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CBRX($0.92) - FDA ruling is expected on Feb 26th. It will most likely not be approved since the Advisory Panel recommended against approving it: http://finance.yahoo.com/news/FDA-Advisory-Committee-prnews-2167578464.html?x=0
Panel vote was 13 No; 4 yes - Something to keep in mind if you are trading.
DSCO ($1.73) - Roth Capital Starts DSCO at Buy PT $6.00
http://www.streetinsider.com/New+Coverage/Roth+Capital+Starts+Discovery+Laboratories+%28DSCO%29+at+Buy/6990968.html
PLX ($6.07) - Protalix Announces Successful European GMP Audit
CARMIEL, Israel , Dec. 1, 2011 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX, TASE:PLX), announced today that the Irish Medicines Board (IMB) has completed a successful GMP (Good Manufacturing Practice) audit of the Company's manufacturing facility in Carmiel, Israel, and has issued a Certificate of GMP Compliance of a Manufacturer for the facility. The IMB Certificate is accepted by all health authorities in the European Union (EU) under the EU's centralized marketing authorization procedure, and by authorities of several other countries that recognize EU Certification. The audit was performed as part of the European Medicines Agency's (EMA) evaluation of the Marketing Authorization Application for taliglucerase alfa for the treatment of Gaucher disease.
In addition to the EMA, the U.S. Food and Drug Administration ( FDA ), Israeli Ministry of Health and Brazilian National Health Surveillance Agency have completed audits of the Company's manufacturing facility and deemed the facility acceptable.
"We are pleased to accomplish this major regulatory milestone," said Dr. Michal Kahana, Protalix's Vice President of Quality Affairs. "This important achievement helps demonstrate the viability of our proprietary plant-cell based technology platform, which is the engine behind all our pipeline candidates."
To date, marketing applications for taliglucerase alfa have been submitted in the United States , European Union , Brazil, Israel and Australia. The Prescription Drug User Fee Act (PDUFA) target date for taliglucerase alfa in the United States is February 1, 2012 .
http://finance.yahoo.com/news/Protalix-Announces-Successful-prnews-2010716784.html?x=0
YMI ($1.24) - Company issues PR
MISSISSAUGA, ON , Nov. 22, 2011 /CNW/ - YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), today reported that, in view of the unusual market activity in the common stock of the Company, the NYSE Amex has contacted the Company in accordance with its usual practice. While it ordinarily does not comment on market activity or market rumours, YM confirmed that it is not aware of any material corporate developments, including without limitation, any financing activities, which could account for the unusual trading activity.
http://finance.yahoo.com/news/YM-BioSciences-Reports-prnews-638201596.html?x=0&l=1
CYCC ($0.64) - Upcoming Catalysts:
1) Presentation of updated sapacitabine data from the Phase 1/2 pilot study in elderly patients with AML at the 2011 American Society of Hematology (ASH) annual meeting
2) Report interim data from the Phase 2 study of sapacitabine in non-small cell lung cancer (NSCLC)
3) Report interim data from the Phase 1 combination study of sapacitabine and seliciclib in patients with solid tumors
4) Report patient biomarker analysis from the APPRAISE Phase 2b randomized discontinuation study of seliciclib in patients with NSCLC.
http://www.cyclacel.com/cyc/investors/news/pressreleases/2011/2011-11-14/
INCY -- FDA Approves Incyte Corp's Jakafi Myelofibrosis Treatment
~ Dow Jones News
INCY ($12.54) - Facts to consider before the upcoming FDA ruling:
1) What is being reviewed by the FDA: New Drug Application for ruxolitinib (INCB18424/INC424)as a potential treatment for patients with myelofibrosis (MF).
2) Fast Track Designation received from the FDA: http://bit.ly/vaaPla
3) Special Protocol Assessment (SPA) reached with the FDA for the COMFORT-I Phase III Study: http://bit.ly/vbyrR9
4) Company ran a second Phase III trial, COMFORT-II, in Europe under the Incyte-Novartis worldwide collaboration and license agreement for ruxolitinib. This was done for the purpose of EU filing.
5) COMFORT-I trial meets primary and key secondary endpoints: http://bit.ly/etnwDs
6) COMFORT-II trial meets Primary Endpoint: http://bit.ly/rXt1oZ
7) FDA grants priority review for the NDA: http://bit.ly/s1XRPP
8) PDUFA Date: December 3, 2011
this is the better week you promised? lol... this market is testing character!
BPAX... thanks for clarifying. I took a starter position on friday on the recent pull back. The insider buy is a vote of confidence for me given the following significant upcoming catalysts:
Bio-T-Gel PDUFA Date: Nov. 14, 2011
LibiGel Phase III Data: 4Q11
LibiGel has three SPAs
Plus, it is trading 20% below the recent financing. I expect a big move coming before the catalyst dates, but the general market may bring it down a little further first. Keeping some money aside to average down if it dips.
thanks
manny_t, I see the SEC form that shows the director buying 80,000 shares today. But, what is the form that shows him buying shares in a private offering recently?
Thanks
$PATH($7.06) - Initiated with an Outperform at Wedbush
http://www.theflyonthewall.com/permalinks/entry.php/PATHid1463825/PATH-NuPathe-initiated-with-an-Outperform-at-Wedbush
CAPS($0.27) - Any near term catalyst for this? The stock was up almost 20% today. Also, there has been some insider buying earlier this week at $0.25:
http://www.otcmarkets.com/edgar/GetFilingPdf?FilingID=8018420
http://www.finviz.com/quote.ashx?t=caps
TSPT($10.98 PM) - Up 5% in pre-market after it closed above the 20-dma yesterday.
TSPT($10.56) - PDUFA date is 7/14. After a recent drop, seems like trying to climb back up above the 20-dma. Technically speaking, if it closes above $10.44, we should see some volume coming in?
This maybe is the reason: Small-Caps Fall as Russell 2000 Reshuffles
"Index managers who are directly or indirectly tracking the Russell indexes will need to rebalance their portfolios at the end of the day, which always causes a spike in trading activity near the close. During the rebalancing at this time last year, about 7.5 billion shares were executed just in NYSE-listed stocks, 50 % higher than the daily average of 5.4 billion," CNBC.com reports.
Full story: http://finance.yahoo.com/news/Small-Caps-Fall-Russell-2000-ETFTrends-200982740.html?x=0&.v=1
DVAX($2.73) - Bullish charts with today's EOD volume/price spike. Some of these smallcaps biotech stocks will certainly hit the radars of the technical traders based on today's action.
Too many biotechs with huge volume and even in AH taking prices higher. This one is beyond understanding (for now).
I wonder if these end of day gains will hold their ground on Monday
Something weird with end of day trading for biotechs. All the stocks jumped quiet significantly in the last few minutes (examples: ALXA, BPAX, PATH, TSPT)
PATH($7.22)- Those insider buys must be from the 08/06/2010, the first day PATH traded as an IPO. 08/06/2010, the first day, was the only time the stock hit $10.
I don't see any any insider selling in the filings. I hope PATH does hit $10 again so those insiders can break even and those buying at today's prices can cash out!
KERX($4.61) - After the recent drop and bullish candle from yesterday, it is still trading below the price where they did recent financing in may (recent financing price: $4.70). Phase III data expected in Q4 2011
PATH($7.22) - Market has been open for more than 20 min. and this has traded just 300 shares. Just waiting to see whether the rest of the shares to come in during the day will move it higher or lower
TTNP($2.01) - Data analysis delayed
Titan Pharmaceuticals Provides Update on Confirmatory Phase 3 Study of Probuphine
http://finance.yahoo.com/news/Titan-Pharmaceuticals-iw-1047680571.html?x=0&.v=1
NEOP($5.00 AH) - Posotive phase III results announced right after the min-bear raid. One can expect that analysts upgrades will follow tomorrow before market opens.
NEOP($4.59) - mini bear raid in progress imo. Phase III results expected in May. Open label study.
KERX($4.60) - Upcoming catalysts I gathered from PRs and recent conference calls here:
MAY 2011
Expect Japanese partner to start Phase III program for Zerenex in Japan
Present full data from the Short-Term Phase III study of Zerenex
Completion of enrollment of patients in the KRX-0401 for the treatment of Multiple Myeloma study
Expects the event that will trigger the unblinding of the KRX-0401 for the treatment of Colorectal Cancer study to occur
Completion of Long-Term Phase III study of Zerenex
Completion of KRX-0401 for the treatment of Multiple Myeloma
Commercialization of KRX-0401 for the treatment of Colorectal Cancer study
NDA filing for Zerenex
KERX($4.58) - Insider (director) purchase of 20,000 shares around $4.34 yesterday: http://investors.keryx.com/phoenix.zhtml?c=122201&p=irol-sec
CYTK($1.37) - Cytokinetics Started At Buy By Roth Capital
NEOP($3.08) - Sudden volume probably came from $heff alert:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=59630537
AVNR($4.22) - A blog about the upcoming catalyst.
Avanir Pharmaceuticals Poised for a Strong New Drug Launch: http://harnek.posterous.com/avanir-pharmaceuticals-poised-for-a-strong-ne
According to the filing, it seems the shares were purchased on December 31, 2010. That is the date I see next to the line: "Date of Event Which Requires Filing of this Statement".
$6.36 - $6.53 was the trading range on December 31st.
RNN(1.3) - One to keep on watch for tomorrow. Seeking alpha article out today: http://seekingalpha.com/article/247986-rexahn-pharma-is-considerably-undervalued-based-on-prospects-recent-developments?source=yahoo
Teva just bought 3.95 million shares at $1.69: http://finance.yahoo.com/news/Teva-buys-395-million-of-apf-3152226010.html?x=0&.v=1
NEOP($2.28) - On the move again today with solid volume. I just hope they don't pull another BPAX and announce an offering tonight.
NEOP($1.99) - Added more here. Looks like it will be in play soon as there are insider buys this month: http://secfilings.com/searchresultswide.aspx?link=1&filingid=7626498
UWBK($0.34) - Breakout... setting up nice the last couple of days... looks like its gonna go today/tomorrow.
UWBK($0.34) - Breakout... setting up nice the last couple of days... looks like its gonna go today/tomorrow.
UWBK($0.34) - Breakout... setting up nice the last couple of days... looks like its gonna go today/tomorrow.
BPAX($2.09) - For the first time in months, I am on the plus side.
ANPI($0.2894) - Got some ANPI. Been watching this last week. I think (and hope) that this will run big. Thanks!