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.
Author Archive - Market Exclusive
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).
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.
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 trading in the US.
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 development.
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 on a hunch.
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 to kick off the study before...
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 US open on Monday.
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 in the infectious disease...
Here’s Why Markets and Avinger Inc (AVGR) Just Gave Us An Oversold Opportunity
US medical device company Avinger Inc (NASDAQ:AVGR) just served up a revision to its second quarter earnings guidance, noting a couple of shortages on both its own and consensus...
What’s Next For CytRx Corporation (CYTR) Holders?
CytRx Corporation (NASDAQ:CYTR) collapsed on Monday after data relating to its lead pivotal hit press, and the company will open on Wednesday at just $1 a share – 60% down on...
Seres Therapeutics Inc (MCRB) Is Attempting To Overturn 1,500 Years Of Medicine
The massive upswing in antibiotic use over the last three decades is causing well documented problems.
Here’s What To Look For Ahead Of The Myokardia Inc (MYOK) Phase II
Myokardia Inc (NASDAQ:MYOK) just announced topline from its lead cardiovascular trial, and alongside the data, reported it intends to carry the drug under investigation into a...
Coherus Biosciences Inc (CHRS) Is Looking To Compete With Amgen, Inc. (AMGN)’s Cancer Blockbuster
The biosimilar space is relatively young.
NDA Watch: TherapeuticsMD Inc (TXMD) and Yuvvexy
At the end of last week, female healthcare focused biotech company TherapeuticsMD Inc (NYSEMKT:TXMD) submitted a new drug application (NDA) to the FDA for its lead development...
Movers And Shakers In Biotech: Kite Pharma Inc (KITE) And Eleven Biotherapeutics Inc (EBIO)
It’s been a busy week in biotech so far, and the late start out of the US doesn’t seem to have had too much of an impact on volatility.
Here’s What You Need to Know About IntelliPharmaCeutics Intl Inc (USA) (IPCI)
IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) is a tiny Canadian biotech with no approved products and a market capitalization of a little over $40 million at last count.
This Protocol Change Means Regenxbio Inc (RGNX) Can Finally Get Started On Its Gene Therapy Trial
Regenxbio Inc (NASDAQ:RGNX) just announced its intention to enroll the first patient in its phase I/II clinical trial of its lead candidate, RGX-501.
Weekly Biotech Report Covering Gilead Sciences, Inc. (GILD) and Celyad SA (ADR) (CYAD)
For the section of our report detailing events in biotech this past couple of weeks, we’ve got two focus companies – one big, one small. They are Gilead Sciences, Inc.
Prothena Corporation PLC (PRTA)’s Amyloidosis Pipeline In Focus
Prothena Corporation PLC (NASDAQ:PRTA) just offered up some insight into its ongoing phase I/II in its lead candidate, NEOD001.
Biotech Movers: Insys Therapeutics Inc (INSY) and Cempra Inc (CEMP)
The long weekend is over in the US, and the markets are back in full swing on Tuesday.
Is Pain Therapeutics, Inc. (PTIE) And Remoxy’s Long And Winding Road Nearing An End?
Pain Therapeutics, Inc.
Here’s Why The XBiotech Inc (XBIT) Data Is So Important
At the end of May, we [Market Exclusive] published this piece discussing a then-upcoming data presentation from Texas based biotech, XBiotech Inc (NASDAQ:XBIT).
Answering Two Most Important Questions Surrounding Ampio Pharmaceuticals Inc (AMPE)
Ampio Pharmaceuticals Inc (NYSEMKT:AMPE) has recently reported topline from its PIVOT trial and the stock lost over 60% on the announcement last Thursday.
Here’s What The ArQule, Inc. (ARQL) Data Really Means
We just got some interim data from ArQule, Inc.
Deconstructing the Lipocine Inc (LPCN) Complete Response Letter
Lipocine Inc (NASDAQ:LPCN) just picked up a complete response letter (CRL) from the FDA, concerning its oral testosterone candidate, LPCN 1021.
Here’s What To Watch From Global Blood Therapeutics Inc (GBT)
Global Blood Therapeutics Inc (NASDAQ:GBT) just kicked off a phase IIa trial in its lead sickle cell candidate, GBT440.
Are Markets Finally Starting To See Intra-Cellular Therapies, Inc. (ITCI)’s Billion-Dollar Potential?
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) just announced that it has kicked off a phase 3 clinical trial for its lead neurological candidate, ITI-007-201.
As Old Bestsellers Plateau, a Look at 4 Next Generation Diabetes Drugs
In part I of our comprehensive report on the type II diabetes market, we broke down the top 4 best selling diabetes drugs, their prospects and the companies behind them.
Innocoll Holdings PLC (INNL) Could Pick Up Two US Approvals Before 2018
As the markets closed out on Friday, we got word that Innocoll Holdings PLC (NASDAQ:INNL) had completed enrollment in two phase III pivotals for its second lead development candidate...
Reata Pharmaceuticals Inc (RETA) Puts Out Positive PAH Data – What’s Next?
Reata Pharmaceuticals Inc (NASDAQ:RETA) just announced data from an interim study of its lead blood pressure study, and they company has picked up a bit of strength on the back...
Taking A Look At Adamas Pharmaceuticals Inc (ADMS)’s Upcoming Parkinson’s NDA
Adamas Pharmaceuticals Inc (NASDAQ:ADMS) just announced its intention to submit an NDA for its lead Parkinson’s candidate before the year draws to a close.
The Top Four Diabetes Best Sellers and One Oral Insulin Pill That May Threaten Them All
At the turn of the millennium, the population of the United States clocked in at 282.2 million.
Summit Therapeutics PLC (ADR) (SMMT) Is Hot On Sarepta Therapeutics Inc (SRPT)’s DMD Tail
Duchenne’s Muscular Dystrophy (DMD) is a hot topic right now.
Weekly Biotech Report Covering Epizyme Inc (EPZM) Tazemetostat & Teva Pharamceutical Industries Ltd. (TEVA) Drug Vantrela
Tazemetostat is an oral administration oncology candidate that is part of a family of drugs called small molecule EZH2 inhibitors.
Is Endo International PLC (ENDP) A Turnaround Opportunity?
Endo International plc (NASDAQ:ENDP) just announced that the FDA would not meet its planned PDUFA for one of the company’s lead development candidates, Opana ER, initially scheduled...
Gold and SPDR Gold Trust (ETF) (GLD) Gain Amid Quest For Safe-Havens
Gold and SPDR Gold Trust (ETF) (NYSEARCA:GLD) prices rallied on Monday ahead of important meetings of monetary regulators in the U.S. Europe and Asia.
Hilltop Holdings Inc. (HTH) Authorized To Buy Back Common Stock Worth $50 Million
According to the report, the company can use the authorized program to buy back the stock through private deals as authorized under Rule 10b-18 of the Securities Exchange Act ...
Tesla Motors Inc (TSLA)’s Co-founder Reveals Electric Garbage Truck
During the 2016 WasteExpo that took place in Las Vegas, Mack LR presented an electric garbage truck that features a powertrain from Tesla Motors Inc (NASDAQ: TSLA)'s co-founder...
How Does MannKind Corporation (MNKD)’s Afrezza Compare With Mealtime Insulin?
MannKind Corporation (NASDAQ:MNKD) recently presented data on its inhaled insulin candidate, Afrezza.
Agios Pharmaceuticals Inc (AGIO)’s AG-348 Excites In Phase 2 Study
Agios Pharmaceuticals Inc (NASDAQ:AGIO) has edged closer to the marketing approval of its anemia drug candidate, AG-348.
Ford Motor Company (F) Introduces 2017 Ford Fusion In Answer To Rivals
Ford Motor Company (NYSE:F) has revealed its powerful 2017 Ford Fusion with an impressive 325 horsepower that it believes will challenge its rivals, and especially German manufacturers...
Colombia Makes Good On Its Threat Against Novartis AG (NVS)
After negotiations with Novartis AG (NYSE:NVS) to lower the price of key leukemia drug Gleevec broke off, the Colombian government is set to take matters into its own hands.
What Does Vogue Acquisition Mean For Johnson & Johnson (JNJ)?
Johnson & Johnson (NYSE:JNJ) is acquiring Vogue International after announcing its intention on June 2. Vogue is a privately-held personal beauty company.
Alder Biopharmaceuticals Inc (ALDR) ALD403 Meets Trial Targets
Alder Biopharmaceuticals Inc (NASDAQ:ALDR) recently took the opportunity at the American Headache Society meeting in San Diego to present data from clinical trials of its compound...
Advanced Accelerator Application SA (AAAP) Signs Another NETSPOT Supplier in Cardinal Health
Advanced Accelerator Application SA (NASDAQ:AAAP) has inked a NETSPOT distribution deal with Cardinal Health Inc (NYSE:CAH), bringing to two the number of partners tapped to supply...
BlackBerry Ltd (BBRY) Progresses Towards Full Integration of Good Technology and WatchDox With BES
The company’s goal with the integration is to introduce a content management solution that is available across multiple platforms.
Can Apollo Education Group Inc (APOL) Make Money Helping Companies Cut Knowledge Cost?
Apollo Education Group Inc (NASDAQ:APOL) and the Center for Creative Leadership (CCL) have come together to help companies save money in the training of their frontline managers...
Alphabet Inc (GOOGL) Tries Major Overhaul On Search Results
Google parent Alphabet Inc (NASDAQ:GOOGL) is testing out a new design layout for search results on its flagship search engine.
