FDA Rejects Xspray's Dasynoc for Third Time, Citing Manufacturing and Labeling Concerns

Xspray Pharma has encountered another setback in its efforts to bring its leukemia drug Dasynoc to market, as the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) rejecting the company's latest approval bid. This marks the third such rejection in as many years, further delaying the potential launch of the drug intended to compete with Bristol Myers Squibb's blockbuster Sprycel.

Manufacturing Issues at Contract Facility

The FDA's decision was primarily based on concerns identified at Xspray's contract manufacturing organization (CMO). While the agency had previously approved Dasynoc-specific manufacturing lines during a preapproval inspection earlier this year, broader issues at the CMO's site have led to a halt on approvals for any new products manufactured there.

Xspray CEO Per Andersson expressed disappointment, stating, "It is unfortunate that manufacturing-related issues beyond our control are delaying our launch." The company has indicated that the CMO has already implemented a remediation plan and will meet with the FDA later this year to address the deficiencies.

Ongoing Labeling Challenges

In addition to the manufacturing concerns, the FDA has once again raised issues with Dasynoc's labeling and product information. This continues a trend from previous rejections, where the agency requested clarifying information on the drug's dosing to help patients "avoid confusion."

The company had previously adjusted its tablet strengths and made new batches of the drug in response to earlier FDA feedback. However, it appears these changes have not fully satisfied the agency's requirements, as the latest CRL requested further information "demonstrating that the discussed product information is appropriate."

Market Impact and Future Outlook

The repeated setbacks have taken a toll on Xspray's market position. Following the announcement of the latest CRL, the company's share price plummeted by approximately 57%. This decline reflects growing investor concern over the viability of Dasynoc and Xspray's ability to navigate the regulatory landscape.

Despite these challenges, Xspray remains committed to bringing Dasynoc to market. The drug, an "optimized" form of dasatinib, has demonstrated bioequivalence to Sprycel at a 30% lower dose. With Sprycel having gone generic last year but still generating $1.3 billion for Bristol Myers Squibb in 2024, there remains a significant market opportunity for Xspray if it can secure FDA approval.

As the company works to address the FDA's concerns, it also has other projects in the pipeline, including a version of Novartis' Tasigna that is expected to undergo FDA review. The pharmaceutical industry will be watching closely to see if Xspray can overcome these regulatory hurdles and successfully bring its products to market in the competitive leukemia treatment landscape.