Shares of Reata Pharmaceuticals Inc. soared 175% to hit a one-year high in early trading on Wednesday, after the U.S. Food and Drug Administration (FDA) approved its rare disease drug and ended years of uncertainty over its future.
Tag Archive for: Biogen
Biogen Inc. (BIIB.O) Chief Executive Officer Christopher Viehbacher said on Wednesday he is banking on high-profile launches of Alzheimer’s disease treatment Leqembi and depression drug zuranolone, as well as deals, to help the company return to revenue growth.
Dealing with the seismic effects of the COVID-19 pandemic, the biopharma industry continues to break new ground during a transformative era of product innovation.
Biogen’s $1.5 billion bet is in the home stretch. On Monday, the Cambridge biotech, along with partner Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.
The application to the EMA was based on results from a late-stage study that showed the drug slowed down the rate of cognitive decline in patients with early Alzheimer’s by 27%, compared with a placebo.
The FDA’s Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis’s ALS candidate tofersen on March 22nd.
The past year has seen incremental victories in the neurodegenerative disease space with the approval of Amylyx’s Relyvrio, in ALS and Biogen and Eisai’s Leqembi (lecanemab) in Alzheimer’s disease. Despite these regulatory milestones, there are still hurdles to overcome, with delivery across the blood-brain barrier topping the list.
The company’s application is based on results from a late-stage study in which the drug was shown to reduce the rate of cognitive decline in patients with early Alzheimer’s by 27%, compared with a placebo.
The $26,500-per-year price tag for Eisai Co. Ltd. and Biogen Inc.’s newly approved Alzheimer’s disease drug is slightly above expectations, but should not dent demand for the promising therapy, Wall Street analysts said.
The U.S. Food and Drug Administration approved Eisai Co Ltd’s and Biogen Inc’s Alzheimer’s drug lecanemab for patients in the earliest stages of the mind-wasting disease, the agency said on Friday.
