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Zacks News
J&J's (JNJ) Darzalex Faspro Gets FDA Nod for Amyloidosis
by Zacks Equity Research
J&J (JNJ) gets accelerated approval for a new indication of Darzalex Faspro in combination with bortezomib, cyclophosphamide and dexamethasone for treating amyloidosis patients.
Novartis' (NVS) Ligelizumab Gets Breakthrough Therapy Status
by Zacks Equity Research
Novartis (NVS) gets Breakthrough Therapy designation by the FDA for ligelizumab for the treatment of chronic spontaneous urticaria.
Lexicon (LXRX) Soars on FDA Permission for Sotagliflozin NDA
by Zacks Equity Research
Lexicon (LXRX) announces that data from two late-stage studies on its type II diabetes candidate, sotagliflozin, can support a regulatory approval application.
Acorda (ACOR) Soars on Sale of Manufacturing Unit for Inbrija
by Zacks Equity Research
Acorda (ACOR) inks an agreement to sell its Inbrija manufacturing operations in Chelsea for $80 million to Catalent. The company also announces a corporate restructuring plan to save costs. Shares up.
Marinus (MRNS) Gets Positive FDA Response for Ganaxolone Study
by Zacks Equity Research
Marinus (MRNS) gets positive FDA response for phase III Marigold study on oral ganaxolone in children and young adults with CDKL5 deficiency disorder that appears sufficient to support the NDA filing.
Regeneron (REGN), U.S. Government Ink Deal for COVID-19 Treatment
by Zacks Equity Research
Regeneron (REGN) inks deal with the U.S. government to sell additional 1.25 million doses (an agreement value of up to $2.625 billion) of its COVID-19 antibody cocktail.
AbbVie (ABBV) Inks Deal to Acquire Medical Device Company
by Zacks Equity Research
AbbVie (ABBV) signs an agreement to acquire privately held Cypris Medical, including the latter's Xact device which is used for performing face and neck lifts.
3 Biotech Stocks Poised to Outperform Amid Coronavirus Pandemic
by Ekta Bagri
The focus on coronavirus treatments should maintain momentum for the Zacks Biomedical and Genetics industry. A strong portfolio and solid pipeline progress position NVAX, HALO and BPMC to outperform.
Editas (EDIT) Gets FDA Nod to Begin Safety Study on EDIT-301
by Zacks Equity Research
The FDA clears the initiation of the safety phase of Editas' (EDIT) early-stage study on investigational gene-editing therapy EDIT-301 for treating sickle cell disease. Shares down.
bluebird (BLUE) to Spin Off Oncology Unit Into Separate Entity
by Zacks Equity Research
bluebird (BLUE) to separate its severe genetic disease and oncology businesses into different and independent publicly traded companies. Shares up.
Horizon (HZNP) Provides Preliminary 2020 Financial Results
by Zacks Equity Research
Horizon (HZNP) provides 2020 preliminary financial results and updates on its key drugs.
Ultragenyx (RARE) Presents Preliminary 2020 Revenues & Guidance
by Zacks Equity Research
Ultragenyx (RARE) provides preliminary 2020 Crysvita revenues and 2021 revenue guidance for the same.
Sarepta (SRPT) Looks Good: Stock Adds 9.1% in Session
by Zacks Equity Research
Sarepta (SRPT) saw a big move last session, as its shares jumped more than 9% on the day, amid huge volumes.
Infrastructure and Energy Alternatives, Carrols Restaurant, Moderna, Blueprint Medicines and Halozyme Therapeutics highlighted as Zacks Bull and Bear of the Day
by Zacks Equity Research
Infrastructure and Energy Alternatives, Carrols Restaurant, Moderna, Blueprint Medicines and Halozyme Therapeutics highlighted as Zacks Bull and Bear of the Day
Merus (MRUS) Stock Up on FDA's Fast Track Tag for Zenocutuzumab
by Zacks Equity Research
The FDA bestows a Fast Track status to Merus' (MRUS) lead pipeline candidate, Zenocutuzumab, for treating metastatic solid tumors harboring NRG1 gene fusions. Shares rise.
Alnylam (ALNY) Posts Positive Top-Line Data From Vutrisiran Study
by Zacks Equity Research
Alnylam (ALNY) reports positive top-line results from the phase III -HELIOS-A study of vutrisiran in development for the treatment of transthyretin-mediated amyloidosis with polyneuropathy.
3 Biotech Stocks Worth Adding to Your Portfolio in 2021
by Ekta Bagri
We highlight a few biotech companies, which outperformed the sector in 2020 and are likely to witness a winning run in the near term.
Catayst (CPRX) Provides Long-Term Portfolio Expansion Plans
by Zacks Equity Research
Catalyst (CPRX) plans to expand its product portfolio beyond Firdapse.
REGENXBIO (RGNX) Provides Update on RGX-314 & Begins New Program
by Zacks Equity Research
REGENXBIO (RGNX) provided an update on the RGX-314 programs. Further, the company made an announcement of a new program, RGX-202, for the treatment of Duchenne Muscular Dystrophy
Calithera (CALA) Plunges as CANTANA Study on Telaglenastat Fails
by Zacks Equity Research
Calithera (CALA) tanks as CANTATA study on its lead pipeline candidate, telaglenastat, did not achieve its primary goal for RCC.
Generation Bio (GBIO) Catches Eye: Stock Jumps 6.1%
by Zacks Equity Research
Generation Bio (GBIO) saw a big move last session, as its shares jumped more than 6% on the day, amid huge volumes.
Lexicon (LXRX) Starts Dosing in Post-Herpetic Neuralgia Study
by Zacks Equity Research
Lexicon (LXRX) initiates dosing in a mid-stage study on LX9211 for the treatment of post-herpetic neuralgia.
Incyte (INCY) Partners With Cellenkos for Myelofibrosis Treatment
by Zacks Equity Research
Incyte (INCY) enters into a collaboration with Cellenkos to evaluate the combination of Jakafi and CK0804 in patients with myelofibrosis.
Bristol Myers' (BMY) Application for UC Drug Validated by EMA
by Zacks Equity Research
Bristol Myers' (BMY) MAA for Zeposia for the treatment of adults with moderately to severely active ulcerative colitis gets validated by EMA.
Exelixis (EXEL) Posts Positive Data From Thyroid Cancer Study
by Zacks Equity Research
Exelixis' (EXEL) cabozantinib meets the co-primary endpoint in the late-stage study for the treatment of differentiated thyroid cancer following anti-VEGFR therapy.