BioRestorative Announces Positive Outcome from Type B Meeting with FDA
BioRestorative Therapies, Inc. (BRTX)
NASDAQ:AMEX Investor Relations:
biorestorative.com/content/investor-relations
Company Research
Source: GlobeNewswire
BioRestorative completed a Type B meeting with the U.S. Food and Drug Administration (“FDA”) regarding a potential accelerated Biologics License Application (“BLA”) approval pathway for the Fast-Track-Designated BRTX-100 program for the treatment of chronic lumbar disc disease (“cLDD”)Consistent positive clinical safety endpoints from BioRestorative’s ongoing 99 patient Phase 2 clinical trial of BRTX-100 in cLDD were discussed in the meeting and the FDA did not raise any clinical safety concerns FDA endorsed the proposed Phase 3 study design (i.e., outcome assessments, dosing strategy, and eligibility criteria), sample size, and powering assumptions pending final review of Phase 3 investigational new drug (“IND”) application submissionFDA feedback confirms alignment of the Company’s ongoing Chemistry Manufacturing and Controls (CMC) activities prior to submission of an IND application for a Phase 3 trialBased on the positive final official summary of this Type B meeting, BioRestorativ
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News
- BioRestorative prices $5M stock offering [Seeking Alpha]Seeking Alpha
- BioRestorative Announces Pricing of $5.0 Million Public OfferingGlobeNewswire
- BioRestorative Completes Patient Enrollment in Landmark Phase 2 Trial of BRTX-100 for Chronic Lumbar Disc DiseaseGlobeNewswire
- ?????????????????????????????2035????18?6170??????49?5700???????????????(CAGR)10.29%???????????? [CNET News]CNET News
- Biorestorative Therapies (NASDAQ:BRTX) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
BRTX
Sec Filings
- 2/12/26 - Form EFFECT
- 2/10/26 - Form S-1/A
- 2/9/26 - Form S-1
- BRTX's page on the SEC website