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Zacks News
Biotech Stock Roundup: EDGE Falls, ALKS Down, FDA OK's AMGN Drug Label Expansion
by Zacks Equity Research
The biotech sector grabbed headlines last week as Edge Therapeutics crashed on news of discontinuation of its phase III study while Amgen's Blincyto got FDA's nod for label expansion.
Rigel (RIGL) Sinks on Failure of Mid-Stage Study on Lead Drug
by Zacks Equity Research
Rigel's (RIGL) stock plunges 13% on the failure of a phase II study on lead drug, fostamatinib, in patients with IgA nephropathy (IgAN).
Sanofi's (SNY) Skin Cancer Candidate Filing Accepted in EU
by Zacks Equity Research
Sanofi's (SNY) filing for its antibody cemiplimab for skin cancer and the label expansion of its marketed drug Dupixent for asthama wins acceptance from EMA.
Alkermes Sinks as FDA Refuses Depression Drug Review
by Zacks Equity Research
Alkermes (ALKS) shares declined by more than 21% as it received a Refusal to File letter from the FDA for its pipeline candidate, ALKS 5461, which was developed for major depressive disorder (MDD).
Celgene (CELG) President and COO to Step Down: What's Ahead?
by Zacks Equity Research
Celgene's (CELG) president and chief operating officer, Scott A. Smith, has decided to step down from his position with immediate effect further adding to the company's woes.
EMA Accepts Regeneron/Sanofi's application for Dupixent
by Zacks Equity Research
Regeneron and partner Sanofi's application for the label expansion of Dupixent has been accepted by the regulatory body in Europe. The application is also under review in the United States.
Amgen's (AMGN) Xgeva Gets EU Approval for Expanded Label
by Zacks Equity Research
Amgen (AMGN) gets EU approval to expand the label of its key drug, Xgeva to include patients with multiple myeloma.
Alnylam Falls on Pfizer's Rare Disease Drug Success
by Zacks Equity Research
Shares of Alnylam (ALNY) fall by more than 8% after Pfizer reports top-line results from the phase III study of tafamidis.
Edge Therapeutics Loses Edge on Failure of Late-Stage Study
by Zacks Equity Research
Edge Therapeutics (EDGE) plummeted significantly after the company announced discontinuation of the pivotal late stage study on lead candidate.
Celgene (CELG) Up on Deal With bluebird For CAR-T Candidate
by Zacks Equity Research
Celgene's (CELG) stock was up by 3% after the company announced a co-promotion agreement with bluebird bio for one of its leading CAR-T candidates.
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.
Celgene Loses 17.8% in 3 Months: Time to Reshuffle Portfolio?
by Zacks Equity Research
Things have not been going Celgene's (CELG) way as the company has suffered a series of setbacks. The stock has lost 17.8% in the last three months.
Add These 7 GARP Stocks to Your Portfolio for Maximum Returns
by Zacks Equity Research
If you're looking for a profitable portfolio of stocks that will offer the best of value and growth investing, try the growth at a reasonable price or GARP strategy.
Roche's Tecentriq Combo Study Meets Co-Primary Endpoint
by Zacks Equity Research
Roche's (RHHBY) phase III study, evaluating a combination of Tecentriq and Avastin plus carboplatin and paclitaxel for first line treatment of advanced lung cancer met its co-primary endpoint of overall survival.
Amgen's Repatha Gains CHMP Nod to Include Outcomes Data
by Zacks Equity Research
Amgen (AMGN) gets CHMP's positive opinion to incorporate a new indication into the European label of its PCSK9 inhibitor, Repatha.
Exelixis Cabometyx Gets Positive CHMP Opinion in Europe
by Zacks Equity Research
Exelixis' European partner, Ipsen, obtains positive opinion from the CHMP for the use of Cabometyx in the first-line treatment of advanced renal cell carcinoma.
Radius Health Down on Negative CHMP Opinion for Lead Drug
by Zacks Equity Research
Shares of Radius Health (RDUS) declined after the company's application for lead drug, abaloparatide-SC, was given a negative opinion by the CHMP in Europe.
Regeneron Collaborates With Alnylam to Develop NASH Treatment
by Zacks Equity Research
Regeneron Pharmaceuticals (REGN) enters a collaboration with Alnylam to discover and develop RNAi-based therapies for treatment of NASH.
Roche's (RHHBY) Lucentis 0.3 mg PFS Receives FDA Approval
by Zacks Equity Research
Roche's (RHHBY) opthalmology drug, Lucentis 0.3 mg prefilled syringe (PFS) is a new method of administering medicine for all forms of diabetic retinopathy.
Valeant (VRX) Stock Declines 21% YTD: What Lies Ahead?
by Zacks Equity Research
Valeant's (VRX) stock has lost roughly 21% of its value in 2018 despite management's efforts for a turnaround after the turmoil in 2016.
Arena Pharmaceuticals (ARNA) in Focus: Stock Moves 10.7% Higher
by Zacks Equity Research
Arena Pharmaceuticals (ARNA) was a big mover last session, as the company saw its shares rise nearly 11% on the day.
GlaxoSmithKline Initiates Phase III Combo Study on Benlysta
by Zacks Equity Research
GlaxoSmithKline (GSK) initiates a phase III study evaluating Benlysta in combination with Rituxanin adult patients with systemic lupus erythematosus.
Biotech Stock RoundUp: ALXN & ARNA Up on Study Data, PRTA Teams Up With Celgene
by Zacks Equity Research
The biotech sector was in focus last week with Alexion gaining on positive data on PNH candidate, Arena surges on ulcerative drug data, Solid Biosciences' stock suffering a crash and Prothena teaming up with Celgene.
Novo Nordisk Poised on Strong Pipeline Amid Competition
by Zacks Equity Research
Novo Nordisk (NVO) has a strong product pipeline and their potential approval will boost sales of the company.
Prothena Rallies on Multi-Year Collaboration With Celgene
by Zacks Equity Research
Shares of Prothena (PRTA) surged significantly after the company announced a multi-year collaboration with leading company Celgene to develop new therapies for a broad range of neurodegenerative diseases.