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Zacks News
Pfizer (PFE) to Boost RSV Portfolio With ReViral Acquisition
by Zacks Equity Research
Pfizer (PFE) inks an agreement to acquire ReViral for up to $525 million, which will add the latter's respiratory syncytial virus therapeutic candidates to its portfolio.
Aptinyx (APTX) Tanks as Neuropathic Pain Study Misses Goal
by Zacks Equity Research
Aptinyx's (APTX) phase IIb study evaluating the effects of NYX-2925 in patients with painful diabetic peripheral neuropathy misses the primary endpoint. Stock falls sharply.
Adverum (ADVM) Up on FDA Feedback for Gene Therapy Study
by Zacks Equity Research
Adverum (ADVM) to submit IND amendment to the FDA by mid-2022 for starting a mid-stage study on its gene therapy candidate ADVM-022 for treating wet AMD eye disorder.
Rhythm Pharmaceuticals (RYTM) Down Due to Study Design Changes
by Zacks Equity Research
Rhythm Pharmaceuticals (RYTM) modifies the design of its two genetic obesity disorder studies to focus on rare patients, thus reducing the targeted population size. RYTM expects to save costs in the process.
Novartis (NVS) Anti-PD-1 Drug Validated by EMA for Lung Cancer
by Zacks Equity Research
Novartis (NVS) application seeking approval of tislelizumab in multiple non-small cell lung cancer and esophageal squamous cell carcinoma indications gets EMA's validation.
Bristol Myers (BMY) Gets EC Nod for CAR T Cell Therapy Breyanzi
by Zacks Equity Research
The European Commission grants marketing authorization to Bristol Myers' (BMY) Breyanzi for treating certain forms of relapsed or refractory large b-cell lymphoma.
Novartis (NVS) Gets FDA Nod for Vijoice in Rare Disorder
by Zacks Equity Research
The FDA approves Novartis' (NVS) Vijoice (alpelisib) for the treatment of select patients with PIK3CA-related overgrowth spectrum.
Bristol Myers (BMY) Gets EC Nod for Opdivo's Label Expansion
by Zacks Equity Research
Bristol Myers (BMY) receives EC approval for label expansion of Opdivo for ESCC and urothelial carcinoma.
Reata (RETA) Submits NDA for Friedreich's Ataxia Candidate
by Zacks Equity Research
Reata (RETA) is seeking approval for omaveloxolone as a treatment for neuromuscular disorder Friedreich's ataxia. It completes the rolling submission of an NDA for the same. Stock rises.
Roche (RHHBY) Late-Stage Study for ES-SCLC Fails to Meet Goal
by Zacks Equity Research
Roche (RHHBY) phase III SKYSCRAPER-02 study assessing tiragolumab plus Tecentriq and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer did not meet co-primary endpoint of progression-free survival.
Pfizer (PFE) 2nd Ulcerative Colitis Study on Etrasimod Succeeds
by Zacks Equity Research
Pfizer's (PFE) ELEVATE UC 52 is the second phase III study on etrasimod for ulcerative colitis to have met primary and key secondary endpoints.
ORIC Stock Plunges on Discontinuation of Oncology Candidate
by Zacks Equity Research
ORIC declines on discontinuation of pipeline candidate ORIC-101 following planned interim analyses of two phase Ib studies.
argenx (ARGX) Up on Positive Autoimmune Disorder Study Data
by Zacks Equity Research
argenx (ARGX) plans to file a BLA for the SC formulation of efgartigimod, developed using Halozyme's ENHANZE technology, for treating myasthenia gravis disease, an autoimmune disorder, in 2022.
Vertex (VRTX) to Begin Pivotal Study on Kidney Candidate
by Zacks Equity Research
Vertex's (VRTX) pivotal phase III study on VX-147 targeting a broad patient population with proteinuric kidney disease mediated by two mutations in the APOL1 gene (AMKD) is expected to begin later this month.
Vallon (VLON) Plummets as ADAIR Study Misses Primary Goal
by Zacks Equity Research
Vallon Pharmaceuticals (VLON) down as SEAL study evaluating lead investigational product candidate, ADAIR, fails to meet its primary endpoint.
Voyager Therapeutics (VYGR) Surges 12.1%: Is This an Indication of Further Gains?
by Zacks Equity Research
Voyager Therapeutics (VYGR) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.
AstraZeneca's (AZN) Fasenra sBLA for Nasal Polyps Gets CRL
by Zacks Equity Research
The FDA gives CRL to AstraZeneca's (AZN) sBLA for Fasenra for chronic rhinosinusitis with nasal polyps (CRSwNP) for want of additional clinical
AstraZeneca (AZN) Stock Up 27% in a Year: What Lies Ahead?
by Zacks Equity Research
AstraZeneca's (AZN) stock has risen 26.9% in the past year compared with an increase of 22.3% for the industry.
After Golden Cross, Voyager Therapeutics (VYGR)'s Technical Outlook is Bright
by Zacks Equity Research
Is it a good or bad thing when a stock experiences a golden cross technical event?
Novartis (NVS) Announces Data on Zolgensma, Acquires Coalesce
by Zacks Equity Research
Novartis (NVS) reports positive data on SMA treatment from a phase III study. It also acquires Coalesce Product Development Limited to strengthen its respiratory and complex generics business.
The Zacks Analyst Blog Highlights Ocugen, Voyager Therapeutics, BioNTech, Regeneron and Gilead Sciences
by Zacks Equity Research
Ocugen, Voyager Therapeutics, BioNTech, Regeneron and Gilead Sciences are included in this blog.
Biotech Stock Roundup: OCGN Down on Update, VYGR Surges on Deal & Other Updates
by Zacks Equity Research
Regulatory and other details from Ocugen (OCGN) as well as Voyager (VYGR) are a few key highlights from the biotech sector during the past week.
Voyager (VYGR) Gains on Deal With Novartis for Gene Therapies
by Zacks Equity Research
Voyager (VYGR) stock rises on the license option agreement with Novartis to get a target-specific access to next-generation TRACER AAV capsids for gene therapy programs.
VBI Vaccines, Inc. (VBIV) Reports Q4 Loss, Lags Revenue Estimates
by Zacks Equity Research
VBI Vaccines, Inc. (VBIV) delivered earnings and revenue surprises of 0% and 40.88%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?
Sarepta Therapeutics (SRPT) Reports Q4 Loss, Tops Revenue Estimates
by Zacks Equity Research
Sarepta Therapeutics (SRPT) delivered earnings and revenue surprises of 5.96% and 6.48%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?