Spruce Biosciences Inc. (SPRB)
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Spruce Biosciences shares pop after FDA grants Breakthrough Therapy Designation for rare disease treatment
Spruce Biosciences (NASDAQ:SPRB) shares surged more than 390% to around $43 following news that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for its tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB). The designation recognizes the potential of TA-ERT as a first disease-modifying therapy for this ultra-rare and fatal genetic disorder.
Spruce Biosciences, Inc. (SPRB) Corporate Update Conference Call (Transcript)
Spruce Biosciences, Inc. (NASDAQ:SPRB ) Corporate Update Conference Call April 15, 2025 8:30 AM ET Company Participants Samir Gharib - President and CFO Javier Szwarcberg - CEO Kirk Ways - Chief Medical Officer Conference Call Participants Joe Schwartz - Leerink Partners Jon Wolleben - JMP Leland Gershell - Oppenheimer Ram Selvaraju - H.C. Wainwright Operator Welcome to the Spruce Biosciences Investor Call [Operator Instructions].
Spruce Biosciences (SPRB) Upgraded to Buy: Here's Why
Spruce Biosciences (SPRB) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).
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Spruce Biosciences Inc. Profile
| Biotechnology Industry | Healthcare Sector | Javier Szwarcberg CEO | NASDAQ Exchange | 85209E208 CUSIP |
| US Country | 20 Employees | - Last Dividend | 7 Aug 2025 Last Split | 9 Oct 2020 IPO Date |
Overview
Spruce Biosciences, Inc. is a pioneering biopharmaceutical enterprise committed to creating and marketing innovative treatments for rare endocrine disorders. With a strategic focus on novel therapeutic development, Spruce Biosciences addresses the unmet medical needs of patients suffering from conditions like congenital adrenal hyperplasia (CAH). The company's scientific efforts are concentrated on delivering non-steroidal therapies designed to improve disease control while minimizing the need for steroids, which are traditionally used but can have significant side effects. Founded in 2014, Spruce Biosciences has established its headquarters in South San Francisco, California, positioning itself in a hub of biomedical innovation. Through collaboration and licensing agreements with major pharmaceutical companies such as Eli Lilly and Kaken Pharmaceutical Co. Ltd., Spruce Biosciences is expanding its global reach and accelerating the development of its key drug candidate, tildacerfont, in various stages of clinical trials for multiple indications.
Products and Services
- Tildacerfont for Congenital Adrenal Hyperplasia (CAH)
This flagship compound represents Spruce Biosciences' core development program, with a focus on treating patients with congenital adrenal hyperplasia (CAH). Tildacerfont is being investigated in Phase 2b clinical trials to evaluate its efficacy in enhancing disease control and reducing the dependency on steroids in adults suffering from classic CAH. The goal is to offer a novel, non-steroidal treatment option that improves quality of life for these patients.
- Tildacerfont for Pediatric CAH
Recognizing the unique challenges faced by children with classic congenital adrenal hyperplasia, Spruce Biosciences is extending its development efforts to this younger demographic. Tildacerfont is currently at the Phase 2 clinical trial stage for this group, aiming to provide a safe and effective treatment that addresses the disease’s manifestations from an early age.
- Tildacerfont for Polycystic Ovary Syndrome (PCOS)
Expanding its therapeutic reach, the company is exploring the potential of tildacerfont in treating females with polycystic ovary syndrome (PCOS). This initiative, also in Phase 2 clinical trials, reflects Spruce Biosciences’ commitment to addressing a broader spectrum of endocrine disorders, leveraging the versatility of its key compound to fulfill the therapeutic needs of a wider patient population.
- Collaborations for Global Reach
Spruce Biosciences has forged strategic partnerships to enhance its research, development, and commercialization capabilities. A notable license agreement with Eli Lilly and Company allows for the exploration of various pharmaceutical uses of their compounds. Furthermore, a collaboration and license agreement with Kaken Pharmaceutical Co. Ltd. focuses on the development, manufacturing, and commercialization of tildacerfont for CAH treatment in Japan. These partnerships are pivotal in advancing Spruce Biosciences’ mission to deliver novel therapies to patients globally.
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