SMSbiotech Receives FDA "Study May Proceed" Notification for First U.S. IND-Cleared Inhaled Stem Cell Therapy in COPD

Phase 1SMS CellsPositive

AI Analysis

Summary

SMSbiotech received FDA 'Study May Proceed' notification for its inhaled stem cell therapy SMS Cells in COPD, clearing the IND application for Phase 1b trial initiation expected in Q4 2026. SMS Cells is described as the only known inhaled, refrigerated, allogeneic stem cell product in active COPD development.

Clinical Trial Data

Phase

Outcome Details

IND application received FDA 'Study May Proceed' notification following 30-day review

Importance:7/10

Sentiment:

0.80

FDA approvalIND clearancestem cell therapyinhaled therapyCOPDPhase 1ballogeneic

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Published by PR Newswire Biotech on September 16, 2026 1:18 PM

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