ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

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.

Roche has received CE mark approval for its SARS-CoV-2 Antigen Self Test Nasal, enabling convenient at-home COVID-19 testing using a nasal swab. Initially available in certain European markets since February 2021, the test can now be widely accessed through pharmacies. It provides results in 15 minutes and integrates with NAVIFY Pass, a digital solution for sharing test results and vaccination status. Roche's CEO emphasized home testing's role in pandemic management, allowing individuals to assess their potential infectiousness and support public health efforts.

Roche (OTCQX: RHHBY) announced promising data on its investigational therapies for non-Hodgkin lymphoma (NHL) at the 2021 ASCO Annual Meeting. The bispecific antibodies, mosunetuzumab and glofitamab, demonstrated significant treatment responses, with complete response rates of 71.4% and 54.5% respectively in clinical trials. Roche is targeting a regulatory filing for mosunetuzumab in follicular lymphoma by the end of 2021. Approximately 500,000 new NHL cases are diagnosed annually, highlighting the urgent need for new treatment options amid limited existing therapies.

Roche announced the European Commission's approval of Venclyxto (venetoclax) in combination with hypomethylating agents for adults with newly diagnosed acute myeloid leukaemia (AML) ineligible for intensive chemotherapy. The VIALE-A study showed that Venclyxto plus azacitidine improved overall survival, reducing the risk of death by 34%, with median survival of 14.7 months compared to 9.6 months with azacitidine alone. The approval opens new treatment options for AML patients, significantly enhancing complete response rates and overall survival outcomes.

Roche (RHHBY) announced interim results from the Phase III IMpower010 study, indicating that Tecentriq (atezolizumab) significantly improved disease-free survival (DFS) by 34% for patients with PD-L1-positive resectable early-stage lung cancer compared to best supportive care (BSC). Specifically, median DFS was not reached for Tecentriq, while BSC showed 35.3 months. The overall study cohort saw a 21% reduction in recurrence or death risk. Safety outcomes aligned with known profiles, with 92.7% experiencing adverse events. Full results will be presented at the ASCO Annual Meeting.