Subsequent Events |
3 Months Ended |
---|---|
Mar. 31, 2025 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events In April 2025, the Company received a formal communication from the U.S. FDA in the form of an information request for a post marketing commitment (“PMC”) to generate additional clinical data. The Company has responded to the U.S. FDA’s information request with a proposed study design and continues to engage with the U.S. FDA to address the PMC request and move to approval as soon as possible. On April 29, 2025, the Company entered into a collaboration and exclusive license agreement, as amended (“Amended Takeda APA”), with Takeda which amends and supersedes its collaboration and exclusive license agreement with Takeda, dated February 24, 2021. The Amended Takeda APA improves financial terms for the Company.
|