The recent rejection of Xspray Pharma’s DasynocTM is an insightful case study on recurring regulatory failure despite clinical success. On 8 October 2025, Xspray Pharma announced that its latest New Drug Application (NDA) for DasynocTM had been rejected by the FDA due to Good Manufacturing Practice issues at the company’s contract manufacturing partner (CMO)1. This is the third time DasynocTM was rejected by the FDA due to non-clinical reasons.
Xspray Pharma is a Swedish pharmaceutical company specialising in particle technology2. The company developed and owns the proprietary HyNapTM technology (Hybrid Nanoparticle-Amorphous Solid Dispersion Technology), which is used to reformulate existing drugs into amorphous (non-crystalline solid) forms. This reformulation could help increase the drug’s bioavailability (how easily the drug is absorbed) and reduce bioavailability variability, therefore improving the drug’s safety and efficacy profiles3.
Xspray Pharma’s current strategic direction is to focus on improving existing protein kinase inhibitor drugs using its HyNapTM platform2. Protein kinase inhibitors (PKIs) interfere with key processes in cancer cells and thus are commonly used as anti-cancer drugs. This is the generic improvement approach, which adds more value than simply releasing generic versions of branded drugs.
DasynocTM is Xspray’s first and leading drug candidate developed using the HyNapTM platform2. This PKI is an improved version of Bristol Myers Squibb’s Sprycel (dasatinib), intended for treating two forms of blood cancer, chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL)4.
The first rejection came in 2023 due to labelling and contract manufacturing information issues5. The FDA requested Xspray to update DasynocTM labelling to avoid confusion on dosing for doctors and patients, as well as to provide more information on the Xspray’s CMO partner.
The second rejection came in 2024 due to labelling and contract manufacturer problems4.
The latest rejection in October 2025 was due to Xspray’s CMO partner not meeting the GMP requirements set by the FDA1.
The case shows the stringency of the drug regulatory process. Apart from clinical efficacy and safety, drug labelling and manufacturing must also meet required standards.
Repeated regulatory rejections due to manufacturing reasons have happened to pharma/biotech companies of all sizes. Similar cases include Zealand Pharma’s Dasiglucagon, rejected two times by the FDA6, and Indian pharma giant Biocon’s biosimilars7.
Repeated rejections delay product launch, which is costly for the business. Consumers’ and investors’ confidence could also be affected, as this signals unreliable business management.
Operational excellence is as vital as clinical innovation in biotech/pharma for success. Pay attention to all aspects of drug commercialisation, not just the clinical aspect. Understanding and adhering to regulatory requirements are essential to prevent costly delays and damage to reputation. Be stringent when selecting business partners, especially when the partnership directly affects product quality.
Xspray Pharma. Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval - Xspray. Available at: https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-provides-update-on-the-fda-process-for-dasynoc-observations-at-contract-manufacturer-delay-approval/. Accessed 15 October 2025.
Xspray Pharma. About us – a timeline. Available at: https://xspraypharma.com/about-us/2313-2/. Accessed 17 October 2025.
Lennernäs H, Brisander M, Liljebris C, Jesson G, Andersson P. Enhanced Bioavailability and Reduced Variability of Dasatinib and Sorafenib with a Novel Amorphous Solid Dispersion Technology Platform. Clinical pharmacology in drug development. 2024;13(9):985-999.
Becker Z. Xspray hits FDA wall with another manufacturing-related rejection. 2025. Available at: https://www.fiercepharma.com/pharma/fda-throws-cold-water-xsprays-commercialization-hopes-another-rejection-manufacturing-label. Accessed 17 October 2025.
Xspray Pharma. Xspray Pharma receives request for additional information concerning Dasynoc from FDA - Xspray. Available at: https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-receives-request-for-additional-information-concerning-dasynoc-from-fda/. Accessed 15 October 2025.
Reuters. US FDA declines to approve Zealand’s drug for low blood sugar in infants. Available at: https://www.reuters.com/business/healthcare-pharmaceuticals/denmarks-zealand-provides-us-fda-update-drug-low-blood-sugar-infants-2024-10-08/?utm_source=chatgpt.com. Accessed 17 October 2025.
Digby-Patel C. Biocon’s Biosimilar Difficulties: Successive FDA Rejections Don’t Inspire Hope. Available at: https://oxfordglobal.com/nextgen-biomed/resources/biocons-biosimilar-difficulties-successive-fda-rejections-dont-inspire-hope?utm_source=chatgpt.com. Accessed 17 October 2025.