ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has received U.S. FDA Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. This four-in-one molecular test utilizes PCR technology for rapid and accurate detection of these viruses within 20 minutes. It requires a single nasal-swab sample, making it suitable for various healthcare settings such as emergency departments and urgent care facilities. The test aims to facilitate swift clinical decision-making, reduce unnecessary antibiotic use, and enhance patient outcomes. Future plans include seeking FDA 510(k) clearance and a CLIA waiver in the U.S., as well as commercial launches in other markets post CE-IVDR approval.

The European Commission has approved Roche’s Alecensa (alectinib) as the first targeted adjuvant treatment for ALK-positive early-stage lung cancer. This approval, backed by Phase III ALINA study data, showed a 76% reduction in the risk of disease recurrence or death compared to chemotherapy. Alecensa is now available for patients with resected stage IB to IIIA ALK-positive non-small cell lung cancer (NSCLC). The ALINA study also showed improved central nervous system disease-free survival. The safety profile of Alecensa remains consistent with prior studies. This approval follows the FDA's approval in April 2024, with global submissions ongoing.

Roche announced five-year data for Evrysdi (risdiplam) showing significant efficacy in treating children with Type 1 spinal muscular atrophy (SMA). The FIREFISH study revealed that 91% of children were alive, with 81% surviving without permanent ventilation. Motor skills improvements were noted, with 59% able to sit unaided for at least 30 seconds, and some able to stand or walk with or without support. The study also showed high rates of maintaining swallowing and feeding abilities. Evrysdi is now approved in over 100 countries, treating more than 15,000 patients globally. No treatment-related adverse events led to discontinuation, and adverse event rates decreased over the study period.

Roche announced that the FDA granted Priority Review to inavolisib, an investigational oral therapy, in combination with palbociclib and fulvestrant, for treating PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. The decision is based on positive Phase III INAVO120 results, which showed the inavolisib-based regimen more than doubled progression-free survival (15.0 months vs. 7.3 months) and reduced the risk of disease worsening or death by 57%. The FDA's target decision date is 27 November 2024. Further analyses will be presented at the 2024 ASCO Annual Meeting. Roche is also filing submissions with other global health authorities.

Genentech, part of Roche Group (OTCQX: RHHBY), announced that the FDA has accepted its New Drug Application and granted Priority Review to inavolisib, an investigational oral therapy. This therapy, combined with palbociclib and fulvestrant, targets advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. The Priority Review is based on Phase III INAVO120 trial results, which showed that the inavolisib-based regimen more than doubled progression-free survival (15.0 months vs. 7.3 months) compared to palbociclib and fulvestrant alone. The FDA's target action date is November 27, 2024. Genentech is also planning submissions to other global health authorities and will present additional analyses at the 2024 American Society of Clinical Oncology Annual Meeting.

Roche announced the retirement of James Sabry, Head of Roche Pharma Partnering, after 14 years with the company. Sabry, who joined Genentech in 2010 and became Head of Pharma Partnering in 2018, will be succeeded by Boris Zaïtra. Zaïtra, currently Head of Group Business Development, will assume the new role of Head of Corporate Business Development on 1 July 2024. This position merges Pharma Partnering and Group Business Development functions. CEO Thomas Schinecker praised Sabry's contributions to the company's R&D pipeline and expressed confidence in Zaïtra's expertise in M&A and leadership.

Roche and Hitachi High-Tech have extended their 46-year partnership for an additional 10 years, focusing on innovations in diagnostic testing. The collaboration, which has resulted in significant technological advancements, aims to enhance patient care and laboratory efficiency.

This renewed agreement will introduce new diagnostic units like cobas® c 703, cobas® ISE neo, and cobas® Mass Spec, emphasizing automation and accuracy. With over 84,000 diagnostic platforms installed globally and 21 billion tests conducted annually, the partnership aims to deliver new solutions quickly and efficiently to healthcare systems worldwide.

Roche announced that its Tina-quant® lipoprotein Lp(a) RxDx assay has received FDA Breakthrough Device Designation. This test measures lipoprotein (a) in the bloodstream, a critical marker for hereditary cardiovascular risk affecting approximately one in five people globally. Developed in collaboration with Amgen, the assay will be available on Roche’s 90,000 serum work area systems worldwide. The designation will help identify patients who might benefit from innovative Lp(a)-lowering therapies in development. The collaboration aims to improve cardiovascular disease management by providing more standardized and accurate Lp(a) testing.

Roche announced that the FDA granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib and fulvestrant, for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. This designation follows positive Phase III INAVO120 results showing the inavolisib-based regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; HR=0.43, 95% CI: 0.32-0.59, p<0.0001).

Approximately 40% of patients with HR-positive breast cancer have a PIK3CA mutation, often leading to poorer prognosis and resistance to endocrine treatment. Data from INAVO120 are being submitted to other health authorities. Inavolisib is under investigation in additional Phase III studies for advanced breast cancer.