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Zacks News
Alimera Sciences (ALIM) Reports Q1 Loss, Lags Revenue Estimates
by Zacks Equity Research
Alimera Sciences (ALIM) delivered earnings and revenue surprises of -26.00% and -3.33%, respectively, for the quarter ended March 2021. Do the numbers hold clues to what lies ahead for the stock?
Bristol Myers' (BMY) CNS Phase III Cancer Study on Opdivo Fails
by Zacks Equity Research
Bristol Myers' (BMY) phase III study on Opdivo in newly diagnosed glioblastoma failed to meet goals.
Jazz (JAZZ) Initiates BLA Submission for Leukemia Candidate
by Zacks Equity Research
Jazz (JAZZ) initiates the submission of a BLA to the FDA for the marketing approval of JZP-458 for the treatment of acute lymphoblastic leukemia or lymphoblastic lymphoma.
ChemoCentryx (CCXI) Reports Positive Top-Line Rare Disease Data
by Zacks Equity Research
ChemoCentryx (CCXI) and Vifor Fresenius Medical Care Renal Pharma report positive top-line data from the study evaluating avacopan for the treatment of C3 Glomerulopathy.
Veracyte (VCYT) in Focus: Stock Moves 7% Higher
by Zacks Equity Research
Veracyte (VCYT) saw a big move last session, as its shares jumped more than 7% on the day, amid huge volumes.
Novo Nordisk (NVO) Files for Semaglutide Label Expansion in EU
by Zacks Equity Research
Novo Nordisk (NVO) files application in Europe for the label expansion of subcutaneous Ozempic (semaglutide) 2.4 mg.
Berkeley Lights (BLI) in Focus: Stock Moves 6.3% Higher
by Zacks Equity Research
Berkeley Lights (BLI) saw a big move last session, as its shares jumped more than 6% on the day, amid huge volumes.
Novartis (NVS) to Acquire Neuroscience Company for Up to $770M
by Zacks Equity Research
Novartis (NVS) to buy neuroscience company, Cadent, for up to $770 million.
Aligos (ALGS) in Focus: Stock Moves 5.6% Higher
by Zacks Equity Research
Aligos (ALGS) saw a big move last session, as its shares jumped nearly 6% on the day, amid huge volumes.
Novartis' (NVS) Entresto Gets FDA Panel Nod for Expanded Use
by Zacks Equity Research
Novartis (NVS) gets positive review from the FDA Advisory Committee to support the use of Entresto in the treatment of patients with heart failure with preserved ejection fraction.
Roche (RHHBY) Gets FDA Nod for Shorter Infusion Time of Ocrevus
by Zacks Equity Research
The FDA approves Roche's (RHHBY) Ocrevus for two-hour infusion time, dosed twice-yearly to patients with relapsing or primary progressive MS.
Bristol Myers (BMY) Gets Positive CHMP Opinion for Inrebic
by Zacks Equity Research
Bristol Myers (BMY) gets positive CHMP opinion for Inrebic for the treatment of adult patients with newly diagnosed and previously treated myelofibrosis.
Alkermes (ALKS) Outlines Value Enhancement Plan, Shares Up
by Zacks Equity Research
Alkermes' (ALKS) Value Enhancement Plan is set to drive growth, improve operational and financial performance, as well as enhance shareholder value.
Ultragenyx (RARE) Gets Orphan Drug Tag for Wilson Disease Drug
by Zacks Equity Research
Ultragenyx (RARE) gets Orphan Drug Designation from the FDA for UX701 for the treatment of Wilson disease.
Checkmate (CMPI), Bristol Myers Ink Deal for Cancer Combo
by Zacks Equity Research
Checkmate Pharmaceuticals (CMPI) inks deal with Bristol Myers to evaluate the combination of its CMP-001 and the latter's Opdivo.
Phathom Pharmaceuticals (PHAT) Surges: Stock Moves 6.9% Higher
by Zacks Equity Research
Phathom Pharmaceuticals (PHAT) saw a big move last session, as its shares jumped nearly 7% on the day, amid huge volumes.
Chimerx's (CMRX) NDA for Brincidofovir Accepted by FDA
by Zacks Equity Research
Chimerix's (CMRX) NDA for brincidofovir as a medical countermeasure for smallpox has been accepted by the FDA.
FDA Approves Label Expannsion of Novo Nordisk's (NVO) Saxenda
by Zacks Equity Research
Novo Nordisk (NVO) gets FDA approval for an updated label for Saxenda (liraglutide) injection 3 mg.
Alnylam (ALNY) Ends Enrollment in Advanced Hyperoxaluria Study
by Zacks Equity Research
Alnylam (ALNY) completes enrollment in its phase III study of Oxlumo for the treatment of advanced primary hyperoxaluria type 1.
CytoDyn (CYDY) Enrolls First Patient in NASH Study on Leronlimab
by Zacks Equity Research
CytoDyn (CYDY) enrolls first patient in the phase II study evaluating leronlimab for the treatment of nonalcoholic steatohepatitis.
Acceleron (XLRN) Gets Orphan Drug Tag for ACE-1334 by FDA
by Zacks Equity Research
The FDA grants orphan drug designation to Acceleron's (XLRN) ACE-1334 for the treatment of patients with systemic sclerosis.
Amicus (FOLD) Initiates Rolling BLA Submission for AT-GAA
by Zacks Equity Research
Amicus (FOLD) initiates a rolling biologics license application (BLA) submission to the FDA for AT-GAA, for the treatment of late onset Pompe disease.
Verastem (VSTM) Begins Phase II Combo Study for Ovarian Cancer
by Zacks Equity Research
Verastem (VSTM) initiates phase II registration-directed study of VS-6766 and defactinib in patients with recurrent low-grade serous ovarian cancer.
HorizonTherapeutics (HZNP) Rises YTD on Approvals & Buyouts
by Zacks Equity Research
Horizon Therapeutics (HZNP) expects continued strong growth for Krystexxa and Tepezza in 2021. It is making efforts to expand the label for its marketed drugs.
Alnylam (ALNY) Gets FDA Nod for Oxlumo to Treat Renal Disease
by Zacks Equity Research
The FDA approves Alnylam's (ALNY) Oxlumo injection for subcutaneous use, to lower urinary oxalate levels in pediatric and adult patients with primary hyperoxaluria type 1.