ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced new data from its haemophilia A clinical program to be presented at the ISTH 2021 Congress from July 17-21, 2021. The final analysis of the phase IIIb STASEY study will affirm Hemlibra's safety and efficacy for patients with factor VIII inhibitors. Spark Therapeutics will share updated results from the phase I/II trial of SPK-8011, showing durable factor VIII expression for up to four years. Both studies highlight Roche's commitment to advancing therapies for haemophilia A, demonstrating significant reductions in annualized bleed rates and confirming a favorable safety profile.

Roche has received European Commission approval for ENSPRYNG (satralizumab), the first treatment for adults and adolescents with AQP4-IgG seropositive NMOSD. This therapy can be used alone or alongside immunosuppressive therapy to reduce relapses and prevent disability. In clinical trials, ENSPRYNG significantly lowered the number and severity of relapses compared to placebo, achieving 83% relapse-free status at 48 weeks in monotherapy and 92% when combined with IST. The treatment is designed for subcutaneous administration every four weeks, enhancing accessibility for patients.

Roche (OTCQX: RHHBY) received Emergency Use Authorization (EUA) from the FDA for its drug Actemra/RoActemra, aimed at treating hospitalized COVID-19 patients requiring respiratory support. This authorization is based on four randomized studies involving over 5,500 patients, suggesting improved outcomes with the drug. The common adverse effects reported were constipation, anxiety, and nausea. While the EUA is a temporary measure during the pandemic, it positions Actemra/RoActemra as a potentially key therapeutic option for affected patients.

Genentech, part of Roche Group, announced that the FDA has granted an Emergency Use Authorization (EUA) for Actemra® (tocilizumab) to treat COVID-19 in hospitalized patients aged 2 and older. The EUA is based on data from four studies involving over 5,500 patients, suggesting that Actemra may improve outcomes for those on systemic corticosteroids requiring oxygen or ventilation support. Despite not being FDA-approved for this use, the EUAs enable access during the pandemic, highlighting ongoing challenges in managing severe COVID-19 cases.

Roche's Port Delivery System (PDS) for neovascular age-related macular degeneration (nAMD) has received FDA acceptance for Priority Review. If approved by October 23, 2021, PDS would be the first implant providing continuous drug delivery, allowing up to six months between treatments, significantly reducing the need for frequent injections. The pivotal Archway study demonstrated that over 98% of patients could go without additional treatment for six months, achieving equivalent vision outcomes compared to monthly injections. The European Medicines Agency has also validated the PDS Marketing Authorisation Application for nAMD.

Roche announced that the FDA has granted Emergency Use Authorization (EUA) for its cobas® SARS-CoV-2 Nucleic acid test, usable on the cobas® Liat® System. This significant milestone introduces the first real-time RT-PCR test capable of identifying SARS-CoV-2 infection within 20 minutes. The test will be available in July and can screen both symptomatic and asymptomatic individuals, enhancing access to rapid testing in various healthcare settings. Roche aims to support COVID-19 management and curb the virus's spread, marking a step forward in public health efforts.

Roche (RHHBY) presented new data on its neuroscience portfolio at the 7th Congress of the European Academy of Neurology. Key highlights include safety and efficacy updates for EVRYSDI in spinal muscular atrophy, now approved in 42 countries, and ENSPRYNG for neuromyelitis optica spectrum disorder, with a positive CHMP opinion. Furthermore, OCREVUS demonstrated benefits in multiple sclerosis. The company emphasizes its commitment to advancing treatments in neurological disorders, aiming to improve patient lives and outcomes.

The latest data from Roche presented at EHA2021 highlights the effectiveness of Venclexta/Venclyxto in treating blood cancers.

A four-year follow-up from the phase III CLL14 study revealed a progression-free survival rate of 74.0% in previously untreated chronic lymphocytic leukaemia (CLL) patients.

Furthermore, the MURANO study indicates genetic factors could help customize treatment strategies.

Additionally, VIALE-A's analysis shows improved outcomes for acute myeloid leukaemia patients achieving undetectable minimal residual disease.

Roche announced interim results from two studies of Evrysdi (risdiplam) for treating spinal muscular atrophy (SMA). The JEWELFISH trial showed a consistent safety profile and over a 2-fold increase in SMN protein levels in patients aged 1-60 with prior treatment. In the RAINBOWFISH study, pre-symptomatic babies treated for a year achieved significant motor milestones. Evrysdi is now approved in 44 countries, addressing unmet needs in the SMA community.