MIRA PHARMACEUTICALS, INC. 8-K

What Happened
MIRA Pharmaceuticals, Inc. announced on June 17, 2026 (Regulation FD disclosure) that it submitted a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration for Ketamir-2, its proprietary oral NMDA receptor modulator, to study chemotherapy-induced peripheral neuropathy (CIPN). The company received an FDA acknowledgment of receipt confirming acceptance of the Phase 2a clinical trial protocol submission for Protocol Mira-002. MIRA attached a press release (Exhibit 99.1) and the FDA submission receipt (Exhibit 99.2) to the 8-K.

Key Details

• Date of filing: June 17, 2026 (Form 8-K, Regulation FD disclosure).
• Drug & indication: Ketamir-2 — oral NMDA receptor modulator for chemotherapy-induced peripheral neuropathy (CIPN).
• Protocol ID: Protocol Mira-002 (Phase 2a clinical trial protocol).
• Regulatory step: FDA acknowledgment of receipt confirming acceptance of the Phase 2a protocol submission; press release attached as Exhibit 99.1 and FDA receipt attached as Exhibit 99.2.

Why It Matters
This 8-K documents a procedural regulatory milestone: FDA acceptance of a Phase 2a protocol advances Ketamir-2 toward clinical testing in patients with CIPN, which is a meaningful step in drug development. For investors, the filing signals progress in MIRA’s clinical program and may affect upcoming clinical timelines and corporate news flow; it does not indicate trial results or regulatory approval.