MAIA Biotechnology Gains Regulatory Approval for Pivotal Clinical Trials in Spain and…
What happened
MAIA Biotechnology, Inc. announced on September 23, 2026, that it received regulatory approval to screen patients for its pivotal Phase 3 THIO-104 clinical trial in two countries. The company gained approval from the Spanish Agency for Medicines and Medical Devices (AEMPS) and Portugal’s National Authority of Medicines and Health Products (INFARMED). These approvals allow the company to conduct the trial in Spain and Portugal for non-small cell lung cancer (NSCLC) patients.
From manilatimes.net
Why it matters
The expansion of the pivotal Phase 3 trial into Spain and Portugal adds important European markets to the research program. The company stated that clinical trial participation offers patients access to investigational therapies in markets where access to newly approved lung cancer treatments has historically lagged.
From manilatimes.net
Who's involved
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The entities involved
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Hungary
country in Central Europe
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Europe
terrestrial continent located in north-western Eurasia
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Spain
country in southwestern Europe with territories in Africa
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Portugal
country in Southwestern Europe
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