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Zacks News
Epizyme Announces FDA Committee Review of Tazemetostat NDA
by Zacks Equity Research
Epizyme (EPZM) announces that the FDA committee will review its NDA for lead candidate, tazemetostat, on Dec 18.
Amarin's Vascepa MAA for Heart Risk Indication Accepted in EU
by Zacks Equity Research
The EMA validates Amarin's (AMRN) regulatory application seeking approval for Vascepa as a treatment to reduce risk of cardiovascular events.
Dicerna Pharmaceuticals (DRNA) Jumps: Stock Rises 10.1%
by Zacks Equity Research
Dicerna Pharmaceuticals (DRNA) saw a big move last session, as its shares jumped more than 10% on the day, amid huge volumes.
Global Blood (GBT) in Focus: Stock Moves 5.2% Higher
by Zacks Equity Research
Global Blood (GBT) shares rose more than 5% in the last trading session, amid huge volumes.
BioDelivery's Belbuca Sales & Symproic Addition Encouraging
by Zacks Equity Research
BioDelivery's (BDSI) efforts to increase preferred coverage for Belbuca and the acquisition of the rights to Symproic are likely to help continue its momentum.
ChemoCentryx Up on Encouraging Rare Disease Candidate Data
by Zacks Equity Research
ChemoCentryx (CCXI) announces positive data pivotal study evaluating its lead candidate, avacopan, in patients with ANCA vasculitis, a rare disease affecting small blood vessels.
Myovant (MYOV) Catches Eye: Stock Jumps 6.7%
by Zacks Equity Research
Myovant (MYOV) saw a big move last session, as its shares jumped nearly 7% on the day, amid huge volumes.
Intercept's (ICPT) NDA for NASH Drug Gets Priority Review
by Zacks Equity Research
Intercept (ICPT) obtains Priority Review for its NDA for OCA in the United States for the treatment of fibrosis due to NASH.
Alexion Gets Approval for Label Expansion of Soliris in Japan
by Zacks Equity Research
Alexion (ALXN) gets Japan Ministry of Health, Labour and Welfare's approval for the label expansion of Soliris.
Biogen Ends Enrollment in Eye Disorder Study on Gene Therapy
by Zacks Equity Research
Biogen (BIIB) completes enrollment in the global phase III STAR clinical study evaluating the gene therapy timrepigene emparvovec for the treatment of a rare, inherited retinal disorder.
Alkermes (ALKS) Up 3% Since Last Earnings Report: Can It Continue?
by Zacks Equity Research
Alkermes (ALKS) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Vertex (VRTX) Gets French Reimbursement for CF Drug Orkambi
by Zacks Equity Research
The French reimbursement for Vertex's (VRTX) cystic fibrosis medicine Orkambi removes a key overhang for the stock.
Alnylam's Givosiran Gets FDA Nod for Acute Hepatic Porphyria
by Zacks Equity Research
Alnylam (ALNY) gets FDA approval for givosiran injection, to be marketed by the trade name of Givlaari, for the treatment of adults with AHP.
Alnylam (ALNY) Catches Eye: Stock Jumps 10.5%
by Zacks Equity Research
Alnylam (ALNY) saw a big move last session, as its shares jumped nearly 11% on the day, amid huge volumes.
Editas Medicine (EDIT) in Focus: Stock Moves 7.8% Higher
by Zacks Equity Research
Editas Medicine (EDIT) saw a big move last session, as its shares jumped nearly 8% on the day, amid huge volumes.
Biotech Stock Roundup: MYOV & KRTX Surge, Pipeline Updates From VRTX, CELG & More
by Zacks Equity Research
Key highlights of the past week include regulatory and pipeline updates along with collaboration deals.
Alkermes Submits NDA to FDA for Schizophrenia & Bipolar I Drug
by Zacks Equity Research
Alkermes (ALKS) submits NDA to the FDA seeking approval of ALKS 3831 for the treatment of schizophrenia and bipolar I disorder.
Alkermes to Acquire Rodin Therapeutics, Boost CNS Pipeline
by Zacks Equity Research
Alkermes (ALKS) will acquire Rodin Therapeutics for an upfront cash payment of $100 million and up to $850 million in milestone payments.
Protalix Finalizes Accelerated Approval Pathway for PRX-102
by Zacks Equity Research
Protalix (PLX) successfully completes the pre-BLA meeting and gets FDA acceptance for using accelerated approval pathway for the BLA submission of Fabry disease candidate, pegunigalsidase alfa.
Celgene's Revlimid-Rituximab Combo Gets Positive CHMP Opinion
by Zacks Equity Research
Celgene (CELG) gets a positive CHMP opinion, recommending the approval of Revlimid in combination with Rituxan for the treatment of adult patients with previously treated FL.
VistaGen's (VTGN) Major Depressive Disorder Drug Disappoints
by Zacks Equity Research
VistaGen (VTGN) announces disappointing results from the ELEVATE study on MDD candidate, AV-101.
Sarepta (SRPT) Stock Down Despite New $48M Gene Therapy Deal
by Zacks Equity Research
Sarepta (SRPT) expands its footing in the gene therapy field and signs a deal with StrideBio to develop up to eight new treatments.
BioDelivery (BDSI) Stock Up on Q3 Earnings Beat & Raised View
by Madhu Goel
BioDelivery (BDSI) beats earnings and sales expectations in the third quarter of 2019. The company raises its 2019 revenue guidance.
Catalyst's (CPRX) Q3 Earnings Beat Estimates, Sales Miss
by Zacks Equity Research
Catalyst (CPRX) beats on earnings but misses sales estimates in the third quarter of 2019.
IVERIC bio (ISEE) Q3 Loss Narrows Y/Y, Zimura Advancing Well
by Zacks Equity Research
IVERIC bio's (ISEE) third-quarter earnings improve year over year. The company plans to initiate a pivotal study on Zimura for treating GA early next year.