Spruce Biosciences (NASDAQ:SPRB – Get Free Report) released 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 NASDAQ SPRB traded up $3.89 during mid-day trading on Tuesday, reaching $66.00. 4,114 shares of the company traded hands, compared to its average volume of 39,082. The firm has a market cap of $70.62 million, a PE ratio of -0.80 and a beta of 3.62. The stock has a fifty day simple moving average of $72.15 and a 200-day simple moving average of $75.55. Spruce Biosciences has a fifty-two week low of $4.28 and a fifty-two week high of $240.00.
Institutional Investors Weigh In On Spruce Biosciences
Analysts Set New Price Targets
A number of equities research analysts have recently issued reports on SPRB shares. HC Wainwright reissued a “buy” rating and issued a $200.00 price target on shares of Spruce Biosciences in a report on Tuesday. Wall Street Zen downgraded shares of Spruce Biosciences from a “hold” rating to a “sell” rating in a report on Saturday, December 27th. Leerink Partners raised shares of Spruce Biosciences from a “market perform” rating to an “outperform” rating and set a $160.00 price target for the company in a research note on Wednesday, December 3rd. Oppenheimer began coverage on Spruce Biosciences in a research note on Tuesday, December 23rd. They issued an “outperform” rating and a $283.00 target price on the stock. Finally, Citigroup reiterated a “market perform” rating on shares of Spruce Biosciences in a report on Tuesday, November 11th. Four analysts have rated the stock with a Buy rating, three have assigned a Hold rating and one has issued a Sell rating to the company. According to data from MarketBeat.com, the company has a consensus rating of “Hold” and an average target price of $170.10.
Get Our Latest Stock Analysis on SPRB
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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