May. 15 at 11:03 PM
$TSOI Breathe Biologics, Inc. Announces Successful Submission of Amendment #31 for IND 19757
Oceanside, CA / May 15, 2026 /
Breathe Biologics, Inc. announced today that the Company has submitted an additional clinical information package to the U.S. Food and Drug Administration (“FDA”) in support of the ongoing Regenerative Medicine Advanced Therapy (“RMAT”) designation review for the Company’s Umbilical Cord-Derived Mesenchymal Stem Cell (“UC-MSC”) program for Acute Respiratory Distress Syndrome (“ARDS”) under IND 19757.
The submission was provided in response to a recent FDA information request and included detailed clinical protocol materials, patient-level clinical outcome data, pulmonary stabilization analyses, mechanistic inflammatory biomarker information, and additional discussion regarding the applicability of COVID-19-associated ARDS clinical findings to broader inflammatory ARDS populations.