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Zacks News
Roche (RHHBY) to Acquire Jecure and Enter the NASH Space
by Zacks Equity Research
Roche (RHHBY) is all set to acquire biotech Jecure Therapeutics, which focuses on the discovery of novel therapeutics for the treatment of NASH and liver fibrosis.
Catalyst's Firdapse Receives FDA Approval for Rare Disease
by Zacks Equity Research
Catalyst's (CPRX) Firdapse gets FDA approval for the treatment of LEMS in adults.
Novartis (NVS) Receives EC Approval for Neulasta Biosimilar
by Zacks Equity Research
Novartis (NVS) obtains EC approval for Ziextenzo, the biosimilar of Amgen's Neulasta.
Pfizer's Epilepsy Drug Lyrica Gets Pediatric Exclusivity
by Zacks Equity Research
Pfizer (PFE) receives pediatric exclusivity for its epilepsy drug, Lyrica, extending the exclusivity period to Jun 30, 2019.
Celgene & Bluebird's CAR T Therapy Study Completes Enrollment
by Zacks Equity Research
Celgene (CELG) and partner bluebird complete enrollment in a phase II study for CAR T cell therapy candidate, bb2121 for patients with relapsed and refractory multiple myeloma.
Aileron Inks Collaboration Deal With Pfizer for Cancer Combo
by Zacks Equity Research
Aileron Therapeutics (ALRN) signs a clinical trial collaboration contract with Pfizer to study the combo of Aileron's ALRN-6924 and Pfizer's Ibrance for treating MDM2-amplified cancers. Stock rises.
Zafgen (ZFGN) Plunges as FDA Puts Hold on Diabetes Drug Trial
by Zacks Equity Research
Zafgen's (ZFGN) stock plunges significantly as the FDA placed a clinical hold on the company's first trial on experimental diabetes drug, ZGN-1061.
Alnylam, Vir Begin Phase I/II Study on Hepatitis B Candidate
by Zacks Equity Research
Alnylam (ALNY) and Vir commence phase I/II study for VIR-2218 for the treatment of chronic HBV infection.
Bristol-Myers' Opdivo-Yervoy Combo Fails in Lung Cancer Trial
by Zacks Equity Research
Bristol-Myers' (BMY) immuno-oncology drug Opdivo combined with Yervoy fails to meet the goal in a late-stage study for extensive-stage SCLC.
Eyenovia Initiates Phase III Study for Mydriasis Candidate
by Zacks Equity Research
Eyenovia (EYEN) starts enrollment in the first phase III study of a two clinical study program to evaluate its mydriasis candidate, MicroStat. Stock rallies.
Bayer's TRK Inhibitor Gets FDA Nod for Advanced Solid Tumors
by Zacks Equity Research
Bayer (BAYRY) receives the FDA approval for larotrectinib for the treatment of adult and pediatric patients having solid tumors with NTRK gene fusion.
Gilead's HIV Franchise, CAR T Therapy Likely to Propel Growth
by Zacks Equity Research
Gilead's (GILD) HIV franchise is expected to maintain momentum and offset the decline from the HCV franchise.
Novartis Gets Approval for Gene Therapy Luxturna in Europe
by Zacks Equity Research
Novartis (NVS) obtains EC approval for a one-time gene therapy, Luxturna for the treatment of patients with vision loss due to a genetic mutation in both copies of the RPE65gene.
Biotech Stock Roundup: GILD's Drug Wins Nod in China, Arena Up On Licensing Deal
by Zacks Equity Research
Regulatory news and licensing contracts are key highlights in the biotech sector this week.
Should Value Investors Consider Gilead (GILD) Stock Now?
by Zacks Equity Research
Let's see if Gilead Sciences, Inc. (GILD) stock is a good choice for value-oriented investors right now, or if investors subscribing to this methodology should look elsewhere for top picks.
Gilead's Vemlidy Gets Approval in China for HBV Infection
by Zacks Equity Research
Gilead (GILD) obtains approval for Vemlidy in China for the treatment of chronic hepatitis B in adults and adolescents.
Emergent's (EBS) Zika Vaccine Candidate Meets Study Endpoint
by Zacks Equity Research
Emergent BioSolutions (EBS) and partner Valneva present positive data from an early-stage study on the Zika vaccine candidate, VLA1601.
Novartis (NVS) Gets FDA Nod for Label Expansion of Promacta
by Zacks Equity Research
Novartis (NVS) obtains FDA approval for the label expansion of Promacta. The CHMP also issues a positive opinion for the label expansion of Kisqali.
Amgen's Blincyto Gets Positive CHMP Opinion for Line Extension
by Zacks Equity Research
Amgen's (AMGN) leukemia drug, Blincyto receives positive CHMP opinion for label expansion to include minimal residual disease.
Biotech Stock Outlook: Approval of New Drugs to Boost Performance
by Zacks Equity Research
While decline in sales of high-profile drugs and competitive pressure are likely to weigh on the biotech sector, we expect approval of new drugs to offset the impact of the same.
Bristol-Myers' Opdivo Receives Positive CHMP Opinion for RCC
by Zacks Equity Research
Bristol-Myers' (BMY) immuno-oncology drug Opdivo combined with low-dose Yervoy gets positive opinion from CHMP for the treatment of intermediate- and poor-risk advanced RCC.
Sangamo's Shares Drop on Rating Downgrade, Pipeline Woes
by Zacks Equity Research
Sangamo Therapeutics (SGMO) postpones data presentation from its haemophilia study, following dose escalation recommendation from an independent committee. This raises concerns about its development.
Acorda Down More Than 30% in the Past 3 Months: Here's Why
by Zacks Equity Research
Acorda's (ACOR) lead MS drug Ampyra is hit by generic competition in the United States while its lead Parkinson disease candidate Inbrija's review timeline gets extended by three months.
BeiGene (BGNE) Catches Eye: Stock Jumps 8.3%
by Zacks Equity Research
BeiGene (BGNE) saw a big move last session, as its shares jumped more than 8% on the day, amid huge volumes.
Biotech Stock Roundup: Gilead, Regeneron Present Data, Cocrystal Pharma Surges
by Zacks Equity Research
With the earnings season coming to an end, data presentations on key drugs and candidates hog the limelight this week.