An update from Spectral Medical ( (TSE:EDT) ) is now available.
Spectral Medical has completed patient enrollment for its Tigris trial, a Phase 3 study evaluating the use of Polymyxin B Hemoperfusion (PMX) in treating endotoxic septic shock. With 157 patients enrolled, the company anticipates releasing topline results in August 2025. This milestone is crucial for Spectral’s regulatory path towards potential PMX approval, with plans to submit clinical results to the FDA by October 2025. The company is also finalizing non-dilutive financing to support PMX commercialization, highlighting its commitment to advancing its regulatory and commercialization efforts.
Spark’s Take on TSE:EDT Stock
According to Spark, TipRanks’ AI Analyst, TSE:EDT is a Neutral.
Spectral Medical’s stock score reflects significant financial challenges, with persistent losses and negative cash flows raising concerns about financial stability. However, recent corporate developments, including progress in a pivotal clinical trial, provide potential upside. Technical analysis suggests positive momentum, though valuation metrics are weak due to a lack of profitability. Overall, while there are promising clinical advancements, the financial and valuation concerns weigh heavily on the stock’s outlook.
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 seeking U.S. FDA approval for its product Toraymyxin (PMX), a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream. PMX is already approved for use in Japan and Europe and has been used over 360,000 times. Spectral holds exclusive development and commercial rights for PMX in the U.S. and Canada.
YTD Price Performance: 52.97%
Average Trading Volume: 16,081
Technical Sentiment Signal: Sell
Current Market Cap: $151.3M
Learn more about EDT stock on TipRanks’ Stock Analysis page.