Tryptamine psychoactive substances, such as α-methyltryptamine (AMT), are monoamine alkaloids characterized by an indole ring ...
However, management announced that it had "reached agreement with the U.S. Food and Drug Administration (FDA) on key elements of an Accelerated Approval pathway for AMT-130". As part of uniQure ...
An accelerated approval allows a drug to launch early on promising test ... The company won't need to run another study before asking for approval of AMT-130. "We have initiated BLA (biological ...
In the third quarter of 2025, the Company expects to present data from its ongoing Phase I/II studies of AMT-130 in support of a potential BLA submission. The update will include follow-up data on all ...