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Astellas and HOVON Phase 3 AML Trial for Xospata Misses Survival Goal

Story Highlights
  • Astellas and HOVON’s Phase 3 AML trial of Xospata missed its primary survival endpoint versus midostaurin.
  • Gilteritinib showed similar efficacy and safety to midostaurin, with limited near-term financial impact for Astellas.
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Astellas and HOVON Phase 3 AML Trial for Xospata Misses Survival Goal

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Astellas Pharma ( (JP:4503) ) has issued an announcement.

Astellas Pharma and the HOVON Foundation reported that their Phase 3 HOVON 156 / AMLSG 28-18 / PASHA trial comparing Xospata (gilteritinib) with a midostaurin-based regimen in newly diagnosed FLT3-mutated acute myeloid leukemia eligible for intensive chemotherapy failed to meet its primary endpoint of overall survival. Gilteritinib showed overall survival and safety broadly comparable to midostaurin-based treatment, and the companies plan deeper analyses of secondary endpoints and subgroups, while Astellas indicated the outcome should have only a minor financial impact for the fiscal year ending March 31, 2026.

Investigators from Astellas, HOVON and partner academic groups emphasized that, despite the disappointing headline result, the data will add to understanding of FLT3-targeted strategies in AML and guide future research. The broad international academic collaboration behind the trial underscores continued efforts to refine treatment options in a genetically defined, high‑risk leukemia segment where Xospata is already established in the relapsed or refractory setting.

The most recent analyst rating on (JP:4503) stock is a Hold with a Yen2651.00 price target. To see the full list of analyst forecasts on Astellas Pharma stock, see the JP:4503 Stock Forecast page.

More about Astellas Pharma

Astellas Pharma Inc. is a global life sciences company focused on turning innovative science into therapies across oncology, ophthalmology, urology, immunology and women’s health. Its portfolio includes Xospata, a FLT3 inhibitor for relapsed or refractory FLT3-positive acute myeloid leukemia, and it targets diseases with high unmet medical need worldwide.

YTD Price Performance: 14.86%

Average Trading Volume: 7,489,922

Technical Sentiment Signal: Buy

Current Market Cap: Yen4329B

Learn more about 4503 stock on TipRanks’ Stock Analysis page.

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