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 (SPRB) has announced key updates regarding its clinical programs, including anticipated topline results from the CAHmelia-203 study for adult classic congenital adrenal hyperplasia (CAH) expected in the second half of 2023. The company is enhancing its Phase 2 CAHptain trial for pediatric CAH, lowering the age requirement and extending the study duration to gather more informative data. Additionally, the Phase 2 P.O.W.E.R. study for polycystic ovary syndrome (PCOS) is set to produce topline results in the first half of 2023. Financially, SPRB estimates cash on hand of approximately $79 million as of December 31, 2022.
Spruce Biosciences has announced a licensing agreement with Kaken Pharmaceutical for the development and commercialization of tildacerfont in Japan, targeted at treating congenital adrenal hyperplasia (CAH). The deal includes a $15 million upfront payment, milestone payments, and tiered royalties on net sales. Kaken will handle clinical development and regulatory approvals in Japan while Spruce retains rights in other regions. This partnership aims to meet the significant unmet medical needs for CAH treatment in Japan, leveraging Kaken's regional experience.
Spruce Biosciences (Nasdaq: SPRB) reported third-quarter financial results for the period ending September 30, 2022. The company is advancing its clinical trials, approaching 50% enrollment in CAHmelia-203 and surpassing 25% in CAHmelia-204. Notable updates include the appointment of Dr. Saba Sile as Vice President of Clinical Development. Financially, Spruce had $90.4 million in cash, with total operating expenses of $11.6 million for Q3 2022, consistent with Q3 2021. The net loss remained stable at $11.4 million, indicating ongoing investment in R&D for therapies targeting rare endocrine disorders.
Spruce Biosciences, Inc. (NASDAQ: SPRB), a biopharmaceutical company focused on rare endocrine disorders, will participate in two investor conferences in November 2022. The conferences include the Credit Suisse 31st Annual Healthcare Conference from November 7-10, where the company will present on November 8 at 2:35 p.m. PT, and the Jefferies 2022 London Healthcare Conference from November 15-17, featuring 1x1 meetings. Webcast access and replays will be available on the company’s investor relations website.
Spruce Biosciences (NASDAQ: SPRB) announced that Samir Gharib, President and CFO, will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 5:00 pm ET. The company focuses on developing therapies for rare endocrine disorders, with its lead candidate, tildacerfont, targeting classical congenital adrenal hyperplasia (CAH). This condition has lacked new treatments for around 50 years. Interested parties can access the live webcast here.
Spruce Biosciences (Nasdaq: SPRB) reported its Q2 2022 financial results, highlighting a net loss of $11.9 million, consistent with the previous year. The company achieved over 25% enrollment in both CAHmelia-203 and CAHmelia-204 studies. P.J. Ramtin has been appointed as Senior VP of Business Operations, bringing extensive industry experience. The patent portfolio for tildacerfont expanded with two new patents, extending exclusivity through 2038. Cash and investments totaled $99.1 million at quarter-end, with R&D expenses rising to $9.1 million as the company progresses clinical development.
Spruce Biosciences (NASDAQ: SPRB) announces participation in two investor conferences in June 2022. The Jefferies Healthcare Conference will take place from June 8-10, 2022, featuring a company presentation on June 8 at 4:00 PM ET. The JMP Securities Life Sciences Conference follows on June 15-16, 2022, highlighted by a fireside chat on June 16 at 11:30 AM ET. Webcasts of both events will be accessible via Spruce's investor relations website, with replays available for 30 days. Spruce is focused on therapies for rare endocrine disorders, including potential treatments for congenital adrenal hyperplasia.
Spruce Biosciences (NASDAQ: SPRB) announced an abstract acceptance for a poster presentation at the 104th Annual Meeting of the Endocrine Society (ENDO 2022) in Atlanta, GA, scheduled for June 11-14, 2022. The presentation will cover survey results assessing patient perceptions on glucocorticoid treatment for congenital adrenal hyperplasia (CAH). Key details include the session date of June 11, 2022, from 1:00 p.m. to 3:00 p.m. ET, presented by Dr. Chris N. Barnes. The company aims to develop non-steroidal therapies for CAH and is also exploring treatments for polycystic ovary syndrome (PCOS).
Spruce Biosciences (Nasdaq: SPRB) reported progress in its CAHmelia-203 study for adult classic congenital adrenal hyperplasia (CAH), achieving 25% enrollment and expects topline data by H2 2023. The company amended its debt facility with Silicon Valley Bank for a $10 million credit line, reducing interest rates. R&D expenses rose to $8.5 million, while total operating expenses increased to $11.7 million, resulting in a net loss of $11.8 million for Q1 2022. The patent portfolio for tildacerfont has also expanded, enhancing market exclusivity.
Spruce Biosciences (NASDAQ: SPRB) announced its participation in two upcoming investor conferences in May 2022. The first event is the RBC Capital Markets Global Healthcare Conference on May 17-18, featuring a fireside chat on May 17 at 10:00 a.m. ET. The second event is the H.C. Wainwright Global Investment Conference from May 23-26, with a company presentation on May 25 at 4:00 p.m. ET. Interested investors can access webcasts via the company’s investor relations website. Spruce focuses on therapies for rare endocrine disorders.
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