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biotechs: Archive

Zacks Equity Research

Incyte's (INCY) sNDA Review for Jakafi in GVHD Gets Extended

Incyte's (INCY) sNDA review of Jakafi for the indication of steroid-refractory chronic GVHD gets extended by three months.

JNJNegative Net Change INCYNegative Net Change NVSNegative Net Change ABBVNegative Net Change

Zacks Equity Research

Biotech Stock Roundup: BIIB's Drug Approval, ALXN Drug Label Expansion & More

The biotech sector was in focus last week with regulatory updates from Biogen (BIIB) and bluebird (BLUE), among others.

BIIBNegative Net Change JNJNegative Net Change ALXNPositive Net Change INCYNegative Net Change ARGXPositive Net Change

Zacks Equity Research

VBI Vaccines (VBIV) Up on Glioblastoma Drug Fast Track Status

VBI Vaccines (VBIV) is developing VBI-1901 as a potential treatment of recurrent glioblastoma patients.

GSKNegative Net Change RGENNegative Net Change BLPHPositive Net Change VBIVPositive Net Change

Zacks Equity Research

Arena (ARNA) Starts Phase II Study on Coronary Drug Temanogrel

Arena (ARNA) is developing temanogrel in a phase II study as potential treatment for coronary microvascular obstruction in patients undergoing percutaneous coronary intervention.

ARNAPositive Net Change RGENNegative Net Change BLPHPositive Net Change

Zacks Equity Research

Moving Average Crossover Alert: Veracyte (VCYT)

Veracyte (VCYT) could be a stock to avoid from a technical perspective, as the firm is seeing unfavorable trends on the moving average crossover front

VCYTNegative Net Change

Zacks Equity Research

Alexion's (ALXN) PNH Drug Ultomiris Gets FDA Nod for Kids

The FDA approves Alexion's (ALXN) Ultomiris for the treatment of PNH in children of one month of age and older as well as adolescents.

ALXNPositive Net Change RGENNegative Net Change TECHNegative Net Change KMDANegative Net Change

Zacks Equity Research

bluebird (BLUE) Resumes SCD & TDT Studies as FDA Lifts Hold

The FDA lifts the clinical hold on bluebird's (BLUE) studies on LentiGlobin for sickle cell disease and betibeglogene autotemcel for transfusion-dependent thalassemia. Shares rise.

RGENNegative Net Change TECHNegative Net Change KMDANegative Net Change

Zacks Equity Research

argenx (ARGX) to Regain AML Candidate After J&J's Dismissal

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.

JNJNegative Net Change RHHBYNegative Net Change ABBVNegative Net Change ARGXPositive Net Change

Zacks Equity Research

Biogen (BIIB) Up as FDA Approves Alzheimer'S Drug Aducanumab

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.

BIIBNegative Net Change RHHBYNegative Net Change NVSNegative Net Change AMGNPositive Net Change

Zacks Equity Research

Moderna (MRNA) Seeks Approval for COVID-19 Vaccine in Teens

Moderna (MRNA) is seeking authorization for conditional use of its COVID-19 vaccine, mRNA-1273, in adolescents in Europe and Canada.

SNYNegative Net Change PFENegative Net Change MRNANegative Net Change BNTXNegative Net Change

Sweta Killa

Biotech ETFs Surge on Biogen's Alzheimer Drug Approval

The approval for Biogen's Alzheimer's disease treatment has spread strong optimism, with many investors pulling in capital to this high growth and high beta sector.

BIIBNegative Net Change LLYNegative Net Change XBINegative Net Change BBCNegative Net Change SBIONegative Net Change PBENegative Net Change GNOMNegative Net Change

Kinjel Shah

3 Drug Stocks Rise as FDA Okays Biogen Alzheimer's Drug

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.

BIIBNegative Net Change AZNNegative Net Change LLYNegative Net Change NVSNegative Net Change AMGNPositive Net Change ANVSPositive Net Change SAVAPositive Net Change

Mark Vickery

Biogen's Alzheimer Drug Wins FDA Approval

Biogen closed the day up 38% but had been up as much as 60% on the news, and this came after a brief halt in share trading.

BIIBNegative Net Change IBBNegative Net Change SFIXNegative Net Change

Zacks Equity Research

Novartis (NVS) Posts Positive Data on Kidney Disease Candidate

Novartis' (NVS) rare kidney disease candidate meets its primary goal in a phase II study.

NVSNegative Net Change BAYRYNegative Net Change OMERNegative Net Change

Zacks Equity Research

Cullinan (CGEM) Rises on Promising Phase I Cancer Study Data

Cullinan Oncology (CGEM) is developing its sole pipeline candidate, CLN-081, as a potential treatment for lung cancer in a phase I/IIa study.

BLPHPositive Net Change LEGNNegative Net Change CGEMNegative Net Change

Zacks Equity Research

Amryt (AMYT) NDA for Skin Disorder Drug Gets Priority Review

Amryt (AMYT) is seeking approval for Oleogel-S10 as a potential treatment for patients with rare and distressing genetic skin disorder, epidermolysis bullosa.

ADPTPositive Net Change XNCRNegative Net Change ORGOPositive Net Change

Zacks Equity Research

Constellation (CNST) Surges on Takeover Deal With MorphoSys

Constellation (CNST) skyrockets following the acquisition deal with German biotech company, MorphoSys, worth $1.7 billion.

INCYNegative Net Change RPRXNegative Net Change MORPositive Net Change CNSTPositive Net Change

Zacks Equity Research

Stock Market News for Jun 3, 2021

Wall Street closed marginally higher on Wednesday.

MRNANegative Net Change

Zacks Equity Research

Bristol Myers (BMY) Gets EC Nod Opdivo+Yervoy in Mesothelioma

The European Commission approves Bristol Myers' (BMY) Opdivo in combination with Yervoy for the first-line treatment of malignant pleural mesothelioma.

RHHBYNegative Net Change MRKNegative Net Change BMYNegative Net Change RGENNegative Net Change

Zacks Equity Research

Biotech Stock Roundup: MRNA COVID-19 Vaccine Update, Drug Approvals for ALKS, MYOV & More

The biotech sector was in focus last week with pipeline and regulatory updates from Moderna (MRNA) and Alkermes (ALKS), among others.

BIIBNegative Net Change ALKSNegative Net Change PFENegative Net Change MRNANegative Net Change MYOVPositive Net Change CVACNegative Net Change

Zacks Equity Research

Immunovant (IMVT) Reports Narrower-Than-Expected Loss in Q4

Immunovant's (IMVT) earnings beat estimates in fourth-quarter fiscal 2021. Focus remains on lead pipeline candidate IMVT-1401. Stock falls.

JNJNegative Net Change ALXNPositive Net Change RGENNegative Net Change IMVTPositive Net Change

Zacks Equity Research

Alkermes' (ALKS) Schizophrenia, Bipolar I Disorder Drug Approved

The FDA approves Alkermes' (ALKS) Lybalvi for the treatment of adults with schizophrenia or bipolar I disorder. Shares up

JNJNegative Net Change ALKSNegative Net Change AZNNegative Net Change ABBVNegative Net Change

Zacks Equity Research

Moderna (MRNA) Files for Full Approval of COVID-19 Vaccine

Moderna (MRNA) seeks full approval for its COVID-19 vaccine, mRNA-1273, in adults with initiation of rolling submission of a BLA. The company also boosts manufacturing capacity for the vaccine.

PFENegative Net Change MRNANegative Net Change TMONegative Net Change BNTXNegative Net Change

Benjamin Rains

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MRNANegative Net Change CHWYPositive Net Change

Zacks Equity Research

Regeneron (REGN) Stock Up 3.5% YTD: What's in Store for 2H21?

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.

REGNNegative Net Change SNYNegative Net Change RHHBYNegative Net Change LLYNegative Net Change