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MIRA Pharmaceuticals Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple Ascending Dose Stage

Tuesday, August 19, 2025 BiopharmaWatch Research 1 min read
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Key Takeaway: MIRA Pharmaceuticals has successfully completed the Single Ascending Dose phase of its Phase 1 clinical trial for Oral Ketamir-2, reporting no safety concerns. The company is now advancing to the Multiple Ascending Dose stage. Additionally, MIRA is preparing to initiate a Phase 2a trial for neuropathic pain in the U.S. in Q4 2025.
Price reaction · baseline $1.48 (2025-08-18 close) · hit pre-market · clean, no other MIRA news in the window
day 0 close · peak
-4.1%

Market Sentiment Analysis

POSITIVE FACTORS

  • Completion of Phase 1 Single Ascending Dose with no safety concerns.
  • Advancement to Multiple Ascending Dose stage indicates progress.
  • Preparation for U.S. Phase 2a trial shows commitment to development.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+5%
120-day peak, hindsight
Typical move
0.6%
average across 2 past catalysts
Cash runway
~21 mo
Low dilution risk

Full Press Release Details

Following FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025 MIAMI, FL / ACCESS Newswire / August 19, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) (“MIRA” or the “Company”), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the successful completion of the Single Ascending Dose (SAD) portion of its ongoing Phase 1 clinical …
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Frequently Asked Questions

What is the status of MIRA's Phase 1 trial?

MIRA has completed the Single Ascending Dose phase with no safety concerns.

What is the next step for MIRA Pharmaceuticals?

MIRA is advancing to the Multiple Ascending Dose stage of the trial.

When will MIRA initiate its Phase 2a trial?

The Phase 2a trial for neuropathic pain is set to begin in Q4 2025.

What condition is MIRA targeting with Ketamir-2?

MIRA is developing Ketamir-2 for neuropathic pain.

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Tags: MIRA Viatris Investor Conferences Healthcare Ketamir-2 Phase 1 neuropathic pain clinical trial
Last updated: Aug 19, 2025

Biotech snapshot

Cash runway
$9M liquidity · $0M/mo burn
~21 mo
Low dilution risk

Catalyst track record

+5%
best trade around MIRA's most recent catalyst

Peak hindsight return over a 120-day window, across 2 tracked FDA/PDUFA catalysts for MIRA.

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