SOUTH SAN FRANCISCO, Calif. — Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced the successful completion of Type B meetings with the U.S. Food and Drug Administration (FDA or the Agency) regarding its...
treatment News
SOUTH SAN FRANCISCO, Calif. — Spruce Biosciences, Inc., a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today announced completion of enrollment in its CAHmelia-204 clinical trial of tildacerfont for the treatment of adult classic congenital adrenal hyperplasia (CAH)....
SOUTH SAN FRANCISCO, Calif. — Spruce Biosciences, Inc. (Nasdaq: SPRB) (“Spruce”), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced that it has completed two pre-BLA meetings with the U.S. Food and Drug Administration (FDA) that support the...
SOUTH SAN FRANCISCO, Calif. – Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to tralesinidase alfa enzyme replacement...
LONDON, UK — Spur Therapeutics today announced that the first patient has been dosed in GALILEO-3, its Phase 3 pivotal clinical trial evaluating avigbagene parvec (FLT201), an investigational gene therapy for Gaucher disease type 1 (GD1). The trial will assess the safety and efficacy of FLT201 in adults currently on stable...
LONDON, UK – Spur Therapeutics today released new data from the GALILEO-1 and GALILEO-2 trials of avigbagene parvec (FLT201), its investigational gene therapy for Gaucher disease type 1 (GD1), which highlight encouraging improvements in skeletal disease, a major and persistent source of morbidity in patients despite long-term standard-of-care treatment. These data are...
LONDON, UK — Spur Therapeutics today announced updated Phase 1/2 data on avigbagene parvec (FLT201), its clinical-stage gene therapy candidate for Gaucher disease, demonstrating favorable safety, dramatic improvements in a validated biomarker of disease severity and treatment response, and sustained clinical benefit through two years of follow-up across all responsive patients....
LONDON, UK — Spur Therapeutics today announced updated clinical data for avigbagene parvec (FLT201), its Gaucher disease gene therapy candidate, demonstrating clinical benefit and favorable safety maintained for more than two years to date following administration of a single low dose. These data are being presented at the European Society of...
STEVENAGE, UK – FLT201, an experimental gene therapy developed by Spur Therapeutics, has shown sustained clinical benefits for up to 21 months in people with Gaucher disease type 1, according to new data from a clinical trial. The findings, presented at the 28th Annual Meeting of the American Society of...
ALISO VIEJO, Calif. — SpyGlass Pharma™, a privately-held ophthalmic biotechnology company, announced today 1-year follow up data from a first-in-human study of 23 patients with glaucoma or ocular hypertension implanted with SpyGlass’ Intraocular Lens (IOL) based Drug Delivery Platform with bimatoprost at the time of cataract surgery. These data will...