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Spruce Biosciences Announces Launch of MPS3BStudy.com

Wed, 26 Aug 2026 08:00:00 -0400

Website Enables Families and Caregivers of Children with MPS IIIB to Learn About and Register Interest in the TA-ERT Expanded Access Program (EAP) and TrAnsform Confirmatory Study

TA-ERT EAP and TrAnsform Confirmatory Study Both Expected to Initiate in the Fourth Quarter of 2026

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 the launch of MPS3BStudy.com, a dedicated online resource for families and caregivers of children with Sanfilippo Syndrome Type B

Spruce Biosciences Announces Launch of MPS3BStudy.com

Wed, 26 Aug 2026 08:00:00 -0400

Website Enables Families and Caregivers of Children with MPS IIIB to Learn About and Register Interest in the TA-ERT Expanded Access Program (EAP) and TrAnsform Confirmatory Study

TA-ERT EAP and TrAnsform Confirmatory Study Both Expected to Initiate in the Fourth Quarter of 2026

Spruce Biosciences Announces Launch of MPS3BStudy.com

Wed, 26 Aug 2026 08:00:00 -0400

Website Enables Families and Caregivers of Children with MPS IIIB to Learn About and Register Interest in the TA-ERT Expanded Access Program (EAP) and TrAnsform Confirmatory Study

TA-ERT EAP and TrAnsform Confirmatory Study Both Expected to Initiate in the Fourth Quarter of 2026

Spruce Biosciences Announces Launch of MPS3BStudy.com

Wed, 26 Aug 2026 08:00:00 -0400

Website Enables Families and Caregivers of Children with MPS IIIB to Learn About and Register Interest in the TA-ERT Expanded Access Program (EAP) and TrAnsform Confirmatory Study

TA-ERT EAP and TrAnsform Confirmatory Study Both Expected to Initiate in the Fourth Quarter of 2026

H.C. Wainwright Reiterates Buy Rating on Spruce Biosciences, Inc. (SPRB)

Wed, 26 Aug 2026 06:43:02 -0400

H.C. Wainwright analyst Raghuram Selvaraju reiterated a Buy rating and $150.00 price target on Spruce Biosciences, Inc. (NASDAQ: SPRB).

The analyst commented: "Recently, Spruce Biosciences announced that it has completed two pre-BLA meetings with the FDA that support the company's plan to submit a Biologics License Application (BLA) for tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo Syndrome Type B (MPS IIIB) next quarter. The agency found the company's drug substance and drug product analytical comparability strategies reasonable to support the BLA, following technology transfer to a leading global biologics manufacturer. Furthermore, the FDA is aligned with Spruce

Spruce Biosciences BLA filing for rare disease drug on track for 2026

Mon, 24 Aug 2026 08:03:47 -0400

Spruce Biosciences (Nasdaq: SPRB) said it has completed two pre-Biologics License Application (BLA) meetings with the U.S. Food and Drug Administration (FDA) and confirmed its BLA submission for tralesinidase alfa enzyme replacement therapy (TA-ERT) remains on track for the fourth quarter of 2026.

TA-ERT is being developed as a treatment for Sanfilippo Syndrome Type B (MPS IIIB), an ultra-rare fatal genetic disease affecting fewer than one in 200,000 people in the United States. There are currently no FDA-approved therapies for the condition.

According to a company statement, the FDA found Spruce's drug substance and drug product analytical comparability strategies reasonable to support

Spruce Biosciences BLA filing for rare disease drug on track for 2026

Mon, 24 Aug 2026 08:03:47 -0400

According to a company statement, the FDA found Spruce's drug substance and drug product analytical comparability strategies reasonable to support

Spruce Biosciences Announces Positive Pre-BLA Meetings with FDA and Confirms BLA Submission for TA-ERT on Track for Q4 2026

Mon, 24 Aug 2026 08:00:00 -0400

FDA Found Spruce's Chemistry, Manufacturing and Controls (CMC) Comparability Strategies Reasonable to Support the BLA Following Technology Transfer to Leading Global Biologics Manufacturer