BioRestorative Granted Type B Meeting with FDA to Discuss Accelerated BLA Approval Pathway for BRTX-100 in Chronic Lumbar Disc Disease
BioRestorative Therapies, Inc. (BRTX)
NASDAQ:AMEX Investor Relations:
biorestorative.com/content/investor-relations
Company Research
Source: GlobeNewswire
MELVILLE, N.Y., Nov. 17, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today announced that it has been granted a Type B meeting with the U.S. Food and Drug Administration (“FDA”) to discuss 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”). The Type B meeting is scheduled for mid-December. “During the Type B meeting with the FDA, we plan on discussing the consistently positive safety and efficacy signals from our ongoing Phase 2 clinical trial of BRTX-100 in cLDD, as demonstrated by every new data analysis completed to-date,” said Lance Alstodt, Chief Executive Officer of BioRestorative. “We also intend to request an accelerated timeline for entering a Phase 3 trial to support our BLA application.”
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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
- BioRestorative Therapies, Inc. (BRTX) Q3 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
- BioRestorative Therapies Reports Third Quarter 2025 Financial Results and Provides Business UpdateGlobeNewswire
- BioRestorative Therapies to Report Third Quarter 2025 Financial Results and Host Conference Call on November 12, 2025GlobeNewswire
- BioRestorative Awarded Notice of Allowance for Japanese Patent – Expands Protection for Potential Cell-Based Alternative to Multi-Billion Dollar GLP-1 Drug MarketGlobeNewswire
BRTX
Sec Filings
- 11/18/25 - Form S-8
- 11/18/25 - Form S-1
- 11/12/25 - Form 10-Q
- BRTX's page on the SEC website