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Zacks News
Gilead (GILD) Gets Full Approval for Breast Cancer Drug Trodelvy
by Zacks Equity Research
Gilead (GILD) obtains full approval for its breast cancer drug, Trodelvy, in the United States for metastatic triple-negative breast cancer.
Roche's (RHHBY) SMA Treatment Evrysdi Secures EC Approval
by Zacks Equity Research
Roche (RHHBY) gains a regulatory nod for its SMA treatment Evrysdi in Europe for patients aged two months and above.
Seagen's (SGEN) MAA for Enfortumab Vedotin Gets EMA Acceptance
by Zacks Equity Research
The European Medicines Agency accepts Seagen (SGEN) and Astellas Pharma's marketing application for enfortumab vedotin for treating adult patients with advanced/metastatic urothelial cancer.
Gilead's (GILD) Breast Cancer Drug MAA Validated by EMA
by Zacks Equity Research
Gilead's (GILD) regulatory application for breast cancer drug has been validated by the regulatory body in Europe.
Bristol-Myers (BMY) Announces Results From Opdivo Combo Study
by Zacks Equity Research
Bristol-Myers (BMY) announces encouraging primary results from a study, evaluating a fixed-dose combination of relatlimab and immuno-oncology drug, Opdivo, in metastatic or unresectable melanoma.
Biotech Stock Roundup: REGN Cocktail Data Positive, INCY's Jakafi Disappoints & More
by Zacks Equity Research
The biotech sector was in focus last week with vaccine and antibody updates from quite a few companies like Regeneron (REGN) and Incyte (INCY).
Regeneron (REGN) Announces Positive Data on COVID-19 Cocktail
by Zacks Equity Research
Regeneron (REGN) announces positive data from a phase III study on its antibody cocktail for COVID-19.
Roche (RHHBY) Stops Dosing in Huntington's Disease Study
by Zacks Equity Research
Roche (RHHBY) halts dosing in the phase III GENERATION HD1 study evaluating tominersen in manifest Huntington's disease following recommendation from an iDMC.
Ionis (IONS) Crashes as Roche-Partnered Huntington's Drug Fails
by Zacks Equity Research
Ionis (IONS) stock sinks as partner Roche stops dosing in a late-stage study on tominersen in Huntington's disease.
Roche's (RHHBY) Tecentriq Meets Primary Goal in Lung Cancer Study
by Zacks Equity Research
Roche's (RHHBY) Tecentriq meets primary endpoint of disease-free survival at the interim analysis in lung cancer patients.
Exelixis (EXEL) Inks Collaboration Deal to Test XL092 Combo in UC
by Zacks Equity Research
Exelixis (EXEL) signs a collaboration and supply agreement with Merck KGaA and Pfizer to investigate XL092 in combination with Bavencio for treating various forms of urothelial carcinoma.
Roche (RHHBY) Inks Deal to Acquire GenMark Diagnostics for $1.8B
by Zacks Equity Research
Roche (RHHBY) signs an agreement to acquire GenMark Diagnostics to test a broad range of pathogens using one patient sample. The deal is valued at around $1.8 billion on a fully diluted basis.
Roche (RHHBY) & Gilead's Drug Combo Study for COVID-19 Fails
by Zacks Equity Research
Roche's (RHHBY) Actemra in combination with Gilead's (GILD) Veklury did not meet the primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia.
Pharma Stock Roundup: EU Nod for J&J COVID-19 Vaccine, Updates From LLY, GSK, MRK
by Kinjel Shah
Europe clears J&J's (JNJ) COVID-19 vaccine. Eli Lilly (LLY), Merck (MRK) and Glaxo (GSK) give update on their COVID-19 antibody/antiviral candidates.
BioMarin (BMRN) Hemophilia Gene Therapy Gets FDA's RMAT Tag
by Zacks Equity Research
FDA grants RMAT designation to BioMarin's (BMRN) gene therapy for severe hemophilia A, valoctocogene roxaparvovec, after rejecting it last year.
Roche (RHHBY) Withdraws Bladder Cancer Indication for Tecentriq
by Zacks Equity Research
Roche (RHHBY) voluntarily withdraws the bladder cancer indication of Tecentriq in the United States.
Pfizer's (PFE) Lorbrena Gets FDA Nod for First-Line Lung Cancer
by Zacks Equity Research
Pfizer's (PFE) label expansion application for Lorbrena as first-line treatment for metastatic lung cancer gets approval in the United States.
Amicus' (FOLD) Q4 Earnings Miss Estimates, Sales Beat on Galafold
by Zacks Equity Research
Amicus (FOLD) reports a wider-than-expected Q4 loss but sales beat estimates.
Puma (PBYI) Q4 Loss Wider Than Expected, Nerlynx Sales Fall
by Zacks Equity Research
Puma Biotech (PBYI) reports wider-than-expected fourth-quarter loss while sales beat estimates.
Epizyme's (EPZM) Q4 Loss Wider than Expected, Sales Beat
by Zacks Equity Research
Epizyme (EPZM) incurs a wider-than-expected loss but beats sales estimates in the fourth quarter of 2020.
Halozyme (HALO) Q4 Earnings Miss, 2021 View Weak, Stock Falls
by Zacks Equity Research
Halozyme (HALO) reports lower-than-expected fourth-quarter earnings. However, revenues beat estimates. The company's outlook for 2021 is below market expectations.
Blueprint Medicines (BPMC) Q4 Earnings Beat, Revenues In Line
by Zacks Equity Research
Blueprint Medicines' (BPMC) earnings beat estimates in the fourth quarter of 2020 while revenues meet the same. Shares up.
Seagen (SGEN) Gets European Commission Nod for Breast Cancer Drug
by Zacks Equity Research
The European Commission approves Seagen's (SGEN) Tukysa in combination with Herceptin and Xeloda to treat adults with HER2-positive locally advanced or metastatic breast cancer.
ImmunoGen (IMGN) Q4 Earnings & Sales Top, Pipeline on Track
by Zacks Equity Research
ImmunoGen (IMGN) reports encouraging fourth-quarter results. Top-line data readout from pivotal studies on its lead candidate, mirvetuximab soravtansine, remains on track.
Prothena's (PRTA) Q4 Loss Narrower Than Expected, Revenues Beat
by Zacks Equity Research
Prothena (PRTA) beats on earnings in the fourth quarter of 2020 and surpasses sales estimates too.