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Zacks News
Seagen (SGEN) Gets Regular Approval, Label Expansion for Padcev
by Zacks Equity Research
Seagen and Astellas' two sBLAs for Padcev get FDA approval for patients with locally advanced or metastatic urothelial cancer. The approval comes one month before the PDUFA date of Aug 17, 2021.
F-star (FSTX), AstraZeneca Team Up for Novel STING Inhibitors
by Zacks Equity Research
F-star partners with AstraZeneca for its novel STING inhibitor compounds. Resultantly, F-star's shares rise 9.1%.
3 Big Drugmakers to Buy Ahead of the Q2 Earnings Season (Revised)
by Kinjel Shah
AstraZeneca (AZN), AbbVie (ABBV) and Bayer (BAYRY) are three large drug sector companies worth buying now.
Biohaven (BHVN) Q2 Nurtec Preliminary Sales Top Expectations
by Zacks Equity Research
Biohaven Pharmaceutical's (BHVN) sole approved drug, Nurtec ODT's preliminary sales outperform expectations. Resultantly, share increase 13.6%.
Vaxart (VXRT) Enters an Agreement With Altesa for Antiviral
by Zacks Equity Research
Vaxart (VXRT) enters a licensing agreement with Altesa Biosciences, Inc., whereby the latter gets rights to develop, manufacture and commercialize vapendavir.
ChemoCentryx (CCXI) Files Amendment to NDA for Avacopan
by Zacks Equity Research
ChemoCentryx (CCXI) files an amendment to its NDA for avacopan for treatment of ANCA-associated vasculitis. The new PDUFA date is Oct 7. The filing constitutes a major amendment to the original NDA.
AstraZeneca (AZN) Gets EC's Clearance for Alexion Acquisition
by Zacks Equity Research
AstraZeneca (AZN) obtains European Commission's permission for the acquisition of Alexion. The deal is expected to close in the third quarter of 2021.
3 Big Drugmakers to Buy Ahead of the Q2 Earnings Season
by Kinjel Shah
AstraZeneca (AZN), AbbVie (ABBV) and Bayer (BAYRY) are three large drug sector companies worth buying now.
Glaxo (GSK)/Alector Ink Deal for Neurodegenerative Indications
by Zacks Equity Research
Glaxo (GSK) and Alector set to co-develop and co-commercialize AL001 and AL101 for neurodegenerative diseases. Glaxo issues a formal response to activist hedge investor, Elliott's call for board changes.
3 Reasons to Invest in Regeneron Pharmaceuticals (REGN) Now
by Zacks Equity Research
Regeneron's (REGN) efforts to expand the label of its approved drugs and concurrently develop the pipeline are impressive and makes it a good bet for investors, for now.
Arcutis (ARQT) Terminates Study of Drug to Treat Vitiligo
by Zacks Equity Research
Arcutis (ARQT) ends phase IIa study evaluating its investigational anti-JAK1 candidate, ARQ-252, to treat vitiligo.
The Zacks Analyst Blog Highlights: Eli Lilly, Pfizer, BioNTech and Bayer
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Eli Lilly, Pfizer, BioNTech and Bayer
Allogene (ALLO) Multiple Myeloma Candidate Gets Fast Track Tag
by Zacks Equity Research
Allogene's (ALLO) next-generation allogeneic CAR T therapy, ALLO-605, gets Fast Track designation from the FDA to treat patients with relapsed or refractory multiple myeloma.
CureVac (CVAC) Announces Final Analysis of its COVID-19 Vaccine Study
by Zacks Equity Research
CureVac (CVAC) announces final analysis from its HERALD study on CVnCoV showing efficacy of 48%.
3 Big Drugmakers Likely to be in Focus in Second Half of 2021
by Kinjel Shah
Eli Lilly (LLY), Pfizer (PFE) and Bayer (BAYRY) are three large drug sector companies worth buying and holding for the next few months and beyond.
Horizon (HZNP) Begins Phase II Study for Lupus Candidate
by Zacks Equity Research
Horizon (HZNP) starts phase II study to evaluate HZN-7734, an antibody to treat systemic lupus, which is an autoimmune disease wherein the immune system mistakenly attacks healthy cells and tissues.
Agios (AGIO) Files MAA in EU for Rare Genetic Disease Drug
by Zacks Equity Research
Agios Pharmaceuticals (AGIO) files a MAA in Europe for its most advanced drug, mitapivat, to treat adults with pyruvate kinase deficiency.
BioMarin's (BMRN) Vosoritide Gets CHMP Nod to Treat Dwarfism
by Zacks Equity Research
Biomarin Pharmaceutical (BMRN) receives positive recommendation from Europe's CHMP for vosoritide to treat achondroplasia in children.
Regeneron (REGN)/Sanofi's Libtayo Approved for Additional Indications
by Zacks Equity Research
Regeneron (REGN) and partner Sanofi win EC approval for Libtayo for skin cancer and lung cancer.
J&J (JNJ)/Bayer Seek Nod for Xarelto for Blood Clots in Kids
by Zacks Equity Research
J&J (JNJ) and its partner Bayer seek approval of Xarelto as a treatment and prevention for venous thromboembolism in pediatric patients.
AstraZeneca (AZN) Rare Disorder Drug Koselugo Gets EU Nod
by Zacks Equity Research
AstraZeneca's (AZN) Koselugo becomes the first medicine approved in Europe for neurofibromatosis type 1 plexiform neurofibromas.
Bayer (BAYRY) Files Applications in US & EU for Cancer Treatment
by Zacks Equity Research
Bayer (BAYRY) submits an sNDA in the United States and an MAA in Europe for the combo of copanlisib and rituximab to treat two types of cancer indication.
CureVac (CVAC) Plummets on Disappointing COVID-19 Vaccine Data
by Zacks Equity Research
CureVac (CVAC) down as it announces that its first-generation COVID-19 vaccine candidate, CVnCoV, did not meet the prespecified statistical success criteria in a phase IIb/III study.
CRISPR (CRSP) Inks Deal for Gene Therapies in Neurological Diseases
by Zacks Equity Research
CRISPR Therapeutics (CRSP) signs a strategic collaboration with Capsida Biotherapeutics to develop/commercialize gene editing therapies for neurological diseases.
Pfizer (PFE) Gets FDA Nod for Pneumococcal Vaccine Prevnar 20
by Zacks Equity Research
Pfizer's (PFE) 20-valent pneumococcal conjugate vaccine candidate helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia.