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Zacks News
Eiger (EIGR) Gets FDA Approval for Zokinvyin Rare Diseases
by Zacks Equity Research
Eiger (EIGR) gets FDA approval for Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies.
Alnylam (ALNY) Gets EU Nod for Oxlumo to Treat Renal Disease
by Zacks Equity Research
Alnylam (ALNY) gets European approval for Oxlumo (lumasiran) for the treatment of primary hyperoxaluria type 1 in all age groups.
Novo Nordisk's (NVO) Phase IIIb Study Meets Primary Endpoint
by Zacks Equity Research
Novo Nordisk's (NVO) semaglutide 2.0 mg demonstrates superior reduction in HbA1c versus once-weekly semaglutide 1.0 mg in people with type II diabetes.
Alkermes (ALKS) Receives FDA CRL in Relation to ALKS 3831
by Zacks Equity Research
Alkermes (ALKS) gets a CRL by the FDA for ALKS 3831 for the treatment of adults with schizophrenia and bipolar I disorder.
Apellis' (APLS) Blood Disorder Drug Gets FDA's Priority Tag
by Zacks Equity Research
The FDA accepts Apeliis' (APLS) NDA for pegcetacoplanand and grants priority review for the treatment of paroxysmal nocturnal hemoglobinuria.
Moderna (MRNA) Surges: Stock Moves 6.5% Higher
by Zacks Equity Research
Moderna (MRNA) saw a big move last session, as its shares jumped nearly 7% on the day, amid huge volumes.
Deciphera (DCPH) Reports Narrower-Than-Expected Loss in Q3
by Zacks Equity Research
Deciphera (DCPH) reports a narrower-than-expected loss and sales beat estimates in the third quarter of 2020.
BioMarin (BMRN) Beats on Q3 Earnings, Lowers Sales View
by Zacks Equity Research
BioMarin (BMRN) beats estimates for both earnings and sales in the third quarter. The company lowers its sales guidance for 2020.
Global Blood (GBT) Q3 Loss Wider Than Expected, Sales Miss
by Zacks Equity Research
Global Blood (GBT) reports a wider-than-expected loss and misses sales estimates in the third quarter of 2020.
Amicus' (FOLD) Q3 Loss Wider Than Expected, Revenues Beat
by Zacks Equity Research
Amicus (FOLD) reports a wider-than-expected loss but sales beat estimates in the third quarter of 2020.
Zoetis' (ZTS) Q3 Earnings and Revenues Surpass Estimates
by Zacks Equity Research
Zoetis (ZTS) beats earnings and sales estimates in the third quarter. The company raises 2020 guidance.
Alimera Sciences (ALIM) Upgraded to Buy: Here's Why
by Zacks Equity Research
Alimera Sciences (ALIM) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).
Alimera Sciences (ALIM) Reports Q3 Loss, Tops Revenue Estimates
by Zacks Equity Research
Alimera Sciences (ALIM) delivered earnings and revenue surprises of 75.51% and 16.03%, respectively, for the quarter ended September 2020. Do the numbers hold clues to what lies ahead for the stock?
Alexion's Ultomiris Gets Approval in Japan for Rare Disease
by Zacks Equity Research
Alexion's (ALXN) Ultomiris gets approval in Japan for the treatment of adults and children living with atypical hemolytic uremic syndrome.
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.
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.
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.
Bayer Collaborates With Recursion for Fibrotic Diseases
by Zacks Equity Research
Bayer (BAYRY) inks deal with Recursion Pharmaceuticals for the treatment of fibrotic diseases.
Catalyst (CPRX) Eyes Firdapse Label Expansion Amid Competition
by Zacks Equity Research
Catalyst's (CPRX) efforts to expand Firdapse label are encouraging. However, with only a few candidates in the pipeline, the company's dependence on Firdapse for growth remains a matter of concern.
Gilead Submits sBLA to FDA for CAR-T in Non-Hodgkin Lymphomas
by Zacks Equity Research
Gilead submits a supplemental Biologics License Application to the FDA for Yescarta for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma.
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.
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.