Venaxis Poised For Run-Up Into Pivotal Study Results [View article]
CT scan is the gold standard for diagnosis and to determine if surgery is required to remove the appendix so APPY1 test would fit in between to determine if the patient is low-risk for appendicitis so that CT scan/radiation exposure is not really necessary which is especially important in younger patients at higher risk to the radiation exposure
Venaxis Poised For Run-Up Into Pivotal Study Results [View article]
They expect to make initial shipments to distributors along w/ hospital marketing studies this quarter but no meaningful revenue is expected to begin until next year
Anika Therapeutics: Growth Stock At Value Prices With Near-Term FDA Catalyst [View article]
tax loss selling is possible but with stock stabilizing in mid-$10s and expected near-term FDA decision for Monovisc plus expected record 4Q revenue early next year I think stock has great upside potential into year-end and through early next year.
Amicus Therapeutics Poised For Rebound Into December Phase III Results [View article]
I guess we will find out next month and there is always risk of failure in P3 trials but I don't see how either company would be hiding anything since results remained blinded to both companies...also with the timeline for the P3 results next month there is an opportunity to trade the stock for a rebound/run-up into the results as it is trading well below the 50/200-day moving averages and had a strong run-up about a month ago to mid-$6s
Amicus Therapeutics Poised For Rebound Into December Phase III Results [View article]
below is what FOLD announced w/ 2Q12 results & during 3Q12 results announced the six-month primary endpoint data is due next month so what data is not being released?
"Amicus and GSK have recently engaged in encouraging interactions with the FDA regarding the planned NDA for migalastat HCl. The agency indicated it would consider safety and efficacy data from both the six- and 12-month kidney biopsies to support conditional approval under subpart H. In order to preserve the integrity and availability of clinical data for the open-label follow-up period, Amicus and GSK have jointly determined that the unblinding and analysis of the data from the primary six-month treatment arm will not occur prior to the fourth quarter 2012. Both companies remain blinded to the results at this time."
During the fourth quarter 2012, Amicus and GSK expect to announce the primary endpoint analysis, based on interstitial capillary globotriaosylceramide (GL-3) as measured in kidney biopsy at 6 months. Results from the 6-month follow-up period in Study 011 are expected in the first half of 2013, which will include 12 months on migalastat HCl in the treatment group and 6 months on migalastat HCl in the placebo-crossover group.
Amicus Therapeutics: Rare Disease Drug Developer Expected To Reveal Phase III Results In 3Q12 [View article]
I am hoping they give some kind of guidance to report the P3 results...would make it a great run-up trade...otherwise results could be out at any time...I ended up closing my position today with the stock in the red on big up market day and going into the weekend so will watch until their quarterly results/update
Amicus Therapeutics: Rare Disease Drug Developer Expected To Reveal Phase III Results In 3Q12 [View article]
1) original agmt OCT 2010 $GSK purchased 6.9M shares @$4.56 which was 19.9% stake at the time
2.) $FOLD sold 11.5M shares @$5.70 in MAR 2012 which diluted $GSK's original stake
3.) expanded agmt w/ $GSK in JUL 2012 includes addt'l purchase of 2.9M shares @$6.30 bringing Glaxo ownership stake back to 19.9% w/ total ownership of 9.8M shares of $FOLD stock
is very tough to catch a falling knife and pick exact bottom...my guess is the stock drifts lower after the failed P3 trial and planned start of second P3 trial for diltiazem not expected until 4Q12...recent big gainers in biotech with near-term late-stage clinical and/or FDA catalysts...also iferanserin was main value driver for stock since diltiazem cream available from compounding pharmacies and there is already approved drug RECTIV for same indication
Neptune Reports Strong Sales Growth Ahead Of Phase II Results [View article]
Amarin was developing AMR101 for other neurological indications in Phase 2 and discovered the triglyceride lowering effect indirectly in these trials and was able to proceed directly to the Phase 3 trials due to a well established safety profile and known mode of action for omega-3s to lower triglycerides. After the failed Phase 2 neuro studies, Amarin did recapitalization to support the Phase 3 trials which ended up being highly successful.
Neptune Reports Strong Sales Growth Ahead Of Phase II Results [View article]
The fact that Lovaza generates about $1 billion in annual global sales clearly validates the major sales potential for more potent prescription-grade omega-3 products since omega-3 supplements have been widely available for years so NEPT is basically trying to do the same thing with krill oil and hopes to generate Phase 2 data during 2H12 to show improved results compared to regular omega-3s based on the unique features of NKO such as the phospholipid make-up and antioxidant properties. It is true Phase 3 results are a long way off but their nutraceutical biz is growing and profitable (see news today on $25 million order) on standalone basis and majority subsidiary Acasti is the R&D branch.
yeah the 510k clearance came quickly this time compared to the first drawn-out attempt! Looking at 1Q12 results, seems NEPH is closing in on break-even/profitable results w/ one remaining milestone pmt from Bellco and potential for more extensive military orders...valuation seems a bit high at over 10X sales but such an early stage that anything could happen from here
Glaxo would be natural fit assuming AMR101 gets the extended patent protection...would be a nice follow-on product to lovaza before generic competition in a few years...Pfizer would also make sense given that Lipitor went generic...I think somewhere in high teens to low twenties for fully diluted valuation around $3 billion makes sense assuming peak sales around $1 billion for AMR101 similar to Lovaza (which likely benefits from extensive off-label use by prescribers)
yeah that ship sailed long ago! I will venture to say that I have no control over ARNA share price at this point w/ the stock trading 10's millions in volume daily and I have no plans to trade it long or short
Venaxis Poised For Run-Up Into Pivotal Study Results [View article]
Venaxis Poised For Run-Up Into Pivotal Study Results [View article]
Nymox Pharma: Developing A Potential Long-Term Treatment For BPH [View article]
http://bit.ly/11nH9zK
Anika Therapeutics: Growth Stock At Value Prices With Near-Term FDA Catalyst [View article]
Amicus Therapeutics Poised For Rebound Into December Phase III Results [View article]
Amicus Therapeutics Poised For Rebound Into December Phase III Results [View article]
2Q12 results> http://bit.ly/SKBUrQ
"Amicus and GSK have recently engaged in encouraging interactions with the FDA regarding the planned NDA for migalastat HCl. The agency indicated it would consider safety and efficacy data from both the six- and 12-month kidney biopsies to support conditional approval under subpart H. In order to preserve the integrity and availability of clinical data for the open-label follow-up period, Amicus and GSK have jointly determined that the unblinding and analysis of the data from the primary six-month treatment arm will not occur prior to the fourth quarter 2012. Both companies remain blinded to the results at this time."
3Q12 results> http://bit.ly/RHJbXk
During the fourth quarter 2012, Amicus and GSK expect to announce the primary endpoint analysis, based on interstitial capillary globotriaosylceramide (GL-3) as measured in kidney biopsy at 6 months. Results from the 6-month follow-up period in Study 011 are expected in the first half of 2013, which will include 12 months on migalastat HCl in the treatment group and 6 months on migalastat HCl in the placebo-crossover group.
Amicus Therapeutics: Rare Disease Drug Developer Expected To Reveal Phase III Results In 3Q12 [View article]
Amicus Therapeutics: Rare Disease Drug Developer Expected To Reveal Phase III Results In 3Q12 [View article]
Amicus Therapeutics: Rare Disease Drug Developer Expected To Reveal Phase III Results In 3Q12 [View article]
2.) $FOLD sold 11.5M shares @$5.70 in MAR 2012 which diluted $GSK's original stake
3.) expanded agmt w/ $GSK in JUL 2012 includes addt'l purchase of 2.9M shares @$6.30 bringing Glaxo ownership stake back to 19.9% w/ total ownership of 9.8M shares of $FOLD stock
5 Near-Term, Low-Priced Bio-Catalyst Trades [View article]
Neptune Reports Strong Sales Growth Ahead Of Phase II Results [View article]
Neptune Reports Strong Sales Growth Ahead Of Phase II Results [View article]
5 Near-Term, Low-Priced Bio-Catalyst Trades [View article]
5 Near-Term, Low-Priced Bio-Catalyst Trades [View article]
5 Near-Term, Low-Priced Bio-Catalyst Trades [View article]