Risk of Clinical Trial Delays and Failure to Obtain Approval for Regenerative Medicine Products
First written in FY2020. 9 of 10 entries say "Restated". Latest entry: FY2026.
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
17 other companies' latest entry also says "Restated".
- FY2026RestatedAnnual report
「Clinical trials may be terminated, or approval may not be obtained, due to unexpected adverse events or an inability to demonstrate efficacy. There is also a risk of delays during the marketing-approval application and review processes.」
The risks of clinical-trial termination, failure to obtain approval, and delays in marketing-approval applications and reviews for regenerative medicine products have been reaffirmed. - FY2026-H1RestatedAnnual report
「Our group is preparing an application for manufacturing and marketing approval, making use of these results and the benefits of the designation, so that we can deliver a new treatment option to patients suffering from spinocerebellar degeneration as soon as possible.」
The policy of proceeding with preparations for marketing approval of regenerative medicine products based on the clinical-trial results has been reaffirmed. - FY2025-H1RestatedAnnual report
「We are preparing an application for approval so that new treatment options can be delivered as soon as possible to patients fighting the disease.」
The plan for the ステムカイマル regenerative medicine product has been reaffirmed: to proceed with preparations for the marketing-approval application after evaluating the clinical-trial results. - FY2024-Q3RestatedAnnual report
「We are preparing an application for approval so that new treatment options can be delivered as soon as possible to patients fighting the disease.」
The plan for the ステムカイマル regenerative medicine product has been reaffirmed: to proceed with preparations for the marketing-approval application after evaluating the clinical-trial results. - FY2023-Q3RestatedAnnual report
「We are currently conducting data analysis and evaluation and will proceed with preparations for the marketing-approval application.」
The plan for the ステムカイマル regenerative medicine product has been reaffirmed: to conduct data analysis and evaluation after completion of the clinical trial and proceed with preparations for the marketing-approval application. - FY2023-Q2RestatedAnnual report
「We are currently conducting data analysis and evaluation and will proceed with preparations for the marketing-approval application.」
The plan for the ステムカイマル regenerative medicine product has been reaffirmed: to conduct data analysis and evaluation after completion of the clinical trial and proceed with preparations for the marketing-approval application. - FY2022-Q3RestatedAnnual report
「This clinical trial evaluates safety and efficacy using a design with a very high level of evidence: multicentre, placebo-controlled, randomised, double-blind and parallel-group. We aim to obtain marketing approval as early as possible. The trial has proceeded on schedule without being affected by COVID-19 to date.」
The plan for the ステムカイマル regenerative medicine product has been reaffirmed: to evaluate safety and efficacy after completing administration to all subjects and aim to obtain approval at an early stage. - FY2022-Q1RestatedAnnual report
「This clinical trial uses a design with a very high level of evidence: multicentre, placebo-controlled, randomised, double-blind and parallel-group. We will evaluate safety and efficacy and aim to obtain marketing approval as early as possible.」
The plan for the ステムカイマル regenerative medicine product has been reaffirmed: to evaluate safety and efficacy after completion of administration and aim to obtain approval. - FY2021RestatedAnnual report
「Clinical trials may be terminated, or approval may not be obtained, due to unexpected adverse events or an inability to demonstrate efficacy. There is also a risk of delays during the marketing-approval application and review processes.」
The risks of clinical-trial termination, failure to obtain approval, and delays in marketing-approval applications and reviews for regenerative medicine products have been reaffirmed. - FY2020First statedAnnual report
「There is a risk that clinical trials may be discontinued or approval may not be obtained because of unexpected adverse events or an inability to demonstrate efficacy. There is also a risk that development costs may increase if the scale of clinical trials is larger than anticipated.」
The risks relating to regenerative medicine products, including ステムカイマル, are described separately: delays in clinical-trial progress, marketing-approval applications and reviews; termination of clinical trials; failure to obtain approval; and rising development costs.