Streetbeat News

RHHBY

Roche Holding AG

CEO

Severin Schwan

Industry

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Open

35.88

Mkt cap

236B

Volume

211K

High

36.01

P/E Ratio

19.05

52-wk high

42.43

Low

35.76

Div yield

0.04

52-wk low

29.20

The U.S. FDA has approved Foundation Medicine's FoundationOne CDx as a companion diagnostic for AstraZeneca's Truqap in combination with Faslodex for treating HR-positive, HER2-negative advanced breast cancer with specific alterations. This approval follows the positive results from the CAPItello-291 trial, which showed significant improvement in progression-free survival. FoundationOne CDx is the first FDA-approved test for this subset of breast cancer patients and is part of Foundation Medicine's portfolio of FDA-approved comprehensive genomic profiling tests.

Portfolio Pulse from Benzinga Newsdesk

November 20, 2023 | 5:04 pm

The FDA has approved Bristol Myers Squibb's Augtyro for treating ROS1-positive non-small cell lung cancer. Acquired through a $4.1 billion deal with Turning Point Therapeutics, Augtyro demonstrated a 79% objective response rate in TKI-naïve patients. It enters a competitive market with existing treatments from Roche, Merck, and AstraZeneca. Augtyro will be available in the U.S. in mid-December 2023, and BMY shares closed at $51.57.

Portfolio Pulse from Vandana Singh

November 16, 2023 | 11:48 am

Synlogic, Inc. (NASDAQ:SYBX), a clinical-stage biotechnology company, has achieved its third pre-specified research milestone and earned a third milestone payment of $2.5 million from its collaboration with Roche for the research and pre-clinical development of a Synthetic Biotic for the treatment of inflammatory bowel disease (IBD).

Portfolio Pulse from Charles Gross

November 07, 2023 | 11:47 am

Sarepta Therapeutics Inc (NASDAQ:SRPT) released topline results from its Phase 3 study of Elevidys, a gene therapy for Duchenne muscular dystrophy. The results showed improvements in patients but did not reach statistical significance. The news led to a 43.8% drop in SRPT shares. Roche Holdings AG (OTC: RHHBY) is collaborating with Sarepta on this project.

Portfolio Pulse from Vandana Singh

October 31, 2023 | 12:13 pm

The FDA has issued a warning against the use of certain over-the-counter eye drop products due to potential risk of eye infections. The brands associated with this warning include CVS Health Corporation, Cardinal Health, Inc., Rite Aid Corp., and Target Corporation. The FDA has recommended that the manufacturer recall all batches of the affected products. Major retail chains have begun removing the implicated products from their shelves and online platforms.

Portfolio Pulse from Nabaparna Bhattacharya

October 28, 2023 | 4:49 pm

Roche's Genentech has received FDA approval for Vabysmo, a new treatment for Retinal Vein Occlusion (RVO). The efficacy and safety of Vabysmo have been established in global clinical trials and reinforced by real-world evidence.

Portfolio Pulse from Benzinga Newsdesk

October 27, 2023 | 6:31 am

Roche Holding AG has agreed to acquire Telavant Holdings, Inc. for $7.1 billion. Telavant, a joint venture between Roivant Sciences Ltd and Pfizer Inc, was formed to develop and commercialize RVT-3101, a new therapy for inflammatory bowel disease. Post-acquisition, Roche will have full rights to further develop and manufacture RVT-3101 and commercialize it in the U.S. and Japan. The deal is expected to close in Q4 2023 or Q1 2024.

Portfolio Pulse from Lekha Gupta

October 23, 2023 | 12:55 pm

Roche has agreed to acquire Telavant, including rights to the novel TL1A-Directed Antibody (RVT-3101), from Roivant for $7.1 billion. The deal gives Roche the rights to develop, manufacture, and commercialize RVT-3101 in the US and Japan for the treatment of inflammatory bowel disease and potentially other diseases. Roche will also have an option to collaborate globally with Pfizer on a next-generation p40/TL1A directed bispecific antibody, currently in Phase 1. Telavant was jointly formed by Roivant and Pfizer in 2022.

Portfolio Pulse from Benzinga Newsdesk

October 23, 2023 | 5:45 am

Roche Holdings AG reported a 1% increase in nine-month sales to CHF 44.1 billion, despite a significant drop in sales of COVID-19 products and biosimilar erosion. Excluding COVID-19 products, Group sales grew by 9%. The company expects a decrease in group sales and adjusted earnings per share in the low single-digit percentage range in 2023. Roche predicted a decline in sales of COVID-19 products of about CHF 4.5 billion. The Diagnostics Division achieved sales of CHF 10.4 billion, a decrease of 18% due to a drop in demand for COVID-19 tests.

Portfolio Pulse from Vandana Singh

October 19, 2023 | 12:46 pm

Roche's Genentech announced results from the primary analysis of the Phase III ALINA study. The data showed an improvement in disease-free survival in early-stage resected ALK-positive non-small cell lung cancer (NSCLC). This is significant as about half of people with early-stage NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy. The data will be presented during an ESMO 2023 Presidential Symposium.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 7:04 am

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