Uncertainty Over the NeoCart and MDNT01 Development Strategy Due to the FDA's Requirement for Additional Clinical Trials
First written in FY2019-Q1. 5 of 12 entries say "Mitigated", first in FY2023-Q1. Latest entry: 2026-05-27.
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
6 other companies' latest entry also says "Mitigated".
- 2026-05-27MitigatedPresentation materials on financial results
「Agreement has been reached with PMDA on the design of the domestic Phase II/III trial」
Although the domestic development policy itself has not yet been finalized, agreement with PMDA on the trial design indicates that the response has become more concrete. - FY2025WorsenedAnnual report
「As a result, the Company was unable to decide on a domestic development strategy because of issues including the supply of clinical-trial products to Japan.」
For MDNT-01, changes to the U.S. development structure and delays in trial preparations created issues including the supply of clinical-trial products to Japan, preventing a domestic development strategy from being decided. - FY2025-H1MitigatedAnnual report
「The Company held a preliminary meeting with the PMDA regarding the domestic trial design, referring to the additional U.S. Phase III trial protocol agreed between Ocugen and the FDA, and is currently preparing consultation materials for face-to-face advice.」
The response to uncertainty over the domestic development strategy for MDNT-01 has become more concrete, with a preliminary meeting held with the PMDA and materials being prepared for face-to-face advice. - FY2024-Q2MitigatedAnnual report
「The Company is currently preparing a domestic trial design with reference to the Phase III trial protocol agreed between Ocugen and the U.S. FDA and has begun discussions with the PMDA on the domestic trial design.」
For MDNT-01, the Company prepared a domestic trial design based on the protocol agreed with the FDA and began discussions with the PMDA, making its efforts toward deciding the domestic development strategy more concrete. - FY2024-Q1MitigatedAnnual report
「The Company is currently preparing a domestic trial protocol with reference to the Phase III trial protocol agreed between Ocugen and the FDA, and plans to determine its domestic development policy and other matters after consulting with the PMDA.」
The development strategy for MDNT-01 in Japan remains undecided. However, the response to the uncertainty has progressed, as the process has been made more concrete through preparation of a domestic trial protocol based on the protocol agreed with the FDA and a plan to decide the strategy after consulting with the PMDA. - FY2023WorsenedAnnual report
「However, because finalization of the Phase III trial protocol required for Ocugen's marketing application was delayed, the Company was unable to determine its development policy and other matters for the autologous cell-cultured cartilage product MDNT-01 in Japan during the fiscal year.」
The development strategy for MDNT-01 in Japan remains uncertain because delays in finalizing the Phase III trial protocol in the United States prevented the strategy from being decided during the fiscal year. - FY2023-Q1MitigatedAnnual report
「Ocugen, which currently holds the assets of NeoCart® and is based in Malvern, Pennsylvania, United States, announced on 16 December 2022 that it had reached agreement with the FDA on the design of the Phase III trial required for a marketing application, with the aim of resuming development in the United States.」
Agreement was reached with the FDA on the Phase III trial design for NeoCart's development in the United States, making the development plan more concrete than it had been when the trial strategy remained undecided. However, the development strategy for MDNT-01 in Japan remains undecided. - FY2020-Q3RestatedAnnual report
「After completion of the asset transfer, the Company will discuss the development of the autologous cell-cultured cartilage product MDNT01 in Japan with Medavate.」
For NeoCart and MDNT01, the Company has continued discussions with Medavate on domestic development under the framework established following the transfer of the license agreement. - FY2020-Q1RestatedAnnual report
「Upon completion of the asset transfer, the license agreement for the autologous cultured cartilage product "NeoCart®" between the Company and Histogenics Corporation will also be transferred to Medavate. Following completion of the asset transfer, the Company will discuss with Medavate the development of the autologous cultured cartilage product "MDNT01" in Japan.」
For NeoCart and MDNT01, the Company has continued discussions on domestic development under the new framework established following completion of the asset transfer and transfer of the license agreement. - FY2019ReframedAnnual report
「The Company announced that it entered into a merger agreement with Ocugen, which is developing innovative clinical-stage biopharmaceuticals in the United States, in April 2019 and merged with Ocugen at the end of September 2019. In May of the same year, Histogenics entered into an asset purchase agreement with Medavate for the autologous cell-cultured cartilage product NeoCart®. As the license agreement between the Company and Histogenics for NeoCart® will also be assigned to Medavate, the Company will discuss the development of the autologous cell-cultured cartilage product MDNT01 in Japan with Medavate after completion of the asset transfer.」
Regarding NeoCart and MDNT01, the counterparty and approach for discussions on domestic development changed following Histogenics' merger with Ocugen and the transfer of assets and licenses to Medavate. - FY2019-Q3ReframedAnnual report
「As the license agreement for the autologous cultured cartilage product "NeoCart®" was also transferred to Medavate, the Company will discuss with Medavate the development of the autologous cultured cartilage product "MDNT01" in Japan.」
In addition to the uncertainty over the MDNT01 development strategy stemming from the FDA's request for additional clinical trials, the counterparty and approach for future discussions on domestic development changed as a result of the transfer of the license agreement. - FY2019-Q1MaterialisedAnnual report
「The Company announced that the FDA had responded that additional clinical trials were required for the BLA. In response, Histogenics announced in December 2018 that it would temporarily suspend development of autologous cultured cartilage NeoCart® in the United States.」
The FDA requested additional clinical trials for NeoCart, resulting in a temporary suspension of US development and uncertainty over the development strategy for MDNT01 in Japan.