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Zacks News
Roche's (RHHBY) BLA for PDS With Ranibizumab Accepted by FDA
by Zacks Equity Research
The FDA accepts and grants Priority Review to Roche's (RHHBY) application for Port Delivery System with ranibizumab for the treatment of nAMD.
Bayer (BAYRY) Files Applications in US & EU for Cancer Treatment
by Zacks Equity Research
Bayer (BAYRY) submits an sNDA in the United States and an MAA in Europe for the combo of copanlisib and rituximab to treat two types of cancer indication.
Top Analyst Reports for AT&T, Walmart & Cisco
by Sheraz Mian
Today's Research Daily features new research reports on 16 major stocks, including AT&T (T), Walmart (WMT), and Cisco (CSCO).
Biogen (BIIB) Ends Development of Anti-Tau Alzheimer's Drug
by Zacks Equity Research
Biogen (BIIB) ends development of investigational anti-tau antibody, gosuranemab for treating Alzheimer's disease after the phase II TANGO study showed no benefit to patients.
Aprea (APRE) Stock Rises as Leukemia Triplet Meets Study Goal
by Zacks Equity Research
Aprea (APRE) announces that treatment with a combination regimen of its pipeline candidate, eprenetapopt, achieves 37% complete response rate in acute myeloid leukemia patients.
Glaxo (GSK)/iTeos Therapeutics to Co-Develop Novel Cancer Drug
by Zacks Equity Research
Glaxo (GSK) signs deal with iTeos Therapeutics to co-develop its investigational cancer candidate known as EOS-448. Glaxo will also study EOS-448 with its other investigational cancer therapies.
Merck (MRK) Signs $1.2B Deal With US for COVID-19 Therapeutic
by Zacks Equity Research
Merck (MRK) is set to supply 1.7 million courses of its oral COVID-19 therapy candidate, molnupiravir, worth $1.2 billion to the U.S. government, following a potential approval or authorization.
argenx (ARGX) to Regain AML Candidate After J&J's Dismissal
by Zacks Equity Research
argenx (ARGX) is developing cusatuzumab as potential treatment for acute myeloid leukemia. However, its partner, J&J, decided to discontinue the development agreement with the company for the candidate.
Biogen (BIIB) Up as FDA Approves Alzheimer'S Drug Aducanumab
by Zacks Equity Research
FDA approves Biogen's (BIIB) Aduhelm (aducanumab), making it the first medicine to be approved to reduce the clinical decline associated with Alzheimer's disease.
Novartis (NVS) Announces Data on Radioligand Therapy at ASCO
by Zacks Equity Research
Novartis (NVS) posts results from a late-stage study on radioligand therapy at the 2021 ASCO.
Bristol Myers (BMY) Gets EC Nod Opdivo+Yervoy in Mesothelioma
by Zacks Equity Research
The European Commission approves Bristol Myers' (BMY) Opdivo in combination with Yervoy for the first-line treatment of malignant pleural mesothelioma.
Regeneron (REGN) Stock Up 3.5% YTD: What's in Store for 2H21?
by Zacks Equity Research
Regeneron's performance so far in the year has been good on the back of a solid product portfolio and an incremental contribution from the antibody cocktail.
Amgen's (AMGN) KRAS Inhibitor Gets FDA Nod for Lung Cancer
by Zacks Equity Research
FDA approval of Amgen's (AMGN) Lumakras for KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer is based on positive data from the phase II CodeBreaK 100 study.
PTC Therapeutics' (PTCT) PTC923 Gets Orphan Drug Tag in US & EU
by Zacks Equity Research
The FDA and the European Commission bestow Orphan Drug status to PTC Therapeutics' (PTCT) PTC923 for the treatment of hyperphenylalaninemia.
AbbVie's (ABBV) Venclyxto Gets EU Nod for First-Line AML
by Zacks Equity Research
European Commission grants approval to AbbVie (ABBV)/Roche's Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia
Exelixis (EXEL) Reports Encouraging Data From Prostate Cancer Study
by Zacks Equity Research
Exelixis (EXEL) announces encouraging results from the cohort 6 of a phase Ib study of Cabometyx in combination with Tecentriq.
BioMarin (BMRN) Hemophilia Gene Therapy Gets EMA's Speedy Review
by Zacks Equity Research
The EMA grants accelerated assessment to BioMarin's (BMRN) request for review of valoctocogene roxaparvovec for treating severe hemophilia A.
Bristol Myers' (BMY) Opdivo-Yervoy Combo Gets Positive CHMP Opinion
by Zacks Equity Research
Bristol Myers' (BMY) Opdivo in combination with Yervoy gets positive CHMP recommendation by the EMA for an additional indication.
Bristol Myers (BMY) Gets FDA Nod for Another Opdivo Indication
by Zacks Equity Research
Bristol Myers (BMY) gets FDA approval for Opdivo (injection for intravenous use) for adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer.
Biotech Stock Roundup: AGEN, SRPT Surge & BIIB, REGN Provide Pipeline Updates
by Zacks Equity Research
The biotech sector was in focus last week with pipeline and regulatory updates from Agenus (AGEN) and Sarepta (SRPT), among others.
Sarepta (SRPT) Rises on Robust DMD Gene Therapy Study Data
by Zacks Equity Research
Sarepta's (SRPT) lead gene therapy candidate, SRP-9001, demonstrates robust improvement in expression of micro-dystrophin protein in DMD patients after 12 weeks of treatment.
Prothena (PRTA) Q1 Loss Wider Than Expected, Pipeline in Focus
by Zacks Equity Research
Prothena (PRTA) reports a wider loss in the first quarter of 2021. The pipeline remains in focus with the planned initiation of three late-stage studies for birtamimab, prasinezumab and PRX004.
Amicus' (FOLD) Q1 Loss Wider Than Expected, Sales Up Y/Y
by Zacks Equity Research
Amicus (FOLD) reports a wider Q1 loss and sales miss estimates.
Halozyme (HALO) Stock Down Despite Q1 Earnings & Sales Beat
by Zacks Equity Research
Halozyme (HALO) first-quarter earnings and sales beat estimates. The company retains 2021 guidance.
ImmunoGen (IMGN) Q1 Earnings Top, Pivotal Studies Delayed
by Zacks Equity Research
ImmunoGen (IMGN) reports narrower-than-expected loss but misses revenue estimates. Meanwhile, data readouts from pivotal studies on lead candidate get delayed due to COVID-19. Stock down.