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Zacks News
Sanofi's (SNY) Dupixent Prurigo Nodularis NDA Gets Priority Tag
by Zacks Equity Research
The FDA grants priority review to Sanofi's (SNY) sBLA for Dupixent to include adults with prurigo nodularis, a chronic inflammatory skin disease.
Reata (RETA) Up More Than 12% YTD: What's Driving the Rally?
by Zacks Equity Research
Reata's (RETA) prospects are likely to improve following the potential approval of its lead candidate, omaveloxolone, expected by the end of 2022 is likely driving its share price.
Novartis (NVS) Wins FDA Nod for Label Expansion of Kymriah
by Zacks Equity Research
Novartis' (NVS) CAR-T cell therapy Kymriah (tisagenlecleucel) gets an FDA approval for a third indication.
Bristol Myers' (BMY) Opdivo Combos Get FDA Nod for ESCC
by Zacks Equity Research
Bristol Myers (BMY) secures an FDA approval for two Opdivo-based regimens as the first-line treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma.
Veeva Systems (VEEV) Vault CTMS to Aid Clinical Trial Management
by Zacks Equity Research
Veeva System's (VEEV) Vault CTMS to streamline complex trial processes for more than 150 companies.
Iovance (IOVA) Down After Announcing Data From Melanoma Study
by Zacks Equity Research
Results from a cohort of the phase II study evaluating Iovance's (IOVA) melanoma candidate were not as superior as data from another cohort of the same study.
Pfizer (PFE) Gets Fast Track Designation for NASH Therapy
by Zacks Equity Research
Pfizer (PFE) obtains Fast Track designation for its investigational combination therapy - ervogastat and clesacostat for the treatment of NASH.
Why Is Alkermes (ALKS) Down 1.4% Since Last Earnings Report?
by Zacks Equity Research
Alkermes (ALKS) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Reasons to Add AMN Healthcare (AMN) Stock to Your Portfolio
by Zacks Equity Research
Investors remain optimistic about AMN Healthcare (AMN) on its broad array of services.
Axcella (AXLA) Up on Decision to Prioritize Long-COVID Program
by Zacks Equity Research
Axcella (AXLA) re-prioritizes its clinical portfolio to focus on the development of AXA1125 targeting long COVID and NASH. It also suspends the development of AXA1665 to focus resources on AXA1125 studies.
Hologic (HOLX) Gets CE Mark for Fusion Molecular Assays
by Zacks Equity Research
Hologic's (HOLX) two new molecular assays monitor transplant patients for EBV and BKV.
Haemonetics (HAE) Gains on Procedure Recovery Amid Cost Woes
by Zacks Equity Research
A strong procedure recovery in the hospital business, the resilience of blood donors in blood centers, and rollouts of Persona technology and NexSys aid Haemonetics (HAE).
J&J (JNJ) Carvykti Gets EU Nod for Advanced Multiple Myeloma
by Zacks Equity Research
The European Commission approved J&J's (JNJ) BCMA-directed CAR-T cell therapy, Carvykti to treat patients with multiple myeloma who have already received multiple treatments.
Reata (RETA) Friedreich's Ataxia NDA Gets Priority Review
by Zacks Equity Research
Reata (RETA) is seeking approval for omaveloxolone as a treatment for neuromuscular disorder Friedreich's ataxia. The FDA grants priority review to the NDA for the same. Stock rises.
Verrica (VRCA) Down 64% as Molluscum Drug Gets CRL From FDA
by Zacks Equity Research
Verrica Pharmaceuticals' (VRCA) new drug application for VP-102 to treat molluscum contagiosum faces rejection from the FDA for a second time.
Roche (RHHBY) Gets EC Approval for Polivy Combination in DLBCL
by Zacks Equity Research
Roche's (RHHBY) Polivy combination receives the European Commission's approval for patients with previously untreated diffuse large B-cell lymphoma.
Esperion (ESPR) Up More Than 12% YTD: What's Driving the Rally?
by Zacks Equity Research
Esperion's (ESPR) marketed drugs are the key drivers of the stock. Sales of the drugs increase more than 100% during the first quarter. Strong sales growth is expected to continue in 2022 as well as 2023.
Reasons to Hold on to Myriad Genetics (MYGN) Stock for Now
by Zacks Equity Research
Investors are optimistic about Myriad Genetics (MYGN) owing to strong Q1 2022 results and growth in testing volumes.
Aerie (AERI) Starts Late-Stage Study to Treat Dry Eye Disease
by Zacks Equity Research
Aerie Pharmaceutials (AERI) doses the first patient in a phase III study on its investigational TRMP8 agonist drug for the treatment of dry eye disease.
Here's Why You Must Add Masimo (MASI) Stock to Your Portfolio
by Zacks Equity Research
Investors continue to be optimistic about Masimo (MASI) due to its focus on patient monitoring.
Masimo's (MASI) PVi Favored by New Study for Pediatric Patients
by Zacks Equity Research
Masimo's (MASI) PVi is expected to take better treatment decisions for pediatric patients with signs of obstructive respiratory disease in the EDs.
Here's Why You Should Retain Amedisys (AMED) Stock for Now
by Zacks Equity Research
Investors are optimistic about the robust performances of Amedisys' (AMED) Home Health and Hospice segments.
Pfizer (PFE) Reports More Positive Data From Etrasimod Study
by Zacks Equity Research
Pfizer (PFE) states that data from the ELEVATE 12 and ELEVATE 52 studies will form the basis of the regulatory submissions on etrasimod expected later this year
Merck (MRK) Keytruda Gets EU Nod for Expanded Breast Cancer Use
by Zacks Equity Research
The European Commission approves Merck's (MRK) Keytruda for high-risk early-stage TNBC, which expands its eligible patient population.
Sanofi, Regeneron's Dupixent Gets FDA Nod for 4th Indication (Revised)
by Zacks Equity Research
The FDA approves Sanofi's (SNY) Dupixent for treating adults and children aged 12 and older with eosinophilic esophagitis, a chronic, progressive inflammatory disease.