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Zacks News
BioMarin (BMRN) Reveals 1-Year Data on Hemophilia Gene Therapy
by Zacks Equity Research
BioMarin (BMRN) announces one-year update from GENEr8-1 phase III study, which shows that valoctocogene roxaparvovec significantly reduces annualized bleeding rate (ABR) by 84% in patients with hemophilia A.
Sarepta (SRPT) Down on Unsatisfactory Data for DMD Candidate
by Zacks Equity Research
Sarepta (SRPT) posts top-line results from part 1 of Study 102, evaluating a single dose of its gene therapy candidate SRP-9001 for treating DMD. Shares fall.
Pharma Stock Roundup: ABBV's Positive Skyrizi Data, AZN, PFE, RHHBY's FDA Updates
by Kinjel Shah
AbbVie's (ABBV) Skyrizi succeeds in psoriatic arthritis and Crohn's disease studies. AstraZeneca (AZN), Pfizer (PFE) and Roche (RHHBY) give FDA updates.
Infinity (INFI) Provides Data on Eganelisib in Urothelial Cancer
by Zacks Equity Research
Infinity (INFI) provides an update on Eganelisib in patients with metastatic urothelial cancer.
3 Biotech Technological Developments to Watch Out For in 2021
by Kinjel Shah
Here we discuss three booming technological developments in the biotech sector, which can capture investor attention in 2021
Roche's (RHHBY) Immunotherapy Gets Breakthrough Therapy Status
by Zacks Equity Research
Roche's (RHHBY) tiragolumab in combination with Tecentriq wins Breakthrough Therapy designation for the first-line treatment of patients with metastatic non-small cell lung cancer.
Pfizer's (PFE) BLA for Somatrogon Gets FDA's Acceptance
by Zacks Equity Research
Pfizer's (PFE) BLA for growth hormone deficiency (GHD) gets accepted by the FDA for standard review. FDA's decision expected in October 2021.
Aprea (APRE) Plunges as Late-Stage MDS Study Fails to Meet Goal
by Zacks Equity Research
Aprea (APRE) down as late-stage study on lead candidate, eprenetapopt, combined with azacitidine (AZA) versus AZA alone in TP53 mutant myelodysplastic syndromes (MDS) fails.
AstraZeneca's (AZN) Lynparza Approved in Japan for 3 Cancers
by Zacks Equity Research
AstraZeneca (AZN) and partner Merck's Lynparza is approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers.
Pfizer (PFE) Lorbrena First-Line sNDA Gets FDA Priority Review
by Zacks Equity Research
Pfizer's (PFE) label expansion application for Lorbrena as first-line treatment for metastatic lung cancer gets priority review from the FDA.
AbbVie (ABBV) Outperforms Industry Year to Date: Here's Why
by Zacks Equity Research
AbbVie's (ABBV) key drug, Humira is seeing strong demand in the United States while generics are eroding ex-U.S. sales. New drugs, Skyrizi and Rinvoq are seeing strong sales uptake.
Roche's (RHHBY) Phesgo Gets EU Nod to Treat Breast Cancer
by Zacks Equity Research
Roche's (RHHBY) fixed-dose combination of Perjeta and Herceptin administered subcutaneously gets approved by the EC for the treatment of early and metastatic HER2-positive breast cancer.
Exelixis (EXEL) Posts Positive Data From Thyroid Cancer Study
by Zacks Equity Research
Exelixis' (EXEL) cabozantinib meets the co-primary endpoint in the late-stage study for the treatment of differentiated thyroid cancer following anti-VEGFR therapy.
Roche's (RHHBY) DME Drug Meets Primary Endpoint in Studies
by Zacks Equity Research
Roche's (RHHBY) investigational bispecific antibody, faricimab, meets the primary endpoints in two late-stage studies for diabetic acular edema.
Blueprint Medicines (BPMC) Rises 40% in Past 3 Months: Here's Why
by Zacks Equity Research
Blueprint Medicines' (BPMC) lead drug, Ayvakit, approved for PDGFRA Exon 18 mutant GIST is off to a solid start. The company's second drug, Gavreto, gets approved for two types of cancer indications.
Roche (RHHBY) Gets FDA Nod for Shorter Infusion Time of Ocrevus
by Zacks Equity Research
The FDA approves Roche's (RHHBY) Ocrevus for two-hour infusion time, dosed twice-yearly to patients with relapsing or primary progressive MS.
Seagen (SGEN) Gets Positive CHMP Opinion for Breast Cancer Drug
by Zacks Equity Research
Seagen (SGEN) gets a positive opinion from the CHMP, recommending the approval of Tukysa for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer.
The Zacks Analyst Blog Highlights: Roche, Wells Fargo, General Electric, Microsoft and Intuit
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Roche, Wells Fargo, General Electric, Microsoft and Intuit
Pharma Stock Roundup: FDA Panel's Nod to PFE/BNTX Coronavirus Vaccine, Other Updates
by Kinjel Shah
An FDA panel recommends granting approval for emergency use of Pfizer's (PFE) COVID-19 vaccine. Glaxo (GSK)/Sanofi (SNY) COVID-19 vaccine plan delays.
Top Stock Reports for Roche, Wells Fargo & General Electric
by Sheraz Mian
Today's Research Daily features new research reports on 16 major stocks, including Roche Holding AG (RHHBY), Wells Fargo & Company (WFC) and General Electric Company (GE).
Rocket Pharmaceuticals (RCKT) Surges on Encouraging Study Data
by Zacks Equity Research
Rocket Pharmaceuticals' (RCKT) AAV-based gene therapy candidate demonstrates early evidence of clinical benefit and tolerability in patients with Danon disease, which affects the cardiac muscle.
Roche (RHHBY), Moderna Ink Deal for Coronavirus Antibody Test
by Zacks Equity Research
Roche (RHHBY) partners with Moderna to allow the latter utilize its Elecsys Anti-SARS-CoV-2 S antibody test in the mRNA-1273 vaccine research studies.
Curis (CRIS) Skyrockets on Promising Phase I Pipeline Updates
by Zacks Equity Research
Curis' (CRIS) hematologic malignancy candidate, CA-4948, shows promising activity in early-stage studies evaluating it in patients with either acute myeloid leukemia or non-Hodgkin's lymphoma. Stock up 350%.
Sarepta (SRPT) DMD Study Shows Proof of Concept for SRP-5051
by Zacks Equity Research
Sarepta's (SRPT) ongoing phase II study data supports continued dose escalation of SRP-5051 and suggests improved efficacy on lower doses compared to Exondys 51.
Pharma Stock Roundup: Approval of PFE/BNTX Coronavirus Vaccine in UK, Other Updates
by Kinjel Shah
Pfizer (PFE) COVID-19 vaccine gets approval for emergency use in the United Kingdom while Roche's (RHHBY) Xolair gets FDA nod for new indication.