Roche Holding AG - RHHBY STOCK NEWS

Roche (RHHBY) announced two-year data from Phase III Pagoda and Pavilion studies evaluating Susvimo for treating diabetic macular edema (DME) and diabetic retinopathy (DR). Susvimo, a refillable eye implant, demonstrated sustained efficacy over two years with safety consistent with its known profile. The US FDA accepted Roche's sBLA for Susvimo in DME and DR based on one-year study data.

Key findings include:

• DME patients maintained vision gains (9.8 eye chart letters) at two years
• 95% of DME patients didn't need additional injections
• 80% of DR patients achieved significant DRSS improvements at two years
• 98% of DR patients didn't require supplemental injections

Susvimo could potentially offer a new treatment paradigm for diabetic eye diseases, reducing the need for frequent injections.

Genentech, a Roche Group member (OTCQX: RHHBY), announced two-year data from Phase III Pagoda and Pavilion studies evaluating Susvimo for diabetic macular edema (DME) and diabetic retinopathy (DR). Susvimo, a refillable eye implant, demonstrated sustained efficacy over two years with consistent safety profile. Key findings include:

- DME: Maintained vision gains (9.8 eye chart letters) at two years
- DR: 80% achieved two-step or greater improvement on DRSS at 100 weeks
- 95-98% of patients didn't need additional injections
- FDA accepted sBLA for Susvimo in DME and DR based on one-year data

If approved, Susvimo could offer a new treatment paradigm for diabetic eye diseases, potentially reducing the frequency of eye injections.

Genentech, a Roche Group member, announced four-year data from the RHONE-X extension study for Vabysmo (faricimab-svoa) in treating diabetic macular edema (DME). The study met all primary endpoints, demonstrating Vabysmo's consistent safety profile. Key findings include:

- Over 90% of patients showed absence of DME after four years
- Nearly 80% of patients received treatment at 3-4 month intervals
- Sustained vision gains and anatomical improvements were observed
- Vabysmo maintained efficacy in preserving vision and drying retinal fluid

This represents the largest long-term extension dataset in DME, reinforcing Vabysmo's potential as a standard treatment for the 29 million people affected worldwide. Vabysmo is currently approved in nearly 100 countries for DME and wet AMD.

Roche announced four-year data from the RHONE-X extension study for Vabysmo (faricimab) in treating diabetic macular edema (DME). The study met all primary endpoints, demonstrating Vabysmo's consistent safety profile. Key findings include:

- Over 90% of patients showed absence of DME after four years
- Nearly 80% of patients received treatment at 3-4 month intervals
- Sustained vision gains and anatomical improvements were observed
- Vabysmo continued to preserve vision and dry retinal fluid

This is the largest long-term extension dataset in DME to date, reinforcing Vabysmo's potential as a standard of care treatment for the 29 million people affected by DME worldwide.

Genentech, a Roche Group member, announced positive Phase I results for CT-996, an oral GLP-1 receptor agonist for obesity treatment. After four weeks, CT-996 demonstrated a clinically meaningful weight loss of -7.3% compared to -1.2% with placebo. The safety profile was consistent with other oral GLP-1 agonists, with no unexpected safety signals.

Key findings include:

• Placebo-adjusted mean weight loss of -6.1% within four weeks
• Once-daily oral dosing regimen supported by pharmacokinetic data
• Potential for dosing without regard to meal timing
• Well-tolerated with mostly mild to moderate gastrointestinal-related adverse events

This marks the second positive readout from Genentech's metabolic pipeline in less than three months, following data for CT-388.

Roche announced positive Phase I results for CT-996, an oral GLP-1 receptor agonist for obesity treatment. Key findings include:

- 7.3% weight loss after 4 weeks (vs 1.2% with placebo)
- Supports once-daily oral dosing
- Safety profile consistent with other oral GLP-1 agonists
- Potential for use in type 2 diabetes and obesity

CT-996 showed a placebo-adjusted mean weight loss of 6.1% in participants with obesity without type 2 diabetes. The drug was well-tolerated with mostly mild to moderate gastrointestinal side effects. Roche sees potential for CT-996 as a therapy for glycemic control, weight loss, and weight maintenance following injectable treatments.

Remix Therapeutics has achieved a near-term milestone in its collaboration with Roche, announced today. This collaboration, initiated in January 2024, focuses on discovering and developing small molecule therapeutics that modulate RNA processing using Remix's REMaster platform. Remix received an upfront payment of $30 million and is now eligible for up to $1 billion in preclinical, clinical, commercial, and sales milestones, as well as tiered royalties. Roche gains exclusive rights to specific targets, while Remix handles discovery and preclinical activities. Roche will manage the development and commercialization of any resulting products.

Roche has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This AI-enabled device offers accurate real-time glucose monitoring for adults with type 1 and type 2 diabetes on flexible insulin therapy.

It provides glucose values for 14 days and predicts hypoglycemia risk within the next 30 minutes and glucose levels for the next two hours using AI algorithms. Clinical evaluations show a mean absolute relative difference (MARD) of 9.2%, with 99.8% of glucose values falling within acceptable ranges.

The Accu-Chek SmartGuide aims to alleviate concerns about nighttime hypoglycemia and enable proactive diabetes management, enhancing the quality of life for users.

Roche has reintroduced Susvimo, an ocular implant for neovascular age-related macular degeneration (nAMD), in the US. The FDA approved updates to Susvimo's implant and refill needle, which address previous performance issues that led to a voluntary recall in 2022. Susvimo offers a twice-yearly refill alternative to regular eye injections, continuously delivering medicine to the eye. This innovative approach, highlighted in Phase III studies, aims to maintain vision for patients with nAMD, a condition affecting 20 million people globally. The product will be available to US retina specialists and patients in the coming weeks.