Radnostix reports FY2026 second-quarter results after FDA 483 and recall actions

Radnostix, Inc. reported weaker second-quarter and first-half 2026 results as the aftereffects of two voluntary Theranostics Products recalls and a Cobalt Products shutdown cut revenue and margins. Second-quarter revenue fell 27% to $2.67 million from $3.66 million a year earlier, while six-month revenue dropped 27% to $5.05 million from $6.89 million. Gross profit declined to $1.36 million in the quarter from $2.14 million, and net loss widened to $0.88 million from $0.16 million. For the first half, net loss increased to $2.23 million from $0.27 million. The company said capsule inventory was fully restored by the end of June 2026, customer volumes returned and sales normalized in July, and all required documentation for both recalls was submitted to the FDA in June as it awaits formal close-out. Radnostix also said all planned corrective and preventive actions tied to the FDA Form 483 issued in April 2025 were completed, with an inspection close-out request submitted on June 19, 2026. In operations, the Cobalt-60 hot-cell rehabilitation completed in the first quarter helped improve margins and remove significant prior-year radiological waste costs in the second quarter, while the June 25 acquisition of Lucerno Dynamics assets, including the Lara System technology platform and Ellexa Explorer Software, expanded the Medical Devices segment. Management said its second-half priorities include stabilizing core revenue, controlling costs, advancing medical device commercialization, returning to cash-flow positive results and monetizing DUF6/NRC-licensed assets by the end of FY2026.

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