Ladenburg downgraded Spruce Biosciences to Neutral from Buy and removed the firm’s previous price target after the company announced that its Phase 2 CAHmelia-203 trial of tildacerfont in adult Congenital Adrenal Hyperplasia, or CAH, patients with severe hyperandrogenemia missed the primary endpoint. The firm had previously assumed that Spruce could avoid additional trials if all three Phase 2 trials were successful, but this “hiccup” with tildacerfont development likely means that the FDA will require a Phase 3 registrational trial after a hypothetical completion of the ongoing Phase 2 CAHmelia-204 and CAHmelia-205 studies, the analyst tells investors.
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