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Zacks News
Top Research Reports for UnitedHealth Group, Coca-Cola & Roche Holding
by Sheraz Mian
Today's Research Daily features new research reports on 16 major stocks, including UnitedHealth Group Incorporated (UNH), The Coca-Cola Company (KO) and Roche Holding AG (RHHBY).
Prothena (PRTA) Stock Gains 88.5% in 6 Months: What Lies Ahead?
by Zacks Equity Research
Prothena (PRTA) surges 88% in the last six months as investors are optimistic on its promising Alzheimer???s Disease pipeline.
Roche (RHHBY) Gets EU Approval for Xofluza in New Patient Base
by Zacks Equity Research
The European Commission approves Roche's (RHHBY) Xofluza for treating uncomplicated influenza and post-exposure prophylaxis of influenza in children aged one year and above.
Halozyme (HALO) Down 9.2% on Weak 2023 Financial Guidance
by Zacks Equity Research
Though Halozyme (HALO) expects a year-over-year increase in revenues and earnings for 2023, the company's guidance fell short of Wall Street expectations.
Biogen's (BIIB) Partner Eisai Files MAA for Lecanemab in Europe
by Zacks Equity Research
Biogen's (BIIB) partner Eisai files a marketing authorization application to the European Medicines Agency for lecanemab for treating early Alzheimer's disease in Europe.
Regeneron (REGN) Down on Ophthalmology Drug Eylea Sales Update
by Zacks Equity Research
Regeneron's (REGN) lead drug Eylea's sales decline in the fourth quarter due to a short-term shift to off-label use of Avastin.
Biogen (BIIB), Eisai's Lecanemab Gets FDA Nod for Alzheimer's
by Zacks Equity Research
FDA approves Biogen (BIIB) and Eisai's lecanemab on an accelerated basis. Eisai filed a supplemental biologics license application (sBLA) to the FDA to get a traditional approval for Leqembi.
Roche's (RHHBY) Cancer Drug Glofitamab Gets FDA Priority Review
by Zacks Equity Research
The FDA accepts and grants priority review to Roche's (RHHBY) biologics license application for glofitamab to treat relapsed or refractory large B-cell lymphoma. The decision is due on Jul 1, 2023.
Biogen (BIIB) Inks Licensing Deal for Implantable Medical Device
by Zacks Equity Research
Biogen (BIIB) signs a license and collaboration agreement with Alcyone Therapeutics to develop the latter's ThecaFlex DRx system to get access to neurological antisense oligonucleotide therapies.
DocuSign and Ford Motor have been highlighted as Zacks Bull and Bear of the Day
by Zacks Equity Research
DocuSign and Ford Motor have been highlighted as Zacks Bull and Bear of the Day.
Pfizer's (PFE) Hemophilia B Gene Therapy Meets Study Goal
by Zacks Equity Research
Data from a late-stage study shows that treatment with Pfizer's (PFE) hemophilia B gene therapy resulted in a 71% reduction in annualized bleed rate (ABR) compared to standard-of-care treatment.
Pharma Stock Roundup: FDA Gives Nod to RHHBY's Lunsumio, Accepts PFE Vaccine BLA
by Kinjel Shah
FDA approves Roche's (RHHBY) Lunsumio for follicular lymphoma and accepts Pfizer's (PFE) BLA for the pentavalent meningococcal vaccine candidate.
Roche's (RHHBY) Lunsumio Gets FDA Nod for Follicular Lymphoma
by Zacks Equity Research
Following the FDA's approval, Roche (RHHBY) Lunsumio is the first CD20xCD3 T-cell engaging bispecific antibody approved to treat follicular lymphoma.
Roche (RHHBY) Actemra Gets FDA Nod for Adults With COVID-19
by Zacks Equity Research
Roche (RHHBY) obtains FDA approval for Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adult patients. The drug was earlier granted an EUA.
Roche's (RHHBY) Hemophilia A Drug Gets Positive CHMP Opinion
by Zacks Equity Research
Roche (RHHBY) receives a positive CHMP recommendation for label expansion of the hemophilia A drug Hemlibra in the European Union (EU).
The Zacks Analyst Blog Highlights Chevron, Roche Holding, General Electric, Centene and Carrier Global
by Zacks Equity Research
Chevron, Roche Holding, General Electric, Centene and Carrier Global are included in this Analyst Blog.
Top Analyst Reports for Chevron, Roche & General Electric
by Sheraz Mian
Today's Research Daily features new research reports on 16 major stocks, including Chevron Corporation (CVX), Roche Holding AG (RHHBY) and General Electric Company (GE).
Regeneron (REGN) Presents Positive Data on MM and FL Drugs
by Zacks Equity Research
Regeneron (REGN) releases positive initial data on two candidates - linvoseltamab and odronextamab at ASH.
Exelixis (EXEL) Reports Data from CONTACT-01, QUARTZ-101 Study
by Zacks Equity Research
Exelixis (EXEL) announces that the phase III study, CONTACT-01, did not meet its primary endpoint. It also releases initial data from the QUARTZ-101 study.
Anavex's (AVXL) Lead Alzheimer's Drug Meets Study Goal
by Zacks Equity Research
Top-line data from a phase IIb/III study shows that Anave's (AVXL) lead drug exhibited statistical and clinical improvement in cognition and function in patients with early Alzheimer's disease.
Oncolytics (ONCY) Up on Lead Drug Securing 2nd FDA Fast Track Tag
by Zacks Equity Research
Oncolytics Biotech (ONCY) receives a fast-track designation from the FDA for pelareorep combined with Roche's Tecentriq in advanced/metastatic pancreatic cancer indication.
Lilly's (LLY) Donanemab Betters Biogen's Alzheimer's Drug
by Zacks Equity Research
Data from a phase III early symptomatic Alzheimer's disease study shows that Eli Lilly's (LLY) donanemab leads to a significant reduction of amyloid buildup in the brain and P-tau in the blood after six months.
Biogen's (BIIB) Lecanemab Shows Benefit but With Side Effects
by Zacks Equity Research
Detailed data from Biogen (BIIB) and Eisai's Clarity AD shows that treatment with lecanemab in the early stages of Alzheimer's disease reduces the rate of cognitive decline but is associated with adverse events like brain hemorrhage.
Biogen (BIIB) Down on Report of Death in Alzheimer's Study
by Zacks Equity Research
Investor confidence in Biogen (BIIB) is rattled following reports of a study participant's death who was administered its Alzheimer's disease (AD) antibody in clinical studies.
Sarepta's (SRPT) DMD Gene Therapy BLA Gets FDA Priority Review
by Zacks Equity Research
The FDA accepts Sarepta's (SRPT) regulatory filing seeking accelerated approval for SRP-9001, a gene therapy for DMD indication. A final decision is expected by May 2023.