Roche Hldg Stock Price, News & Analysis

Roche (RHHBY) has received European Commission approval for Columvi in combination with gemcitabine and oxaliplatin (GemOx) for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant.

The approval is based on the Phase III STARGLO study results, which showed that the Columvi combination demonstrated a 41% reduction in death risk compared to MabThera/Rituxan plus chemotherapy. The study revealed a median overall survival of 25.5 months for the Columvi combination versus 12.9 months for R-GemOx, with more than twice as many patients experiencing complete response (58.5% vs 25.3%).

This marks Columvi as the first bispecific antibody regimen available in Europe for DLBCL patients whose cancer has returned or didn't respond to initial treatment. The treatment offers an 'off-the-shelf' option with fixed duration, allowing immediate availability and a defined treatment endpoint.

Roche (RHHBY) has presented new data at AD/PD 2025 Conference showcasing advancements in Alzheimer's treatment and diagnostics. The company's trontinemab demonstrated promising Phase Ib/IIa results, showing rapid and deep amyloid plaque reduction in 81% of participants receiving 3.6 mg/kg dose after 28 weeks. The drug maintained a favorable safety profile with ARIA-E observed in less than 5% of participants.

The company plans to initiate a Phase III programme for trontinemab later this year. Additionally, Roche's Elecsys® pTau181 plasma test showed potential in accurately ruling out amyloid pathology in a study of 604 participants. This blood test is expected to be available in Europe by late 2025.

In Parkinson's disease research, the Phase IIb PADOVA study of prasinezumab, while missing its primary endpoint, showed possible benefits in early-stage patients, particularly those treated with levodopa.

Genentech and Roche presented significant advancements in Alzheimer's treatment and diagnostics at AD/PD 2025. The Phase Ib/IIa Brainshuttle AD study of trontinemab showed promising results, with 81% of participants in the 3.6 mg/kg dose group experiencing amyloid plaque reduction below threshold after 28 weeks. The drug demonstrated a favorable safety profile with ARIA-E observed in less than 5% of participants.

The company's Elecsys pTau181 plasma test showed potential in accurately ruling out amyloid pathology in a study of 604 participants. This minimally invasive blood test is expected to be available in Europe by late 2025. Additionally, Phase III trials for trontinemab will commence later this year.

In Parkinson's research, the Phase IIb PADOVA study of prasinezumab, while missing its primary endpoint, showed possible benefits in early-stage Parkinson's disease, particularly in levodopa-treated patients.

Roche (RHHBY) announced that its Phase III MUSETTE trial, testing a higher dose of OCREVUS® (ocrelizumab) against the current 600 mg dose in relapsing multiple sclerosis (RMS), did not meet its primary endpoint of showing additional benefit in slowing disability progression over 120 weeks of treatment.

The study revealed that the current 600 mg dose demonstrated optimal efficacy, with disability progression rates remaining low and consistent with previous pivotal studies. Notably, OCREVUS showed the lowest annualized relapse rate ever observed in a Phase III RMS study, with relapses occurring approximately once every 16 years.

OCREVUS maintains its position as the most prescribed disease-modifying therapy in the United States, with over 400,000 patients treated globally. Roche is expanding treatment accessibility through a new subcutaneous formulation and is developing a high-concentration formulation for convenient on-body device delivery.

Genentech announced that its Phase III MUSETTE trial, testing a higher dose of Ocrevus (ocrelizumab) against the standard 600 mg dose in relapsing multiple sclerosis (RMS), did not meet its primary endpoint of showing additional benefit in slowing disability progression.

The study revealed that disability progression rates remained low and consistent with previous pivotal studies. The standard 600 mg dose demonstrated strong efficacy with the lowest annualized relapse rate (ARR) observed in any Phase III RMS study, with relapses occurring approximately once every 16 years.

Ocrevus, the first B-cell therapy approved for RMS and PPMS, has become the most prescribed disease-modifying therapy in the United States, treating over 400,000 patients globally. The company is developing new delivery methods, including Ocrevus Zunovo™ and a high-concentration formulation for on-body device delivery.

Quest Diagnostics (NYSE: DGX) has launched a new FDA-cleared HPV self-collection solution for cervical cancer screening. The service allows patients to collect their own specimens in healthcare settings and will be available at Quest's 2,000 patient service centers starting next month.

The solution utilizes Roche's FDA-cleared HPV self-collection technology, approved for use with their cobas® HPV test in May 2024. This initiative follows Quest's successful launch of self-collection services for STIs in October 2024.

The self-collection option comes at no extra charge and aims to address the declining screening rates, with 4.4 million fewer American women receiving screenings in 2021 compared to 2019. The service is not FDA approved for at-home collection and is not intended to replace regular pelvic examinations.

Roche (SIX: RO, ROG; OTCQX: RHHBY) held its Annual General Meeting where shareholders approved all Board of Directors' proposals with 77.03% of total shares represented. Dr Severin Schwan was re-elected as Chairman with 97.93% approval.

Key highlights include:

• Approval of the 38th consecutive dividend increase to CHF 9.70 per share
• Confirmation of 2024 Annual Financial Statements, Consolidated Financial Statements, Remuneration Report, and Sustainability Report
• Re-election of all Board members for one-year terms
• Appointment of KPMG AG as statutory auditors for 2025

Shareholders also approved the Corporate Executive Committee's total bonuses for 2024 (95.00% approval) and maximum future remuneration for both Board of Directors (95.15%) and Corporate Executive Committee (95.22%) until the 2026 Annual General Meeting.

Roche (RHHBY) presented new data at the MDA conference (March 16-19, 2025) showcasing advancements in its neuromuscular portfolio. The company shared significant findings from two key treatments:

Evrysdi for SMA: Five-year SUNFISH study data demonstrated sustained stabilization of motor function improvements in Types 2 or 3 spinal muscular atrophy patients. The study, involving 231 participants aged 2-25 years, showed over 99% treatment adherence and maintained independence in daily activities. Untreated patients typically experienced significant decline over the same period.

Elevidys for Duchenne: Two-year EMBARK trial data and a pooled analysis showed statistically significant and clinically meaningful improvements in motor function. MRI assessments at weeks 52 and 104 indicated stabilization or slowing of disease progression compared to placebo. The treatment demonstrated positive outcomes in patients aged 4-8 years, with no new safety signals observed.

Roche (RHHBY) has entered into an exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialize petrelintide, a long-acting amylin analog for treating obesity. The partnership includes developing petrelintide as both a standalone therapy and in combination with Roche's incretin asset CT-388.

Under the agreement terms, Zealand Pharma will receive $1.65 billion in upfront payments, including $1.4 billion at closing and $250 million over two years. Additional potential payments include $1.2 billion in development milestones and $2.4 billion in sales-based milestones, totaling up to $5.3 billion.

The companies will share profits and losses 50/50 in the US and Europe, with Roche gaining exclusive commercialization rights in other markets. Zealand will receive tiered double-digit royalties up to high teens percentage on net sales in rest of world markets. The transaction is expected to close in Q2 2025, subject to regulatory approvals.