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Spruce Biosciences, Inc. (NASDAQ: SPRB) is a clinical-stage biopharmaceutical company dedicated to pioneering new therapies for rare endocrine disorders. The company's mission is to develop and commercialize novel treatments that address unmet medical needs within this specialized field.
Spruce Biosciences is currently advancing its primary product candidate, tildacerfont. This innovative therapy is being developed to serve as the first non-steroidal treatment designed to significantly improve disease management and lessen the dependency on steroids for patients with classic congenital adrenal hyperplasia (CAH). CAH is a genetic disorder affecting the adrenal glands, leading to an imbalance in hormone production. Tildacerfont aims to address this imbalance, offering a promising alternative for patients who have limited treatment options.
The company has made notable strides in its development programs, with ongoing clinical trials aiming to demonstrate the efficacy and safety of tildacerfont. These efforts are crucial in pushing the boundaries of current endocrine disorder treatments and providing new hope for those affected by these rare conditions.
In addition to its flagship product, Spruce Biosciences actively explores other potential therapies and partnerships to expand its impact in the field of endocrinology. The company’s financial health is supported by strategic investments and collaborations, ensuring robust progress towards its goals.
Spruce Biosciences’ commitment to addressing rare endocrine diseases positions it as a significant player in the biopharmaceutical industry. With a clear focus on innovation and patient care, the company continues to make meaningful advancements in medical science. Stay updated with the latest developments from Spruce Biosciences to learn more about its ongoing projects and clinical trials.
Spruce Biosciences (NASDAQ: SPRB) announced disappointing topline results from two clinical trials evaluating tildacerfont for Congenital Adrenal Hyperplasia (CAH). The CAHmelia-204 Phase 2b study failed to meet its primary endpoint of reducing glucocorticoid usage in adult CAH patients. The trial showed a minimal placebo-adjusted reduction of 0.7mg in daily glucocorticoid dose.
The CAHptain-205 Phase 2 study suggested that higher doses and twice-daily (BID) dosing may be necessary for efficacy. While tildacerfont was generally safe and well-tolerated in both trials, the company will discontinue these clinical trials and wind down its investment in tildacerfont for CAH treatment while evaluating strategic options and implementing cost-reduction measures.
Spruce Biosciences (SPRB) reported Q3 2024 financial results and provided corporate updates. The company anticipates topline data from two key clinical trials of tildacerfont in December 2024: the CAHmelia-204 study in adult CAH patients and the CAHptain-205 study in adult and pediatric CAH patients. Financial highlights include cash position of $60.1 million, expected to fund operations through end of 2025. Q3 collaboration revenue was $0.6 million, while R&D expenses decreased to $6.6 million. Net loss for Q3 was $8.7 million, improved from $12.4 million in the same period of 2023.
Spruce Biosciences (Nasdaq: SPRB), a late-stage biopharmaceutical company specializing in novel therapies for endocrine and neurological disorders, has announced its participation in the Guggenheim Securities Healthcare Innovation Conference. The company's CEO, Javier Szwarcberg, M.D., M.P.H., will deliver a presentation on November 11, 2024, at 3:30 p.m. ET. The presentation will be accessible via live webcast, with a recording available on the company's investor relations website for approximately 90 days following the event.
Spruce Biosciences (Nasdaq: SPRB), a late-stage biopharmaceutical company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's CEO, Javier Szwarcberg, M.D., M.P.H., is scheduled to present on September 10, 2024, at 4:30 p.m. ET.
Spruce Biosciences focuses on developing and commercializing novel therapies for endocrine and neurological disorders with significant unmet medical needs. Interested parties can access the live webcast of the presentation through a provided link. An archived version of the webcast will be available on the company's investor relations website for approximately 90 days after the event.
Spruce Biosciences (SPRB) reported Q2 2024 financial results and provided corporate updates. Key highlights include:
1. Strategic collaboration with HMNC Brain Health to develop tildacerfont for Major Depressive Disorder (MDD).
2. Topline data from CAHmelia-204 and CAHptain-205 studies of tildacerfont in Congenital Adrenal Hyperplasia (CAH) expected in Q4 2024.
3. Cash runway through the end of 2025 with $69.7 million in cash and cash equivalents as of June 30, 2024.
4. Q2 2024 financial results: Collaboration revenue of $1.6 million, R&D expenses of $8.1 million, G&A expenses of $3.6 million, and net loss of $9.2 million.
5. Anticipated End of Phase 2 meeting with FDA in H1 2025.
Spruce Biosciences (Nasdaq: SPRB), a late-stage biopharmaceutical company, has been recognized as a Best Place to Work in 2024 by the San Francisco Business Times and Silicon Valley Business Journal. The accolade highlights Spruce's dedication to creating a mission-driven culture emphasizing trust, innovation, ownership, and diversity. CEO Javier Szwarcberg expressed pride in the employees' commitment, which underpins the company's efforts to develop therapies for endocrine and neurological disorders. The award was based on anonymous employee surveys from over 230 companies, evaluating factors such as collaborative culture, benefits, and management practices.
Spruce Biosciences (Nasdaq: SPRB) and HMNC Brain Health announced a strategic collaboration to develop a treatment for Major Depressive Disorder (MDD) using Spruce's tildacerfont and HMNC's Cortibon Genetic Selection Tool. The Phase 2 study is set to begin in Q4 2024. Should the study be successful, Spruce has the option to acquire exclusive rights to Cortibon. This collaboration aims to advance precision medicine in treating MDD, potentially addressing up to 50% of MDD patients worldwide. The collaboration leverages genetic markers to predict medication response, aiming to enhance treatment efficacy and reduce costs.
Spruce Biosciences presented positive results from its Phase 2 POWER study on tildacerfont, targeting polycystic ovary syndrome (PCOS), at ENDO 2024. Tildacerfont, a CRF1 receptor antagonist, significantly reduced DHEAS levels and increased SHBG levels versus placebo in women with elevated baseline DHEAS. These results suggest potential therapeutic benefits, including a reduction in health risks linked to hyperandrogenism. The study involved 27 women and showed that tildacerfont was well-tolerated with no serious adverse effects.
Spruce Biosciences, a late-stage biopharmaceutical company specializing in therapies for rare endocrine disorders, will participate in the Jefferies Global Healthcare Conference.
CEO Javier Szwarcberg will present on June 5, 2024, at 5:00 p.m. ET.
The presentation will be accessible via a live webcast, with an archived version available for 90 days on the company's investor relations website.
Spruce Biosciences (Nasdaq: SPRB) announced that three abstracts have been accepted for presentation at the 106th Annual Meeting of the Endocrine Society (ENDO 2024), taking place from June 1-4, 2024, in Boston.
The company will present final results from its Phase 2 POWER study of tildacerfont for the treatment of polycystic ovary syndrome (PCOS). Additionally, they will highlight comorbidities associated with congenital adrenal hyperplasia (CAH) and the importance of transitionary care between pediatric and adult endocrinology practices for CAH patients.
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