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On Thursday, Oppenheimer adjusted its outlook on Spruce Biosciences, Inc. (NASDAQ:SPRB), reducing the price target to $4 for the shares from the previous $7, while maintaining an Outperform rating on the company’s stock.
The revision follows Spruce Biosciences’ announcement of top-line results from their CAHmelia-203 and CAHptain-205 studies, which evaluate the efficacy of tildacerfont in treating adult and pediatric classic congenital adrenal hyperplasia (CAH).
The CAHmelia-203 study, which focused on patients with severe hyperandrogenemia, did not meet its primary endpoint of change in androstenedione (A4) levels from baseline to week 12. This outcome prompted Spruce Biosciences to halt further development of the drug for this particular patient group.
Despite this setback, the company reported that data from the CAHptain-205 trial support continued dose-ranging studies, with additional dose cohorts expected to be read out in the fourth quarter of 2024.
Spruce Biosciences remains optimistic about the prospects of the CAHmelia-204 study, slated for a readout in the third quarter of 2024. The company believes this study involves a distinct patient population from that of the CAHmelia-203 trial. Success in the CAHmelia-204 and CAHptain-205 studies could lead to discussions with the FDA about a registrational clinical program design for both adult and pediatric CAH at the End of Phase 2 (EOP2) meeting, anticipated to occur in the first quarter of 2025.
In response to these developments, Oppenheimer has updated its model with fourth quarter 2023 and full-year 2023 numbers for Spruce Biosciences. The firm’s decision to maintain an Outperform rating reflects its continued confidence in the potential of tildacerfont, despite the recent challenges encountered in the CAHmelia-203 study.
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