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Zacks News
Apellis (APLS) Up More Than 40% in Past 3 Months: Here's Why
by Zacks Equity Research
Approval of Apellis' (APLS) Empaveli for treating paroxysmal nocturnal hemoglobinuria lends a significant boost to the company's growth prospects. The drug's label expansion studies also hold promise.
Lexicon (LXRX) Submits NDA to the FDA for Cardiovascular Drug
by Zacks Equity Research
Lexicon (LXRX) submits an application to the FDA seeking approval for sotagliflozin to lower the risk of cardiovascular death and hospitalization and urgent visits for heart failure in adult patients.
Blueprint Medicines (BPMC) Up 24.8% in Past 6 Months: Here's Why
by Zacks Equity Research
Blueprint Medicines' (BPMC) Ayvakit, approved to treat PDGFRA Exon 18 mutant gastrointestinal stromal tumors, has seen strong uptake since approval. Other pipeline candidates are also progressing well.
Kodiak Sciences (KOD) Focuses on Developing Eye Candidate KSI-301
by Zacks Equity Research
Kodiak Sciences (KOD) progresses well with the development of its lead candidate, KSI-301, for treating various retinal vascular diseases. Stiff competition in the target market remains a woe.
Kiniksa (KNSA) COVID-19 Study for ARDS Fails to Meet Main Goal
by Zacks Equity Research
Kiniksa (KNSA) reports that the phase III portion of mavrilimumab???s phase II/III study for COVID-related ARDS did not meet the primary efficacy endpoint.
Palatin (PTN) Begins Phase III Study For Dry Eye Disease
by Zacks Equity Research
Palatin (PTN) commences the pivotal phase III study evaluating PL9643 for the treatment of dry eye disease. Top-line data from the same is expected in the second half of 2022.
Goldman Sachs, GameStop, Repligen, Sarepta Therapeutics and BeiGene highlighted as Zacks Bull and Bear of the Day
by Zacks Equity Research
Goldman Sachs, GameStop, Repligen, Sarepta Therapeutics and BeiGene highlighted as Zacks Bull and Bear of the Day
3 Biotech Stocks Worth Adding to Your Portfolio Next Year
by Ekta Bagri
Here we present three biotech companies, which are likely to perform well in 2022, backed by strong fundamentals.
The Zacks Analyst Blog Highlights: Daqo New Energy, Pinterest, Sarepta Therapeutics, JOYY and Chindata Group
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Daqo New Energy, Pinterest, Sarepta Therapeutics, JOYY and Chindata Group
Lilly's (LLY) Eczema Study on Lebrikizumab Combo Meets Goal
by Zacks Equity Research
Eli Lilly's (LLY) pivotal phase III study on lebrikizumab in combination with topical corticosteroids meets the primary and key secondary endpoints.
Novartis (NVS) to Buy Gyroscope, Submits Herceptin Biosimilar to EMA
by Zacks Equity Research
Novartis (NVS) is set to acquire ocular gene therapy company Gyroscope Therapeutic. Generic arm Sandoz submits a marketing authorization application for a proposed biosimilar of Herceptin.
ACADIA (ACAD) Up on Resubmission Plan for Nuplazid sNDA to FDA
by Zacks Equity Research
ACADIA (ACAD) to resubmit sNDA for Nuplazid (pimavanserin) to the FDA for treating hallucinations and delusions associated with dementia focused on Alzheimer's disease psychosis. Shares rise.
Sanofi (SNY) to Acquire Amunix, Boost Immuno-oncology Pipeline
by Zacks Equity Research
Sanofi (SNY) inks a deal to acquire privately-held Amunix Pharmaceuticals, which will add potentially transformative cancer therapies to its immuno-oncology pipeline.
Novartis (NVS) Collaborates With BeiGene for Oncology Drug
by Zacks Equity Research
Novartis (NVS) signs collaboration and license agreement with BeiGene for ociperlimab (BGB-A1217), expanding research and development activities in immuno-oncology.
Gilead's (GILD) Veklury Gets EC Nod for Use in Early COVID-19
by Zacks Equity Research
Gilead's (GILD) Veklury can now be used in the EU at the early stages of COVID-19 to help prevent disease progression in high-risk patients.
These 5 Loser Stocks of 2021 Could be Big Winners in 2022
by Anindya Barman
The momentum in the equity markets is expected to stay on firm-footing in 2022. DQ, PINS, SRPT, YY and CD have a chance to outperform next year.
Seagen (SGEN) Gets Positive CHMP Opinion for Bladder Cancer Drug
by Zacks Equity Research
The CHMP gives a positive opinion on, and recommends approval to Seagen's (SGEN) Padcev as a monotherapy for treating adult patients with locally advanced/metastatic urothelial cancer.
Pfizer (PFE) to Test 3-Dose COVID-19 Vaccine Regimen in Kids
by Zacks Equity Research
Pfizer (PFE) and BioNTech (BNTX) to evaluate a third, 3 ug dose at least two months after the second dose of Comirnaty in children aged six months to five years for better protection against COVID-19.
Global Blood (GBT) Gets FDA Nod for Oxbryta Label Expansion
by Zacks Equity Research
The FDA approves Global Blood's (GBT) sNDA for Oxbryta to treat SCD in children aged four to less the 12 years, and NDA for a pediatric weight-based formulation of the drug.
Vir (VIR), Glaxo's Xevudy Wins EC Approval for COVID-19
by Zacks Equity Research
Vir Biotechnology, Inc. (VIR) and partner GlaxoSmithKline obtain the European Commission's nod for Xevudy for the early treatment of COVID-19.
Emergent (EBS) Begins Dosing in Study on Influenza Vaccine
by Zacks Equity Research
Emergent (EBS) initiates a phase I study evaluating EBS-UFV-001, the company's investigational universal influenza vaccine candidate.
uniQure (QURE) Falls on Data From Huntington's Disease Study
by Zacks Equity Research
uniQure (QURE) reports initial data on the first four patients enrolled in the lower-dose cohort of its ongoing phase I/II clinical trial of AMT-130 for treating Huntington's disease.
Bristol Myers' (BMY) Orencia Gets FDA Nod for New Indication
by Zacks Equity Research
The FDA approves Bristol Myers' (BMY) Orencia in combination with a calcineurin inhibitor and methotrexate to prevent acute graft versus host disease. This is the fourth FDA-approved indication for the drug.
Apellis (APLS), Sobi Get EU Nod for Rare Blood Disorder Drug
by Zacks Equity Research
The European Commission approves Apellis (APLS) and Sobi's Aspaveli for the treatment of paroxysmal nocturnal hemoglobinuria in adult patients. Shares rise.
Calliditas' (CALT) Tarpeyo Wins FDA Approval for Renal Disease
by Zacks Equity Research
Calliditas (CALT) obtains accelerated approval for Tarpeyo to reduce proteinuria in IgA nephropathy in the United States.