SPRUCE BIOSCIENCES, INC.
Bus iness. Overview We are a biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. We have a diverse portf…
Bus iness. Overview We are a biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. We have a diverse portfolio of product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are either no approved therapies treating the underlying disease or suboptimal treatment options. We were founded in April 2016 and are led by a management team experienced in the development and commercialization of groundbreaking therapeutics. Our Strategy Seek regulatory approval and maximize the U.S. commercial potential of TA-ERT for the treatment of MPS IIIB. We intend to seek U.S. accelerated approval of tralesinidase alfa enzyme replacement therapy ( TA-ERT ) for Mucopolysaccharidosis Type IIIB ( MPS IIIB ) based on existing non-clinical and clinical data. As a condition of seeking such approval of a biologics license application ( BLA ) from the U.S. Food and Drug Administration ( FDA ), we will initiate a confirmatory trial. If the BLA is approved, we intend to build a highly specialized commercial and medical affairs organization to support the commercialization of TA-ERT. Given that a relatively small number of clinicians and specialists treat most of the patients with MPS IIIB, we believe this market can be effectively addressed with a modest-sized and targeted patient-centric field team, alongside various high-touch patient initiatives.
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