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 announces the initiation of its Phase 2 clinical program for tildacerfont in pediatric classic Congenital Adrenal Hyperplasia (CAH) in 2021, with data expected by the first half of 2023. This open-label study will evaluate safety and pharmacokinetics in children aged 6-17 with varying doses. The Phase 3 registrational program is also anticipated to commence in 2023. The company is focused on addressing significant unmet medical needs in rare endocrine disorders, aiming to provide a non-steroidal treatment for classic CAH.
Spruce Biosciences, Inc. (Nasdaq: SPRB) reported Q2 2021 financial results highlighting advancements in its clinical programs. The FDA cleared the IND for tildacerfont for polycystic ovary syndrome (PCOS), enabling a Phase 2 study later this year. A new patent extends exclusivity for tildacerfont until 2038. In clinical trials, tildacerfont showed promising results in reducing ACTH and androstenedione levels in classic congenital adrenal hyperplasia (CAH) patients. The company ended Q2 with $139 million in cash, supporting ongoing development initiatives.
Spruce Biosciences, Inc. (Nasdaq: SPRB) has appointed Dr. Kirk Ways to its board of directors, enhancing its leadership during a crucial growth phase. Dr. Ways, with over 30 years in pharmaceutical drug discovery, previously was Chief Medical Officer at Nuvelution Pharma and held key roles at Johnson & Johnson. His expertise in clinical development will support Spruce's program for tildacerfont, aimed at treating rare endocrine disorders, including congenital adrenal hyperplasia. The company is focused on delivering innovative therapies for patients with significant unmet medical needs.
Spruce Biosciences (Nasdaq: SPRB) has published results from two Phase 2 clinical studies of tildacerfont for treating classic congenital adrenal hyperplasia (CAH). The studies demonstrated tildacerfont's ability to significantly reduce key hormone levels, including ACTH and androstenedione, particularly in patients with poor disease control. In 60% of cases, normalization of ACTH was observed. The findings support ongoing late-stage trials (CAHmelia-203 and CAHmelia-204) aimed at further assessing tildacerfont's efficacy and its potential to reduce glucocorticoid dosage.
Spruce Biosciences, Inc. (Nasdaq: SPRB) presented promising data from its Phase 2 clinical trial of tildacerfont for treating classic congenital adrenal hyperplasia (CAH) at the 23rd European Congress of Endocrinology. The open-label study showed significant reductions in disease-driving hormones such as ACTH, 17-OHP, and A4 in patients with poor disease control, achieving up to 84% reduction in ACTH levels. Notably, 60% of patients experienced normalization of ACTH levels without increasing steroid doses. The ongoing CAHmelia program aims to further evaluate the treatment's potential to reduce glucocorticoid usage.
Spruce Biosciences (Nasdaq: SPRB), a biopharmaceutical company, announced that CEO Richard King will participate in a virtual fireside chat at the RBC Capital Markets Global Healthcare Conference on May 19, 2021, at 5:25 PM EDT. Interested parties can access the live webcast through the company's investor relations website and an archived replay will be available for 30 days post-event. Spruce is focused on developing therapies for rare endocrine disorders, including its product candidate tildacerfont, aimed at treating classic congenital adrenal hyperplasia and a specific form of polycystic ovary syndrome.
Spruce Biosciences (Nasdaq: SPRB) reported its first-quarter financial results for 2021, highlighting advancements in therapies for rare endocrine disorders. The company has $148.6 million in cash, enabling it to progress its clinical trials, including the Phase 2 program for pediatric classic congenital adrenal hyperplasia (CAH). R&D expenses rose to $6.7 million, while G&A expenses climbed to $3.1 million, resulting in a net loss of $9.9 million. The company plans to submit an IND for polycystic ovary syndrome and initiate critical trials later in the year.
Spruce Biosciences, Inc. (Nasdaq: SPRB) reported its Q4 and 2020 financial results, marking a transformative year in developing therapies for rare endocrine disorders.
Key updates include the initiation of the CAHmelia program for classic congenital adrenal hyperplasia and plans for Phase 2 trials in pediatric classic CAH and PCOS. The company has $157.2 million in cash, enhancing its ability to fund ongoing clinical studies. R&D expenses rose significantly to $23.9 million, with a net loss of $29.5 million reported for the year.
Spruce Biosciences (Nasdaq: SPRB) presented promising results from its Phase 2 trials of tildacerfont for treating congenital adrenal hyperplasia (CAH) at the Endocrine Society’s 2021 Annual Meeting. Data showed significant reductions in key biomarkers: 84% in ACTH, 80% in 17-OHP, and 79% in A4 levels after 12 weeks. The drug was well tolerated, with no new safety concerns. Tildacerfont aims to be the first non-steroidal therapy for CAH, highlighting a significant milestone for patients who have lacked novel treatments for decades.
Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company, announced that it will present data from its Phase 1 and 2 trials of tildacerfont for classic congenital adrenal hyperplasia (CAH) at the ENDO 2021 Annual Meeting from March 20-23. Key presentations include results from a 12-week Phase 2 trial and assessments of steroid hormones during the study. Tildacerfont aims to provide a novel non-steroidal therapy, addressing a significant unmet need in CAH, which has lacked new treatments for about 50 years.
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