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Spectral Medical Advances Towards FDA Approval with Tigris Trial Progress

Story Highlights
  • Spectral Medical completed patient enrollment in the Tigris trial, aiming for FDA approval.
  • The company secured funding from Vantive, supporting its financial and commercialization plans.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Spectral Medical Advances Towards FDA Approval with Tigris Trial Progress

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Spectral Medical ( (TSE:EDT) ) just unveiled an update.

Spectral Medical announced significant progress in its clinical and operational efforts during the second quarter of 2025, particularly with the completion of patient enrollment in the Tigris trial. The company is on track to release topline results for this Phase III trial, which evaluates PMX for endotoxic septic shock, by mid-August 2025. These results are crucial for the company’s Premarket Approval submission to the FDA. Spectral has also secured non-dilutive funding from its partner Vantive, aiding its financial stability and readiness for potential FDA approval and commercialization. The company’s efforts are aligned with market readiness and regulatory timelines, indicating a strategic focus on execution across regulatory, clinical, and commercial fronts.

Spark’s Take on TSE:EDT Stock

According to Spark, TipRanks’ AI Analyst, TSE:EDT is a Neutral.

The low overall score reflects significant financial challenges and poor valuation metrics, which are partially offset by technical indicators showing some positive trends and promising corporate developments. The successful completion of trials and secured funding are critical to potential future success, though current financial instability remains a major concern.

To see Spark’s full report on TSE:EDT stock, click here.

More about Spectral Medical

Spectral Medical Inc. is a late-stage theranostic company focused on advancing therapeutic options for sepsis and septic shock. The company is primarily engaged in the development of PMX, a treatment for endotoxic septic shock, and is working towards gaining FDA approval for its use.

Average Trading Volume: 57,683

Technical Sentiment Signal: Buy

Current Market Cap: C$237.2M

For a thorough assessment of EDT stock, go to TipRanks’ Stock Analysis page.

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