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Zacks News
NuCana (NCNA) Surges: Stock Moves 6.3% Higher
by Zacks Equity Research
NuCana (NCNA) saw a big move last session, as its shares jumped more than 6% on the day, amid huge volumes.
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.
bluebird-Bristol Myers' CAR T Cell Therapy BLA Accepted by FDA
by Zacks Equity Research
The FDA accepts bluebird (BLUE) and Bristol Myers Squibb's BLA for idecabtagene vicleucel for the treatment of adult patients with multiple myeloma.
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.
Alexion's New Formulation of Ultomiris Gets CHMP Backing
by Zacks Equity Research
Alexion (ALXN) gets a positive opinion from the CHMP recommending marketing authorization for a new 100 mg/mL intravenous advanced formulation of Ultomiris in the EU.
Axovant (AXGT) Catches Eye: Stock Jumps 12%
by Zacks Equity Research
Axovant (AXGT) saw a big move last session, as its shares jumped nearly 12% on the day, amid huge volumes.
Agenus (AGEN) Initiates Rolling BLA Submission of Balstilimab
by Zacks Equity Research
Agenus (AGEN) initiates the rolling submission of its BLA to the FDA for balstilimab alone for the treatment of recurrent/metastatic cervical cancer.
Immunomedics Releases Trodelvy Data From Cancer Studies
by Zacks Equity Research
Immunomedics (IMMU) releases data from different cancer studies on its lead drug, Trodelvy.
Geron (GERN) Looks Good: Stock Adds 6.5% in Session
by Zacks Equity Research
Geron (GERN) saw a big move last session, as its shares jumped nearly 7% on the day, amid huge volumes.
Emergent BioSolutions Sees Hammer Chart Pattern: Time to Buy?
by Zacks Equity Research
Emergent BioSolutions has been struggling lately, but the selling pressure may be coming to an end soon.
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.
Has Emergent Biosolutions (EBS) Outpaced Other Medical Stocks This Year?
by Zacks Equity Research
Is (EBS) Outperforming Other Medical Stocks This Year?
ChemoCentryx's NDA for Autoimmune Disease Drug Accepted by FDA
by Zacks Equity Research
The FDA accepts ChemoCentryx's (CCXI) NDA for avacopan, for the treatment of ANCA-associated vasculitis.
Dr. Reddy's Settles Revlimid Patent Suit With Bristol Myers
by Zacks Equity Research
Dr. Reddy's (RDY) settles litigation with Bristol Myers relating to patents for Revlimid (lenalidomide) capsules.
Merus (MRUS) Looks Good: Stock Adds 7% in Session
by Zacks Equity Research
Merus (MRUS) saw a big move last session, as its shares jumped nearly 7% on the day, amid huge volumes.
Apellis Submits Pegcetacoplan Applications to FDA and EMA
by Zacks Equity Research
Apellis (APLS) submits an NDA to the FDA and an MAA to the European Medicines Agency for pegcetacoplan for the treatment of paroxysmal nocturnal hemoglobinuria.
IGM Biosciences (IGMS) Catches Eye: Stock Jumps 8.7%
by Zacks Equity Research
IGM Biosciences (IGMS) saw a big move last session, as its shares jumped nearly 9% on the day, amid huge volumes.
Vaxart Gets FDA Nod for Phase I Study on Coronavirus Vaccine
by Zacks Equity Research
Vaxart's (VXRT) investigational new drug application for oral coronavirus vaccine candidate gets a clearance from the FDA. The company will begin a phase I study later this month.
Seattle Genetics Up on Two New Oncology Deals With Merck
by Zacks Equity Research
Seattle Genetics (SGEN) strikes a couple of deals with Merck to co-develop ladiratuzumab vedotin for breast cancer and other solid tumors. Also, Merck will market the company's Tukysa in some places.
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.
Novartis' Eye Drug's Safety Label Update Approved by EMA
by Zacks Equity Research
Novartis' (NVS) eye drug Beovu's safety label update receives approval from the Committee for Medicinal Products for Human Use.
Mallinckrodt Gets CRL From FDA for Terlipressin, Shares Fall
by Zacks Equity Research
Mallinckrodt (MNK) gets a Complete Response Letter from the FDA for its NDA seeking approval for terlipressin to treat adults with hepatorenal syndrome type 1.
Galapagos (GLPG) Surges: Stock Moves 8.8% Higher
by Zacks Equity Research
Galapagos (GLPG) saw a big move last session, as its shares jumped nearly 9% on the day, amid huge volumes.
Immunomedics to be Acquired by Gilead for About 21 Billion
by Zacks Equity Research
Immunomedics Inc. (IMMU) will be acquired by Gilead (GILD) for about $21 billion.