Business Insider

BioRestorative Granted Type B Meeting with FDA to Discuss Accelerated BLA Approval Pathway for BRTX-100 in Chronic Lumbar Disc Disease

MELVILLE, N.Y., Nov. 17, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX) , a ...
Business Insider

Capricor Therapeutics Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular ...

-Company Plans to Complete Rolling BLA Submission by End of 2024; Application May be Eligible for Priority Review by FDA- SAN DIEGO, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: ...
Seeking Alpha

Axogen raises 2025 revenue growth target to at least 17% as BLA approval nears

The company raised its full-year 2025 revenue growth guidance to "at least 17% or revenue of at least $219 million." Gross margin guidance remains in the "range of 73% to 75%, inclusive of onetime ...

Ultragenyx Completes Rolling Submission of Biologics License Application (BLA) to U.S. FDA for DTX401 AAV Gene Therapy for Glycogen Storage Disease Type Ia (GSDIa)

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), ...