Roche (RHHBY) announces that its mid to late-stage lung cancer study evaluating the tiragolumab combination therapy compared with Keytruda fails to meet primary endpoints.
Roche will end a lung cancer trial testing its new immunotherapy after the drug did not show a benefit over established treatment Keytruda by Merck & Co , casting further doubt on the drug candidate pioneered by the Swiss company.
Roche (RHHBY) gets CHMP recommendation for a label expansion of ophthalmology drug Vabysmo (faricimab) and PiaSky (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria.
Roche (RHHBY) obtains approval for the subcutaneous formulation of relapsing multiple sclerosis drug Ocrevus in Europe. In addition, a review of the company's MAA for gene therapy, Elevidys, is also underway.
The stock price of Roche (OTCMKTS: RHHBY) trades at $35 per share, about 33% below its peak level of over $53 seen in April 2022. In contrast, its peer Bristol Myers Squibb stock (NYSE: BMY) saw a 48% decline over this period.
The U.S. Food and Drug Administration on Thursday approved Roche's drug for a chronic blood disorder, the Swiss drugmaker said.
Roche (RHHBY) gets exclusive, target-specific rights to Ascidian's RNA exon editing technology for undisclosed neurological targets for an initial payment of $42 million.
Roche continues to face challenges tied to lackluster revenue and profit outlook, questionable pipeline, and an underperforming diagnostics business. Roche spends aggressively on its pipeline (R&D and M&A) and is more successful than peers in converting R&D to revenue by some metrics, but trailing growth rates are quite lackluster. If key pipeline candidates like tiragolumab, prasinezumab, and RG6631 come through, Roche could see revenue and earnings reacceleration.
Roche's (RHHBY) Columvi significantly extends survival in patients with relapsed or refractory diffuse large B-cell lymphoma in the phase III STARGLO study.
Roche's (RHHBY) Alecensa gets the European Commission's approval as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer.
The FDA grants priority review to Roche's (RHHBY) NDA for the inavolisib combination regimen for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.
Roche's (RHHBY) inavolisib gets Breakthrough Therapy Designation in the United States for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.