WILMINGTON, DE — NRx Pharmaceuticals (Nasdaq: NRXP) said it supports an executive order signed April 18, 2026, directing federal agencies to accelerate research and regulatory pathways for treatments targeting serious mental illness, including psychedelic-based therapies.
The order calls for expanded clinical research, increased data sharing, and expedited approval processes for drugs addressing conditions such as depression, post-traumatic stress disorder, and suicidality.
It also directs the Food and Drug Administration to issue National Priority Vouchers for qualifying therapies with Breakthrough Therapy designation and to coordinate with the Department of Health and Human Services and the Department of Veterans Affairs to expand clinical trial participation.
NRx said it has applied for a priority voucher in connection with its planned New Drug Application for NRX-100, a ketamine-based therapy under development for depression, including cases involving suicidal ideation.
The company previously received Fast Track designation for NRX-100 and has held discussions with the FDA regarding its regulatory pathway.
Jonathan Javitt, chief executive officer of NRx Pharmaceuticals, said the order may support the use of existing clinical trial data and real-world evidence in future regulatory submissions.
“FDA’s supportive guidance on the use of existing clinical trials and Real World Evidence has now been amplified by a Presidential Executive Order,” Javitt said.
Suicide remains a leading cause of death among Americans under age 35, and treatment options for suicidality in depression remain limited, according to the company.
NRx Pharmaceuticals develops therapies for central nervous system disorders, including depression and post-traumatic stress disorder.
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