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Zacks News
Amgen Gets FDA Nod to Add ASPIRE Data on Kyprolis Label
by Zacks Equity Research
Amgen (AMGN) gets FDA approval to add overall survival data from the phase III ASPIRE study on the label of its multiple myeloma drug, Kyprolis.
3 Biotech Stocks Up in the Past Month on Industry Turnaround
by Zacks Equity Research
We take a look at three biotech stocks whose share price has increased in the past month due to as the biotech industry bounced back in the past month after declining in the initial four months of the year.
Catalyst's Fridapse Gets Priority Review by FDA, Shares Up
by Zacks Equity Research
The FDA grants Priority Review to Catalyst's (CPRX) lead pipeline candidate, Firdapse, and set an action date of Nov 28, 2018.
5 Biotech Stocks to Boost Your Portfolio's Health This Year
by Kinjel Shah
Though the biotech industry is down this year, there are still a few stocks which can strengthen your portfolio.
Allergan Recalls Taytulla Oral Contraceptives, Stock Down
by Zacks Equity Research
Allergan (AGN) recalls some sample packs of Taytulla oral birth control pills. Shares decline.
Biotech Stock Roundup: GILD Epclusa's China Approval, BMRN Palynziq's FDA Nod
by Zacks Equity Research
The biotech sector grabbed headlines last week with drug approvals and licensing deals. Investors will await pipeline development news at the ASCO in the coming week.
Here's Why Sarepta is Up More Than 60% So Far This Year
by Zacks Equity Research
Sarepta's (SRPT) key product, Exondys 51, continue to perform well and lead pipeline candidate, golodirsen, progresses well in 2018.
BioMarin's Palynziq Gets FDA Approval for Phenylketonuria
by Zacks Equity Research
BioMarin's (BMRN) enzyme therapy, Palynziq (pegvaliase) gets approval for the treatment of phenylketonuria in adult patients.
BioMarin Begins Mid Stage Study on Gene Therapy Candidate
by Zacks Equity Research
BioMarin (BMRN) initiates a mid-stage study to evaluate its gene therapy candidate, valoctocogene roxaparvovec for treating in AAV5+ severe hemophilia A.
Merck KGaA (MKGAF) Q1 Earnings and Revenues Decline Y/Y
by Zacks Equity Research
Merck KGaA (MKGAF) reports dismal first-quarter results with earnings declining year over year. Revenues fall due to continued negative currency movement.
BioMarin (BMRN) Q1 Earnings Lower Than Expected, Sales Beat
by Zacks Equity Research
BioMarin (BMRN) reported mixed first-quarter results with earnings missing estimates but sales beating the same.
What's in the Cards for BioMarin (BMRN) in Q1 Earnings?
by Zacks Equity Research
BioMarin (BMRN) is likely to see continued momentum in Kuvan and Vimizim sales. On the call, management is likely to comment on the launch preparation for pegvaliase.
Catalyst Enrolls First Patient in Phase III Firdapse Study
by Zacks Equity Research
Catalyst (CPRX) enrolls the first patient in its phase III clinical trial (MSK-002) to evaluate the efficacy and safety of Firdapse in patients with MuSK antibody positive Myasthenia Gravis.
The Zacks Analyst Blog Highlights: Agios Pharmaceuticals, BioMarin Pharmaceutical, Vertex Pharmaceuticals and Incyte
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Agios Pharmaceuticals, BioMarin Pharmaceutical, Vertex Pharmaceuticals and Incyte
Pfizer Starts Phase Ib for Duchenne Muscular Dystrophy Drug
by Zacks Equity Research
Pfizer (PFE) commences dosing in a phase Ib study, evaluating its gene therapy candidate, PF-06939926, for treating five to 12-yearold boys with duchenne muscular dystrophy.
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.