DUBLIN, Ireland — Prothena Corporation plc (NASDAQ:PRTA) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to coramitug, a potential best-in-class amyloid depleter antibody currently in Phase 3 development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Fast Track Designation is intended to...
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Bagsværd, Denmark – Novo Nordisk today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending an update of the Alhemo® (concizumab) label to include the treatment of severe hemophilia A and moderate or severe haemophilia B without inhibitors. “If...
BAGSVÆRD, Denmark and PLAINSBORO, N.J. — Today, Novo Nordisk announced Mim8 (denecimig) has been submitted for review to the U.S. Food and Drug Administration (FDA) through a Biologics License Application (BLA), a formal request to evaluate a biologic medicine. Denecimig is an investigational, next-generation bispecific antibody Factor VIIIa (FVIIIa) mimetic,...
LEXINGTON, Mass. – Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) today announced that it has entered into a definitive agreement with Novo Nordisk under which Novo Nordisk will acquire Dicerna, a biopharmaceutical company focused on the development of investigational ribonucleic acid interference (RNAi) therapeutics, for $38.25 per share in cash, which represents a total equity value...
Novo Nordisk has entered into a definitive agreement to acquire Dicerna Pharmaceuticals (Dicerna) for a total equity value of approximately USD 3.3 billion. The acquisition of Dicerna’s ribonucleic acid interference (RNAi) platform is a strategic addition to Novo Nordisk’s existing research technology platforms and supports the strategy of using a...
PLAINSBORO, N.J. and BAGSVÆRD, Denmark — Novo Nordisk today unveiled new data from the phase 3 FRONTIER4 extension study evaluating the long-term safety and efficacy of investigational denecimig (Mim8) subcutaneous prophylaxis in children, adolescents, and adults with hemophilia A, with or without inhibitors, across a range of dosing frequencies including once-monthly, once-every-two-weeks,...
Bagsværd, Denmark – Novo Nordisk today announced the headline results from the kidney outcomes trial FLOW. The announcement today follows the decision to stop the trial early due to efficacy, which was announced on 10 October 2023, based on a recommendation from an Independent Data Monitoring Committee. The double-blind trial...
ST. HELIER, Jersey – Novocure (NASDAQ: NVCR) today announced it has entered into a clinical trial collaboration agreement with GT Medical Technologies, Inc., to develop Tumor Treating Fields (TTFields) together with GT Medical Technologies’ GammaTile Surgically Targeted Radiation Therapy (STaRT) for treatment of recurrent glioblastoma (GBM). Novocure’s TTFields are electric...
ROOT, Switzerland — NovoCure Ltd. (NASDAQ: NVCR) today announced that the final patient has been enrolled in the global phase 3 TRIDENT clinical trial evaluating the safety and efficacy of initiating Optune Gio® (formerly known as Optune®) concurrent with radiation therapy and temozolomide (TMZ) for the treatment of adult patients...
BAAR, Switzerland — Novocure (NASDAQ: NVCR) announced positive results today from the Phase 2 PANOVA-4 trial of Tumor Treating Fields (TTFields) therapy concomitant with atezolizumab (Tecentriq®), gemcitabine and nab-paclitaxel (gem/nab-pac) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). PANOVA-4 met its pre-specified primary endpoint, achieving a statistically significant improvement...