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Zacks News
Gene Therapy in Limelight on Novartis Deal: 3 Stocks in Focus
by Zacks Equity Research
With the announcement of Novartis (NVS) acquiring AveXis, a clinical stage gene therapy company, several companies have started to develop the therapy with many of them having promising candidates in their pipelines.
Catalyst (CPRX) Up on New Drug Application for Firdapse
by Zacks Equity Research
Catalyst (CPRX) new drug application for its lead pipeline candidate keeps it on a growth trajectory.
BioMarin's MAA for Phenylketonuria Candidate Gains EU Nod
by Zacks Equity Research
BioMarin's (BMRN) MAA submission for its pipeline PKU candidate, pegvaliase, gets accepted in the EU. The same is under priority review in the United States with decision awaited this May.
BioMarin Pharmaceutical (BMRN) Down 3.1% Since Earnings Report: Can It Rebound?
by Zacks Equity Research
BioMarin Pharmaceutical (BMRN) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
BioMarin (BMRN) Q4 Loss Wider Than Expected, Sales Beat
by Zacks Equity Research
BioMarin (BMRN) reports wider-than-expected loss in the fourth quarter of 2017 but beat estimates for sales on higher product revenues.
What to Expect From BioMarin (BMRN) This Earnings Season?
by Zacks Equity Research
BioMarin (BMRN) is likely to see continued momentum in Kuvan sales in Q4. On the call, management is likely to comment on Brineura's launch progress and on the launch preparation for pegvaliase.
Catalyst Gets Positive FDA Advise on Firdapse NDA Refiling
by Zacks Equity Research
Catalyst (CPRX) posts positive results from a recent Type C meeting with the FDA on resubmitting the new drug application for Firdapse in treating Lambert-Eaton myasthenic syndrome.
Vertex (VRTX) & Other Drug Stocks with FDA Catalysts this February
by Arpita Dutt
Here is a look at Vertex (VRTX) and a few other companies that await a decision from the FDA in February for label expansions or new drugs.
Surging Earnings Estimates Signal Good News for BioMarin Pharmaceutical (BMRN)
by Zacks Equity Research
BioMarin Pharmaceutical (BMRN) could be an interesting play for investors as it is seeing solid activity on the earnings estimate revision, along with decent short-term momentum.
What Drives Catalyst Pharmaceuticals Above 250% This Year?
by Zacks Equity Research
We take a look at the factors that drive phenomenal growth in Catalyst Pharmaceuticals' (CPRX) share price in 2017.
Biotech Stock Roundup: BIIB, CELG Hit by Pipeline News, Acquisition Deals for Ignyta, Sucampo
by Arpita Dutt
A couple of acquisition agreements as well as pipeline news from Celgene (CELG) and Biogen were the key highlights this week in the biotech sector.
BioMarin's (BMRN) Pegvaliase Review Period Extended by FDA
by Zacks Equity Research
BioMarin (BMRN) extended the review period of its biologics license application (BLA) for pegvaliase by three months to May 25, 2018.
BioMarin's (BMRN) Gene Therapy Enters First Phase III Study
by Zacks Equity Research
BioMarin (BMRN) commences the first phase III study to evaluate the 6e13 vg/kg dose of its investigational gene therapy, valoctocogene roxaparvovec, for severe hemophilia A.
Spark Therapeutics Stock Plunges on Hemophilia Therapy Data
by Zacks Equity Research
Spark Therapeutics (ONCE) plunged 35% as investors were not impressed by the data from a phase I/II study on its Hemophilia A candidate, SPK-8011.
BioMarin Pharmaceutical (BMRN) Jumps: Stock Rises 7.5%
by Zacks Equity Research
BioMarin Pharmaceutical (BMRN) saw a big move last session, as its shares jumped more than 7% on the day, amid huge volumes.
Here's Why Sarepta Stock is Up More Than 70% in 6 Months
by Zacks Equity Research
Sarepta's (SRPT) key product, Exondys 51, and lead pipeline candidate, golodirsen, have put up a good show in the past six months.
Catalyst (CPRX) Reports Positive Phase III Data on Firdapse
by Zacks Equity Research
Catalyst (CPRX) reported encouraging top-line results from a phase III study for its pipeline candidate, Firdapse, for the treatment of Lambert-Eaton myasthenic syndrome.
Catalyst Initiates Phase II Study for Pipeline Drug Firdapse
by Zacks Equity Research
Catalyst (CPRX) announces the initiation of phase II study to evaluate safety, tolerability and efficacy of its lead pipeline candidate, Firdapse.
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.