Roche Hldg Stock Price, News & Analysis

Genentech and Roche (OTCQX: RHHBY) presented significant advancements in Alzheimer's disease research at AAIC 2025. The Phase Ib/IIa Brainshuttle™ AD study of trontinemab showed 91% of participants becoming amyloid PET negative, with ARIA-E remaining below 5%. The company announced plans for Phase III TRONTIER 1 and 2 trials in early symptomatic Alzheimer's disease, starting in 2025.

Additionally, Roche revealed plans for a new Phase III trial investigating trontinemab in preclinical Alzheimer's disease. The company's Elecsys® pTau217 blood test demonstrated comparable results to PET scans for amyloid pathology detection, potentially transforming Alzheimer's diagnosis with a simple blood draw versus traditional methods.

Roche (OTCQX:RHHBY) announced that the European Medicines Agency's CHMP has issued a negative opinion on the conditional marketing authorization for Elevidys™ (delandistrogene moxeparvovec) in the EU. The therapy was intended for ambulatory individuals aged 3-7 years with Duchenne muscular dystrophy (DMD).

Despite the Phase III EMBARK study showing sustained disease stabilization and clinically meaningful improvements across secondary endpoints, the primary endpoint was not met after one year. The therapy has treated over 900 individuals with DMD, including 760 ambulatory patients, in clinical and real-world settings. Roche plans to continue dialogue with EMA to explore potential paths forward.

Roche Diagnostics (OTCQX: RHHBY) will showcase its diagnostic innovations at the 2025 ADLM Scientific Meeting and Clinical Lab Expo in Chicago from July 28-31. The company will highlight its comprehensive diagnostic solutions including the cobas® portfolio, featuring integrated platforms for clinical chemistry and molecular diagnostics.

Key presentations include workshops on cardiovascular risk assessment focusing on Lipoprotein(a) testing and cervical cancer screening innovations. Notable product showcases include the future cobas® Mass Spec solution, cobas® pure integrated solutions, and advanced molecular diagnostic systems like the cobas® liat and eplex systems.

The company emphasizes its commitment to AI-powered digital transformation, laboratory efficiency, and expanding healthcare partnerships through its navify® digital solutions platform.

Roche (OTCQX:RHHBY) reported strong H1 2025 results with 7% Group sales growth (CER) to CHF 30.9 billion. The Pharmaceuticals Division led growth with a 10% increase to CHF 24.0 billion, driven by key medicines including Phesgo, Xolair, Hemlibra, Vabysmo, and Ocrevus. The Diagnostics Division remained stable despite China pricing reforms.

Core operating profit rose 11% to CHF 12.0 billion, with core EPS up 12% and IFRS net income increasing 23%. Notable regulatory achievements included US approval for Susvimo, EU approvals for Itovebi and Evrysdi, and advancement of key molecules into phase III trials. The company confirmed its 2025 outlook, expecting mid-single-digit sales growth and high-single-digit core EPS growth.

Roche (OTCQX: RHHBY) has achieved a significant milestone with CE Mark approval for its Elecsys pTau181 blood test, designed to rule out Alzheimer's disease. This minimally invasive test, developed in collaboration with Eli Lilly, measures phosphorylated Tau protein levels to indicate amyloid pathology.

The test demonstrated impressive clinical results with a 93.8% negative predictive value and 83.6% sensitivity in a comprehensive study of 787 patients across the US, Europe, and Australia. This breakthrough could significantly reduce the need for more invasive and expensive diagnostic procedures like PET scans and CSF assessments for patients with negative results.

Additionally, Roche is developing the Elecsys pTau217 blood test, showing promising results in detecting amyloid pathology with enhanced sample stability at various temperatures.

Roche (OTCQX:RHHBY) has received European Commission approval for Itovebi™ (inavolisib), in combination with palbociclib and fulvestrant, for treating PIK3CA-mutated, ER-positive, HER2-negative advanced breast cancer. The approval follows significant results from the phase III INAVO120 trial.

The Itovebi-based regimen demonstrated a 57% reduction in disease progression risk, extending progression-free survival to 15.0 months versus 7.3 months for the control group. Final analysis showed a 33% reduction in death risk and delayed chemotherapy necessity by approximately two years. The treatment targets PIK3CA mutations, present in up to 40% of ER-positive breast cancers.

Roche (OTCQX: RHHBY) announced plans to modernize its capital structure by proposing to exchange non-voting equity securities (Genussscheine) for participation certificates (Partizipationsscheine) with a nominal value of CHF 0.001 each. The proposal will be presented at the Annual General Meeting on March 10, 2026.

The company will also reduce the nominal value of bearer shares from CHF 1.00 to CHF 0.001, resulting in a cash repayment of CHF 0.999 per share (total CHF 106.58 million). The new participation certificates will maintain economic equivalence to Genussscheine, including dividend rights and liquidation proceeds. Additionally, Roche will discontinue printed dividend vouchers and transition to intermediated securities.

Genentech (OTCQX: RHHBY) has reported mixed results from two clinical trials evaluating astegolimab for Chronic Obstructive Pulmonary Disease (COPD). The Phase IIb ALIENTO study (n=1,301) met its primary endpoint, showing a 15.4% reduction in annualized exacerbation rate (AER) at 52 weeks. However, the Phase III ARNASA study (n=1,375) missed its primary endpoint, achieving only a numerical 14.5% reduction in AER.

Both trials tested astegolimab against placebo in moderate to very severe COPD patients, including both current and former smokers. The safety profile remained consistent with previous data, with no new safety signals identified. The company plans to discuss these results with regulatory authorities to determine next steps.

Roche (OTCQX:RHHBY) has announced mixed results from two clinical trials evaluating astegolimab for chronic obstructive pulmonary disease (COPD). The pivotal phase IIb ALIENTO study (n=1,301) met its primary endpoint, showing a 15.4% reduction in annualized exacerbation rate (AER) at 52 weeks. However, the phase III ARNASA study (n=1,375) missed its primary endpoint, showing only a numerical 14.5% reduction in AER.

Both trials tested astegolimab against placebo on top of standard care in moderate to very severe COPD patients, including both current and former smokers. While the safety profile remained consistent with previous data, the total number of exacerbations was lower than anticipated in both trials. Roche plans to discuss these results with regulatory authorities to determine next steps.