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Spruce Biosciences received FDA Breakthrough Therapy Designation for TA-ERT in treating San Filippo Syndrome Type B [MPS IIIB]. BTD enables potential rolling BLA submission, Priority Review, and Accelerated Approval pathway, supported by strong 5-year biomarker and clinical data for TA-ERT. Company plans to file a BLA for TA-ERT for MPS IIIB patients in Q1 2026, aiming to deliver the first dise...
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to tralesinidase alfa enzyme repl...
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, announced that it will resume trading on the Nasdaq Capital Market at the market open today, September 15, 2025, under the ticker symbol “SPRB” and C...
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (OTCQB: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today reported financial results for the second quarter ended June 30, 2025 and provided corporate updates. “We remain steadfast in our efforts to adv...
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (OTCQB: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced results from a long-term data integration of tralesinidase alfa enzyme replacement therapy (TA-ERT) clinical program in patients with ...
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (OTCQB: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced that it will implement a 1-for-75 reverse stock split of its issued and outstanding shares of common stock (“Reverse Stock Split”), ef...
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