KETAFREE

August 7, 2026: NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) said it will host a conference call on August 10, 2026 at 8:30 a.m. ET to discuss the FDA’s completion of first-cycle review of the company’s ANDA for preservative-free ketamine. The call is expected to address both the regulatory path to approval and commercial plans.

The company identifies the program as NRX-100 (preservative-free intravenous ketamine). In the release, NRx also states it has filed an ANDA and initiated an NDA filing for NRX-100, with an application to the Commissioner’s National Priority Voucher Program, for treatment of suicidal ideation in patients with depression, including bipolar depression. NRX-100 has Fast Track designation for suicidal ideation in depression, including bipolar depression.

NRx also notes NRX-101 (oral D-cycloserine/lurasidone) has Breakthrough Therapy designation for suicidal bipolar depression, but no new regulatory or clinical milestone for NRX-101 is announced in this release.