Another slow day, although there was some more interesting news. Biotechs continued to underperform the broader market and I suspect that will be a trend for the next couple of days as the move last week is digested. This is going out a little early because I have to head out before the end of […]
June 6- EOD
Perhaps we had a turnaround Thursday but could of course all be crushed by a bad jobs report (or perhaps a good jobs report- you never know in this market). 1. There is some additional CELG news that has not been getting a lot of attention. As way of background, CELG 2017 guidance has about […]
An October full of data and decisions
With October underway, we felt the need to highlight some of the most important upcoming data readouts and regulatory decisions. This month is particularly busy on the regulatory side of things with 5 PDUFAs, 4 Advisory Committees, 6 FDA actions, and multiple potential European Medicines Agency(EMA) decisions. The events are listed in chronological order. Eli […]
AMRN – Issues surrounding the NCE status
We wanted to take a moment to post some analysis on the upcoming FDA decision around Amarin (NASDAQ: AMRN). Amarin’s AMR101 was approved on July 27th under the tradename, VASCEPA. There has been a substantial amount of worry on whether VASCEPA will receive New Chemical Entity(NCE) status and the benefits it brings a new drug. […]
AMRN HZNP – Amarin’s VASCEPA and Horizon’s RAYOS receive FDA approval
Late Thursday afternoon, we learned that both Amarin (NASDAQ: AMRN) and Horizon Pharmaceuticals (NASDAQ: HZNP) separate new drug applications had been approved by the FDA. We have some insight to share on both names. With respect to Horizon, unfortunately, their future is not looking so bright. Rayos is a delayed-release formulation of low-dose prednisone. Prednisone […]
Upcoming FDA Decisions
We will have several regulatory decisions expected this week, some more important than others. This coming week got slightly tamer with the FDA’s approval decision for Carfilzomib on Friday for Onyx and Ligand. Horizon Pharmaceuticals (NASDAQ: HZNP) has a PDUFA date of Thursday, July 26, 2012 for LODOTRA(delayed-release low-dose prednisone), for the treatment of rheumatoid […]
Updates from the Jefferies Global Healthcare Conference
The 2012 Jefferies Global Healthcare Conference was held June 4-7, 2012. You can access the full schedule and webcasts here. I’ll provide brief updates on the presentations by several companies in this post. Keep your eye on the Chimera Proprietary Calendar for all upcoming investor meetings, with links to the webcasts and schedules. Note that […]
AMRN – Update on Amarin’s AMR101 as PDUFA date draws closer
Amarin Corp (NASDAQ: AMRN) released first quarter 2012 financial results and held a conference call on May 8, 2012. It is often hard to distinguish the signal from the noise when it comes to chatter about AMRN on Twitter and other venues, so we will try to objectively update where things stand as the July […]
Updates from the Citi Global Healthcare Conference
The annual Citi Global Healthcare Conference was held February 27-29, 2012, and as always we listened in on the webcasts to identify key takeaways for Chimera Research Group shareholders. These write-ups may be brief due to overlap with comments at other recent investor conferences – see links below. Amarin $AMRN (Leerink Swann notes – company overview) “We […]
Updates from the Leerink Swann Global Healthcare Conference
The annual Leerink Swann Global Healthcare Conference was held February 15-16th, 2012. Several companies that I follow for BiotechDueDiligence and Chimera Research Group presented, and I will summarize the highlights below. Isis Pharmaceutical $ISIS (Archived Chimera content – Pipeline Notes) KYNAMRO (mipomersen) Genzyme/Sanofi are preparing for launch this year. EU application was filed July 2011. […]
Upcoming FDA Decisions and Advisory Panels
To help save everyone some time, we went ahead and rounded up the upcoming FDA PDUFA dates and FDA Advisory Committees. We will have trade ideas and opinions on some of these events in the near future. We have highlighted some of those which we feel are the biggest importance to the market with asterisks(*). […]
AMRN – Will AMR101 receive New Chemical Entity (NCE) Status from the FDA?
Why does this question of New Chemical Entity (NCE) status matter? Simply put, if AMR101 is designated as a New Chemical Entity (NCE) by the FDA, the product receives five years of market exclusivity after approval in the United States, regardless of the patent situation (sometimes referred to as Hatch-Waxman exclusivity). During this time the FDA will […]
AMRN – Put Sale
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