Out-licensing of TMS-007 and Late-Stage Phase II Clinical Trial
First written in FY2023-Q3. 7 of 15 entries say "Advanced", first in FY2025-Q1. Latest entry: 2026-08-25.
No other company in this theme has enough history to compare yet.
- FY2027-H1AdvancedAnnual report
「During the interim accounting period, enrollment in the CORXEL-led global Phase II/III ORION trial progressed smoothly. The Company is participating as the sponsor in Japan, where the first patient was dosed in February 2026.」
Enrollment in the CORXEL-led ORION trial progressed smoothly, and the first patient in Japan was dosed in February 2026, beginning domestic enrollment. - FY2026-H1AdvancedAnnual report
「During the interim accounting period (1 March 2025 to 31 August 2025), the Company worked to steadily advance its pipeline and expand it through internal and external sources. For TMS-007 (JX10), the most advanced clinical program in the Company’s pipeline, CORXEL Pharmaceuticals Hong Kong Limited (CORXEL) administered the first dose to the first patient in May 2025 in the global Phase II/III ORION trial. In Japan, the Company submitted a clinical trial notification as the sponsor of the Japanese portion and registered the trial on the clinical research database jRCT (Japan Registry of Clinical Trials).」
The first patient was dosed in the CORXEL-led ORION trial in May 2025. In Japan, the Company submitted the clinical trial notification to PMDA and registered the trial on jRCT, advancing preparations for dosing in the domestic portion. - FY2025AdvancedAnnual report
「The Phase II/III clinical trial ORION, which began in February 2025, is a global trial led by CORXEL for patients with ischemic stroke 4.5 to 24 hours after symptom onset. The Company holds exclusive commercialization rights for TMS-007 in Japan and is proceeding with arrangements to participate in the trial as its Japanese partner.」
The start of CORXEL-led global Phase II/III trial ORION was announced in February 2025, and the Company progressed preparations to participate as the Japanese partner and to develop TMS-007 in Japan. CORXEL will reimburse 75% of Japan trial costs, capped at $10 million. - FY2025-H1RestatedAnnual report
「During the interim accounting period, the Company supported preparations for the next clinical trial being conducted primarily by JIXING. The Company expects JIXING to announce an update on progress around March 2025.」
The Company continued supporting preparations for the next TMS-007 clinical trial led by JIXING and expected a progress update around March 2025. The trial start itself had not been completed. - FY2025-Q1AdvancedAnnual report
「The Company currently holds the exclusive development and commercialization rights for TMS-007 in Japan, as well as the right to receive milestone payments and royalties from Ji Xing Pharmaceuticals (Hong Kong) Limited (JIXING) for development and sales outside Japan. During the first quarter, the Company supported preparations for the next clinical trial led by JIXING.」
For TMS-007 (JX10), the Company advanced to supporting preparations for the next clinical trial led by JIXING. - FY2024-Q3ReframedAnnual report
「Following Biogen’s strategic change, it decided to transfer its position under the option agreement to a third party and selected Ji Xing Pharmaceuticals Hong Kong Limited, a subsidiary of JIXING, a biotechnology company based in China focused primarily on cardiovascular and ophthalmology fields. JIXING HK will consider the specific development strategy for TMS-007 going forward.」
While Biogen’s suspension of the late Phase II trial continued, its position under the option agreement was transferred to JIXING HK, changing the development partner for TMS-007. JIXING HK will consider the specific development strategy going forward. - FY2024-Q2SoftenedAnnual report
「Biogen announced at its 25 April 2023 first-quarter results presentation that it had temporarily suspended the start of the late Phase II clinical trial for TMS-007 (BIIB131) and would reassess whether to begin it. The situation remained unchanged at its 25 July 2023 second-quarter results presentation and continues to date. The expected trial start date in the ClinicalTrials.gov registration was updated twice and is now listed as 1 December 2023.」
Biogen’s suspension and reassessment continued, and the expected start date on ClinicalTrials.gov was updated to 1 December 2023. The registration continued to list expected enrollment of 760 patients and expected completion on 7 July 2025. - FY2024-Q1SoftenedAnnual report
「Biogen subsequently announced at its 25 April 2023 first-quarter results presentation that it had temporarily suspended the start of the late Phase II clinical trial for TMS-007 (BIIB131) and would reassess whether to begin the trial. On 26 April 2023, the ClinicalTrials.gov registration was updated, changing the expected trial start date to 21 August 2023.」
While the suspension and reassessment continued, the expected start date on ClinicalTrials.gov was changed from 17 April 2023 to 21 August 2023. The registration also indicated expected enrollment of 760 patients and expected completion on 7 July 2025. - FY2023SoftenedAnnual report
「Details of the trial were registered and published on the U.S. clinical trial database ClinicalTrials.gov on 10 March 2023. However, at its 25 April 2023 announcement of first-quarter results, Biogen announced that it had temporarily suspended the start of the late Phase II clinical trial for TMS-007 (BIIB131) and would reassess whether to begin the trial.」
Although registration on ClinicalTrials.gov had been completed, Biogen announced that it had temporarily suspended the trial start and would reassess whether to proceed. The registration indicated an expected enrollment of 760 patients and expected completion in July 2025. - FY2023-Q3First statedAnnual report
「TMS-007, which targets acute ischemic stroke and was out-licensed to Biogen MA Inc. (Biogen) in May 2021, is being developed by Biogen with the late Phase II clinical trial planned to begin in the first half of 2023. The Company continues to provide ancillary support.」
TMS-007 was out-licensed to Biogen in May 2021. Biogen planned to begin a late Phase II clinical trial in the first half of 2023, with the Company continuing to provide ancillary support.