Spruce Biosciences, Inc. Stock Price, News & Analysis

Spruce Biosciences, Inc. (Nasdaq: SPRB) announced plans to initiate Phase 2 trials for pediatric classic congenital adrenal hyperplasia (CAH) and polycystic ovary syndrome (PCOS). The adult CAHmelia program has been expanded to Australia and Canada to enhance patient recruitment. Financially, as of September 30, 2021, the company reported $131.3 million in cash and investments. However, R&D expenses increased to $8.6 million in Q3 2021, reflecting ongoing development costs, and the net loss rose to $11.4 million.

Spruce Biosciences, Inc. (NASDAQ: SPRB) has appointed Mike Grey as interim CEO, effective immediately, succeeding Richard King, who is retiring. Grey, the Executive Chairman, emphasized the company's commitment to advancing tildacerfont for treating classic congenital adrenal hyperplasia (CAH), a significant unmet need in rare endocrine disorders. The clinical program is expanding, with upcoming Phase 2 trials for CAH in children and polycystic ovary syndrome (PCOS) in women. Additionally, Pamela Wedel has been appointed Vice President of Development Operations, bringing over 30 years of drug development experience.

Spruce Biosciences (NASDAQ: SPRB), a biopharmaceutical company, announced participation in four investor conferences this September. The conferences include H.C. Wainwright Global Investment Conference (Sept 13-14), Baird 2021 Global Healthcare Conference (Sept 14-15), Oppenheimer Fall Healthcare Life Sciences Summit (Sept 20-22), and SVB Leerink CybeRx Series (Sept 22-23). The company is focused on developing therapies for rare endocrine disorders, particularly tildacerfont for classic congenital adrenal hyperplasia and polycystic ovary syndrome.

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.