Roche Hldg (RHHBY) Stock News

Roche (RHHBY) has received European Commission approval for a new tablet formulation of Evrysdi (risdiplam), marking a significant advancement in Spinal Muscular Atrophy (SMA) treatment. The 5mg tablet, which can be swallowed whole or dispersed in water, offers room-temperature stability and doesn't require refrigeration. This new formulation maintains the same efficacy and safety as the original oral solution, as demonstrated in bioequivalence studies. Evrysdi, the only non-invasive disease-modifying SMA treatment, has treated over 18,000 patients globally. The tablet is approved for patients aged two years or older, weighing 20kg or more, who can swallow without a feeding tube. The original oral solution will remain available for patients requiring different doses or preferring that format.

Roche announced positive Phase III IMforte study results for Tecentriq combined with lurbinectedin as first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC). The combination showed remarkable efficacy, reducing disease progression/death risk by 46% and death risk by 27% compared to Tecentriq alone. The median overall survival improved to 13.2 months versus 10.6 months with Tecentriq monotherapy, while progression-free survival increased to 5.4 months versus 2.1 months. The study marks the first Phase III trial in ES-SCLC first-line maintenance demonstrating significant improvements in both progression-free and overall survival. The treatment showed consistent safety profiles with no new safety signals, offering hope for ES-SCLC patients, where only 20% survive beyond two years.

Genentech (RHHBY) announced positive Phase III IMforte study results for Tecentriq combined with lurbinectedin as first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC). The combination therapy demonstrated a 46% reduction in disease progression/death risk and 27% reduction in death risk compared to Tecentriq alone. The study showed median overall survival of 13.2 months for the combination versus 10.6 months for Tecentriq alone, and progression-free survival of 5.4 months versus 2.1 months respectively. This marks the first Phase III study in ES-SCLC first-line maintenance to show significant improvements in both progression-free and overall survival. The results, presented at the 2025 ASCO Annual Meeting and published in The Lancet, could represent a practice-changing treatment option for this aggressive cancer type, where only 20% of patients survive beyond two years.

Roche announced positive final results from the phase III INAVO120 study for Itovebi (inavolisib). The drug, combined with palbociclib and fulvestrant, demonstrated a 30% reduction in death risk for patients with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer. The median overall survival improved to 34.0 months with Itovebi versus 27.0 months in the control group. The treatment doubled progression-free survival to 17.2 months compared to 7.3 months and delayed chemotherapy by approximately two years. The PIK3CA mutation affects about 40% of HR-positive advanced breast cancers and typically indicates poor prognosis. Itovebi is already approved in several countries including the US, Switzerland, and China, with pending European approval. The drug showed good tolerability with no new safety concerns.

Genentech (RHHBY) announced positive final results from the Phase III INAVO120 study of Itovebi (inavolisib) for PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer. The Itovebi-based regimen, combined with palbociclib and fulvestrant, significantly reduced death risk by over 30% compared to palbociclib and fulvestrant alone. The median overall survival improved to 34.0 months versus 27.0 months in the control arm. The treatment doubled progression-free survival to 17.2 months from 7.3 months and delayed chemotherapy by approximately two years. The PIK3CA mutation affects about 40% of HR-positive advanced breast cancers and typically indicates poor prognosis. The study results are being presented at the 2025 ASCO Annual Meeting and published in the New England Journal of Medicine.

Roche announced promising 96-week data for fenebrutinib in treating relapsing multiple sclerosis (RMS). The Phase II FENopta open-label extension study showed patients maintained no disability progression and low disease activity for up to two years. Key findings include an annualized relapse rate of 0.06 (equivalent to one relapse every 17 years), zero new T1 gadolinium-enhancing lesions at 96 weeks, and a reduction in T2 lesions from 6.72 to 0.34 in the placebo-to-treatment group. Of 99 patients who entered the study, 93 remained after 96 weeks. The safety profile remained consistent with previous data, with common adverse events including COVID-19 (10%) and urinary tract infection (10%). Three Phase III trials are ongoing, with initial results expected by end of 2025.

Roche (RHHBY) received a positive CHMP recommendation for Itovebi (inavolisib) in combination with palbociclib and fulvestrant for treating PIK3CA-mutated, ER-positive, HER2-negative advanced breast cancer. The recommendation is based on Phase III INAVO120 trial results showing the Itovebi regimen reduced disease progression risk by 57% compared to standard treatment (15.0 vs 7.3 months PFS). The treatment demonstrated significant overall survival benefits in final analysis. PIK3CA mutations occur in ~40% of hormone receptor-positive breast cancers, making the disease more aggressive. The Itovebi combination is already approved in several countries including the US, Switzerland, and China. Roche is conducting three additional Phase III studies exploring Itovebi in various breast cancer combinations.

Roche (RHHBY) has announced a strategic collaboration with Broad Clinical Labs to develop and implement applications using Roche's next-generation Sequencing By Expansion (SBX) technology. The initial focus will be on trio-based whole genome sequencing for critically ill newborns and their biological parents in neonatal intensive care units (NICUs), aiming to enable faster diagnosis of genetic disorders.

The collaboration will explore integrating SBX technology into routine clinical practice and research applications. The technology offers ultra-fast turnaround times, exceptional scalability, and cost efficiency. Additionally, the partnership will investigate SBX capabilities for RNA sequencing, including bulk and single-cell approaches, to gain novel molecular insights for disease understanding and therapeutic target identification.

Roche (RHHBY) announced promising two-year follow-up data from the phase III STARGLO study for Columvi® in combination with chemotherapy for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The data showed a 40% improvement in overall survival compared to standard treatment. Key findings include:

- 89% of complete responders were alive one year post-treatment - 82% maintained remission after one year - 58.5% complete remission rate (vs 25.3% in control group) - 59% reduction in disease progression/death risk

The Columvi combination is now approved in over 30 countries for R/R DLBCL patients who aren't candidates for autologous stem cell transplant. The treatment's safety profile remained consistent with previous analyses, with cytokine release syndrome being a common but generally low-grade adverse event.