Spruce Biosciences (NASDAQ:SPRB – Get Free Report) issued its quarterly earnings results on Monday. The company reported ($9.58) EPS for the quarter, missing analysts’ consensus estimates of ($9.16) by ($0.42), Zacks reports.
Here are the key takeaways from Spruce Biosciences’ conference call:
- FDA engagement has been constructive — Spruce holds Breakthrough Therapy designation and reports FDA feedback indicating the heparan sulfate non?reducing end biomarker could support an accelerated approval pathway.
- Clinical and long?term extension data show near?normalization of heparan sulfate biomarkers through six years with supportive clinical signals (Bayley, Vineland, MRI), which the company says strengthen the approval case.
- Spruce delayed its BLA to Q4 2026 because the FDA requires the first PPQ validation batch included with the filing (three PPQ batches overall), creating a timing setback for submission and review.
- The FDA allowed the company to initiate the confirmatory trial while the BLA is under review; Spruce plans an ~18?month enrollment and has submitted the protocol and feasibility assessment to the agency.
- Cash runway is about $50M (plus one debt tranche) and the company expects it may be roughly a quarter short of funding to reach PDUFA, relying on additional debt tranches, strategic/non?dilutive options, or a monetizable PRV if approved.
Spruce Biosciences Price Performance
Shares of Spruce Biosciences stock traded up $3.89 on Tuesday, reaching $66.00. 4,114 shares of the company traded hands, compared to its average volume of 39,082. Spruce Biosciences has a 52 week low of $4.28 and a 52 week high of $240.00. The firm has a market capitalization of $70.62 million, a PE ratio of -0.80 and a beta of 3.62. The company has a 50 day moving average of $72.15 and a 200 day moving average of $75.55.
Analysts Set New Price Targets
Read Our Latest Research Report on Spruce Biosciences
Hedge Funds Weigh In On Spruce Biosciences
Several hedge funds and other institutional investors have recently modified their holdings of the company. SkyView Investment Advisors LLC bought a new stake in Spruce Biosciences during the fourth quarter worth approximately $261,000. State Street Corp acquired a new position in Spruce Biosciences during the fourth quarter worth $558,000. Superstring Capital Management LP purchased a new stake in shares of Spruce Biosciences in the fourth quarter valued at about $1,057,000. Geode Capital Management LLC purchased a new stake in Spruce Biosciences during the 4th quarter worth approximately $1,109,000. Finally, Caligan Partners LP acquired a new position in shares of Spruce Biosciences in the 4th quarter valued at $1,787,000. 91.71% of the stock is owned by institutional investors.
Spruce Biosciences Company Profile
Spruce Biosciences, Inc is a clinical-stage biopharmaceutical company dedicated to developing therapies for rare endocrine and dermatological disorders. Headquartered in San Diego, California, Spruce focuses on conditions with significant unmet medical needs, employing a precision medicine approach to identify and advance treatment candidates through late-stage clinical trials.
The company’s lead asset, tildacerfont, is an oral corticotropin-releasing factor type 1 (CRF1) receptor antagonist being evaluated for the treatment of congenital adrenal hyperplasia (CAH), a genetic disorder characterized by insufficient cortisol production and excess androgen levels.
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