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 reports developments as a late-stage biopharmaceutical company focused on novel therapies for neurological disorders with significant unmet medical need. Its recurring news centers on tralesinidase alfa enzyme replacement therapy, or TA-ERT, for Sanfilippo Syndrome Type B (MPS IIIB), including clinical data presentations, FDA interactions and regulatory planning for the program.
Company updates also cover financial results, capital actions involving common stock and pre-funded warrants, investor conference participation, and additions to commercial leadership as Spruce builds capabilities around a potential rare-disease launch.
Spruce Biosciences (OTCQB: SPRB) announced significant long-term clinical data for tralesinidase alfa enzyme replacement therapy (TA-ERT) in treating Sanfilippo Syndrome Type B (MPS IIIB). The integrated data from multiple clinical studies spanning five years demonstrated profound efficacy and safety.
Key findings include a 91.5 ng/mL reduction in CSF HS-NRE levels from baseline (p<0.0001), with most patients achieving normalization within eight weeks of treatment. The FDA confirmed CSF HS-NRE as a surrogate biomarker for accelerated approval. The therapy showed significant cognitive function preservation, with treated patients showing stable BSID-C scores compared to declining scores in untreated patients. At age 10, treated patients showed a 34.66-point higher BSID-C score (p<0.0001).
Safety data over 7.3 years showed an adequate profile, with no deaths reported. Common side effects included vomiting (100%), pyrexia (90.9%), and upper respiratory tract infection (77.3%).
Spruce Biosciences (OTCQB: SPRB), a late-stage biopharmaceutical company, has announced a 1-for-75 reverse stock split effective August 4, 2025, at 5:00 p.m. Eastern Time. The split aims to regain Nasdaq Capital Market compliance by meeting minimum bid price requirements.
The reverse split will reduce outstanding shares from 42.2 million to approximately 0.6 million. Trading on a split-adjusted basis will begin August 5, 2025, under the same symbol "SPRB" but with a new CUSIP number (85209E208). Nasdaq relisting is anticipated after maintaining the required minimum bid price for 20 consecutive trading days.
Proportionate adjustments will be made to outstanding stock options, restricted stock units, and warrants. Computershare Inc. will serve as the exchange agent, with fractional shares settled in cash.
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.