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Zacks News
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.
PhaseBio (PHAS) Dips on Mixed Data From Antiplatelet Drug Study
by Zacks Equity Research
PhaseBio's (PHAS) phase III study evaluating bentracimab for the reversal of antiplatelet effects of ticagrelor meets primary endpoint. The stock falls on high rates of the drug's side effects.
ChemoCentryx (CCXI) Gets Positive CHMP Opinion for Tavneos
by Zacks Equity Research
ChemoCentryx (CCXI) receives a positive recommendation from the CHMP for its lead drug Tavneos to treat two forms of ANCA-associated vasculitis.
Gilead (GILD), Everest Medicine Report Phase II Cancer Study Data (Revised)
by Zacks Equity Research
Gilead (GLD) and partner Everest Medicine report that the mid-stage study of sacituzumab govitecan for triple-negative breast cancer achieved its main goal.
Biogen (BIIB) Up on New Data From Phase III Studies on Aduhelm
by Zacks Equity Research
Biogen's (BIIB) Aduhelm significantly lowers plasma p-tau-181, a pathological hallmark of Alzheimer's disease, in phase III studies.
Gilead (GILD), Everest Medicine Report Phase II Cancer Study Data
by Zacks Equity Research
Gilead (GLD) and partner Everest Medicine report that the mid-stage study of sacituzumab govitecan for triple-negative breast cancer achieved its main goal.
Sarepta (SRPT) Q3 Earnings Beat, 2021 Sales View Raised
by Zacks Equity Research
Strong demand for Sarepta's (SRPT) DMD drugs boosts its top line in the third quarter. The company also raises revenues guidance for the year. Stock up in after-market trading.
Sarepta Therapeutics (SRPT) Reports Q3 Loss, Tops Revenue Estimates
by Zacks Equity Research
Sarepta Therapeutics (SRPT) delivered earnings and revenue surprises of 67.74% and 11.33%, respectively, for the quarter ended September 2021. Do the numbers hold clues to what lies ahead for the stock?
The Zacks Analyst Blog Highlights: CRISPR Therapeutics, Editas Medicine, Sarepta Therapeutics and Beam Therapeutics
by Zacks Equity Research
The Zacks Analyst Blog Highlights: CRISPR Therapeutics, Editas Medicine, Sarepta Therapeutics and Beam Therapeutics