The Latest Breaking News from Roche Holdings AG

On Thursday, Roche Holdings AG (OTC:RHHBY) agreed to acquire 89bio, Inc. (NASDAQ:ETNB) for $2.4 billion. 89Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies for liver and cardiometabolic diseases.

Sarepta Therapeutics Inc (NASDAQ:SRPT) shared new functional data across multiple studies from the SRP-9001 (delandistrogene moxeparvovec) program for Duchenne muscular dystrophy.  SRP-9001 is an investigational gene therapy under development in partnership with Roche Holdings AG (OTC:RHHBY).  Results from Cohort 1 demonstrated a 3.8-point improvement and 3.2-point improvement on the Duchenne functional scale 52 weeks after…

Genentech, a unit of Roche Holdings AG (OTC: RHHBY), announced results from its Phase 3 SKYSCRAPER-01 study, evaluating tiragolumab in PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC). 

The development of Roche Holdings AG's (OTC: RHHBY) multiple sclerosis candidate fenebrutinib is negatively impacted by Russia's ongoing invasion of Ukraine.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval for Roche Holdings AG's (OTC:RHHBY) mosunetuzumab for relapsed or refractory (R/R) follicular lymphoma (FL). The opinion covers mosunetuzumab for adult patients who have received at least two prior systemic therapies.  The CHMP recommendation is based on…

The U.S. FDA is warning that noninvasive prenatal screening (NIPS) tests may provide false results, such as stating a fetus may have a genetic abnormality when the fetus was healthy. FDA issues warning on possible false results from noninvasive prenatal screening tests. The agency noted that these tests, also known as…

The FDA has extended its review of Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) marketing application of REGEN-COV (casirivimab and imdevimab) for non-hospitalized COVID-19 patients and as prophylaxis in certain individuals.  The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use. Regeneron has submitted additional data from its completed prophylaxis trial that the…

The FDA has granted priority review to Roche Holdings AG's (OTC:RHHBY) Actemra/RoActemra (tocilizumab) for COVID-19 in hospitalized adults. "If approved, Actemra/RoActemra would be the first U.S. FDA-approved immunomodulator for treating COVID-19 in hospitalized patients," Roche said. The Compay also added that more than 1 million people hospitalized with COVID-19 had been treated with Actemra/RoActemra…

At the annual congress of the Muscular Dystrophy Association (MDA), Roche Holdings AG (OTC:RHHBY) announced new data for its spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). Evrysdi is a novel survival motor neuron 2 (SMN2) splicing modifier, licensed from PTC Therapeutics Inc (NASDAQ:PTCT). At the annual MDA event, Roche’s presentations included new three-year data from the…