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Stock impact report

BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment [Yahoo! Finance]

BioRestorative Therapies, Inc. (BRTX) 
NASDAQ:AMEX Investor Relations: biorestorative.com/content/investor-relations
Company Research Source: Yahoo! Finance
MELVILLE, N.Y., April 16, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc . (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: BRTX , a clinical stage company focused on stem cell-based therapies, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared an important amendment to the protocol of the ongoing Phase 2 study investigating the use of BRTX-100, the Company's lead cell therapy candidate, in treating chronic lumbar disc disease (“cLDD”). The protocol amendment removes saline injection in the control arm of the study and replaces it with a sham injection. “The FDA clearance of this important amendment highlights our positive relationship with the agency, brings additional safety to our subject participants, and helps preclude the possibility of transient clinical outcomes in the control group, which can impact end of study readouts,” said Lance Alstodt, BioRestorative's Chief Executive Officer. “To further clarify, control patients in our Phase Show less Read more
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