Unsuccessful R&D and Extended Development Timelines
First written in FY2016. 16 of 22 entries say "Restated". Latest entry: FY2023.
The whole theme swung hardest in 2022: 20 of 41 companies on the "Worse" side.
5 other companies' latest entry also says "Mitigated".
- FY2023MitigatedAnnual report
「The Group prepares detailed clinical trial plans and manages progress under a global development structure. At the start of development and each time a program advances to the next development phase, the Group makes an appropriate decision on whether to continue or discontinue development from the perspectives of the balance between efficacy and safety and return on investment.」
In response to the risks of R&D failure and prolonged development, the Company specified clinical trial planning, progress management, and decisions on continuation or discontinuation at each development stage. - FY2023-Q3RestatedAnnual report
「During the nine months ended the third quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2023-Q2RestatedAnnual report
「During the six months ended the second quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2023-Q1RestatedAnnual report
「During the three months ended the first quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2022-Q3Continuation of research following a review of development policyAnnual report
「However, it has become clear that Z-100 exhibits diverse pharmacological effects based on immunostimulatory activity, including an inhibitory effect on cancer. In addition, in the previous trial conducted from 2004 to 2013, a subgroup analysis limited to subjects with stage IIIB disease showed a statistically significant difference in overall survival, the primary endpoint, in favor of the Z-100 group over the placebo group. Accordingly, we intend to continue research and development of Z-100.」
After no statistically significant difference was observed in the Phase III international joint clinical trial for Z-100, a policy of continuing R&D based on subgroup analyses of past trials and other factors was presented. R&D failure continues to be recorded as an actual occurrence. - FY2022-Q2MaterialisedAnnual report
「With respect to "Z-100," the Company had been conducting a Phase III international joint clinical trial for cervical cancer in 7 Asian countries, including Japan. However, because no statistically significant difference was observed in overall survival, the primary endpoint, between the Z-100 and placebo groups, the Company decided to review its development policy.」
No statistically significant difference was observed in the primary endpoint of the Phase III international joint clinical trial for Z-100, and a review of the development policy actually took place. - FY2022-Q1RestatedAnnual report
「During the three months ended the first quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2020RestatedAnnual report
「For these reasons, development may be abandoned midway or the development period may be extended due to changes in the development plan. If this occurs, major changes to the business plan may be required, and the business results and financial condition of the Group may be affected.」
The risks that R&D failure, changes to the development plan, and extended development periods could affect business results and other matters continue to be described. - FY2020-Q3RestatedAnnual report
「During the nine months ended the third quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2020-Q2RestatedAnnual report
「During the six months ended the second quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2019RestatedAnnual report
「For these reasons, development may be abandoned midway or the development period may be extended due to changes in the development plan. If this occurs, major changes to the business plan may be required, and the business results and financial condition of the Group may be affected.」
The risks of R&D failure, changes to the development plan, and extended development periods continue to be described. - FY2019-Q3RestatedAnnual report
「During the nine months ended the third quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2019-Q2RestatedAnnual report
「During the six months ended the second quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2019-Q1RestatedAnnual report
「During the three months ended the first quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2018-Q3MaterialisedAnnual report
「The contract for TP09, a treatment for familial adenomatous polyposis being developed in a Phase III trial jointly with US-based Cancer Prevention Pharmaceuticals, INC., has ended.」
The risk related to the development plan and alliance actually materialized as the termination of the contract for TP09, which was under joint development. - FY2018-Q2RestatedAnnual report
「During the six months ended the second quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2018-Q1MaterialisedAnnual report
「Z-215, a proton pump inhibitor licensed from EA Pharma Co., Ltd., had been undergoing Phase II trials for gastroesophageal reflux disease. However, after reconsidering the development plan, we discontinued development of the drug.」
The risk related to R&D failure and changes to the development plan actually materialized as the discontinuation of development of Z-215. - FY2017RestatedAnnual report
「The likelihood of creating compounds that may become pharmaceutical candidates at the research stage is not high. In addition, unexpected adverse effects may arise or the expected efficacy may not be confirmed during clinical research.」
The risks of R&D failure, adverse effects, and extended development periods continue to be described. - FY2017-Q3RestatedAnnual report
「During the nine months ended the third quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2017-Q2RestatedAnnual report
「During the six months ended the second quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2017-Q1RestatedAnnual report
「During the three months ended the first quarter of the current fiscal year, there were no new occurrences or material changes in the principal risks likely to affect the business results or financial condition of the Group.」
It is stated that there were no new occurrences or material changes in the principal risks, including R&D failure and development delays. - FY2016First statedAnnual report
「The likelihood of creating compounds that may become pharmaceutical candidates at the research stage is not high. In addition, unexpected adverse effects may arise or the expected efficacy may not be confirmed during clinical research.」
This includes the possibility of abandoning development or extending the development period due to changes in the development plan.