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Zacks News
Bristol-Myers' Opdivo Meets Goals in Bladder Cancer Study
by Zacks Equity Research
Bristol-Myers' (BMY) Opdivo meets primary endpoint in a phase III study in patients with urothelial carcinoma.
Gilead's Rheumatoid Arthritis Drug Gets Approval in Japan
by Zacks Equity Research
Gilead's (GILD) rheumatoid arthritis drug, Jyseleca, wins approval in Japan.
BioMarin Initiates Gene Therapy Study for Phenylketonuria
by Zacks Equity Research
BioMarin (BMRN), a leader in the phenylketonuria segment, initiates development of its first gene therapy for treating the rare genetic enzyme deficiency disorder.
Athersys Gets FDA's RMAT Designation for Cell Therapy in ARDS
by Zacks Equity Research
The FDA bestows a Regenerative Medicine Advanced Therapy status on Athersys' (ATHX) MultiStem cell therapy candidate for treating acute respiratory distress syndrome.
Pfizer Seeks Xalkori's Label Expansion, Gets Priority Review
by Zacks Equity Research
Pfizer's (PFE) sNDA seeking label expansion of lung cancer drug, Xalkori, for a hematologic indication gets priority review from the FDA.
Blueprint Medicines Up on Positive Top-Line Data From SM Study
by Zacks Equity Research
Blueprint Medicines (BPMC) reports positive top-line results from the EXPLORER and the PATHFINDER studies, which are evaluating Ayvakit for patients with advanced systemic mastocytosis. Shares up.
Genocea to Initiate a Phase I/II Oncology Study on GEN-011
by Zacks Equity Research
Genocea's (GNCA) investigational new drug application to initiate a clinical study to evaluate its neoantigen-specific cell therapy candidate, GEN-011 in cancer patients gets FDA clearance.
Axsome Expedites Development Plan for Narcolepsy Candidate
by Zacks Equity Research
Axsome (AXSM) accelerates the development plan for AXS-12 to treat narcolepsy after a Breakthrough Therapy meeting with the FDA authorities. Stock dips.
Seattle Genetics' Padcev Study Aids Urothelial Cancer Survival
by Zacks Equity Research
Seattle Genetics' (SGEN) phase III EV-301 study on Padcev meets the main goal of overall survival compared to chemotherapy in patients previously treated for locally advanced/metastatic urothelial cancer.
Is Horizon Therapeutics Public Limited (HZNP) Stock Outpacing Its Medical Peers This Year?
by Zacks Equity Research
Is (HZNP) Outperforming Other Medical Stocks This Year?
Vertex Eyes Label Expansion of Triple Combo CF Drug in Europe
by Zacks Equity Research
Vertex's (VRTX) label expansion application Kaftrio in combination with Kalydeco gets accepted for review by the European Medicines Agency.
Cue Biopharma (CUE) Catches Eye: Stock Jumps 5.2%
by Zacks Equity Research
Cue Biopharma (CUE) saw a big move last session, as its shares jumped more than 5% on the day, amid huge volumes.
Exelixis Inks a Couple of Deals to Develop Novel ADCs for Cancer
by Zacks Equity Research
Exelixis (EXEL) signs a collaboration agreement with private biotech NBE-Therapeutics for developing novel antibody-drug conjugates (ADCS) to address cancer. It also inks a similar deal with Catalent.
AVEO Acquires Full Global Rights to Ficlatuzumab From Biodesix
by Zacks Equity Research
AVEO reclaims complete rights to ficlatuzumab from Biodesix for an undisclosed sum. The candidate is being developed for several cancer indications.
Merck Announces Detailed Data on Late-Stage Cough Candidate
by Zacks Equity Research
Merck (MRK) announced detailed data from two pivotal studies evaluating gefapixant in patients with refractory or unexplained chronic cough.
Gilead-HiFiBiO Ink Deal to Develop Antibodies Against Leukemia
by Zacks Equity Research
Gilead's (GILD) subsidiary, Kite, enters into a two-year research deal with HiFiBiOto develop antibodies against acute myeloid leukemia.
Horizon Therapeutics' Stock Rises YTD on Approvals & Buyouts
by Zacks Equity Research
Horizon Therapeutics (HZNP) expects continued strong growth for Krystexxa and Tepezza, going forward in 2020. It is making efforts to expand the label for its marketed drugs.
How Has HZNP Performed 30 Days Post Earnings
by Zacks Equity Research
Horizon Therapeutics (HZNP) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Amarin Loses Patent Appeal in Vascepa Lawsuit, Stock Dips
by Zacks Equity Research
Amarin (AMRN) receives a setback as the U.S. Court of Appeals upholds a ruling by Nevada district court in favor of the generic companies related to patent litigation against Vascepa.
Intercept's (ICPT) Stock Rises After Layoff Announcement
by Zacks Equity Research
Intercept (ICPT) plans to lay off its workforce to save costs and streamline operations.
Athenex's NDA for Breast Cancer Drug Gets Priority Review
by Zacks Equity Research
The FDA accepts Athenex's (ATNX) NDA for oral paclitaxel and encequidar, intended to treat metastatic breast cancer, under a priority review. The FDA's verdict is awaited on Feb 28, 2021. Stock up.
Vertex Seeks Nod for Cystic Fibrosis Drugs for Rare Mutations
by Zacks Equity Research
Vertex's (VRTX) sNDAs seek approval of Trikafta, Symdeko, and Kalydeco for additional rare mutations in the CFTR genes.
Bristol Myers Gets FDA Approval for Oral AML Therapy Onureg
by Zacks Equity Research
Bristol Myers' (BMY) Onureg becomes the first and only FDA-approved continued AML therapy for patients in remission.
Gilead Inks Deal With Jounce to License an Oncology Candidate
by Zacks Equity Research
Gilead (GILD) signs a deal with Jounce Therapeutics to exclusively license the latter's monoclonal antibody, JTX-1811.
Aimmune Set to be Acquired by Nestle for $2.6B, Stock Up
by Zacks Equity Research
Aimmune (AIMT) reaches an agreement with Nestle, S.A wherein the latter will acquire the company in an all-cash transaction worth $2.6 billion. Shares surge.