According to the company, manufacturing and quality review of new tablet batches required to address the FDA's questions have proceeded according to plan at Xspray's U.S. contract manufacturer, meeting all (search) quality requirements.
Regulatory Timeline and Financial Outlook
The FDA can apply two different processing times for the resubmitted application—either two or six months from the resubmission date. Regardless of which timeline the FDA follows, Xspray has reiterated that it has sufficient funding to support Dasynoc through approval.
"We are well prepared to launch Dasynoc on the US market upon approval later this year," Andersson stated, indicating the company's confidence in both the regulatory outcome and its commercial readiness.
About Xspray Pharma
Xspray Pharma (search) AB is a pharmaceutical company focused on developing improved protein kinase inhibitors (search) (PKIs) for cancer treatment using its proprietary HyNap technology platform. The company aims to enhance clinical outcomes for cancer patients by improving existing cancer therapies.
The Swedish company's shares are traded on Nasdaq Stockholm under the ticker XSPRAY. If approved, Dasynoc would represent a significant milestone for the company as it transitions from development to commercialization in the competitive oncology market.