RO News - Candlesense

Roche receives CE mark for Contivue, its Port Delivery Platform containing Susvimo, for neovascular age-related macular degeneration (nAMD)

(RO) Basel, 04 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received the EU CE mark for its Port Delivery Platform containing Susvimo, which will now be known as ...

When is the EMA decision expected for Susvimo, and what are the potential pricing and reimbursement implications in the EU market? What competitive advantages does Contivue offer over existing nAMD delivery platforms from companies like Novartis and Alcon, and how might this influence market share? How will the CE marking of Contivue with Susvimo affect Roche's upcoming quarterly earnings and revenue forecasts?

Regulatory approval

4 days ago

Roche and Alnylam advance zilebesiran into global phase III cardiovascular outcomes trial for people with uncontrolled hypertension

(RO) Basel, 30 August 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam (Nasdaq: ALNY) today announced the decision to initiate a Phase III cardiovascular outcomes trial (CVOT) to evaluate the ...

What are the regulatory, reimbursement, and revenue forecast implications if the trial demonstrates a significant reduction in major adverse cardiovascular events? How does zilebesiran’s efficacy, safety, and RNAi mechanism compare to existing hypertension treatments and competing pipeline candidates from other pharma companies? What is the anticipated timeline, enrollment size, and potential market impact of the Phase III CVOT for zilebesiran on Roche and Alnylam’s valuations?

Clinical trials

9 days ago

Roche’s US subsidiary Genentech breaks ground on state-of-the-art manufacturing facility in North Carolina, USA

Basel, 25 August 2025 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today broke ground on its newest US manufacturing site in Holly Springs, North Carolina. This significan...

How does this expansion compare to recent capacity upgrades by competitors in the metabolic medicines space and what could it mean for market share? What is the expected timeline for ramping up production of next‑generation obesity treatments at the North Carolina site? How will the new manufacturing facility affect Genentech's and Roche's revenue forecasts and valuation?

Manufacturing

13 days ago