This Canadian stock has an upside of 147%, Research Capital says

Research Capital Corporation analyst Andre Uddin says Spectral Medical (Spectral Medical Stock Quote, Chart, News, Analysts, Financials TSX:EDT) has reached a key regulatory catalyst with the submission of its Premarket Approval application to the U.S. Food and Drug Administration for its PMX columns.

In a May 29 update, Uddin maintained his “Speculative Buy” rating and $3.50 target on Spectral.

“We remain bullish on PMX given its strong safety and durability data, as well as its potential to become the only approved sepsis treatment in the U.S. market,” Uddin said.

Spectral announced the PMA submission for PMX, which, if approved, would become the only FDA-approved therapy for sepsis in the United States.

The submission supports the combined use of PMX columns and the company’s Endotoxin Activity Assay, which is designed to identify patients most likely to benefit from PMX treatment.

The company previously reported survival benefits from its pivotal Tigris trial among patients treated with PMX. Uddin said a fully adjusted Bayesian analysis showed a 95.3% posterior probability of benefit at Day 28 and a greater than 99% posterior probability of benefit at Day 90.

Absolute mortality risk reductions were 10.3% and 15.5% at Days 28 and 90, respectively, corresponding to numbers needed to treat of 9.7 and 6.5 to prevent one death. The findings were also published in The Lancet Respiratory Medicine.

Top-line 12-month survival data are expected soon, and management has indicated that the PMA submission included the one-year data.

“We expect the FDA receipt of the PMA submission to occur within 45 days — likely by mid-July 2026,” Uddin said.

“Following acceptance, we would anticipate a standard 180-day review period, which should lead to an approval decision in early 2027,” he said. “If approved (and we expect it should), we believe EDT and its partner, Vantive, should commence a U.S. commercial launch during 2027.”

Uddin said his valuation is based on a net present value analysis of projected PMX revenue and cash flow in the U.S. and Canada from 2026 to 2038.

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