Salience Clinical, LLC

The FDA’s 2024 non-approval of MDMA-assisted therapy was a hard lesson. Methodological weaknesses don’t get overlooked just because the science feels compelling or the patient need is real. Regulators did their job. The April 2026 executive actions aimed at accelerating breakthrough mental health treatments have reopened real opportunities but only for sponsors who do the work rigorously. The window is open. Whether the field walks through it or stumbles is a different question.