Update: Several hours after the initial publication of this report on September 2, Novo Nordisk announced that the FDA has extended the regulatory review for IDeglira, with...
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September 6 - News, Stock Analysis
Catalyst Pharmaceuticals Inc (NASDAQ:CPRX) just reported that the FDA has granted Orphan Drug Designation to its lead development candidate, and the company is up nearly 10% on...
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September 6 - News, Stock Analysis
Despite the labor day halt in the US, the end of the week last week brought with it plenty of volatility, and as we move into the start of a fresh week’s trading out of the ...
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September 6 - News, Stock Analysis
Array Biopharma Inc (NASDAQ:ARRY) just had its latest NDA accepted by the FDA, and the agency has put forward a PDUFA date for the candidate of June 30, 2017.
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September 2 - News, Stock Analysis
News just broke that Toronto based biotech Cynapsus Therapeutics Inc (NASDAQ:CYNA) is set to be bought out by Sunovion Pharmaceuticals, and shares of the former are up more than...
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September 1 - News, Stock Analysis
Karyopharm Therapeutics Inc (NASDAQ:KPTI) is set to report an overview of the topline data from its lead multiple myeloma trial on September 6 and markets are rallying in advance...
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August 31 - News, Stock Analysis
Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) just put out data from its lead pivotal, and the company is up close to 50% on the numbers.
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August 30 - News, Stock Analysis
It’s rare for a developing biotech to trade in a pattern that resembles a more established pharma company with much higher liquidity.
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August 30 - News, Stock Analysis
A little known Californian biotech working on a liver disease drug just hit international headlines on suggestions that it might be an effective treatment for the Zika virus.
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August 30 - News, Stock Analysis
Novartis AG (ADR) (NYSE:NVS) just put out data from its multiple sclerosis (MS) trial, and it looks as if the company is winning the race to bring a drug to market that offers...
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August 29 - News, Stock Analysis
Back on May 12, 2015, the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee released a briefing document detailing the process...
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August 29 - News, Stock Analysis
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 a bit of a dive on the...
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August 29 - News, Stock Analysis
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 progressive multiple...
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August 26 - News, Stock Analysis
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 from relapsing forms...
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August 26 - News, Stock Analysis
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) just put out data from its long term investigation into the safety and efficacy of its lead prostate candidate, and the company ...
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August 25 - News, Stock Analysis
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 market open in the US ...
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August 24 - News, Stock Analysis
Next month, an advisory panel will get together to discuss, and rule upon, Spectrum Pharmaceuticals, Inc.
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August 23 - News, Stock Analysis
Rigel Pharmaceuticals, Inc.
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August 23 - News, Stock Analysis
Yet again, we’ve had a busy start to the week in biotech.
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August 23 - News, Stock Analysis
We just learnt that the FDA has pushed back its decision day on Sanofi SA (ADR) (NYSE:SNY)’s insulin combo candidate IGlarLixi.
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August 22 - News, Stock Analysis
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 Shkreli, is pitching to buy...
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August 22 - News, Stock Analysis
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.
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August 19 - News, Stock Analysis
Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP), a Market Exclusive favorite, has been on a 23% tear since Tuesday, August 16.
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August 19 - News, Stock Analysis
Oncomed Pharmaceuticals Inc (NASDAQ:OMED) put out its second-quarter earnings earlier this month, and alongside the numbers, gave us an update as to the progress of its development...
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August 18 - News, Stock Analysis
Portola Pharmaceuticals Inc (NASDAQ:PTLA) has held a conference call to discuss its latest earnings, and on the call, reiterated its intentions to submit a new drug application...
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August 18 - News, Stock Analysis
Aimmune Therapeutics Inc (NASDAQ:AIMT) just updated us as to the progress of its ongoing pivotal in peanut allergy, and suggested that enrollment will complete this quarter or...
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August 16 - News, Stock Analysis
Coherus Biosciences Inc (NASDAQ:CHRS) submitted a biologics licensing application (BLA) for its lead biosimilar development candidate earlier this month, and is drawing a lot ...
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August 16 - News, Stock Analysis
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.
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August 15 - News, Stock Analysis
Catabasis Pharmaceuticals Inc (NASDAQ:CATB) is a tiny junior biotech based in Massachusetts, with one lead development candidate of any note (there are a couple of preclinical...
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August 15 - News, Stock Analysis
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, Vadadustat.
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August 12 - News, Stock Analysis
It’s every junior biotech company’s dream to be accepted into an accelerated approval pathway for a potentially blockbuster drug. Very few achieve it.
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August 11 - News, Stock Analysis
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) took a big hit yesterday, as the company announced its second-quarter earnings and missed on expectations – well, sort of.
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August 11 - News, Stock Analysis
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 before the end of this quarter...
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August 9 - News, Stock Analysis
The problem with being at the top of one of the largest healthcare market niches in the world is extremely heightened expectations.
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August 9 - News, Stock Analysis
Dynavax Technologies Corporation (NASDAQ:DVAX) just reported its second quarter financials, and alongside the numbers, gave us an update as to the progress of its lead development...
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August 8 - News, Stock Analysis
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 companies in question.
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August 5 - News, Stock Analysis
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 therapeutic areas.
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August 3 - News, Stock Analysis
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 with from a development ...
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August 3 - News, Stock Analysis
Those familiar with the biotech space will no doubt already be aware of the development solithromycin – Cempra Inc (NASDAQ:CEMP)’s pneumonia drug.
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August 3 - News, Stock Analysis
Heron Therapeutics Inc (NASDAQ:HRTX) just announced topline from its two lead pain management phase II trials.
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August 2 - News, Stock Analysis
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.
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August 1 - News, Stock Analysis
Seres Therapeutics Inc (NASDAQ:MCRB) just put out interim data from its lead trial, and the data doesn’t look good.
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August 1 - News, Stock Analysis
Ultragenyx Pharmaceutical Inc (NASDAQ:RARE) just announced that it has completed enrollment in its pivotal study of its lead rickets candidate, and given us an idea of when it...
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August 1 - News, Stock Analysis
Last week, the FDA had two major decisions to make regarding troubled drug maker Valeant Pharmaceuticals Intl Inc (NYSE:VRX).
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July 29 - News, Stock Analysis
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 indication.
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July 28 - News, Stock Analysis
Seattle Genetics, Inc. (NASDAQ:SGEN) just reported second quarter financials, and the company is up nearly 10% on the data.
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July 28 - News, Stock Analysis
Recro Pharma Inc (NASDAQ:REPH) is up more than 27% on Wednesday after announcing data from its lead acute pain trial.
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July 27 - News, Stock Analysis
Back in March, we discussed Alder Biopharmaceuticals Inc (NASDAQ:ALDR)’s lead migraine candidate ALD403.
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July 27 - News, Stock Analysis
August is going to be a big month in biotech, with a number of drugs up for FDA review.
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July 25 - News, Stock Analysis
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 some updated results relating...
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July 25 - News, Stock Analysis
