Xspray Pharma has taken hit after hit during its repeated efforts to commercialize its leukemia prospect Dasynoc. On its third attempt to win the FDA’s favor, the company has run into yet another setback.
The FDA turned down Dasynoc’s latest approval bid in chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) with a complete response letter (CRL) after identifying concerns at Xspray’s contract manufacturing organization, Xspray disclosed in an update Wednesday.
Although none of the agency’s observations were directed specifically at the Dasynoc production lines, the FDA is holding off on approving any new products made at the CMO's site until the deficiencies are corrected, Xspray said. The manufacturer has already implemented a remediation plan and will meet with the FDA later this year.
“It is unfortunate that manufacturing-related issues beyond our control are delaying our launch,” Xspray CEO Per Andersson said in a statement. “We will now work closely with both the manufacturer and the FDA to expedite the process and enable a resubmission as soon as the corrective actions have been completed.”
The FDA had already signed off on the CMO’s Dasynoc-specific manufacturing lines during a preapproval inspection earlier this year, according to an Xspray update in June. Around that time, Xspray also revised Dasynoc’s proposed tablet strengths, addressing concerns raised in a prior CRL.
By now, CRLs are familiar territory for Xspray. In 2023, the FDA shot down the company’s first approval bid based on concerns with Dasynoc’s label and Xspray’s third-party manufacturer. Specifically, the agency asked for clarifying information on the drug’s dosing that could help patients “avoid confusion.”
Another CRL, again highlighting the same label comprehension issue and CMO concerns, came in 2024. This time, the FDA suggested a “dialogue” to adapt the labeling strategy, leaving Xspray caught off guard by the “unexpected” requests that delayed its planned September 2024 launch.
After its subsequent chat with the FDA, Xspray agreed to make new batches of the drug with an adjusted tablet strength to limit the risk of dosing errors. By April 2025, the company's adjusted plan had gone “according to plan,” Andersson said, emphasizing that the company still had enough funds to take the drug to the FDA finish line.
However, it seems that the FDA may be still unsure of the company’s label and product information. Along with the manufacturing issues cited in the recent CRL, the agency also requested information “demonstrating that the discussed product information is appropriate," according to the company.
Xspray’s share price has tumbled by roughly 57% since the Wednesday disclosure.
Dasynoc (dasatinib), is an “optimized” form of Bristol Myers Squibb’s blockbuster Sprycel that has proven bioequivalence at a 30% lower dose, according to Xspray. BMS and Xspray settled their related patent litigation in 2023, paving the way for what would have been an early market entry for Dasynoc in September 2024. Sprycel went generic last year but still generated $1.3 billion for BMS in 2024.
Besides its version of Sprycel, Xspray has a version of Novartis' Tasigna that's expected to undergo an FDA review, according to the company.