Heartseed (219A) · RiskMitigated
Risk of clinical trial delays and failure to obtain approval
First written in FY2024. 3 of 5 entries say "Mitigated", first in FY2025. Latest entry: 2026-06-12.
5entries
2years
3from disclosures
How it moved
Same theme, other companies
Uncertainty over Prolonged or Discontinued Drug Development Pipelines and CommercializationA theme 70 companies write about · 87 as a headwind · 0 as a tailwind
The whole theme swung hardest in 2022: 20 of 41 companies on the "Worse" side.
5 other companies' latest entry also says "Mitigated".
Ridges = years it wrote progress, valleys = years it wrote worse. Most hopeful companies at the back. Drag to turn, scroll to zoom, right-drag to pan. On a phone, two fingers turn and pinch to zoom; one finger scrolls the page.
Showing 14 of the 70 companies compared. The sentences above are computed from all 70.Full recordFilings, disclosures and news, newest first
- FY2025MitigatedAnnual report
「There are also concerns that clinical trials may be delayed because of difficulties in patient recruitment and that applications for approval or the review process may be delayed.」
Although completion of administration to all 10 LAPiS patients and the 52-week follow-up advanced the existing trial, risks remain of delays or discontinuation in the HS-005 trial and in approval applications or reviews, as well as failure to obtain approval. - FY2024First statedAnnual report
「There is a risk that clinical trials may be delayed because of difficulties in patient recruitment, that applications for approval or the review process may be delayed, or, in some cases, that clinical trials may be discontinued or approval may not be obtained, preventing product commercialization.」
The Company identifies delays or discontinuation of clinical trials, failure to obtain approval, increased R&D expenses and delays in or loss of revenue generation.