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MNKD FDA PDUFA should be very much around 4/15/14; so if you buy in chunks you should average your cost. They also have about $94M in COH as of last Q so there shouldn't be a new offering worry as a result. jmho
MNKD <link back 1/3/14> This one is definitely more than just rattling the saber it is actually just starting to move imho. Watch for entry PDUFA 4/15/14 this is not too early to start the watch imo.
MNKD FDA PDUFA 4-14 starting to move, 1st leg is done but it should have a few more b4 the above date. Watch for your entries if you want it.
BOL
T2M
IGXT Feb 3rd FDA PDUFA - nice to see it start to finally move.lol Though not much yet it could do very well for a run up.
Guess time will tell.
BOL 2 any other holders I have a bunch at .59 and some a bit lower.
T2M
IGXT Feb 3rd PDUFA starting to move a bit and on 3x the 20MA Vol which is good but sure no where near over bought! jmho It's nice to finally see this move a little today,
ATHX up 10% on some good volume vs 20MA for volume.Hugging the upper bolli
CPRX This Cardio efficacy study passed - Full Ph3 due 2QTR according to Biopharm as of 11/12/13. Company website says the PH3 is a test to block potassium for LEMS. Today it merely states it is cardio safe, which many times is a PH 2b. Nice support I think the new leg should begin shortly. jmvho
CPRX 8K just released
Form 8-K for CATALYST PHARMACEUTICAL PARTNERS, INC.
8-Jan-2014
Other Events, Financial Statements and Exhibits
Item 8.01 Other Events
On January 6, 2014, the Company issued a press release announcing the Company's successful completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) about Firdapse? tablets (Amifampridine), its lead product being evaluated for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS), and updating the progress of its Phase 3 clinical trial evaluating Firdapse? for the treatment of LEMS. The press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
On January 7, 2014, the Company issued a press release announcing that on January 3, 2014, the previously reported stockholder class action lawsuit that had been filed against the Company and certain of its officers and directors was dismissed without prejudice. The press release is attached to this Current Report on Form 8-K as Exhibit 99.2 and is incorporated herein by reference.
On January 8, 2014, the Company issued a press release announcing positive results from a study jointly funded with, and conducted by BioMarin Pharmaceuticals to assess the cardiac study of Firdapse? tablets (Amifampridine). The study met the primary endpoint, demonstrating that at and above therapeutic levels, there was no effect of Firdapse? (administered as phosphate salt) on heart rate or cardiac depolarization. The press release is attached to this Current Report on Form 8-K as Exhibit 99.3 and is incorporated herein by reference.
http://biz.yahoo.com/e/140108/cprx8-k.html
ATHX Veryyy Bullish article on a bio with a catalyst 3/31
http://seekingalpha.com/article/1933031-prognosticating-2014-athersys-shares-will-continue-to-climb?source=yahoo
Price target of 5.50+
ATHX Risk Reward - Bullish Article
[img] http://seekingalpha.com/article/1933031-prognosticating-2014-athersys-shares-will-continue-to-climb?source=yahoo
Prognosticating 2014: Athersys Shares Will Continue To Climb
Jan. 7, 2014 2:51 PM ET | 25 comments | About: ATHX, Includes: GALE
Disclosure: I am long ATHX. (More...)
Risk vs. reward ratio
Investors looking at Athersys, Inc. (ATHX) who've done their due diligence should see a favorable risk vs. reward ratio and relative safe haven for investment dollars. At least that's the picture through April 2014 when Athersys investors will have first pause to re-evaluate their risk tolerance ahead of the ulcerative colitis phase II initial data release. Those who are both seasoned and savvy investors in the biotechnology arena understand the following: This far away from the April data release they face almost no risk for significant downside. They also know for at least the next three months it will remain this way. On the other hand, Athersys investors have potential for higher than normal rewards heading toward April.
The overall investment sentiment is strongly bullish and the steadily increasing share price is testament to that fact. To explain the bullish sentiment one needs to use a certain level of due diligence. For example, one of the most important questions upon investigating any development stage biotechnology company should be: Is the company strapped for cash? That question comes only after the most obvious question is answered. Does this company possess something worthy of an investment in the first place? In the case of Athersys most investors are investing in the belief MultiStem, a platform based on an adult stem cell derived from bone marrow, will be a success in treating both ulcerative colitis and ischemic stroke. Both are currently hard to treat diseases and patients are in need of better options for treatment. MultiStem is specifically derived of multipotent adult progenitor cells (MAPCs). For those further interested in what MultiStem is they should look at the development of multiStem.
Getting back to the important question, is Athersys strapped for cash? The answer is absolutely not. Could Athersys benefit from a higher market cap, sure, what company wouldn't? The thing investors are really interested in is whether the company has in the past raised capital in a way that spares its investors as much downside risk as possible, and whether it has enough money to see its key catalysts through. In the case of Athersys, those questions are both answered with a yes. Athersys CEO Gil Van Bokkelen seems keenly aware and in tune with his company's investors. Evidence of this can be seen in the recent registered direct offering announced on November 27th, 2013, that closed on or about December 3rd, 2013. That offering occurred with almost no undermining of the then current share price. That's most often not the case when a biotech company raises capital. The offering was done because Athersys was approached by an interested investor and Gil made sure his team explained it to all investors in the last webcast. If being approached by a large investor wanting more shares in Athersys isn't an indication of a bullish sentiment for the future share price direction, maybe those investors who can't see it that way should paper trade a while longer. Athersys has also renewed a deal with Aspire Capital should financial conditions warrant the need for more capital. (not likely any time soon). In other words, the risk of an equity placement is virtually non-existent ahead of the ulcerative colitis data release.
Deciphering price targets
In the diagram below investors and potential investors are given a quick snapshot of where things stand as far as risk and reward vs. current share price. This should help with the question that many investors will inevitably be asking: Is it too late to jump on board? It's interesting to note that Edison's projection is right where most conservative share price estimates are, in the middle. That's not to be confused with the risk/reward tipping point, better known as an even bet ahead of a key company event. For those who may not know it, Edison is a leading international investment research firm.
Note the distance between price targets. The distance does not necessarily mean how fast a target will be reached. Rather it's indicative of that generality from past similar acting biotechnology stocks. To see why the line is so short between $2.50 and $3.00 an investor should look at how fast Galena Biopharma, Inc. (GALE) went to $3.00 after breaching $2.50 then $4.00 after breaking over $3.00 as an example. The Yahoo Finance price history can be utilized in that endeavor. Sometimes targets are broken faster or slower than the lines in the illustration tend to portray, however, they are far more accurate at determining length of time for consolidation at each price target. In other words, if a target on a longer distanced line is achieved too fast investors can expect more profit taking to occur, followed by the typical ups and downs of re-accumulation and new base forming for the next leg up.
Share price targets given in this article are upgrades to previously lower estimates and no longer agree with Edison's estimate. The evolving higher price per share estimates can be seen by reviewing past articles posted via the U.S. Biotech Investor site as well as other articles on the Seeking Alpha site. Actually, looking at the above illustration an investor should be able to see the overly conservative nature of the Edison share price estimate ahead of the ulcerative colitis top-line data release coming up in April or May of this year.
Here's the reason for the departure from Edison's price targets. There's still plenty of time to the known phase II data release event in April or May, with much to look forward to. Current market cap demands more respect, investor sentiment is bullish and should remain so, potential for surprise catalysts ahead of known events, and more is known about alternative markets like Japan. Those are examples of things used to determine a fair value per share ahead of the ulcerative colitis data release. Looking at time to event (data release) and current investor sentiment while combining it with the visual diagram above should illustrate the true absurdity of an investor believing Edison's $3.40 projection will be the top share price ahead of April 2014. That's meant as no disrespect to Edison Research which chose to err on the side of caution, it's just the nature of the game. To be fair to Edison, they came out early with their price target and boldly stated it. Edison did this while the Athersys market cap was a mere $105 million and based on a $1.75 share price. Price target projections from just about all sources have been moving higher ahead of the coming data release. Edison's call being one of the earliest was bold at the time.
Further explaining why current price projections were edged higher: In the latest webcast new light was shed on potential catalysts (like potential GvHD partnering). These potentials had to be more accurately factored in projections concerning share price targets ahead of the ulcerative colitis data release. The timing of potential new events doesn't really matter, what matters is the perception that investors see for share price appreciation.
A look at the last 3 months of 2013
With the year-end comes the occasion for biotechnology investors to revise their investment choices. This usually comes after evaluating the future potential of multiple biotechnology companies both in the short term (months) and long term (year or years). It's logical to assume that Athersys, Inc. will be viewed favorably and as a worthy addition to many portfolios. Fresh on the minds of many will be the recent breaking developments near the end of 2013 like the European orphan drug designation and the end of the enrolment for the ulcerative colitis trial conducted by Pfizer.
Another recent development is the finalized legislation in Japan that provides a framework for accelerated approval of stem cell products. Japan is the world's second-largest mature healthcare market.
Japan's parliament, the Diet, enacted a bill in the last quarter of 2013 which revised the existing Pharmaceutical Affairs Law to define new medical products which contain stem cells to be termed regenerative medicine products. The bill allows the Japanese government to give conditional approval to such products if their safety is confirmed in clinical trials, as may occur on completion of well designed Phase II trials. William (B.J.) Lehmann, President and Chief Operating Officer of Athersys, said they are "aggressively going after Japan." Hopefully news will be coming from Gil Van Bokken's recent visits to Japan. See: Q3 2013 - earnings call transcript for comments concerning Japan.
Here's a quick snapshot
?End of enrollment for the ulcerative colitis trial - achieved
?Initiation of the GvHD phase II/III trial in 2014 likely
?Initiation of the acute myocardial infarction phase II trial 2014 likely
?Potential realization of a partnership for the obesity drug
?Potential realization of a partnership for ischemic stroke in Japan
?Potential for future grants or awards
?Potential milestone payments from RTI or Pfizer
?Small potential for Bristol Myers squib news
?Regulatory changes to accelerate regenerative medicine use in Japan may bring development and partnering news for rights to the Japanese market. *See: Ramifications of Japanese legislation
The above mentioned GvHD indication may in fact have two catalysts: Initiation of the trial and a potential partnering per the last webcast hosted on December 4th, 2013. The same may also hold true for the acute myocardial infarction indication. After listening to the webcast one gets the feeling investors may be treated to unexpected news sooner than anticipated.
Major catalysts
? Ulcerative colitis trial initial data release -April or May 2014
? Ischemic stroke trial initial data release - July 2014
Conclusion
Herein lies a low risk and probable high reward investment opportunity. Shares of Athersys should be valued at a minimum of $5.50 ahead of April 2014 when the top line data for a phase II ulcerative colitis trail will be released. The bullish sentiment should increase as April approaches. A second trial for ischemic stroke is around the corner and reduces risk for investors if the ulcerative colitis data is less than expected. For a price projection beyond both trials data release please see: Treatment for ischemic stroke.
For those who will no doubt argue a $5.50 price projection is too conservative ahead of April. Notice the illustration in this article does extend past the $5.50 mark. Room exists for an upgrade should any of the listed snapshot events occur prior to April 2014. seekingalpha.com/article/1933031-prognosticating-2014-athersys-shares-will-continue-to-climb?source=yahoo
UPDATE YOUR ALERT SUBSCRIPTIONS NOW:[/img]
CPRX 8K just released
Form 8-K for CATALYST PHARMACEUTICAL PARTNERS, INC.
8-Jan-2014
Other Events, Financial Statements and Exhibits
Item 8.01 Other Events
On January 6, 2014, the Company issued a press release announcing the Company's successful completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) about Firdapse? tablets (Amifampridine), its lead product being evaluated for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS), and updating the progress of its Phase 3 clinical trial evaluating Firdapse? for the treatment of LEMS. The press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
On January 7, 2014, the Company issued a press release announcing that on January 3, 2014, the previously reported stockholder class action lawsuit that had been filed against the Company and certain of its officers and directors was dismissed without prejudice. The press release is attached to this Current Report on Form 8-K as Exhibit 99.2 and is incorporated herein by reference.
On January 8, 2014, the Company issued a press release announcing positive results from a study jointly funded with, and conducted by BioMarin Pharmaceuticals to assess the cardiac study of Firdapse? tablets (Amifampridine). The study met the primary endpoint, demonstrating that at and above therapeutic levels, there was no effect of Firdapse? (administered as phosphate salt) on heart rate or cardiac depolarization. The press release is attached to this Current Report on Form 8-K as Exhibit 99.3 and is incorporated herein by reference.
http://biz.yahoo.com/e/140108/cprx8-k.html
CPRX Today's PH3 is for a rare disorder and cardio safety- but there is also another PH3 for the same drug which is due 6/30 LES - so there may be the start of a new leg fairly soon, after some profit taking. Watch this one carefully due to the next event, within the next week or possible today it may hold much of the gains from this PH3. Should be interesting to see.
Cardio safety is now established for the drug and that is a good sign!
BOL
T2M
SCON 41% climb today and exited the other 1/2 of my holdings but nowhere near at that %. I only ecked out 11.+% gain instead. It sold auto pilot and *man was that a crappy pilot. He must have been still taking flying lessons. I missed a ton later in the day.
Oh well - out now Thanks to Read This Now for tip on the symbol 2-3 months ago.
Good over all trade regardless so TYVM RTN
T2M
Bob I was hoping you had spotted something I did not, as I posted before many times I have a huge deficit on paper; so Huge insider buys would have been a tripling up type indicator for me. I really wish I missed a few more important ones. But any are ok.
NP Bob - now I will just go back to compensating for my own stupidity on my trading of it last year.
NPA
T2M I was just hoping. lol
GTXI I hope BS is correct and there are more Form 4s that are *huge* as he put it.
I still own a ton of it and have been working off that loss for months. lol
GXTI Bob Stocks I only see 3 insider buys Hyde for 8k+, Furr 3.8K+ and Robinson for 6.6K+ shares What HUGE BUYS ARE YOU REFERRING TO?? Am I missing more Form 4s the above are marked as latest in Schwabs news?
??? " Bob Stocks Member Level Monday, 01/06/14 02:08:24 PM
Re: Bob Stocks post# 75523
Post # of 75535
GTXI $1.78 moving nicely here...with good reason those were huge insider buys.
MSTX Very nice news today moving this up on 4x 20MA vol. This stock also was recently assigned a very nice price target wayyyy above current levels.
Last weeks Friday post:
trade2much Member Level Friday, 01/03/14 06:22:54 PM
Re: trade2much post# 79151
Post # of 79191
MSTX<link back for huge 1/2 insider buys 5 separate ones.
DD just look at the news listed unreal; PT of $2.25 Orphan status etc
http://finviz.com/quote.ashx?t=mstx
MSTX <link back> Below was announced AFTER the market closed the other day and for good reason. Seldom do you see 5 strong insider buys at once on the same day and at market. I think it was a precursor to what was announced today, not much on coincidence. The volume today is 4x what the 20MA for Vol is. It has some resistance to work through in the low 60s so it should be fun to see what happens.
<Link back>
"MSTX Just out today - Very nice insider buys
CFO
http://archive.fast-edgar.com//20140103/ASZZA22C3222D2C2222I2MZ2RCN3Z22RE562/
CEO
http://archive.fast-edgar.com//20140103/AMZ2G22C3222R2D2222T2MZ245ACV22RE262/
Pres COO
http://archive.fast-edgar.com//20140103/AEZZN22C322282D2222Q2MZ2RWBNZ22REF62/
Head of Development
http://archive.fast-edgar.com//20140103/A8ZZ322C3222P2D222282MZ2SPDAZ22REZ62/
Chief Medical Officer
http://archive.fast-edgar.com//20140103/AVZ2322C3222H2E2222N2MZ29T7NL22RE262/
Senior VP Commercial
http://archive.fast-edgar.com//20140103/AVZ2322C3222H2E2222N2MZ29T7NL22RE262/ "
Bucc thanks for the headsup sure one to keep and eye on.
TYVM
T2M
Beginner Results 2013 Another Great job!
Just a question for you: " are you devoting equal $$ per investment, symbol, or are you picking favorites according to DD?
I can't tell from the ibox, but it would be great to know. It would make a rather huge difference knowing if and how you are weighting you average to achieve the great results.
TIA
T2M
MSTX<link back for huge 1/2 insider buys 5 separate ones.
DD just look at the news listed unreal; PT of $2.25 Orphan status etc
http://finviz.com/quote.ashx?t=mstx
carp1 seldom have I seen so many at once there are 5 big buys listed, bodes very well.
MSTX Just out today 1800 1/3 - Very nice insider buys
CFO
http://archive.fast-edgar.com//20140103/ASZZA22C3222D2C2222I2MZ2RCN3Z22RE562/
CEO
http://archive.fast-edgar.com//20140103/AMZ2G22C3222R2D2222T2MZ245ACV22RE262/
Pres COO
http://archive.fast-edgar.com//20140103/AEZZN22C322282D2222Q2MZ2RWBNZ22REF62/
Head of Development
http://archive.fast-edgar.com//20140103/A8ZZ322C3222P2D222282MZ2SPDAZ22REZ62/
Chief Medical Officer
http://archive.fast-edgar.com//20140103/AVZ2322C3222H2E2222N2MZ29T7NL22RE262/
Senior VP Commercial
http://archive.fast-edgar.com//20140103/AVZ2322C3222H2E2222N2MZ29T7NL22RE262/
MSTX Just out today - Very nice insider buys
CFO
http://archive.fast-edgar.com//20140103/ASZZA22C3222D2C2222I2MZ2RCN3Z22RE562/
CEO
http://archive.fast-edgar.com//20140103/AMZ2G22C3222R2D2222T2MZ245ACV22RE262/
Pres COO
http://archive.fast-edgar.com//20140103/AEZZN22C322282D2222Q2MZ2RWBNZ22REF62/
Head of Development
http://archive.fast-edgar.com//20140103/A8ZZ322C3222P2D222282MZ2SPDAZ22REZ62/
Chief Medical Officer
http://archive.fast-edgar.com//20140103/AVZ2322C3222H2E2222N2MZ29T7NL22RE262/
Senior VP Commercial
http://archive.fast-edgar.com//20140103/AVZ2322C3222H2E2222N2MZ29T7NL22RE262/
CLSN 10 bags - I appreciate the technical heads up. I put an order in this a.m for $3.93 and it filled today so I shall see how it goes. The chart is interesting, I do however like to try to combine catalysts with technical and all I see now is a Fall 2014 PH2, anything else anyone is aware of?
TIA
T2M
CPRX Good Point Sheff "Remember that they have Breakthrough Designation (BTD) for Firdapse in LEMS"
TY
CPRX TYVM Sheff
"LEMS will be huge for $CPRX. The Phase III data is expected to be released in Q2 2014 and will be the basis for their NDA filing. Definitely a strong catalyst. Investors are awaiting confirmation of the completion enrollment Firdapse study."
CN glad it worked well, nothing like some good luck!
BOL
T2M
CHTP AF article is not bad for CHTP, though it is not glowing it is a plus imo
http://www.thestreet.com/story/12201246/2/biotech-stock-mailbag-inovio-chelsea-exelixis-ariad-immunocellular.html
MSTX<link back annotated chart> Moving well today and for the very recent past. I think it is in for a bit of a haul, jmho
MNKD Watching it rattle the saber watch carefully it has a 4/15 PDUFA <link back>
BOL
IDRA Just sold remaining 1/2 at 24.3% Gain. Now to see about a retrace. jmho
Sheff - 100% agree on the flips, I have donated a ton of $ to the Schwab charity for homeless commissions in the past. -
I don't buy and hold bios and follow your trading reasoning, applying it to many bios.
I am happy with 10-25% modest gains when they avail themselves, usually just trading on support and resistance levels. I also have a good trading buddy who constantly works on flip focus with me.
Thanks again,
T2M
PVCT I have flipped it 3x now in different accounts. This morning on auto pilot exited it gained another trade with 21.9%.
Reentered with a 1/3 as much in another account and with a tight stop so we will see when the string breaks.
BOL CN
Sheff - CHTP yes I stayed in as well. Very quickly looked at their cash burn, seems like 3-4M per Q -
They just issued stock in Sept., not too much though, so I am not strongly thinking it is that type thing. With 20M COH accd Finviz who knows, that is not exactly cash ladden. Not aware of any milestones. Couldn't find any rev source on it though. That is why I was thinking bear raid although did not look at the Short position of float yet.
Guess we sit tight for a bit. Thanks for input.
T2M
SHEFF Wow CHTP got nailed today and now seems to be making a little up.
Was 15%+ down? Any ideas Sheff? If they just announced the Adcom is it merely profit taking? That is what I was thinking but...?
Just a BEAR RAID? Looking like that, guess time today will tell.
TIA