We have talked about BioMarin several times before( #1, #2 and #3). Today, we wanted to put out a brief note on some recent options activity we have noticed. On Friday, we saw some very large options activity that is certainly worth mentioning. The largest trade that happened was a 3-way trade, that does not appear tied […]
INCY – Incyte: Taking The Long View
The pain has not stopped for INCY shareholders since the company offered disappointing revenue guidance in its 2Q conference call August 2. A less than stellar projection of $120 to $135 million in 2012 Jakafi sales did not sit well with investors. This was compounded by the company’s decision to switch mid-year from a sell-through accounting method to […]
Upcoming events for REGN, MDVN, and BMRN
This is the third installment in our series about upcoming events across the biotech sector(be sure to see our 1st piece and 2nd piece). This time around we want to take a look at some upcoming events at some larger biotech companies and what we will be drivers for them going forward. If there are any companies […]
Upcoming events for EXEL, ARQL, CLDX
This is the second installment in our series about upcoming events across the biotech sector(see our 1st piece). As we have said before, this fall should be full of meaningful data catalysts for biotech companies. In our next segment, we will take a look at a few larger biotech companies and what we will be […]
XNPT – What’s going on at Xenoport
Many market commentators have been amazed by the recent move in Xenoport(NASDAQ: XNPT), which is up more than 100% since April. Much of this move is easily explained by excitement for their early-stage drug, XP23829. As we will explain below, there appears to be good rationale for this move and likely a move higher. XP23829 […]
SRPT – Sarepta – Approaching Major Catalyst
Sarepta’s release of positive interim data from its DMD drug on July 24 has lit a fire under the stock- and stoked animated discussion in the twitterverse. We revisit this story as a critical catalyst approaches. Due to the severity of the disease and the young age of those afflicted, investors uniformly cheer for eteplirsen, Sarepta’s […]
Upcoming events for NKTR, THLD, ASTX
Given the plethora of data coming in the next 3 months, we thought we would do a few short series on biotech companies that will be quite busy this fall. We hope to do 3 or 4 installments in the next few weeks to give readers some broad coverage of what’s happening from small marketcap […]
Upcoming medical conferences(September thru October)
With the summer almost over, we want to highlight some of the major medical meetings that will be pivotal events for many companies. September thru early December is ripe with upcoming data releases that can be presented at these events. We have attempted to list some of the more important conferences, but it’s entirely possible […]
Smallcap Phase 3 data expected by year-end 2012
This report will focus on some of the most anticipated Phase 3 trials that should read-out by the end of 2012. We’ve provided some thoughts on the potential for success of each program. This installment will focus on companies with market capitalizations below $1 billion. (Note, they are in alphabetical order, not most to least […]
SNMX – Senomyx shareholders need a bitter-blocker
Senomyx $SNMX is a company that uses biotechnology to develop novel flavor ingredients for the global food and beverage industry [see our initiation report for a detailed profile, and see the 2q-2012 news release for current status of each program]. We thought shares were attractively valued then, but SNMX has continued it’s steady downward slide ever since, […]
ESMO12 Abstracts of interest
The European Society for Medical Oncology (ESMO) Congress 2012 kicks off on September 28th thru October 2nd. Abstract titles are currently able to be viewed and searched here(link), but no other descriptive information is available. Abstracts will be available before-hand on September 17th, with late-breaking abstracts coming during the Congress. Synta Pharmaceuticals (NASDAQ: SNTA) Several sources […]
A glance at the upcoming European Respiratory Society meeting
This year’s meeting of the European Respiratory Society will be held in Vienna on September 1-5. There will be a good deal of presentations from some companies developing drugs in the respiratory space that we’ve covered in this article . British company Vectura (LSE: VEC) along with partner Novartis (NYSE: NVS), will be presenting further data […]
SGYP – Synergy Pharmaceuticals, Expecting Positive Data
Synergy is a different kind of company- that is for certain. It is the epitome of a virtual biotech: it’s staff of nine is charged with running a pivotal 880 patient Phase II/III study; initiating follow-on projects; and in-licensing new compounds. The company’s lead candidate is plecanatide, a peptide analog of the human hormone uroguanylin. […]
September at the FDA
Upcoming regulatory decisions at the FDA in September should make for another FDA decisions expected on 4 New Drug Applications(NDAs) Salix Pharmaceuticals (NASDAQ: SLXP) – 9/5/12 Salix has a PDUFA date of Wednesday, September 5th, for Crofelemer 125 mg tablets. The indication sought is “for the control and symptomatic relief of diarrhea in patients with […]
ONCY – What’s going on at Oncolytics
Oncolytics Biotech (NASDAQ: ONCY) is running a two-stage Phase III clinical trial examining REOLYSIN® in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers (REO 018). We originally believed there was a chance to see data before August options expiration. This analysis provides further insight into why we believe this trial […]
HALO – Halozyme – The Platform Still Stands
Halozyme shares cratered following a Complete Response Letter (CRL) received by Pharma partner Baxter for the potential blockbuster drug HyQ on August 1. The FDA had concerns over high levels of non-neutralizing antibodies patients developed to recombinant human hyaluronidase, or rHuPH20, Halozyme’s platform technology. HyQ is a combination of PH20 with Baxter’s Gammagard (basically a […]
DEPO – Quick Update on Depomed
With Depomed’s recent PPS drop to below $5, many long-term investors have found themselves questioning their investment thesis. Although this past quarter has seen some interesting news releases, none have been able to move the stock price. Furthermore, the endless staring and tracking of weekly Gralise data has left investors, who lack patience, without a […]
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. […]
SRPT – Sarepta Makes Strides In DMD
Duchenne’s Muscular Dystrophy (DMD) is a genetic disorder that afflicts approximately 1 out of every 3,600 male infants. The inherited disease is caused by mutations in the gene for dystrophin- a muscle protein- resulting in muscle weakness at an early age that quickly worsens over time. Breathing difficulties and heart disease typically begin in the […]
BMRN – Update on BioMarin’s BMN-673
As a follow up to our initial piece on BioMarin Pharmaceutical (NASDAQ: BMRN), we caught the 2Q quarterly conference call. We were particularly interested in what was said with respect to their oncology program, BMN-673, a PARP inhibitor. This program is currently being evaluated in 2 Phase 1 trials, one in hematological malignancies and another […]
