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Zacks News
Biogen (BIIB) Gets FDA Nod for Narrow Label of Aduhelm
by Zacks Equity Research
The FDA approves label update for Biogen's (BIIB) new Alzheimer's drug, Aduhelm. The updated label narrows the patient population, which is eligible for the drug.
Oncology Space Gains Momentum in 2021: 5 Stocks to Focus on
by Debanjana Dey
Oncology stocks like OncoCyte (OCX), PerkinElmer (PKI), Catalent (CTLT), Cardiff Oncology (CRDF) and NovoCure (NVCR) are expected to continue their run over the next few months.
Deciphera (DCPH) Begins Dosing in Study on Cancer Candidate
by Zacks Equity Research
Deciphera (DCPH) doses the first patient in a phase I study evaluating its ULK kinase inhibitor, DCC-3116, for treating advanced/metastatic tumors driven by mutations in RAS/RAF genes.
Gilead's (GILD) Kite Announces Positive Data on Yescarta
by Zacks Equity Research
Gilead (GILD) announces results from the ZUMA-7 study on Yescarta and completes submission of application to the FDA seeking approval of lenacapavir.
Incyte's (INCY) Lymphoma Drug Obtains Positive CHMP Opinion
by Zacks Equity Research
Incyte (INCY) and MorphoSys (MOR) receive positive CHMP opinion for tafasitamab in combination with Revlimid for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Lilly's (LLY) AD Candidate Gets Breakthrough Therapy Status
by Zacks Equity Research
Eli Lilly (LLY) is developing donanemab in a phase III study and plans to file a regulatory application seeking accelerated approval for the candidate as a treatment for AD in 2021.
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.
Sanofi's (SNY) Aubagio Gets EU Nod for MS in Pediatric Patients
by Zacks Equity Research
The European Commission approves Sanofi's (SNY) Aubagio for the treatment of pediatric patients aged 10 to 17 years with relapsing-remitting multiple sclerosis.
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.
Incyte (INCY) Faces Delay in Approval of Atopic Dermatitis Cream
by Zacks Equity Research
Incyte's (INCY) NDA review for ruxolitinib cream for the treatment of atopic dermatitis gets extended.
Pharma Stock Roundup: FDA Approval for NVO, PFE Products & Other Updates
by Kinjel Shah
FDA approves Novo Nordisk's (NVO) obesity treatment, Wegovy and Pfizer's (PFE) 20-valent pneumococcal conjugate vaccine, Prevnar 20.
Incyte's (INCY) sNDA Review for Jakafi in GVHD Gets Extended
by Zacks Equity Research
Incyte's (INCY) sNDA review of Jakafi for the indication of steroid-refractory chronic GVHD gets extended by three months.
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.
3 Drug Stocks Rise as FDA Okays Biogen Alzheimer's Drug
by Kinjel Shah
FDA approves Biogen's (BIIB) Alzheimer's disease ("AD") drug, Aduhelm (aducanumab). Stocks of Eli Lilly (LLY), Cassava Sciences (SAVA) and Annovis Bio (ANVS) rise as they also have AD candidates in their portfolio.
Novartis (NVS) Posts Positive Data on Kidney Disease Candidate
by Zacks Equity Research
Novartis' (NVS) rare kidney disease candidate meets its primary goal in a phase II study.
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.
AbbVie's (ABBV) Skyrizi Succeeds in Crohn's Maintenance Study
by Zacks Equity Research
AbbVie (ABBV) is focusing on label expansion of Skyrizi beyond plaque psoriasis. The drug achieves endoscopic response and clinical remission as maintenance treatment for Crohn's disease study.
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.
Pharma Stock Roundup: JNJ Cancer Drug Gets FDA Nod, PFE, GSK, SNY Begin New Studies
by Kinjel Shah
Sanofi (SNY) and Glaxo's (GSK) COVID-19 vaccine candidate enters phase III. FDA approves J&J's (JNJ) Rybrevant (amivantamab) for a rare lung cancer
Novartis (NVS) & Molecular Partners Initiate Study for COVID-19
by Zacks Equity Research
Novartis (NVS) initiates study for investigating its novel DARPin therapeutic candidate, ensovibep (MP0420), for the treatment of COVID-19, in collaboration with Molecular Partners.
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.
J&J's (JNJ) Multiple Sclerosis Drug Ponvory Gets EU Approval
by Zacks Equity Research
J&J's (JNJ) oral multiple sclerosis drug, Ponvory, receives approval in Europe after demonstrating superior efficacy in reducing annual relapses compared to Sanofi's Aubagio in clinical studies.
Pharma Stock Roundup: GSK/SNY COVID-19 Vaccine Data, PFE's New EU Supply Deal
by Kinjel Shah
Sanofi (SNY) and Glaxo's (GSK) COVID-19 vaccine shows strong antibody response in phase II. Lilly's fifth phase III study on tirzepatide meets all key endpoints
Incyte (INCY) Announces Positive Results From Vitiligo Study
by Zacks Equity Research
Incyte (INCY) announces positive data from phase III studies on ruxolitinib cream for the treatment of vitiligo.
Ionis (IONS) Q1 Loss Widens Year Over Year, Sales Miss
by Zacks Equity Research
Ionis (IONS) Q1 adjusted loss per share was wider than the year-ago figure. The company maintains its guidance for 2021.