Swedish pharmaceutical company Xspray Pharma has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) based on previously communicated issues at third-party manufacturer NerPharMa concerning outstanding Good Manufacturing Practice (GMP) observations, as well as a request for additional commercial-scale consecutive batch data following already implemented corrective actions.

The CRL is related to Xspray Pharma’s leukemia candidate Dasynoc. The company emphasized in Wednesday’s announcement that the FDA has not raised questions regarding Dasynoc’s clinical data, bioequivalence, or stability, while noting the risk of medication error raised in the agency’s previous CRLs has been resolved.

Blake Leitch, CEO of Xspray Pharma, said in a statement that the most recent CRL “confirms that the remaining uncertainty is now linked to NerPharMa sufficiently addressing the FDA’s observations at their manufacturing site and batch data from consecutive manufacturing runs being provided.”

At the same time, Leitch noted that Xspray had “already targeted to proceed with commercial manufacturing” as part of the company’s operational plan and it “will accelerate this step to ensure a [New Drug Application] resubmission will occur as soon as possible in 2026.”

According to Xspray’s announcement, contract development and manufacturing organization (CDMO) NerPharMa has completed and announced to the FDA that the remediation work at its facility is complete.

“The FDA has yet to determine if a reinspection is required for the agency to finalize their assessment of the facility’s status,” Xspray said. “Since Xspray’s launch planning necessitated additional commercial scale batches to be produced, the manufacture of these batches will now be prioritized to satisfy the FDA’s request for additional data.”

During a Thursday call with analysts, Leitch said the FDA inspection observations at NerPharMa’s facility were classified as Official Action Indicated (OAI), an agency classification indicating it has found serious compliance issues and is recommending regulatory or administrative enforcement actions.

“We are anticipating a response and still a decision from the FDA as it relates to the OAI status at NerPharMa,” Leitch commented, while noting that NerPharMa’s manufacturing operation was recently inspected by the Italian Medicines Agency (AIFA) in May “with an outcome that was positive.”

CDMO’s site cited by FDA 

NerPharMa, a CDMO in Milan, Italy, operates a facility that it says is accredited by multiple regulatory authorities including the FDA and European Medicines Agency. The site, which has over 100 employees, provides manufacturing services for biologics and high-potency integrated drug products and drug substances in oral solid dosages and injectables.

In a Form 483 issued in June 2025, the FDA said that “procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process” based on an inspection of NerPharMa’s Milan facility.

However, according to NerPharMa, it is a “trusted” and “reliable CDMO partner” in oncology and immunology manufacturing.

Leitch commented during Thursday’s call with analysts that “the principal bottleneck remains NerPharMa’s regulatory status.” He added what is within Xspray’s “control” is the manufacturing of the consecutive commercial batches — and their appended data packages — requested by the FDA. “We won’t receive an approval until both items are satisfied.”   

Asked whether Xspray could potentially change to another third-party manufacturer, Leitch replied that “a new facility takes roughly 18 months or more to become operational” and “funding that, instead of funding launch readiness” would significantly push out the Prescription Drug User Fee Act (PDUFA) decision date for Dasynoc and U.S. launch.

Xspray now plans to resubmit its application to the agency as soon as possible this year and secure a new PDUFA date, which was previously set for August 25.

However, this isn’t the first time the company has been hit with a CRL from the agency related to NerPharMa’s lack of GMP compliance. In March 2026, Xspray provided a regulatory update that previously communicated GMP-related observations against NerPharMa remain.

“The responsibility for resolving these issues rests with the facility’s new owner Benta Group, who themselves emphasize the importance of quality and regulatory compliance,” the company said in its update earlier this year. “Measures are being implemented with the goal of getting the facility approved for new drugs in time for Xspray’s launch plans. Xspray is in close dialogue with the facility’s new owners.”

In February 2026, Lebanon-based Benta Group announced the acquisition of NerPharMa from NMS Group to boost its European industrial platform and expanding its specialized oncology, biologics, and high potency manufacturing capabilities.

At the time, Xspray welcomed the acquisition of NerPharMa’s facility by Benta Group, describing it as a “well-established company with core operations in pharmaceutical contract manufacturing and a strong reputation for quality, regulatory compliance and operational standards.”