nilotinib amorphous (XS003) / Xspray Pharma - LARVOL DELTA

Xspray Pharma AB…announces that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for XS003 (nilotinib) for review under the 505(b)(2) regulatory pathway. (Xspray Pharma Press Release) - "The FDA has set a PDUFA date to June 18, 2026, which is the date by when the agency is expected to announce a decision on the application."

FDA filing • PDUFA • Chronic Myeloid Leukemia

XSpray Pharma achieves significant milestone - demonstrating bioequivalence with absorption advantages compared to Tasigna (Nasdaq) - P1 | N=27 | NCT02068898 | Sponsor: XSpray Microparticles | "Xspray Pharma has now completed the population pharmacokinetic (PopPK) modeling that constitutes key regulatory documentation ahead of submitting a New Drug Application (NDA) for the product candidate XS003. The analysis confirms bioequivalence with the reference drug Tasigna, at less than half the dose – a strong indication marking a potential paradigm shift in the treatment of CML with nilotinib...The results confirm formal bioequivalence between XS003 and Tasigna in terms of systemic exposure (AUC and Cmax) – despite the XS003 dose being less than half that of the reference drug. In addition, a clinical study has shown that XS003 has significantly improved food interaction and a more predictable dose response, which can facilitate precise dose adjustments in clinical practice....With these results, Xspray Pharma plans to submit a NDA application in the near future."

P1 data • Chronic Myeloid Leukemia

Xspray Pharma…has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML) (Businesswire) - "The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna....Data from registration studies demonstrate bioequivalence with the reference product, despite XS003 being administered at less than half the dose of the reference product....Xspray expects the FDA to initiate its review within 60 days, with a regulatory decision anticipated approximately eight months thereafter."

FDA approval • FDA filing • Chronic Myeloid Leukemia

Xspray Pharma’s XS003 Study Shows Matching Bioavailability to Tasigna at More than a 50% Lower Dose (Businesswire) - P=NA | N=NA | "Xspray Pharma AB...announced today new clinical data from its XS003 registration study program....In the announced study, XS003 demonstrates matching bioavailability to Tasigna, with a 50% reduced dose.... The results show that the XS003 amorphous formulation of nilotinib uses less than 50% of the active ingredient compared to crystalline forms. Thus, there is significantly less excess material available for overdosing, potentially making it a safer drug....XS003 is being developed under the 505(b)(2) NDA process, which streamlines the approval process, and is expected to be submitted to the FDA in the first half of 2025."

Clinical data • FDA filing • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology