Spruce Biosciences (NASDAQ:SPRB) Stock

Spruce Biosciences

Spruce Biosciences Inc is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with unmet medical needs. The company is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy to offer markedly improved disease control and reduce steroid burden for patients suffering from classic congenital adrenal hyperplasia (CAH).

Spruce Biosciences Inc

SPAREBANKEN 1 OSTLANDET by Sparebank 1 Ostlandet

HC Wainwright &amp; Co. analyst Raghuram Selvaraju reiterates Spruce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) from Neutral to Neutral.

News

Reiteration

Analyst Ratings

SPRB

HC Wainwright & Co. Reiterates Neutral on Spruce Biosciencesto Neutral

Guggenheim analyst Evan Wang reiterates Spruce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) from Neutral to Neutral.

Guggenheim Reiterates Neutral on Spruce Biosciencesto Neutral

JMP Securities analyst Jonathan Wolleben downgrades Spruce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) from Market Outperform to Market Perform and maintains the price target from $3 to $3.

Downgrades

Price Target

JMP Securities Downgrades Spruce Biosciences to Market Perform, Maintains Price Target to $3

RBC Capital analyst Gregory Renza reiterates Spruce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) with a Sector Perform and lowers the price target from $2 to $1.5.

RBC Capital Reiterates Sector Perform on Spruce Biosciences, Lowers Price Target to $1.5

On Tuesday, Spruce Biosciences, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) revealed topline results from its CAHmelia-204 study of tildacerfont in adult CAH and its CAHptain-205 study of tildacerfont in <a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/b42423734/spruce-biosciences-announces-topline-results-from-cahmelia-204-in-adult-cah-and-cahptain-205-in-ad" rel="noreferrer noopener">adult and pediatric CAH</a>.
Congenital adrenal hyperplasia (CAH) is&nbsp;a genetic disease that affects the adrenal glands and prevents the production of hormones like cortisol, aldosterone, and androgens.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39155412/nano-cap-spruce-biosciences-collaborates-with-hmnc-brain-health-to-develop-treatment-for-major-de" rel="noreferrer noopener">Nano-Cap Spruce Biosciences Collaborates With HMNC Brain Health To Develop Treatment for Major Depressive Disorder</a>
&#8220;In the interim, the CAHmelia-204 and CAHptain-205 clinical trials will be discontinued, and we will be winding down Spruce&#8217;s investment in tildacerfont for the treatment of CAH as we conserve financial resources and look to maximize shareholder value,&#8221; said Javier Szwarcberg, CEO of Spruce.
CAHmelia-204 was a Phase 2b trial that evaluated the safety and efficacy of tildacerfont in reducing supraphysiologic GC usage in 100 adults with classic CAH on a mean glucocorticoid (GC) dose of 35mg/day of hydrocortisone equivalents (HCe) (19mg/m2/day) and mean androstenedione (A4) level of 214 ng/dL at baseline.
The clinical trial did not achieve the primary efficacy endpoint of the absolute change in daily GC dose from baseline at week 24. 200mg QD of tildacerfont demonstrated a placebo-adjusted reduction from baseline in a daily GC dose of 0.7mg HCe.
Approximately 98% of patients were highly compliant with the study drug. Tildacerfont was generally safe and well tolerated, with no serious adverse events (SAEs).
CAHptain-205 was a Phase 2 trial that evaluated the safety, pharmacodynamics (changes in A4 levels), and pharmacokinetics of QD and BID doses of tildacerfont from 50mg QD to 400mg BID in pediatric and adult patients with CAH.
A trend of larger reductions from baseline in A4 levels with higher BID doses of tildacerfont was observed.
Tildacerfont was generally safe and well tolerated across all doses, with no drug-related SAEs.
Price Action: SPRB stock is down 23.40% at $0.41 during the premarket session at last check Wednesday.
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General

Penny Stock Spruce Biosciences Winds Down Tildacerfont Studies For Rare Genetic Disorder

WIIM

Spruce Biosciences shares are trading lower after Oppenheimer downgraded the stock from Outperform to Perform.

Oppenheimer analyst Hartaj Singh downgrades Spruce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) from Outperform to Perform.

Oppenheimer Downgrades Spruce Biosciences to Perform

Trading Halt: Halt status updated at 4:25:00 PM ET: Quotation Resumption: News and Resumption Times

CAHmelia-204 Study of 200mg Once-Daily (QD) Tildacerfont in Adult Congenital Adrenal Hyperplasia (CAH) Did Not Achieve Primary Endpoint of Glucocorticoid (GC) Reduction
Dose-Ranging Data from CAHptain-205 Study of Tildacerfont in Adult and Pediatric CAH Suggests Higher Doses and Twice-Daily (BID) Dosing May Be Necessary for Efficacy in CAH
Evaluation of Strategic Opportunities and Cost-Reduction Activities Underway
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sprucebiosciences.com%2F&amp;esheet=54164943&amp;newsitemid=20241210266378&amp;lan=en-US&amp;anchor=Spruce+Biosciences%2C+Inc&amp;index=1&amp;md5=8f797c64b104d2a33b5c5fe63c560514">Spruce Biosciences, Inc</a>. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological and endocrine disorders with significant unmet medical need, today announced topline results from its CAHmelia-204 study of tildacerfont in adult CAH and its CAHptain-205 study of tildacerfont in adult and pediatric CAH.

Spruce Biosciences Announces Topline Results From CAHmelia-204 In Adult CAH And CAHptain-205 In Adult And Pediatric CAH; Data Suggests Higher Doses And Twice-Daily Dosing May Be Necessary For Efficacy In CAH; Did Not Achieve Primary Endpoint Of Glucocorticoid Reduction; Evaluation Of Strategic Opportunities And Cost-Reduction Activities Underway

Trading Halt: Halted at 4:00:15 p.m. ET - Trading Halt: Halt News Pending

RBC Capital analyst Gregory Renza reiterates Spruce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) with a Sector Perform and maintains $2 price target.

RBC Capital Reiterates Sector Perform on Spruce Biosciences, Maintains $2 Price Target

Spruce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) reported quarterly losses of $(0.21) per share which beat the analyst consensus estimate of $(0.24) by 12.5 percent. This is a 30 percent increase over losses of $(0.30) per share from the same period last year. The company reported quarterly sales of $602.00 thousand which missed the analyst consensus estimate of $1.49 million by 59.60 percent. This is a 80.41 percent decrease over sales of $3.07 million the same period last year.

Earnings

Earnings Beats

Earnings Misses

Spruce Biosciences Q3 EPS $(0.21) Beats $(0.24) Estimate, Sales $602.00K Miss $1.49M Estimate

Spruce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) reported quarterly losses of $(0.21) per share which beat the analyst consensus estimate of $(0.24) by 12.5 percent. This is a 30 percent increase over losses of $(0.30) per share from the same period last year.

Spruce Biosciences Q3 EPS $(0.21) Beats $(0.24) Estimate

HC Wainwright &amp; Co. analyst Raghuram Selvaraju reiterates Spruce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) with a Neutral.

HC Wainwright & Co. Reiterates Neutral on Spruce Biosciences

Spruce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) reported quarterly losses of $(0.22) per share which beat the analyst consensus estimate of $(0.30) by 26.67 percent. This is a 31.25 percent increase over losses of $(0.32) per share from the same period last year. The company reported quarterly sales of $1.61 million which beat the analyst consensus estimate of $1.50 million by 7.69 percent. This is a 25.64 percent decrease over sales of $2.17 million the same period last year.

Spruce Biosciences Q2 EPS $(0.22) Beats $(0.30) Estimate, Sales $1.61M Beat $1.50M Estimate

Oppenheimer analyst Hartaj Singh maintains Spruce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) with a Outperform and lowers the price target from $4 to $3.

Oppenheimer Maintains Outperform on Spruce Biosciences, Lowers Price Target to $3

Contracts

Spruce Biosciences And HMNC Brain Health Collaborate To Develop Spruce's Investigational Product Candidate, Tildacerfont With HMNC's Companion Diagnostic For Major Depressive Disorder,  HMNC To Initiate Phase 2 Study In Q4 2024

Spruce Biosciences Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRB#NASDAQ">SPRB</a>) and HMNC Brain Health GmbH have collaborated to develop Spruce&#8217;s investigational product candidate, tildacerfont, and HMNC&#8217;s companion diagnostic, the proprietary Cortibon Genetic Selection Tool for major depressive disorder (MDD).&nbsp;
Spruce Biosciences is a late-stage biopharmaceutical company developing its wholly-owned product candidate, tildacerfont, for classic congenital adrenal hyperplasia, polycystic ovary syndrome, and MDD.
&#8220;We believe that Cortibon has the potential to enable tildacerfont to be advanced as a precision therapeutic for personalized medicine in patients with MDD,&#8221; said Javier Szwarcberg, CEO of Spruce Biosciences. &#8220;Hyperactive CRF neurotransmission and CRF1 receptor signal transduction are critical mechanisms for stress pathophysiology that may lead to major depression. Tildacerfont may mediate responses to stress, which has the potential to address up to 50% of MDD patients worldwide using Cortibon.&#8221;
&#8220;We are excited to collaborate with HMNC and initiate a Phase 2 proof-of-concept study of tildacerfont and Cortibon for the treatment of MDD later this year,&#8221;&nbsp;Szwarcberg added.
Under the agreement, HMNC will fund and conduct a Phase 2 proof-of-concept study of tildacerfont in MDD patients, who will be screened using Cortibon.
Spruce has the option to in-license exclusive worldwide rights to Cortibon after the completion of the study, if the results are positive.
If Spruce exercises its option, it will be responsible for the future worldwide development and commercialization of tildacerfont and Cortibon for MDD under a collaboration framework that leverages HMNC&#8217;s ongoing expertise in precision psychiatry and companion diagnostics.
Under the license terms, HMNC would be entitled to receive certain milestone payments and tiered royalties on net sales of tildacerfont in MDD.&nbsp;
Cortibon is HMNC&#8217;s proprietary companion diagnostic. By utilizing genetic markers, Cortibon aims to identify MDD patients who are more likely to respond to CRF1 receptor antagonism, thereby enhancing treatment outcomes and reducing the trial-and-error period typical in depression treatment.
Price Action: SPRB shares closed at $0.72 on Monday.

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