8-K - NRx Pharmaceuticals, Inc. | StockGist

AI Analysis

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NRx Pharmaceuticals issued a press release announcing a path to New Drug Application for NRX-100 (preservative-free ketamine) for Treatment-Resistant Depression in the context of suicidality, following a Type C FDA meeting, using existing clinical data and Real World Evidence from over 65,000 patients. The company anticipates NDA submission in Q2 2026 targeting full approval.

Key Takeaways

1Completed in-person Type C FDA meeting on February 17, 2026 with Division of Psychiatry Products

2Path to full NDA for NRX-100 based on clinical trials and Real World Evidence from 65,000 patients

3Expanded indication to Treatment-Resistant Depression with suicidality

4NDA submission anticipated in Q2 2026 with 2026 PDUFA date

5No additional nonclinical data or bridging studies required

6ANDA for preservative-free ketamine generic under review with decision in Summer 2026

Current Report Details

Event Type

Other Event

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

8.01

. Other Events. On February 17, 2026, NRx Pharmaceuticals, Inc. (the “Company”) issued a press release regarding a path to a new drug application with real worl

Other Event

9.01

Financial Statements and Exhibits. (d) Exhibits Exhibit Number Description 99.1 Press Release dated February 17, 2026 104 Cover Page Interactive Data File (embe

Exhibits Only

Source Document

Exhibits (2)

8-K

FORM 8-K

99.1

EXHIBIT 99.1