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Zacks News
Ultragenyx's rhGUS Gets FDA Nod for Rare Genetic Disease
by Zacks Equity Research
Ultragenyx (RARE) clinches an FDA approval for rhGUS, a treatment option of mucopolysaccharidosis VII. The company assures the drug to be available in the United States by the month-end.
BioMarin (BMRN) Q3 Loss Narrows, Profit Guidance Raised
by Zacks Equity Research
BioMarin (BMRN) reported a narrower-than-expected loss in the third quarter of 2017 but missed estimates for sales. The biotech also raised its previously issued adjusted net income guidance for 2017.
Sarepta (SRPT) Q3 Loss Narrows, Exondys 51 Sales View Raised
by Zacks Equity Research
Sarepta (SRPT) beat estimates on both counts in the third quarter of 2017 on strong sales of Exondys 51. Sarepta's pipeline candidate, golodirsen, shows potential.
What's in Store for BioMarin (BMRN) This Earnings Season?
by Zacks Equity Research
BioMarin (BMRN) is likely to see continued momentum in Kuvan sales in Q3. However, slowdown in Federal purchasing orders in Brazil will hurt Naglazyme and Vimizim product revenues.
Zacks Industry Outlook Highlights: Acorda Therapeutics, BioMarin Pharmaceutical, Valeant Pharmaceuticals International, Teva Pharmaceuticals and Sanofi
by Zacks Equity Research
Zacks Industry Outlook Highlights: Acorda Therapeutics, BioMarin Pharmaceutical, Valeant Pharmaceuticals International, Teva Pharmaceuticals and Sanofi
Here's Why Sarepta Stock is Up More Than 60% So Far in 2017
by Zacks Equity Research
Sarepta (SRPT) shares have been on an uptrend so far this year, fueled by its DMD drug, Exondys 51's strong performance. The settlement of a patent litigation also boosted the stock.
Biotech Stock Roundup: FDA Nod for First Cancer Biosimilar, HALO up on Deals, Raised Outlook
by Arpita Dutt
Data presentations, regulatory updates and licensing deals were among the key highlights this week with the focus being on the FDA approval of the first cancer biosimilar - Amgen's (AMGN) Mvasi.
BioMarin Says FDA Not Planning an AdCom for Pegvaliase BLA
by Zacks Equity Research
The FDA currently shows no intent to hold an AdCom to discuss the BLA for BioMarin's (BMRN) pipeline candidate, pegvaliase.
BioMarin Presents Interim Data on BMN 250 from Phase I/II
by Zacks Equity Research
BioMarin's (BMRN) interim data from a current dose escalation phase I/II study on BMN 250 shows improvement signs in cognitive Development Quotient.
Sarepta's Golodirsen Positive in DMD Study, Shares Soar
by Zacks Equity Research
Sarepta's (SRPT) Duchenne Muscular Dystrophy candidate, Golodirsen, achieved positive muscle biopsy results in first in-human study. Shares surged in response.
BioMarin (BMRN) Up 2.5% Since Earnings Report: Can It Continue?
by Zacks Equity Research
BioMarin (BMRN) reported earnings about a month ago. What's next for the stock? We take a look at earnings estimates for some clues.
Stock Market News For August 31, 2017
by Zacks Equity Research
Stock market closed higher on Wednesday following a couple of bullish economic reports, even as the S&P 500 notched up a four-day winning streak.
BioMarin (BMRN) in Focus: Stock Moves 5.6% Higher
by Zacks Equity Research
BioMarin (BMRN) shares rose nearly 6% in the last trading session, amid huge volumes.
Biotech Stock Roundup: CAR-T in Focus on Gilead-Kite Deal, Incyte Up on Baricitinib Update
by Arpita Dutt
It's all about CAR-T stocks this week with Gilead (GILD) announcing its intention to acquire Kite Pharma for $11.9 billion and Novartis gaining FDA approval for the first CAR-T cell therapy.
BioMarin's Pegvaliase BLA Granted Priority Review by the FDA
by Zacks Equity Research
BioMarin Pharmaceutical (BMRN) announced that the FDA has accepted and granted priority review to the BLA for phenylketonuria candidate, Pegvaliase with a decision expected in February 2018.
BioMarin (BMRN) Q2 Loss Narrows, Sales Surpass Estimates
by Zacks Equity Research
BioMarin Pharmaceutical Inc. (BMRN) reported a narrower-than-expected loss in Q2 and also beat estimates for sales. The biotech also raised its previously issued full year sales outlook.
Is Zoetis (ZTS) Poised for a Beat This Earnings Season?
by Zacks Equity Research
Zoetis, Inc. (ZTS) is expected to focus on performance of companion animal business during its second-quarter results.
Can Horizon Pharma (HZNP) Spring a Surprise in Q2 Earnings?
by Zacks Equity Research
Horizon Pharma (HZNP) is set to report second-quarter results next week and we expect investor focus on sales of key drugs.
Will Teladoc (TDOC) Pull Off a Surprise in Q2 Earnings?
by Zacks Equity Research
Teladoc's (TDOC) second-quarter earnings may be driven by higher revenues and increased membership, partly offset by an increase in operating expenses.
Why Earnings Season Could Be Great for BioMarin (BMRN)
by Zacks Equity Research
BioMarin (BMRN) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.
Can BioMarin (BMRN) Keep the Earnings Streak Alive in Q2?
by Zacks Equity Research
BioMarin Pharmaceutical Inc. (BMRN) is likely to see continued momentum in Vimizim and Kuvan sales backed by robust patient growth in Q2.
Sarepta Therapeutics (SRPT) Stock Surged 24% Today: Here's Why
by Madeleine Johnson
On Thursday, shares of Sarepta Therapeutics (SRPT) are surging, up almost 24% to $42.14 per share in morning trading after the biotech company reported second-quarter revenues that blew past expectations in its earnings report yesterday after the bell.
Sarepta (SRPT) Q2 Loss Narrows, Ups Exondys 51 Sales View
by Zacks Equity Research
Increase in Exondys 51 sales led Sarepta (SRPT) to post a narrower-than-expected loss in the second quarter of 2017.
Sarepta & BioMarin Settle Patent Litigation on Exon Skipping
by Zacks Equity Research
Sarepta Therapeutics, Inc. (SRPT), and BioMarin Pharmaceutical Inc., have settled their ongoing global patent litigation pertaining to exon skipping technology used in Duchenne muscular dystrophy therapies.
Shire Completes NDA Filing for Hemophilia Drug with FDA
by Zacks Equity Research
Shire plc (SHPG) recently announced that it has filed an investigational new drug (IND) application with the FDA, seeking approval for its recombinant factor VIII (FVIII) gene therapy candidate, SHP654, for the treatment of patients with Hemophilia A.