March 25 (Reuters) - Regeneron Pharmaceuticals said on Monday the U.S. Food and Drug Administration has declined to approve its blood cancer therapy for two most common subtypes of non-Hodgkin lymphoma due to an issue related to the enrollment status of the confirmatory trials. (Reporting by Sneha S K, Puyaan Singh and Sriparna Roy in Bengaluru; Editing by Shinjini Ganguli)
The risk at these companies is above average, and they're sure to remain volatile. This volatility, however, includes explosively bullish potential.
Eli Lilly, Novo Nordisk, Merck and AbbVie are part of the Zacks Industry Outlook article.
Gilead stock pared its gains Friday after beating first-quarter sales forecasts on the back of its Covid treatment, Veklury.
Gilead (GILD) reports narrower-than-expected loss in the first quarter. Its sales beat estimates on higher HIV, Oncology and Liver Disease sales.
Pfizer has received approval from the Food and Drug Administration for a rare genetic bleeding disorder treatment—the drug-maker’s first gene therapy to be approved in the U.S. The treatment, Beqvez, is for adults with moderate to severe hemophilia B—a disorder that prevents normal blood clotting—and will be available by prescription to eligible patients this quarter, according to the company. “Many people with hemophilia B struggle with the commitment and lifestyle disruption of regular FIX infusions, as well as spontaneous bleeding episodes, which can lead to painful joint damage and mobility issues,” said Adam Cuker, director of University of Pennsylvania’s Comprehensive Hemophilia and Thrombosis Program.
The IRA adds another hurdle to an already challenging research landscape, according to a study from the Pioneer Institute.
Friday, the FDA approved Pfizer Inc’s (NYSE:PFE) Beqvez (fidanacogene elaparvovec-dzkt) for moderate to severe hemophilia B in adult patients who currently use factor IX (FIX) prophylaxis therapy or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var capsid. Beqvez is a one-time treatment designed to enable hemophilia B patients to produce FIX themselves
Some companies, however, reported a market capitalisation decline, including Gilead Sciences and Roche.
The FDA approved Pfizer's hemophilia gene therapy on Friday. But Pfizer stock only inched ahead on the approval early Friday.
With the US obesity rate hovering at around 40%, tens of millions of Americans could take GLP-1 drugs over the next few years.