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Spruce Biosciences (SPRB) Falls 86% in a Month: Here's Why

Spruce Biosciences SPRB stock has declined 86.1% in the past month due to the failure of a key study on its lead pipeline candidate, tildacerfont.

Spruce Biosciences is developing tildacerfont in the CAHmelia program as a non-steroidal, once-daily therapy for patients suffering from classic congenital adrenal hyperplasia (CAH). The CAHmelia program in adult classic CAH comprises two phase IIb studies. The first study is CAHmelia-203, which assesses androstenedione (A4 - a steroid hormone) reduction in adult CAH patients with severe hyperandrogenemia, a difficult-to-treat CAH patient population.

Last week, Spruce Biosciences announced that the CAHmelia-203 phase IIb study of tildacerfont in adult patients with CAH failed to meet the primary efficacy endpoint of change in A4 from baseline to week 12. In the study, a 200mg once-daily dose of tildacerfont demonstrated a placebo-adjusted reduction of -2.6% in A4 at week 12, which was not statistically significant. Spruce Biosciences said the negative outcome of the study was due to poor treatment compliance.

Following the failure of the CAHmelia-203 study, Spruce Biosciences said it is terminating the CAHmelia-203 study and also announced a workforce reduction of approximately 21% to extend its cash runway through the end of 2025.


Spruce Biosciences’ stock has declined 67% in the past year compared with a decline of 6.8% for the industry.

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The second study, CAHmelia-204 assesses glucocorticoid (GC) reduction, a potentially registrational endpoint, in a different population of adult CAH patients with relatively controlled A4 levels and historically better adherence to GC therapy. Top-line data from the CAHmelia-204 study is anticipated in the third quarter of 2024.

Last week, Spruce Biosciences also announced top-line data from the CAHptain-205 study of tildacerfont in pediatric classic CAH.  In the pediatric study, 73% of the 30 patients treated with tildacerfont met the efficacy endpoint of A4 or GC reduction from baseline at 12 weeks.

Overall, the data suggested that tildacerfont may allow clinically meaningful reduction of A4 and GC levels in children and adolescents. Spruce Biosciences plans to continue dose-ranging across additional cohorts of the CAHptain-205 study to evaluate dose selection for the registrational program. Top-line data from additional dosing cohorts of the CAHptain-205 study are expected to be announced in the fourth quarter of 2024.

Nonetheless, the failure of the CAHmelia-203 study raises uncertainty around the success of the CAHmelia-204 study as well as the path forward for tildacerfont.

Zacks Rank and Other Stocks to Consider

Spruce Biosciences currently has a Zacks Rank #2 (Buy).

Spruce Biosciences, Inc. Price and Consensus

Spruce Biosciences, Inc. Price and Consensus
Spruce Biosciences, Inc. Price and Consensus

Spruce Biosciences, Inc. price-consensus-chart | Spruce Biosciences, Inc. Quote

Some other top-ranked stocks in the healthcare sector are Vanda Pharmaceuticals VNDA, ADMA Biologics ADMA and MorphoSys MOR, all three sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, 2024 estimates for Vanda Pharmaceuticals have improved from a loss of 46 cents to earnings of 1 cent. For 2025, loss estimates have narrowed from 94 cents to 48 cents per share in the past 60 days. In the past year, shares of VNDA have declined 42.0%.

Vanda Pharmaceuticals delivered a three-quarter average earnings surprise of 92.88%.

In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Estimates for 2025 have increased from 32 cents to 50 cents. In the past year, shares of ADMA Biologics have risen 110.0%.

Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same once. ADMA delivered a four-quarter average earnings surprise of 85.0%.

In the past 60 days, estimates for MorphoSys’ 2024 loss per share have improved from $2.26 to $2.08. Estimates for 2025 have narrowed from a loss of $1.09 per share to a loss of 89 cents per share. In the past year, shares of MOR have risen 363.5%.

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