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Zacks News
AstraZeneca Gets FDA Nod for Calquence Line Extension in CLL
by Zacks Equity Research
The FDA approves AstraZeneca's (AZN) Calquence to treat CLL patients, based on positive data from two phase III studies.
Pfizer Gets FDA Approval for Biosimilar of AbbVie's Humira
by Zacks Equity Research
The approval of Humira biosimilar is the fourth U.S. approval of a biosimilar product for Pfizer (PFE) in 2019.
Celgene's Revlimid-Rituximab Combo Gets Positive CHMP Opinion
by Zacks Equity Research
Celgene (CELG) gets a positive CHMP opinion, recommending the approval of Revlimid in combination with Rituxan for the treatment of adult patients with previously treated FL.
Roche Gets CHMP Opinion for Breast Cancer & Lymphoma Drugs
by Zacks Equity Research
Roche's (RHHBY) breast cancer candidate and lymphona candidate get positive CHMP opinion. The company inks a deal to acquire Promedior, Inc.
Halozyme (HALO) Earnings & Revenues Miss Estimates in Q3
by Zacks Equity Research
Halozyme (HALO) reports lower-than-expected earnings and revenues in third-quarter 2019. It lowers the sales outlook for 2019 and raises the same for operating expenses.
Roche's SMA Drug Meets Primary Endpoint in Pivotal Study
by Zacks Equity Research
Roche's (RHHBY) risdiplam meets primary endpoint in SUNFISH study in SMA patients.
Bristol-Myers' Opdivo/Yervoy sBLA for HCC Gets Priority Review
by Zacks Equity Research
Bristol-Myers' (BMY) label expansion application for Opdivo plus Yervoy combo regimen to include patients with hepatocellular carcinoma, a form of liver cancer, makes progress.
AbbVie Eyes Approval for Imbruvica+Rituxan in First-Line CLL
by Zacks Equity Research
AbbVie (ABBV) submits a regulatory application with the FDA seeking label expansion of Imbruvica as a first-line treatment for chronic lymphocytic leukemia in combination with Roche's Rituxan.
Global Blood's (GBT) Q3 Loss Widens, Voxelotor in Focus
by Zacks Equity Research
Global Blood (GBT) incurs a wider-than-expected loss in the third quarter of 2019. Moreover, voxelotor for the treatment of sickle cell disease is under review in the United States.
Puma (PBYI) Q3 Earnings Beat, Nerlynx Sales Weak, Stock Down
by Zacks Equity Research
Puma Biotech (PBYI) incurs narrower loss in Q3. Sales of Nerlynx decline sequentially. Stock drops 18%.
Prothena (PRTA) Reports Narrower-than-Expected Loss in Q3
by Zacks Equity Research
Prothena (PRTA) posts a narrower Q3 loss while sales surpass estimates.
Blueprint Medicines (BPMC) Q3 Earnings & Sales Top Estimates
by Zacks Equity Research
Blueprint Medicines' (BPMC) loss is narrower than estimated in the third quarter with revenues also beating the mark. Shares rise.
Mylan's (MYL) Q3 Earnings Beat Estimates, Revenues Miss
by Zacks Equity Research
Mylan's (MYL) earnings beat estimates but sales miss the same in the third quarter of 2019. The company updates guidance for 2019.
Value Biotech ETFs & Stocks to Buy Now
by Sanghamitra Saha
Biotech valuation looks attractive amid a volley of good news. Investors can tap these stocks and ETFs.
Infinity (INFI) Q3 Loss Wider Than Expected, IPI-549 in Focus
by Zacks Equity Research
Infinity's (INFI) wider-than-estimated loss in Q3 displeases investors. Revenues too fall short of the mark.
Immunomedics (IMMU) Reports Wider-Than-Expected Loss in Q3
by Zacks Equity Research
Immunomedics' (IMMU) loss lags estimates in Q3. The company fails to generate any revenues at the same time.
Exelixis (EXEL) Q3 Earnings Beat on Strong Cabometyx Sales
by Zacks Equity Research
Exelixis (EXEL) reports solid third-quarter 2019 results as Cabometyx maintains momentum.
Seattle Genetics (SGEN) Q3 Loss Widens, Revenues Top Mark
by Zacks Equity Research
Seattle Genetics (SGEN) incurs wider-than-expected loss in third-quarter 2019 but rides high on revenue beat.
Amgen (AMGN) Beats on Q3 Earnings, Ends Neuroscience R&D
by Zacks Equity Research
Amgen (AMGN) posts encouraging third-quarter 2019 results. It raises its previously issued sales guidance slightly while increasing the earnings range significantly.
Exelixis (EXEL) to Report Q3 Earnings: What's in the Cards?
by Zacks Equity Research
Investors are looking forward to Cabometyx's performance and pipeline updates, when Exelixis (EXEL) reports Q3 results.
Imbruvica to Offset Humira Woes in AbbVie (ABBV) Q3 Earnings?
by Zacks Equity Research
Rising competition in international markets for Humira might have hurt AbbVie's (ABBV) top line in the third quarter. However, strong growth of Imbruvica is expected to have offset the loss.
Pharma Stock Roundup: LLY, NVS, AZN's Q3 Earnings, Updates From FDA
by Kinjel Shah
Lilly (LLY), Novartis (NVS) and AstraZeneca (AZN) release Q3 results. FDA approves Glaxo's (GSK) Zejula and AstraZeneca's Farxiga for more patients. CHMP gives nod to several drugs
Bristol-Myers Up as Pivotal NSCLC Study Meets Primary Endpoint
by Zacks Equity Research
Bristol-Myers' (BMY) phase III study evaluating a combination regimen of Opdivo meets primary endpoint of superior overall survival in patients with advanced lung cancer in first-line setting.
Biogen (BIIB) Beats on Q3 Earnings, Eyes FDA Nod for Aducanumab
by Zacks Equity Research
Biogen (BIIB) beats estimates for both earnings and sales in the third quarter. It is set to pursue FDA approval of aducanumab. Shares skyrocket in pre-market trading.
AstraZeneca's Breast Cancer Candidate BLA Gets Priority Review
by Zacks Equity Research
AstraZeneca (AZN) announces acceptance of BLA seeking approval for trastuzumab deruxtecan in metastatic breast cancer by the FDA. The FDA also grants priority review.