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FDA Accepts Xspray Pharma’s NDA-resubmission for Dasynoc® – PDUFA Date set to 31 July 2024

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Xspray Pharma AB announces FDA acceptance of NDA resubmission for Dasynoc®, setting a PDUFA date for July 31, 2024. The company plans to launch the innovative CML treatment on September 1, 2024, following a patent litigation settlement with Bristol Myers Squibb.
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The acceptance by the FDA of Xspray Pharma's resubmission of the New Drug Application for Dasynoc® represents a pivotal step forward in the treatment of chronic myeloid leukemia (CML). Dasynoc®, an amorphous form of dasatinib, is purported to have improved properties over the crystalline form currently available. From a medical standpoint, the potential benefits of Dasynoc® lie in its optimized pharmacokinetic profile, which could lead to better patient outcomes in terms of efficacy and side effect management.

Should the FDA grant approval by the PDUFA date, the availability of Dasynoc® could mean an expanded arsenal of therapeutic options for oncologists and their patients. It is important to monitor how this new formulation compares with existing CML treatments in terms of response rates, progression-free survival and overall survival, as well as its side effect profile. This will ultimately determine its place in therapy and impact on patient care.

The assignment of a PDUFA date to Xspray Pharma's Dasynoc® is a significant event that can influence the company's market performance. Investors closely watch such milestones as they often lead to stock price volatility. The market impact hinges on the potential of Dasynoc® to capture market share in the CML treatment space, which is currently dominated by a few key players.

The successful commercialization of Dasynoc®, should it receive FDA approval, will depend on effective marketing strategies, competitive pricing and insurance coverage. Xspray Pharma's strategic planning for a commercial launch indicates confidence in their product's market potential. However, the actual market uptake of Dasynoc® will be a critical factor to watch post-launch, as it will affect the company's revenue and growth trajectory.

The FDA's acceptance of the NDA resubmission for Dasynoc® and the setting of a PDUFA date are material events that could have a significant impact on Xspray Pharma's financial future. The market often reacts positively to such regulatory advancements, potentially leading to an increase in investor confidence and stock value.

From a financial perspective, the cost implications of the ongoing preparation for commercial launch and the outcomes of the patent litigation settlement with Bristol Myers Squibb are also of interest. The company's ability to manage these expenses while investing in the commercialization process will be key to its financial health. Additionally, the potential revenue from Dasynoc®, if approved, would need to be evaluated against the development and marketing costs to assess the long-term financial benefits for Xspray Pharma and its stakeholders.

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY): The U.S. Food and Drug Administration (FDA) has accepted the resubmission of Xspray Pharma’s New Drug Application (NDA) for Dasynoc®, following a Complete Response Letter (CRL) where additional information was requested. The FDA has now assigned a Prescription Drug User Fee Act (PDUFA) date to 31st of July, 2024. This is the FDA’s deadline for completing the approval process, marking a significant milestone for Dasynoc®, Xspray’s innovative protein kinase inhibitor (PKI) product candidate for CML treatment.

With an established PDUFA date set to 31st of July, Xspray Pharma continues to strategically plan for the commercial launch of Dasynoc® on September 1, 2024. These dates align with the company’s comprehensive preparation following the patent litigation settlement with Bristol Myers Squibb (BMS), paving the way for Dasynoc® to become a new option for chronic myeloid leukemia (CML) treatment pending FDA approval.

“With the new time line communicated by the FDA, I am pleased to confirm that Xspray Pharma is on track to launch our lead product candidate Dasynoc® on September 1 if approved, as previously communicated. We appreciate the FDA’s diligent review of our resubmission and look forward to collaborating closely with the agency in the lead-up to the PDUFA date,” said Per Andersson, CEO of Xspray Pharma AB. “Our team is fully committed to addressing the FDA’s requirements and ensuring that healthcare providers and patients have clear, comprehensive information on Dasynoc®’s dosing and administration.”

Dasynoc®, an optimized version of dasatinib, highlights Xspray Pharma’s dedication to advancing cancer treatment through innovative drug formulations. The product candidate has the potential to become a best-in-class product with a strong patent position for amorphous dasatinib products with improved properties for patients with CML. As the PDUFA date approaches, the company remains focused on its goal to improve the lives of those affected by CML with this novel therapy.

About Xspray Pharma AB

Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap™ technology platform. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies. For more information about Xspray Pharma AB and its innovative approach to cancer treatment, please visit www.xspraypharma.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding the regulatory approval process and potential commercial launch of Dasynoc®. Actual results may vary based on the FDA’s final decision and other factors.

Xspray US-Media

Charlotte Wray

RXMD

cwray@rxmedyn.com

646-599-8601



For additional information

Per Andersson, PhD, CEO

Xspray Pharma AB

Mob: +46 (0) 706 88 23 48

E-mail: per.andersson@xspray.com

Source: Xspray Pharma

The PDUFA date for Dasynoc® is set for July 31, 2024.

Dasynoc® is an optimized version of dasatinib, aiming to become a best-in-class product for patients with CML.

Xspray Pharma plans to launch Dasynoc® on September 1, 2024, if approved.

Per Andersson is the CEO of Xspray Pharma AB.

Xspray Pharma has achieved a significant milestone with the FDA accepting the NDA resubmission for Dasynoc®.

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