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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.
GTx's (GTXI) Enobosarm Positive in Phase II, Shares Down
by Zacks Equity Research
GTx (GTXI) posts positive data from a phase II study of enobosarm for treating women with stress urinary incontinence. However, shares dip possibly with the release falling below market estimates.
Alexion (ALXN) Reports Interim Results for Soliris Study
by Zacks Equity Research
Alexion (ALXN) announced results from an interim analysis of an ongoing phase III REGAIN study of Soliris. The study showed sustained treatment benefits of Soliris treatment for patients with refractory generalized myasthenia gravis.
Perrigo's Stock Up, Starboard's CEO Calls it a Key Pick
by Zacks Equity Research
Perrigo's (PRGO) shares rise with Jeff Smith, CEO of Starboard Value, certifying the company as a top investment pick, courtesy its highly potential generic business.
Marinus Stock Surges on Successful Phase II Epilepsy Study
by Zacks Equity Research
Marinus (MRNS) announced positive top-line data from a phase II study on its epilepsy candidate, ganaxolone, for treating CDKL5 disorder.
Ultragenyx's Burosumab Positive in Phase II for XLH and TIO
by Zacks Equity Research
Ultragenyx's (RARE) burosumab passes the test with positive data from two phase II studies. The candidate gets evaluated for X-linked hypophosphatemia and tumor-induced osteomalacia.
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.
Merck (MRK) Opts for Buying German Immuno-Oncology Biotech
by Zacks Equity Research
Merck (MRK) to acquire Germany-based Rigontec, a leader in retinoic acid-inducible gene I (RIG-I), a novel immuno-oncology treatment approach targeting therapeutics.
The Medicines Company's Infection Drug Vabomere Gets FDA Nod
by Zacks Equity Research
The Medicines Company's (MDCO) infection-resistant antibiotic Vabomere secures a fast FDA approval for urinary tract diseases. The drug is likely to hit the market in fourth-quarter 2017.
FDA's Refusal-to-File Letter for Inbrija Pushes Acorda Down
by Zacks Equity Research
Acorda (ACOR) receives a refusal to file (RTF) letter from the FDA in connection with Inbrija's NDA.
The Medicines Co's Inclisiran Positive in Extension Study
by Zacks Equity Research
The Medicines Company (MDCO) and partner Alnylam publish new one-year safety and efficacy data from phase II extension study of Inclisiran for hypercholesterolemia.
Anthera's Blisibimod Positive in Phase II Extension Study
by Zacks Equity Research
Anthera's (ANTH) blisibimod passes test in an extended phase II study to prove efficacy for IgA nephropathy treatment. The study also shows a trend toward preservation of renal function.
J&J's (JNJ) Xarelto/Aspirin Regimen Positive in Phase III
by Zacks Equity Research
J&J's (JNJ) blood thinner Xarelto shows a significant risk reduction in major cardiovascular events in patients with stable coronary and peripheral artery disease.
Minerva-J&J's Amendment of MIN-202 Contract Wins EU Approval
by Zacks Equity Research
The EU approves of Minerva's (NERV) amendment of MIN-202 license agreement with Janssen. Per the deal, Minerva will receive an upfront payment from Janssen.
Adamas (ADMS) Dyskinesia Drug Gets FDA Approval, Stock Soars
by Zacks Equity Research
Adamas Pharmaceuticals' (ADMS) Gocovri was approved by the FDA for treating dyskinesia in patients with Parkinson's disease. This led to an upside in shares.
Ultragenyx Files BLA to FDA for Hypophosphatemia Candidate
by Zacks Equity Research
Ultragenyx (RARE) forwards a BLA to the FDA for burosumab with a view to treat patients with X-linked hypophosphatemia (XLH). The decision on acceptance will be known within a couple of months.
Kite Pharma at New 52-Week High: What's Driving the Stock?
by Zacks Equity Research
Kite Pharma (KITE) shares hit a new 52-week high as the company's CAR-T therapy with axicabtagene ciloleucel nears an FDA nod. It has also filed regulatory application for the candidate in the EU.
Ultragenyx (RARE) Posts Disappointing Phase III Ace-ER Data
by Zacks Equity Research
Ultragenyx (RARE) plans to discontinue further clinical development of Ace-ER after posting discouraging data from a phase III study that evaluated the candidate on patients with GNE Myopathy.
Jazz Pharmaceuticals Arm Announces $500M Senior Notes Offer
by Zacks Equity Research
Jazz Pharmaceuticals (JAZZ) announces private offering of exchangeable senior notes to qualified institutional buyers to raise proceeds and repay debt.
FDA Accepts Portola's (PTLA) BLA Resubmission for AndexXa
by Zacks Equity Research
FDA acknowledges Portola's (PTLA) resubmitted BLA for AndexXa to raise hopes for an urgent need of antidotes for Factor Xa inhibitors in the market.
Geron's (GERN) Imetelstat Progressing Well, Setbacks Concern
by Zacks Equity Research
Geron Corporation's (GERN) telomerase inhibitor, imetelstat, is being evaluated in two late stage studies. The candidate is progressing well in the Janssen sponsored studies.
Drug Stocks Q2 Earnings Roster for Aug 8: ACAD, JAZZ & More
by Zacks Equity Research
A look at the pharma/biotech companies that are set to report second-quarter results on Aug 8.
Will ACADIA (ACAD) Pull Off a Surprise this Earnings Season?
by Zacks Equity Research
ACADIA Pharmaceuticals' (ACAD) Nuplazid is expected to maintain the growth trend, established since its launch, in the second quarter.
Minerva On Track to Initiate Phase III Schizophrenia Study
by Zacks Equity Research
Minerva Neurosciences, Inc. (NERV) announced that it is on track to begin phase III studies on its key schizophrenia pipeline candidate MIN-101 in the second half of this year, as planned.
What's in the Cards for ACADIA (ACAD) this Earnings Season?
by Zacks Equity Research
ACADIA Pharmaceuticals Inc. (ACAD) is expected to report first-quarter 2017 results on May 4.