Risk of lengthy, costly new-drug development and development discontinuation
First written in FY2019. 3 of 5 entries say "Materialised", first in 2026-05-15. Latest entry: FY2026.
Delta-Fly Pharma moved to the "Worse" side of this theme in 2026, 6 years after the typical company in this theme (2020).
The whole theme swung hardest in 2022: 20 of 41 companies on the "Worse" side.
23 other companies' latest entry also says "Materialised".
- FY2026MaterialisedAnnual report
「Based on the results of the interim analysis, the DSMB discussed the matter and reported that the trial would be discontinued because the superiority specified in the study protocol had not been demonstrated.」
長期・高コストで開発中止に至る不確実性について、DFP-10917単剤の米国第3相比較試験が中止となった事実が示された。 - FY2022RestatedAnnual report
「医療用医薬品の開発には多額の研究開発投資と長い期間を要し、臨床試験で有用な効果を確認できないこと等により研究開発が予定通りに進行しないため、開発の延長や中止の判断を行うことなど、以下のような不確実性を認識しています。」
長期・高コストで、臨床試験結果等により開発延長・中止となる不確実性を引き続き記載している。 - FY2019First statedAnnual report
「Developing a single drug requires a long period of approximately 10–15 years and substantial funding ranging from several billion yen to several tens of billions of yen. Despite this, drug development carries a significant risk of discontinuation at each stage before approval because of test data and changes in the business environment. Improving the efficiency of the research and development process and reducing development risk are therefore major challenges for pharmaceutical companies and drug-discovery ventures worldwide.」
Explains that drug development requires 10–15 years and several billion to several tens of billions of yen, with a risk of discontinuation at each stage.