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Zacks News
Why Is Sarepta Therapeutics (SRPT) Down 4.4% Since Last Earnings Report?
by Zacks Equity Research
Sarepta Therapeutics (SRPT) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Novartis (NVS) Highlights Growth Profile at its R&D Day
by Zacks Equity Research
Novartis (NVS) throws light on its pipeline progress, key areas of focus and long-term targets at its R&D day. Here, we discuss key highlights from the same.
Glaxo (GSK), Vir COVID Drug Appears Effective Against Omicron
by Zacks Equity Research
Glaxo (GSK) and Vir Biotechnology announce promising pre-clinical data from the study of their antibody candidate, sotrovimab, against mutations found in the Omicron variant.
Ultragenyx (RARE) Begins Dosing in Phase I/II Study of UX053
by Zacks Equity Research
Ultragenyx (RARE) doses the first patient in a phase I/II study evaluating its investigational mRNA candidate, UX053, for treating glycogen storage disease type III.
Amgen (AMGN) Kyprolis Gets FDA Nod for Use With Darzalex Faspro
by Zacks Equity Research
Amgen (AMGN) gets FDA nod for the label expansion of Kyprolis in combination with Darzalex Faspro and dexamethasone for treating patients with multiple myeloma at first or subsequent relapse.
Vertex (VRTX) Up on Kidney Disease Drug's Success in Phase II
by Zacks Equity Research
Vertex's (VRTX) APOL1 inhibitor, VX-147, led to a significant reduction in protein in urine in a phase II study in APOL1-mediated FSGS, a severe kidney disorder.
Merck (MRK) Vaxneuvance sBLA for Pediatrics Gets Priority Review
by Zacks Equity Research
Merck (MRK) is seeking label expansion for Vaxneuvance for use in pediatric patients aged six weeks through 17 years for the prevention of invasive pneumococcal disease. A decision is expected by on Apr 1, 2022.
Deciphera (DCPH) to Prioritize Key Pipeline Drugs, Cut Jobs
by Zacks Equity Research
Deciphera (DCPH) announces a corporate restructuring plan to prioritize development of vimseltinib and DCC-3116, streamline commercial operations and reduce workforce by almost 35%. Shares rise.
Fennec (FENC) Gets CRL From FDA for Pedmark, Stock Down
by Zacks Equity Research
Fennec (FENC) suffers a setback again with a CRL for its new drug application (NDA) for Pedmark. Shares are down in pre-market trading.
Blueprint Medicines (BPMC) Set to Acquire Lengo Therapeutics
by Zacks Equity Research
Blueprint Medicines (BPMC) inks an agreement to acquire privately held Lengo Therapeutics. The company is looking to boost its lung cancer portfolio with this acquisition.
BioCryst (BCRX) Begins Enrollment in PNH Study on BCX9930
by Zacks Equity Research
BioCryst (BCRX) starts patient enrollment in the pivotal REDEEM-2 study evaluating BCX9930 for treating patients with paroxysmal nocturnal hemoglobinuria.
Merck's (MRK) Keytruda Gets Europe Nod for Two Carcinomas
by Zacks Equity Research
Merck's (MRK) Keytruda, in combination with Eisai's Lenvima, gets approval for treating first-line renal cell carcinoma and recurrent endometrial carcinoma in Europe.
Wall Street Analysts See a 60% Upside in Sarepta Therapeutics (SRPT): Can the Stock Really Move This High?
by Zacks Equity Research
The mean of analysts' price targets for Sarepta Therapeutics (SRPT) points to a 59.8% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
Bristol Myers (BMY) Top Drugs Maintain Momentum Amid Competition
by Zacks Equity Research
Bristol Myers' (BMY) performance has been good of late, driven by Revlimid, Eliquis, Opdivo and its new product portfolio amid stiff competition.
4 Reasons Why You Should Add Sarepta (SRPT) to Your Portfolio
by Zacks Equity Research
Sarepta's (SRPT) stock creates a significant opportunity for investors on the back of solid demand for its commercialized drugs and steady progress with its key pipeline candidates.
Gilead Sciences (GILD) Stock Gains 20% YTD: What Lies Ahead?
by Zacks Equity Research
Gilead's (GILD) performance in the year has been pretty good on contribution from Veklury. The company is now focusing on its oncology business as the virology business faces challenges.
Selecta (SELB) Down on FDA's Clinical Hold on Phase I/II Study
by Zacks Equity Research
The FDA issues a clinical hold on Selecta's (SELB) phase I/II study evaluating SEL-302 for the treatment of patients with methylmalonic acidemia. Shares down in after-hours trading.
Bristol Myers (BMY) Zeposia Gets EC Nod for Ulcerative Colitis
by Zacks Equity Research
Bristol Myers (BMY) wins EC approval for Zeposia for a second indication ??? ulcerative colitis.
REGENXBIO (RGNX) DMD Gene Therapy Gets Orphan Drug Status
by Zacks Equity Research
REGENXBIO (RGNX) is developing a gene therapy candidate, RGX-202, for treating DMD, which is currently in the pre-clinical stage. An IND application is expected by the end of 2021.
bluebird (BLUE) Filing for Thalassemia Therapy Gets Priority Review
by Zacks Equity Research
bluebird (BLUE) application seeking approval for beti-cel for thalassemia gets priority review in the United States.
BioMarin's (BMRN) Dwarfism Drug Gets FDA's Nod, Stock Up
by Zacks Equity Research
Biomarin Pharmaceuticals's (BMRN) Voxzogo is the first medicine in the United States to be approved to treat achondroplasia, the most common form of dwarfism.
Roche (RHHBY) Gets Approval for Gavreto for NSCLC in EU
by Zacks Equity Research
Roche (RHHBY) wins EC approval for Gavreto for the treatment of adults with RET fusion-positive advanced NSCLC.
Bristol Myers' (BMY) Cardiovascular Drug Review Extended by FDA
by Zacks Equity Research
Bristol Myers (BMY) announces extension of FDA review of its cardiovascular drug mavacamten. The new target action date is Apr 28, 2022.
Biogen's (BIIB) Aducanumab Gets CHMP's Negative Trend Vote
by Zacks Equity Research
Biogen's (BIIB) regulatory application seeking approval for its Alzheimer's drug, Aduhelm, in Europe hits setback as it receives negative trend vote from the CHMP.
Biogen's (BIIB) Oral MS Drug Vumerity Gets Approval in Europe
by Zacks Equity Research
Biogen's (BIIB) Vumerity gets marketing authorization in Europe for the treatment of adults with relapsing-remitting multiple sclerosis.