Risk of Delays in Full U.S. Approval and European Approval of Veterinary Pharmaceuticals
First written in FY2023. 3 of 5 entries say "Restated". Latest entry: 2026-05-12.
No other company in this theme has enough history to compare yet.
- 2026-05-12MaterialisedEarnings
「In the healthcare business, research and development expenses are expected to increase due to the delay in obtaining full approval in the United States for the veterinary drug “PANOQUELL®.”」
米国完全承認の遅延が、研究開発費の増加見通しとして具体的な影響を伴って記載された。 - FY2025-H1RestatedAnnual report
「During the interim consolidated accounting period under review, there were no significant changes in the matters described in this interim report regarding the business and accounting conditions that could materially affect investors’ decisions, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
動物用医薬品の米国完全承認・欧州承認遅延リスクについて、重要な変更はないと扱っている。 - FY2024-Q3RestatedAnnual report
「During the cumulative third quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that could materially affect investors’ decisions, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
動物用医薬品の米国完全承認・欧州承認遅延リスクについて、重要な変更はないと扱っている。 - FY2024-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that could materially affect investors’ decisions, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
動物用医薬品の米国完全承認・欧州承認遅延リスクについて、重要な変更はないと扱っている。 - FY2023First statedAnnual report
「当社のPANOQUELL-CA1は2022年11月に最重要市場である米国で米国食品医薬品局(FDA)の条件付き承認を取得しました。今後、米国での完全承認や欧州での規制当局による承認が拒否された又は遅延した場合、販売が想定を大きく下回り、当社グループの業績に影響を及ぼす可能性があります。」
動物用医薬品について、米国条件付き承認後の完全承認および欧州承認の拒否・遅延を独立した優先重要リスクとして初めて明示した。