Roche Hldg Stock Price, News & Analysis

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.

Genentech, part of the Roche Group, reported positive Phase Ib results for its dual GLP-1/GIP receptor agonist, CT-388, in treating obesity.

Over 24 weeks, a weekly subcutaneous injection of CT-388 led to a significant placebo-adjusted weight loss of 18.8% (p < 0.001). Important results included 100% of treated participants achieving over 5% weight loss, 70% over 15%, and 45% over 20%. Additionally, pre-diabetic participants normalized their glycemia levels.

No new safety signals were detected. Adverse events were consistent with the incretin drug class. Further trials involving obese patients with type 2 diabetes are expected to report results in the second half of 2024.

Roche reports positive Phase I results for its dual GLP-1/GIP receptor agonist CT-388 in treating obesity and type 2 diabetes. Over 24 weeks, CT-388 achieved a significant placebo-adjusted weight loss of 18.8% (p < 0.001). At week 24, 100% of participants treated with CT-388 achieved >5% weight loss, 70% achieved >15%, and 45% achieved >20%. The treatment normalized glycemia in all pre-diabetic patients, showing strong glucose homeostasis impact. No new safety signals were detected, and the treatment was well-tolerated.

Looking forward, Roche plans to evaluate CT-388 in obese patients with type 2 diabetes over a 12-week treatment duration, with data expected in the second half of 2024.

Roche announced the FDA approval of its HPV self-collection solution, one of the first such options in the U.S. This tool improves access to HPV testing by allowing women to privately collect their own samples, which are then analyzed in a lab. The solution addresses a significant gap, as over half of U.S. cervical cancer patients are underscreened. Over 13,000 U.S. women are diagnosed with cervical cancer annually, and approximately 4,000 die from it. HPV self-collection could enable early detection and treatment, supporting the WHO's goal to eliminate cervical cancer by 2030. Roche collaborated with the National Cancer Institute for this initiative.