Spruce: BTD For TA-ERT For MPS IIIB Could Ignite BLA Submission With Added Bonuses (Rating Upgrade)

2025-10-07 10:38:34 ET

The last time I spoke about Spruce Biosciences ( SPRB ) was in a Seeking Alpha article entitled " Spruce Biosciences: H2 2023 Data Could Be A Game Changer For CAHT Treatment ". At that time I had a "Hold" rating on the belief that the company would do well to develop its drug tildacerfont for the treatment of patients with congenital adrenal hyperplasia [CAH]. This didn't pan out well, but as I will show below, the company has taken this drug and partnered with HMNC to target a subset of MDD patients with it in a phase 2 study. I'm upgrading the stock from a "Hold" rating to a "Buy" rating because it has been able to achieve remarkable progress in developing an enzyme replacement therapy TA-ERT. Specifically, it recently announced that it had received Breakthrough Therapy Designation [BTD] from the FDA for the development of its enzyme replacement therapy [ERT] clinical candidate tralesinidase alfa enzyme replacement therapy [TA-ERT] for the treatment of patients with San Filippo Syndrome Type B [MPS IIIB]. There are two reasons why this development is significant as it relates to the advancement of this clinical program. The first of which is that this BTD of TA-ERT allows for potential positive developments of a rolling Biologics License Application [BLA] submission along with the possibility of priority review. This leads to the second reason, which is the actual BLA filing that the company believes could be filed in Q1 of 2026. ...

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