Xspray Pharma disclosed on Aug. 19 that the FDA had issued a complete response letter for Dasynoc, its amorphous dasatinib for chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia, six days ahead of the Aug. 25 action date. The letter turns on unresolved good manufacturing practice observations at contract manufacturer NerPharMa and a request for additional consecutive commercial-scale batch data. It is the third such letter for this application since July 2024.
- Date: announced 03:17 CEST on Aug. 19, 2026, against a PDUFA date of Aug. 25, 2026.
- Cited: outstanding GMP observations at NerPharMa, plus consecutive commercial-scale batch data following corrective actions already made.
- Not cited: clinical data, bioequivalence or stability; the medication-error risk raised in earlier letters is resolved.
- Next step: prioritize manufacture of the commercial-scale batches and resubmit the NDA within 2026 for a new action date.
- Product: amorphous dasatinib shown bioequivalent at a 30% lower dose and designed for use alongside acid-reducing medicines.
What the agency asked for
The letter leaves the product itself untouched. Xspray states that the FDA raised no questions about clinical data, bioequivalence or stability, and that the medication-error concern carried in previous letters has been closed out. What remains is the Italian site: NerPharMa has told the FDA that its remediation work is complete, and the agency has yet to decide whether a reinspection is needed before it finalizes the facility's status. Chief executive Blake Leitch said the company had already planned commercial manufacturing and would pull it forward.
"We will accelerate this step to ensure a resubmission will occur this as soon as possible in 2026 while simultaneously remain focused on working with our partner to ensure that the remaining FDA requirements of NerPharMa can be met as efficiently as possible," Leitch said, adding that the letter does not change the financial position set out in the second-quarter report published Aug. 5.
Three letters, two of them about someone else's plant
The first complete response letter arrived in July 2024 and concerned tablet strengths, with the FDA recommending adjustments to reduce the risk of dosing errors and asking for new batches before resubmission. The second, announced Oct. 8, 2025, rested on GMP observations at the contract manufacturer, none of them directed at the Dasynoc production line, while the agency paused approvals of new products at the facility during remediation. Xspray resubmitted on Feb. 26, 2026 and drew the Aug. 25 action date. The same manufacturer figured in a complete response letter for Xspray's nilotinib product Nilopki on June 4, 2026, so both of the company's US applications now wait on one site, whose new owner Benta Group has reported a positive inspection outcome from the Italian Medicines Agency.
Why This Matters to the APO|APE Reader
Under the 2023 settlement that ended Bristol Myers Squibb's patent litigation over Dasynoc, the contested patents and their associated regulatory exclusivities expire on Sept. 28, 2026, a date that arrives before any resubmission review can finish. Xspray built its commercial argument on CML patients taking proton pump inhibitors, whose absorption of conventional dasatinib is impaired, and every month of delay narrows the gap between an approved Dasynoc and unrestricted generic competition for the reference product. The company reported a pre-tax loss of SEK 39.8 million for the second quarter and raised roughly SEK 113 million in an April rights issue.
Sources
- Xspray Pharma receives Complete Response Letter (CRL) from FDA for Dasynoc. Xspray Pharma AB, August 19, 2026
- Xspray Pharma provides update on the FDA process for Dasynoc, observations at contract manufacturer delay approval. Xspray Pharma AB, October 8, 2025
- Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission. Xspray Pharma AB, September 19, 2024
- Xspray Pharma and Bristol Myers Squibb Reach Settlement on Dasynoc Patent Litigation, Paving Way for Early Market Launch. Xspray Pharma AB, September 11, 2023
