Efficacy and safety risks in future clinical trials of CBP501
First written in FY2016. 9 of 16 entries say "Restated". Latest entry: 2026-10-14.
The whole theme swung hardest in 2022: 20 of 40 companies on the "Worse" side.
22 other companies' latest entry also says "Materialised".
- 2026-10-14MaterialisedShare Issuance and Disposal
「2024年2月にその承認が得られないことが確定した」
CBP501の臨床第3相試験に関する開始承認上の不確実性について、米国では承認が得られないことが確定したと記載された。一方、欧州での試験開始の蓋然性は高まっているものと判断されている。 - FY2026RestatedAnnual report
「However, problems may arise in these future clinical trials, including failure to confirm efficacy or the emergence of significant safety concerns.」
Continues to disclose the risk that efficacy may not be confirmed or significant safety concerns may arise in next-stage or pivotal trials of CBP501 and other compounds. - FY2025-H1MitigatedAnnual report
「The triple-combination regimen including CBP501 achieved the primary endpoint, producing clinically meaningful improvements with tolerable safety and durable responses.」
The company reported tolerable safety, durable responses and achievement of the primary endpoint for the triple-combination regimen including CBP501, addressing some of the uncertainties in its clinical development to date. However, the efficacy or safety of the next-phase trial, or regulatory approval, is not guaranteed. - FY2024RestatedAnnual report
「However, problems may arise in these future clinical trials, including failure to confirm efficacy or the emergence of significant safety concerns.」
Even after completion of the Phase 2 trial of CBP501, the company continues to disclose the risk that efficacy may not be confirmed or safety concerns may arise in future pivotal and other trials. - FY2024-Q3MitigatedAnnual report
「The clinical trial achieved its primary endpoint in the three-drug combination arm, which included CBP501. Following this achievement, the company obtained regulatory approval in the United States to start the next clinical trial, a Phase 2b trial, and has begun some preparations for its commencement. In Europe, it is currently submitting applications to the regulatory authorities and preparing to start a Phase 3 trial aimed at obtaining approval.」
Following achievement of the primary endpoint in the three-drug combination arm that included CBP501, the company addressed some of the previous development uncertainties by obtaining approval to begin a US Phase 2b trial and advancing preparations and an application for a European Phase 3 trial. However, efficacy, safety and approval in the next-stage trial are not guaranteed. - FY2024-Q1RestatedAnnual report
「The company achieved the primary endpoint in the three-drug combination arm that included CBP501 and is currently preparing to begin the next-stage clinical trial aimed at obtaining approval.」
Although the company reconfirms that the primary endpoint was achieved in the Phase 2 trial, this does not guarantee efficacy, safety or approval in the next-stage trial, and risks remain for future trials. - FY2023RestatedAnnual report
「However, problems may arise in these future clinical trials, including failure to confirm efficacy or the emergence of significant safety concerns.」
Continues to disclose the risk that efficacy may not be confirmed or significant safety concerns may arise in next-stage or pivotal trials of CBP501 and other compounds. - FY2023-Q3RestatedAnnual report
「The trial achieved its primary endpoint in the three-drug combination arm including CBP501, and the Company decided to end the trial early after the first stage of its two-stage design. Preparations are currently under way to begin a Phase 3 clinical trial.」
Reconfirms that the primary endpoint of the Phase 2 trial was achieved, but this does not guarantee efficacy, safety or approval in a Phase 3 trial, and risks remain for future trials. - FY2023-Q2MitigatedAnnual report
「The company decided to end the trial early after the first stage of a two-stage trial, having achieved its primary endpoint in the three-drug combination arm that included CBP501.」
The filing indicated that the primary endpoint had been achieved in the three-drug combination arm that included CBP501. However, it stated that this did not guarantee efficacy or safety in a Phase 3 trial or approval, and risks remain for future trials. - FY2022RestatedAnnual report
「However, problems may arise in these future clinical trials, including failure to confirm efficacy or the emergence of significant safety concerns.」
Continues to disclose the risk that efficacy may not be confirmed or safety concerns may arise in future clinical trials of CBP501 and CBS9106. - FY2021RestatedAnnual report
「However, problems may arise in these future clinical trials, including failure to confirm efficacy or the emergence of significant safety concerns.」
Continues to disclose the risk that efficacy may not be confirmed or significant safety concerns may arise in future clinical trials of CBP501 and other compounds. - FY2020RestatedAnnual report
「However, problems may arise in these future clinical trials, including failure to confirm efficacy or the emergence of significant safety concerns.」
Continues to disclose the risk that efficacy may not be confirmed or significant safety concerns may arise in future clinical trials of CBP501 and other compounds. - FY2017RestatedAnnual report
「However, further clinical trials, including a future Phase 3 trial, will be necessary before the efficacy, safety and other characteristics of CBP501 are confirmed by the regulatory authorities and it receives NDA approval and is launched.」
Continues to disclose the possibility that efficacy or safety will not be confirmed in future clinical trials after approval of the IND for the Phase 1b trial, resulting in changes to or discontinuation of development. - FY2016First statedAnnual report
「However, further clinical trials, including a future Phase 3 trial, will be necessary before the efficacy, safety and other characteristics of CBP501 are confirmed by the regulatory authorities and it receives NDA approval and is launched.」
Indicates that Phase 3 trials and other studies will be necessary after the Phase 2 trial and that approval and launch may not be achieved.