Spruce Biosciences, Inc. - SPRB STOCK NEWS

Spruce Biosciences, Inc. (NASDAQ: SPRB) announced updates on its CAHmelia clinical program for tildacerfont, targeting adult classic congenital adrenal hyperplasia. The company plans to expand its global trial sites by up to 50, enhancing recruitment and optimizing study design for CAHmelia-203 and CAHmelia-204. Strategic prioritization extends its cash runway into Q2 2024, with topline data expected in 2H 2023 and 2H 2024 respectively. Additionally, a Phase 2 trial for pediatric CAH has been initiated, while a PCOS program is also underway.

Spruce Biosciences has appointed Dr. Javier Szwarcberg as CEO and promoted Samir Gharib to President, who will also remain CFO. Dr. Szwarcberg brings over 18 years of experience, having led 22 clinical trials and achieved 4 drug approvals. His focus will be on advancing tildacerfont, a potential first non-steroidal therapy for classic congenital adrenal hyperplasia (CAH). Gharib's promotion aims to leverage his business acumen for the company’s growth. Szwarcberg will receive stock options as part of his inducement award.

Spruce Biosciences, a late-stage biopharmaceutical company, announced that CFO Samir Gharib will present at the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 29 to December 2, 2021. A pre-recorded presentation will be available on-demand starting November 22, 2021, at 10:00 AM EST on the company's investor relations website. Spruce focuses on developing therapies for rare endocrine disorders, including the potential first non-steroidal treatment for classic congenital adrenal hyperplasia and polycystic ovary syndrome.

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.