Roche unveils a new class of next-generation sequencing with its novel sequencing by expansion technology

Roche’s innovative sequencing by expansion (SBX) technology represents a leap forward in next-generation sequencing (NGS), which is playing a vital role in decoding complex diseases like cancer, immune disorders and neurodegenerative conditions Combined with an innovative, high throughput sensor module, SBX uses expanded synthetic molecules to determine the DNA sequence of a target molecule, creating... Read more

FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy (SMA)

Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration... Read more

New England Journal of Medicine publishes new data for Roche’s Gazyva/Gazyvaro which shows superiority over standard therapy in people with active lupus nephritis

Nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone1 Analysis showed consistent CRR benefit across patient subgroups, highlighting potential to treat a broad patient population with high unmet need1 Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody... Read more

FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME) With as few as two treatments per year, Susvimo may help people with DME maintain their vision Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular... Read more

Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU

As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.1 These patients may now be eligible for a targeted treatment, which could significantly improve their outcomes. The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since... Read more

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2024 results with 7% sales growth; fourth quarter marks third straight quarter of 9% growth

Basel, 30 January 2025 Group sales grew by 7%1 at constant exchange rates (CER; 3% in CHF), driven by strong demand for both medicines and diagnostics. Excluding COVID-19, Group sales increased by 9%. COVID-19 will not adversely impact our results from 2025 onwards. The fourth quarter was the third consecutive quarter of 9% sales growth,... Read more

Change to the Roche Enlarged Corporate Executive Committee

Basel, 29 January 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Wafaa Mamilli (1967) will join the company as Chief Digital Technology Officer (CDTO), reporting to Group CEO, Thomas Schinecker, and will become a member of the enlarged Corporate Executive Committee starting 10 February 2025.  She will be based at Genentech in South... Read more

Roche’s Itovebi demonstrated statistically significant and clinically meaningful overall survival benefit in a certain type of HR-positive advanced breast cancer

Updated overall survival (OS) results – a key secondary endpoint – reinforce the significant benefit of the ItovebiTM (inavolisib)-based regimen for patients with advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer in the first-line setting Primary analysis showed the Itovebi-based regimen reached statistical significance, more than doubling progression-free survival in this patient population1 Full OS results from... Read more

Roche announces new results from EMBARK demonstrating significant sustained benefits of Elevidys in ambulatory individuals with Duchenne muscular dystrophy (DMD)

Across three key functional outcomes, North Star Ambulatory Assessment (NSAA), Time to Rise (TTR) and 10-meter walk/run (10MWR), results were statistically significant and clinically meaningful two years after treatment with Elevidys, compared to a pre-specified propensity-weighted untreated external control group Functional differences between individuals treated with Elevidys and those in the external control group increased... Read more

Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care

More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15–49 years old, most of which are asymptomatic.1 FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralized settings like urgent care centers, retail clinics, and community health venues. The tests use highly sensitive, gold-standard... Read more