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Stock Analysis

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Inside the FDA Ebola Edition: Frontrunners Merck & Co., Inc. (MRK), GlaxoSmithKline PLC (ADR) (GSK)

Introduction Back on May 12, 2015, the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee released a briefing......(read more)
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Here’s What We’re Looking At From Neuroderm Ltd (NDRM)’s Parkinson’s Trial

Neuroderm Ltd (NASDAQ:NDRM) just announced the kicking off of a pivotal trial in its lead Parkinson’s disease (PD) candidate, and the company has taken......(read more)
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Novartis AG (NVS) Announces Positive Phase III Results For MS Drug

Novartis AG (NYSE:NVS) has announced that the Phase III EXPAND study, which is evaluating the efficacy and safety of oral, once daily, BAF312 in secondary......(read more)
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AbbVie Inc (ABBV) Expected To Launch Zinbryta In The US This Month

AbbVie Inc (NYSE:ABBV) and Biogen Inc (NASDAQ:BIIB) drug Zinbryta was approved by the Food and Drug Administration (FDA) as a therapy for adults suffering......(read more)
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Nymox Pharmaceutical Corporation (NYMX) Has More Upside Potential, Even After Gains

Nymox Pharmaceutical Corporation (NASDAQ:NYMX) just put out data from its long term investigation into the safety and efficacy of its lead prostate candidate......(read more)
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Our Take On The Clovis Oncology Inc (CLVS) Announcement

Clovis Oncology Inc (NASDAQ:CLVS) just reported that the FDA has accepted its new drug application (NDA) and the company is up close to 30% ahead of the......(read more)
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Our Take On Spectrum Pharmaceuticals, Inc. (SPPI)’s Near Term Panel Review

Next month, an advisory panel will get together to discuss, and rule upon, Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI)’s lead bladder cancer development......(read more)
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What We’re Looking For From The Upcoming Rigel Pharmaceuticals, Inc. (RIGL) Data

Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) gave us a business update earlier this month, and suggested it would put out data from the first of two phase......(read more)
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Movers and Shakers In Biotech: Cyclacel Pharmaceuticals Inc (CYCC) and Corium International Inc (CORI)

Yet again, we’ve had a busy start to the week in biotech. A number of companies are moving on news or data reported at the close of last week, and others......(read more)
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FDA’s Sanofi SA (ADR) (SNY) Delay Highlights Some Red Flags With IGlarLixi

We just learnt that the FDA has pushed back its decision day on Sanofi SA (ADR) (NYSE:SNY)’s insulin combo candidate IGlarLixi. Markets haven’t moved......(read more)
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What Will Retrophin Inc (RTRX) Get For Its Money On A Raptor Pharmaceutical Corp. (RPTP) Deal?

The rumor mill is working hard right now in the biotech space, and the latest word is that Retrophin Inc (NASDAQ:RTRX), the company founded by Martin......(read more)
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Cerulean Pharma Inc (CERU): What’s Next?

Cerulean Pharma Inc (NASDAQ:CERU) has had a rough week. The company put out topline from its lead oncology trial August 17, and the numbers are not good......(read more)
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Why Corbus Pharmaceuticals Holdings Inc (CRBP) Climbed 23% This Week

Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP), a Market Exclusive favorite, has been on a 23% tear since Tuesday, August 16. Small $170 million biotechs......(read more)
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What To Look For In The Upcoming Oncomed Pharmaceuticals Inc (OMED) Trial Data

Oncomed Pharmaceuticals Inc (NASDAQ:OMED) put out its second-quarter earnings earlier this month, and alongside the numbers, gave us an update as to......(read more)
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Portola Pharmaceuticals Inc (PTLA): A Misinterpretation Discount?

Portola Pharmaceuticals Inc (NASDAQ:PTLA) has held a conference call to discuss its latest earnings, and on the call, reiterated its intentions to submit......(read more)
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Aimmune Therapeutics Inc (AIMT) Is Bringing A 100 Year Old Treatment Into The 21st Century

Aimmune Therapeutics Inc (NASDAQ:AIMT) just updated us as to the progress of its ongoing pivotal in peanut allergy, and suggested that enrollment will......(read more)
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Coherus Biosciences Inc (CHRS) Has Set Its Sights On Amgen, Inc. (AMGN)

Coherus Biosciences Inc (NASDAQ:CHRS) submitted a biologics licensing application (BLA) for its lead biosimilar development candidate earlier this month......(read more)
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Movers and Shakers in Biotech: Global Blood Therapeutics Inc (GBT) and Eleven Biotherapeutics Inc (EBIO)

It’s the start of a new week in biotech, and a number of potential catalysts promise to inject some volatility into the space going forward. A few companies......(read more)
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What We’re Watching For In The Upcoming Catabasis Pharmaceuticals Inc (CATB) Data

Catabasis Pharmaceuticals Inc (NASDAQ:CATB) is a tiny junior biotech based in Massachusetts, with one lead development candidate of any note (there are......(read more)
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Calculating The Impact Of Akebia Therapeutics Inc (AKBA)’s Pivotals

Akebia Therapeutics Inc (NASDAQ:AKBA) just gave word of the initiation of its pivotal trial in a second indication for its lead renal anemia candidate......(read more)
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Will Pluristem Therapeutics Inc. (PSTI) Succeed in CLI Where Sanofi SA (ADR) (SNY) Failed?

It’s every junior biotech company’s dream to be accepted into an accelerated approval pathway for a potentially blockbuster drug. Very few achieve......(read more)
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AMAG Pharmaceuticals, Inc. (AMAG) Is An Attractive Contrarian Entry

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) took a big hit yesterday, as the company announced its second-quarter earnings and missed on expectations –......(read more)
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Our Take On Kamada Ltd (KMDA)’s Upcoming Catalysts

So we just learnt that development stage biotech company Kamada Ltd (NASDAQ:KMDA) is set to put out topline from a phase II in antitrypsin deficiency......(read more)
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The Cryptic World of Oral Insulin, Novo Nordisk A/S (ADR) (NVO) vs Oramed Pharmaceuticals, Inc. (ORMP)

The problem with being at the top of one of the largest healthcare market niches in the world is extremely heightened expectations. The World Health Organization......(read more)
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Looking At Dynavax Technologies Corporation (DVAX)’s Upcoming Hep B Catalysts

Dynavax Technologies Corporation (NASDAQ:DVAX) just reported its second quarter financials, and alongside the numbers, gave us an update as to the progress......(read more)
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Two Big Parkinson’s Updates From Adamas Pharmaceuticals Inc (ADMS) And Acorda Therapeutics Inc (ACOR)

We just got a couple of updates in the Parkinson’s space, and both have the potential to serve up some volatility in the market capitalisations of the......(read more)
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Here’s A Look At Two Promising CLI Companies And Their Near Term Milestones – Pluristem Therapeutics Inc. (PSTI) Cesca Therapeutics Inc (KOOL)

Stem cell therapy is one of the most exciting areas of development stage healthcare right now, and it’s being put to the test in a wide range of potential......(read more)
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Here’s A Look At Prothena Corporation PLC (PRTA)’s Upcoming Milestones

Prothena Corporation PLC (NASDAQ:PRTA) just gave us an update as to the status of its pipeline, in doing so, presented us with some timeframes to work......(read more)
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Cempra Inc (CEMP) Has A Busy Fourth Quarter Coming Up

Those familiar with the biotech space will no doubt already be aware of the development solithromycin – Cempra Inc (NASDAQ:CEMP)’s pneumonia drug.......(read more)
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What’s In The Latest Heron Therapeutics Inc (HRTX) Data?

Heron Therapeutics Inc (NASDAQ:HRTX) just announced topline from its two lead pain management phase II trials. The trials were set up to investigate the......(read more)
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ADMA Biologics Inc (ADMA) Just Gave Us A CRL Opportunity

ADMA Biologics Inc (NASDAQ:ADMA) just picked up a complete response letter (CRL) from the FDA, and the company is down more than 31% after hours on Friday......(read more)
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What’s Next For Seres Therapeutics Inc (MCRB)?

Seres Therapeutics Inc (NASDAQ:MCRB) just put out interim data from its lead trial, and the data doesn’t look good. The company is down more than 70......(read more)
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Here’s What We’re Looking For From Ultragenyx Pharmaceutical Inc (RARE)

Ultragenyx Pharmaceutical Inc (NASDAQ:RARE) just announced that it has completed enrollment in its pivotal study of its lead rickets candidate, and given......(read more)
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Biotech Week In Review: Valeant, Progenics, Relistor and Vesneo – Valeant Pharmaceuticals Intl Inc (VRX) Progenics Pharmaceuticals, Inc. (PGNX)

Last week, the FDA had two major decisions to make regarding troubled drug maker Valeant Pharmaceuticals Intl Inc (NYSE:VRX). The first was whether or......(read more)
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RedHill Biopharma Ltd – ADR (RDHL) GI Topline Is Set For 2016 Release

RedHill Biopharma Ltd – ADR (NASDAQ:RDHL) just informed markets that it intends to put out topline data from its phase III trial of Bekinda in a gastroenteritis......(read more)
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Delving Into Seattle Genetics, Inc. (SGEN)’s Upcoming Readout

Seattle Genetics, Inc. (NASDAQ:SGEN) just reported second quarter financials, and the company is up nearly 10% on the data. Alongside the numbers, however......(read more)
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A Look At Recro Pharma Inc (REPH) and Alkermes Plc (ALKS)’s Topline Triumph

Recro Pharma Inc (NASDAQ:REPH) is up more than 27% on Wednesday after announcing data from its lead acute pain trial. The company has developed an IV......(read more)
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Moleculin Biotech Inc (MBRX): Proceed With Caution

Moleculin Biotech Inc (NASDAQ:MBRX), an oncology-focused pharmaceutical firm that just joined public markets in June, is making some waves in the biotech......(read more)
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Here’s What’s Important About Alder Biopharmaceuticals Inc (ALDR)’s Latest Release

Back in March, we discussed Alder Biopharmaceuticals Inc (NASDAQ:ALDR)’s lead migraine candidate ALD403. The company had just reported topline from......(read more)
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Two Under The Radar Biotech Decisions To Watch Next Month

August is going to be a big month in biotech, with a number of drugs up for FDA review. Here are two August PDUFAs that might fly under the radar, but......(read more)
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A Look At Puma Biotechnology Inc (PBYI)’s Breast Cancer Candidate

At the end of last week, Puma Biotechnology Inc (NYSE:PBYI) announced the filing of an NDA for its lead breast cancer candidate, as well as releasing......(read more)
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Market Exclusive’s Inside the FDA: This Week Bezlotoxumab from Merck & Co., Inc. (MRK)

On July 23, the Food and Drug Administration will make its decision on bezlotoxumab, brand name Zinplava, a Merck & Co., Inc. (NYSE:MRK) monoclonal......(read more)
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Here Is A Buywrite Strategy for the Upcoming Yahoo! Inc (YHOO) And Verizon Communications Inc. (VZ) Deal

The rumors are out this morning that Verizon Communications Inc. (NYSE:VZ) is close to an agreement to buy Yahoo! Inc. (NASDAQ:YHOO). One intriguing way......(read more)
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Japan is Breathing Life into the Stem Cell Space, Astellas Pharma (ALPMF) & Pluristem Therapeutics Inc. (PSTI) Are Benefiting

Japan is the stem cell capital of the world. From the Nobel winning efforts of Shinya Yamanaka in the field of mature to pluripotent stem cell reprogramming......(read more)
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Can Valeant Pharmaceuticals Intl Inc (VRX) Hit Three For Three Tomorrow?

It’s been a big week so far for Valeant Pharmaceuticals Intl Inc (NYSE:VRX), and things might still get better. The company is up close to 4% early......(read more)
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What To Look Out For In The Latest Eiger Biopharmaceuticals Inc (EIGR) Trial

Eiger Biopharmaceuticals Inc (NASDAQ:EIGR) just announced first dosing in its phase II LIBERTY trial, and markets seem to have turned a blind eye to the......(read more)
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Merck & Co., Inc. (MRK) and OpGen Inc (OPGN) Are Quietly Changing The Infectious Disease Landscape

Imagine the following scenario. A patient walks into a hospital with an infectious disease. He sees a physician or a nurse, who diagnoses him, usually......(read more)
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Cynapsus Therapeutics Inc (CYNA) Is Closing In On A Parkinson’s NDA

Cynapsus Therapeutics Inc (NASDAQ:CYNA) just closed on the details of a pivotal trial in Europe with the European Medicines Agency (EMA), and expects......(read more)
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Biotech Movers: Elite Pharmaceuticals Inc (ELTP) and Synergy Pharmaceuticals Inc (SGYP)

Two biotech companies had a rough end to the week last week, and it looks as though things aren’t going to get much better for them heading into the......(read more)
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Here’s A Thought On How Motif Bio PLC (MTFB) Can Boost Its Chances Of Success

London based biotech Motif Bio PLC (LON:MTFB) just filed for a NASDAQ listing by way of an IPO in the US, and it’s drawing quite a lot of attention......(read more)
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