Roche Hldg Stock Price, News & Analysis

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.

Genentech (OTCQX: RHHBY) received a Complete Response Letter (CRL) from the FDA regarding its supplemental Biologics License Application (sBLA) for Columvi in combination with GemOx for second-line DLBCL treatment. The FDA determined that the STARGLO study data was insufficient to support the proposed indication in U.S. patients.

Despite this setback, Columvi maintains its accelerated approval for third-line DLBCL treatment. The company is in discussions with the FDA about using the Phase III SKYGLO study as a new postmarketing requirement. The STARGLO study demonstrated a 41% reduction in death risk, and the combination is already approved in over 35 countries.

Roche (OTCQX: RHHBY) announced key leadership changes in its enlarged Corporate Executive Committee. Dr. Hans Clevers, Head of Roche Pharma Research and Early Development (pRED), will retire at the end of August 2025. Dr. Clevers, who joined the Board in 2019 and became pRED Head in March 2022, will continue leading the Institute of Human Biology until a successor is named.

Additionally, Barbara Schädler, Head of Group Communications, will retire from the company at the end of 2025. Schädler, who joined Roche in 2019, was credited with modernizing the company's communication function and leading the internal COVID-19 taskforce. The company will announce successors for both positions in due course.

Roche announced promising phase I/II data for NXT007, a next-generation bispecific antibody for hemophilia A treatment. The NXTAGE study showed NXT007 achieved zero treated bleeds in highest dose groups and demonstrated a tolerable safety profile with no thromboembolic events. The study included 30 participants aged 12-65 across four cohorts receiving subcutaneous NXT007 every 2-4 weeks. Three phase III studies are planned for 2026, including a head-to-head comparison with Roche's Hemlibra. NXT007 aims to provide haemostatic normalization and reduced treatment burden for patients. The drug leverages Roche's expertise in hemophilia A and bispecific antibody development, with additional phase II data expected later this year.

Roche announced significant results from the phase III SUNMO study for its Lunsumio and Polivy combination therapy in treating relapsed/refractory large B-cell lymphoma. The combination showed remarkable efficacy with 11.5 months median progression-free survival, three times longer than the comparison treatment R-GemOx. The therapy demonstrated a 59% reduction in disease progression risk and doubled the complete response rate at 51.4% versus 24.3% for R-GemOx. The treatment showed a favorable safety profile suitable for outpatient use, with low incidence of cytokine release syndrome. This novel combination of a bispecific antibody and antibody-drug conjugate avoids traditional chemotherapy and has been added to NCCN Guidelines as a category 2A recommendation for second-line DLBCL treatment in non-transplant patients.