Biotech 101: Phase 3 Successful, What’s Next?
Information on the clinical trial process in the biotech space is all too readily available. Indeed, we have our own educational material available here where you can read all about the various stages...
View ArticleA Billion Dollar Decision Is Just Around The Corner For Alexion
Back in September, the FDA reported it was pushing its PDUFA review date for Kanuma, Alexion Pharmaceuticals’ (NASDAQ:ALXN) Lysosomal Acid Lipase Deficiency (LAL-D) candidate, back by three months. The...
View ArticleHeron’s Big Day Is Just Around The Corner
The clinical development process can be a long and costly one. For some companies, however, it can be longer and costlier than others. In 2009, Heron Therapeutics, Inc. (NASDAQ:HRTX) submitted an NDA...
View ArticleHere are Two Biotech Stocks to Watch in January
As we head into the new year festivities, our thoughts are already focused on a number of opportunities in biotech stocks during the coming weeks. Here are a couple of stocks with PDUFA dates looming,...
View ArticleIs the Advanced Accelerator Application SA (ADR) (NASDAQ:AAAP) Delay Cause...
At the end of last week, Advanced Accelerator Application SA (ADR) (NASDAQ:AAAP) released an update that addressed the status of its two lead product candidates. The company is fresh off the back of a...
View ArticleBioMarin Pharmaceutical Inc. (NASDAQ:BMRN) is Preparing to Release PEG-PAL...
This month, we’ll get topline from a BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) phase III in phenylketonuria (PKU). The drug is a promising candidate to treat an as yet incurable condition, and has...
View ArticleAralez Pharmaceuticals Inc (NASDAQ:ARLZ) Finally Gets an NDA Acceptance for...
On March 28, 2016, Aralez Pharmaceuticals Inc (NASDAQ:ARLZ) announced the FDA acceptance of its NDA for its lead pipeline candidate, Yosprala. For those not familiar with the company, or the drug in...
View ArticleHere’s Why a Relypsa Inc (NASDAQ:RLYP) Buyout is Risky Before May 26
Across the Thursday US session, California based biotech Relypsa Inc (NASDAQ:RLYP) gained close to 70% on speculation that it’s is looking to sell itself to a big pharma suitor. News outlet Reuters...
View ArticleTwo Companies to Watch: Heron Therapeutics Inc (NASDAQ:HRTX) and RedHill...
Here are two companies that have just given us an update, and in doing so have become ones to keep an as the second quarter, 2016, matures – Heron Therapeutics Inc (NASDAQ:HRTX) and RedHill Biopharma...
View ArticleHere’s What Happened With KemPharm Inc (NASDAQ:KMPH)
On May 5, 2016, an advisory panel met to review Apadaz – the abuse deterrent opioid candidate developed by KemPharm Inc (NASDAQ:KMPH) and currently under FDA consideration. The panel reported the...
View ArticleTwo 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 that are worth watching as they roll around....
View ArticleLooking At Dynavax Technologies Corporation (NASDAQ:DVAX)’s Upcoming Hep B...
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 candidate,...
View ArticleBioMarin Pharmaceutical Inc. (NASDAQ:BMRN)’s Setback Isn’t Really A Setback
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) just announced that the FDA has delayed its PDUFA for the companies lead Batten Disease candidate, meaning the agency won’t get round to offering up a...
View ArticleTwo Biotechs With Bad News This Week: What Happens Now?
When things go well in biotech, it can be a great ride. When things repeatedly go well, however, it can be easy to forget how quickly, and how frequently, things don’t go to plan. More often than not...
View ArticleHere’s Our Take On Neurocrine Biosciences, Inc. (NASDAQ:NBIX)’s Ingrezza
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) just notified markets that the FDA has accepted a new drug application (NDA) for its lead drug candidate, Ingrezza, and alongside the acceptance, has set a...
View ArticleHere Are Two Dates To Keep An Eye On In Biotech Across The Next Two Weeks
The fourth quarter of this year is set to be a big one in the biotech space, with a number of key development slated across October, November and December. We’ve scanned forward throughout numerous...
View ArticleHere’s Our Take On Cempra Inc (NASDAQ:CEMP)’s Delay
Cempra Inc (NASDAQ:CEMP) just announced that it may not meet its PDUFA for solithromycin, and the company has taken a big hit on the news. The response is somewhat justifiable – the implications of the...
View ArticleAdamas Pharmaceuticals Inc (NASDAQ:ADMS) Is Up On PDUFA: What’s Next?
Adamas Pharmaceuticals Inc (NASDAQ:ADMS) is up close to 15% on its 2017 open, on the back of a couple of positive developments out of its Parkinson’s disease pipeline. The company had a pretty rocky...
View ArticleSynergy Pharmaceuticals Inc (NASDAQ:SGYP): A Top January Pick Ahead Of PDUFA
Synergy Pharmaceuticals Inc (NASDAQ:SGYP) has gradually picked up strength over the last six months or so, as the company creeps towards its PDUFA date for Plecanatide. The drug, which the FDA accepted...
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