Basel, Switzerland – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new data from the positive Phase III FENhance 1 and 2 studies, which met their primary endpoint. The studies showed that fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, reduced the annualised relapse rate (ARR) by 51.1% (p<0.001)...
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Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a detailed analysis of the phase III ALLEGORY trial of Gazyva®/Gazyvaro® (obinutuzumab) in adults with systemic lupus erythematosus (SLE) was published in the New England Journal of Medicine (NEJM). The study demonstrated a statistically significant and clinically meaningful benefit...
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival – three times longer than R-GemOx1 This well-tolerated investigational combination therapy avoids traditional chemotherapy and may be suitable for outpatient community care These data demonstrate Roche’s commitment to providing options for diverse patient and healthcare system needs in...
Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new, five-year efficacy, safety and durability data from the Phase III Portal study, a long-term extension of the Phase III Archway study, of Susvimo® (ranibizumab injection) for the treatment of people with nAMD.1 Results show that Susvimo’s immediate and predictable...
46% reduction in the risk of disease progression or death, and 27% reduction in the risk of death, in an aggressive cancer type with limited survival and few treatment options 1 First Phase III study in ES-SCLC first-line maintenance to demonstrate clinically meaningful improvements in both progression-free and overall survival 2,3 Data...
CRANBURY, N.J. – Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRESLADI™ (marnetegragene autotemcel), an autologous hematopoietic stem cell-based gene...
CRANBURY, N.J. — Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s pivotal Phase 2 trial of...
CRANBURY, N.J. — Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for KRESLADI™ (marnetegragene...
HEBER CITY, Utah (ABC-4 Sports) – Just eight months ago, Jade Hafen wasn’t sure if he would be able to walk again. After competing in a calf roping event, Hafen collapsed, unable to move his legs. He was eventually diagnosed with Guillain-Barre syndrome, a dehabilitating nerve disorder in which the...
BASEL, Switzerland, LONDON, UK, NEW YORK, NY and DURHAM, N.C. — Roivant (Nasdaq: ROIV) and Priovant Therapeutics today announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM). On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean TIS of 46.5 compared to 31.2...