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Zacks News
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.
Biotech Stock Roundup: Cara Plunges on Study Data, Regulatory Updates & More
by Arpita Dutt
Key highlights in the biotech sector include mixed data from Cara (CARA) and regulatory updates from companies like BioMarin.
BioMarin Files BLA for Phenylketonuria Candidate Pegvaliase
by Zacks Equity Research
BioMarin Pharmaceutical Inc. (BMRN) announced that it has filed a biologics license application (BLA) with the FDA for its pipeline candidate, pegvaliase for phenylketonuria (PKU).
Why is Catalyst Pharmaceuticals' Stock Up 160% this Year?
by Zacks Equity Research
Shares of Catalyst Pharmaceuticals, Inc. (CPRX) have soared 161% this year so far, massively outperforming the Zacks classified Medical Drugs industry's gain of 10.2%.
BioMarin (BMRN) in Focus: Stock Moves 7% Higher
by Zacks Equity Research
BioMarin (BMRN) was a big mover last session, as the company saw its shares rise 7% on the day.
BioMarin (BMRN) Down 8% Since Earnings Report: Can It Rebound?
by Zacks Equity Research
BioMarin (BMRN) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
BioMarin's (BMRN) Brineura Approved by European Commission
by Zacks Equity Research
BioMarin Pharmaceutical Inc. (BMRN) announced that the European Commission has approved Brineura (cerliponase alfa) for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2).
Ultragenyx Receives Priority Review for rhGUS from FDA
by Zacks Equity Research
The FDA has accepted Ultragenyx Pharmaceutical Inc. (RARE)'s BLA for rhGUS on a priority review basis and set a PDUFA action date of Nov 16, 2017.