Welcome to our dedicated page for Spruce Biosciences news (Ticker: SPRB), a resource for investors and traders seeking the latest updates and insights on Spruce Biosciences stock.
Spruce Biosciences, Inc. (SPRB) generates news that centers on its late-stage biopharmaceutical efforts to develop and commercialize therapies for neurological disorders with significant unmet medical need. Company announcements focus heavily on tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB), an ultra-rare, serious, and fatal genetic disease for which Spruce states there are currently no FDA-approved treatments.
News coverage for SPRB commonly includes clinical and regulatory milestones. Examples from company releases include integrated long-term clinical data for TA-ERT, demonstrating profound and durable reductions in cerebral spinal fluid heparan sulfate non-reducing end (CSF HS-NRE) and stabilization of cognition and cortical grey matter volume, as well as the U.S. FDA granting Breakthrough Therapy Designation for TA-ERT and confirming CSF HS-NRE as a surrogate biomarker reasonably likely to predict clinical benefit.
Investors also see financing and capital markets updates in Spruce’s news flow. The company has reported a private placement with institutional investors expected to provide approximately $50.0 million in gross proceeds to advance TA-ERT, and a loan and security agreement with Avenue Venture Opportunities Fund II, L.P. providing access to up to $50.0 million in term loans tied to regulatory and commercial milestones. Additional headlines cover reverse stock split actions, conditional approval and resumption of trading on the Nasdaq Capital Market, and related listing matters.
Corporate governance and pipeline diversification are further themes in SPRB news. Spruce has announced board changes, including the appointment of Keli Walbert to its board of directors and compensation committee, as well as director resignations. The company has also issued updates on tildacerfont, being studied in major depressive disorder under a collaboration with HMNC Holding GmbH, and referenced SPR202 for congenital adrenal hyperplasia. For readers tracking SPRB, this news page provides a centralized view of the company’s clinical progress, regulatory interactions, financing events, and governance developments.
Spruce Biosciences (NASDAQ: SPRB) has announced a strategic transformation with the acquisition of tralesinidase alfa enzyme replacement therapy (TA-ERT) for treating Sanfilippo Syndrome Type B (MPS IIIB). The company plans to submit a Biologics License Application (BLA) to the FDA in the first half of 2026.
TA-ERT has shown promising results in clinical studies, significantly normalizing cerebral spinal fluid heparan sulfate levels over five years. The FDA has confirmed that this biomarker could serve as a basis for accelerated approval. The therapy has received fast-track designation, rare pediatric disease designation, and orphan drug status in both the U.S. and EU.
Financially, Spruce reported $38.8 million in cash and cash equivalents as of December 31, 2024, with an expected runway through the end of 2025. The company has 42.2 million shares outstanding and 21.4 million shares reserved for warrants and equity securities.
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.
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