GTCB is a very interesting company who is getting EMEA approval for it´s drug somewhere in september-october with high probability. This will be the approval of a whole new technique.
In addition to that: I think GTCB is completing a bull flag right now. With the 50 MA crossing the 200MA I Think this is a very interesting moment. Watch this one break out and get in
Im in for this already several months (traded it a little.. now long from 1.45) and I´m long at least a few more months untill after the approval
anyway, here´s the chart. tell me your thoughts!
(http://www.wistudat.net/stock/GTCB-20-jul.PNG)
its taking long now, so I hardly dare still calling this a bull flag.
But anyhow, if you call it a bull flag or a bearish price channel, GTCB is slowly breaking the resistance. Yesterday's close was above
Looking at the chart I also discovered a nice Adam and Eve pattern. Didn't recognize it at the time.. ::)
gtcb showed some nice action today.. a nice white candle on top of the former resistance of the bull flag, Id really like GTCB to take out the high of june as resistance.
and another day up..
this is looking better and better :)
after hours 1.85
I will never understand the after hours trades ??? ??? :-\
and another 'white' day.
I think it's on it's way to test the resistance on 1.85
of course still holding this one.. (at least one good pick in my portfolio :P)
and another test of 1,78 failed.. chart is still looking good though.. maybe the stock will pullback to 1,60 before making another attempt. But that's not worth the rist (of missing a big jump up like in june)
today it reached 1,79 in it's attempt to get higher, again a failure but a strong close at 1,75 though.
I'm not sure how you call this pattern, but assuming this mirrored ascending triangle will continue I expect a greater range for today. This would meen a profitable trading range, therefor I sold yesterday at 1,78 and will attempt to get back somewhere around 1,66 / 1,68
looks like I made a terrible mistake.. :'(
the day after i sold the stock went up to 1,84 to spike yesterday right to 2,10
why does this always happen right AFTER I sell? >:(
this whole thread of messages is you.
i watched it every day but didn't buy.
i dont know much about pharma drugs.
that always happens to me too.
i sell. it goes up.
applause.
it went to 2,40 but is now back on 1,91.
good entry point......the downfall was because of a PB but it was actually good. Strange why people always sell on PB.
gr N
Free $ since 1.08...
...'m waiting 4 a rebound !
And....that's on !
Doyle,what price you got?
1.12 $...
but now....it seems to be calm...and not going up so fare
1.12?real good price.
Congtats!Doyle!
Loaded the boat, all in today at what I thought was 1.00... actually filled at 0.99. (see 1,000,000$ board for my realtime post)
oversold capitulation today. They took advantage of a weak market as well.
Will likely get out tomorrow for a quick flip.
g
was out.....
SHIT ! :-\
Watch...more than 100 % in PM
• UPDATE - EU panel backs goat-derived drug after rethink
at Reuters (Fri 7:43am)
• InPlay: GTC Biotherapeutics receives CHMP recommendation to grant mkt authorization
Briefing.com (Fri 7:14am)
• ATryn(R) Receives CHMP Recommendation to Grant Market Authorization
Business Wire (Fri 7:12am)
http://finance.yahoo.com/q?s=gtcb
Me too :(. Sold yesterday after keeping for 2 months!!
bwaaaaaaaaaaaaaaaa ha haha ahaaaaaaaa
--excuse me....but I can't resist laughing !!!! (it's too stupid!)
Too funny !....
pfffffff( what a shit! )
Sorry 4 us..
(my future rocket...and I'm still believing it...is INSM =clinical phase2 results end of june )
have a look :
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=1600811390&tid=insm&sid=1600811390&mid=102295
I open and closed too many positions in INSM in past 6 months. To be honest, got tired of it. Either the market for the product is small or law suit is killing it. No good news is getting it up. I am out for good unless lawsuit is out of way
yes....Sometimes to not saying every days.. I'm disgusted about it
but I've got the time..and my little finger says me that it will explode without telling us ( like GTCB lol )
Good for you :)
GTCB looks ready to break out of symmetric triangle today on this news:
GTC Biotherapeutics and LFB Biotechnologies Enter Strategic Collaboration for Recombinant Plasma Proteins and Monoclonal Antibodies
http://biz.yahoo.com/bw/061002/20061002005515.html?.v=1
Chart looks poised, buys coming in PM around 1.30, sugesting breakout. Possibly one to watch this morning.
Picked up some GTCB on Mon morning at 1.33 as it was looking strong, but it topped out and died at descending resistance, eventually also managing to test support at 1.19. Not a pretty day, but yesterday was slightly better, forming a nice hammer candle, although volume dropped off significantly.
Looks like there is a resistance band from 1.30-1.35 which may get tested again shortly. Suggested stop would be 1.18, which leaves substantial risk from my entry point. Although my initial reasoning for buying (breakthrough descending resistance on volume) didn't turn out as expected, GTCB held above the stepper descending resistance (now support), so will hold to see where this one goes this week. It may have some strength yet...
Apparently some news for GTCB today, though not on yahoo yet:
TC BIOTHERAPEUTICS AWARDED $1.4 MILLION IN CONTINUED SBIR FUNDING FOR CD137 MONOCLONAL ANTIBODY PROGRAM
FRAMINGHAM, MA – October 5, 2006 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced today that it was awarded an additional grant of $1.4 million for its CD137 monoclonal antibody program from the Small Business Innovative Research, or SBIR, program of the National Institutes of Health. The first year committed funding is approximately $780,000. This grant will fund process development, characterization of the antibody and efficacy testing in preclinical models in anticipation of future manufacturing for clinical trials. GTC in-licensed the CD137 antibody from the Mayo Clinic and obtained initial SBIR funding in 2004. The work planned under this additional grant will be performed over two years in collaboration with Dr. Scott Strome at the University of Maryland and Dr. Lieping Chen at the Johns Hopkins School of Medicine.
"The CD137 antibody appears to have significant potential for the treatment of solid tumors and autoimmune diseases," stated Harry Meade, Ph.D., GTC's Senior Vice President of Research and Chief Scientific Officer. "We are gratified that the SBIR program recognized this potential and the further funding will enable us to continue our work in the preclinical evaluation of CD137's activity."
CD137, also known as 4-1BB, is a member of the tumor necrosis factor/nerve growth factor family of receptors and is a surface glycoprotein found on certain cells of the immune system.
The SBIR program is a source of federal government funding administered by various government agencies for domestic small business concerns to engage in research and development activities with the potential for commercial development.
Saying that, I really didn't like the look of yesterday's trading. Chart is really more of a descending triangle. LOD was 1.20, right around support. Here's hoping it gets kicked into gear a bit here. This is not a stock I want or intend to hold long term, and right now I think i would prefer to get out, limiting my losses.
bizjournals.com
GTC Biotherapeutics granted fast-track on vein therapy
Tuesday September 4, 2:06 pm ET
Federal regulators are granting GTC Biotherapeutics Inc. an expedited permitting process for its vein therapy treatment, the company announced on Tuesday.
Framingham, Mass.-based GTC (Nasdaq: GTCB - News) said that the U.S. Food and Drug Administration has granted fast-track designation for ATryn, a plasma treatment designed to combat hereditary antithrombin deficiency, which can lead to blood clotting.
Fast-track designation is given for treatments deemed to treat life threatening conditions for which no other comparable treatment exists. As part of the designation, GTC also gained the ability to submit its marketing approval application for ATryn as sections are completed rather than all at once, which should enable an FDA review to begin more quickly.
GTC said it expects to begin applying for marketing approval for the drug by its fourth quarter, completing the application process by the end of its fiscal 2008 first quarter.
ATryn is produced in the milk of goats engineered to have the human antithrombin gene, in order to generate a steady supply of the substance. GTC has already gained approval to use the drug in the European Union.
Published September 4, 2007 by the Boston Business Journal
"GTCB" Threads have been Merged.
Please use the search before starting new threads on a Stock Pick.
Chances are a thread already exist.
So why not post whatever you have to comment about on that pick to that thread.
"Simplicity" My fellow traders. ;D
All history on a stock pick in 1 thread is awesome. ;)
Just trying to get threads together,so we don't have a numerous amount floating around on the same stock. :( ::)
Thank You....and good luck with all your trades....make some $$$ ;) ;D
Anybody out there following GTCB?
It caught my eye Friday afternoon when it had a nice little pop late in the afternoon.
Rumors are starting about their meeting with the FDA on Jan 9th and was wondering if anyone here has any skinny on them?
WRAPUP 2-U.S. FDA staff backs CSL, GTC blood clot drugs
Wed Jan 7, 2009 12:25pm EST
WASHINGTON, Jan 7 (Reuters) - Two proposed therapies to treat rare blood disorders appear safe and effective for U.S. approval, including one made from genetically engineered goats, Food and Drug Administration staff reviewers said in documents released on Wednesday.
GTC Biotherapeutics Inc's (GTCB.O) anti-clotting drug Atryn, made from human proteins inserted into goat milk, and CSL Ltd's (CSL.AX) clot disorder treatment Riastap appeared to work in company studies, the FDA staff said in reports prepared for an advisory panel that meets on Friday.
Both products would need further study after they begin sales, the agency reviewers said.
On Friday, a panel of outside advisers will make a recommendation to the FDA on whether the two therapies are safe and effective. The agency usually takes their advice.
Shares of GTC soared 28 percent to 73 cents on the Nasdaq at midday on Wednesday.
The drug is GTC's first product to be submitted for approval in the United States and is part of a series of anti-clotting drugs that the Framingham, Massachusetts-based company is developing, officials said.
"This is an important tipping point for us," the company's chief executive, Geoff Cox, told Reuters on Tuesday. He added that Atryn, if approved, could bring in between $40 million and $50 million in the next four to five years.
Atryn treats hereditary antithrombin deficiency, in which irregular protein levels can cause excessive clotting. The treatment is made using a human protein produced in milk from genetically engineered goats.
While patients usually take traditional blood thinners such as warfarin, such drugs are not suitable for high-risk surgeries or giving birth, company officials have said.
In its review, the FDA said company data showed Atryn helped prevent clotting in patients and had an "acceptable" level of risks.
GTC is also developing further studies to test the drug in patients at risk for clots in non-hereditary conditions such as coronary bypass surgery, which if approved later by the FDA could also boost sales, Cox said.
To make Atryn, company scientists injected human DNA into goat cells to breed about 200 genetically modified goats at its Massachusetts facility. Females then express the human anti-clotting protein in their milk when they begin lactating after giving birth.
The drug is licensed to Ovation Pharmaceuticals Inc [OVAPH.UL] in the United States.
The other product under FDA review, Riastap, made by the company's CSL Behring unit, is intended for patients with congenital fibrinogen deficiency, which limits the blood's ability to clot.
Company research showed Riastap increased clot firmness, which was "sufficient" to support accelerated approval for drugs for serious diseases, FDA reviewers said. Accelerated approval requires further study after marketing to confirm the product provides meaningful benefits to patients.
The safety of Riastap, derived from human blood plasma, "appears to be acceptable," the FDA reviewers said. The drug is already sold in parts of Europe as Haemocomplettan P.
Australia-based CSL is the world's top maker of plasma products. CSL shares closed down nearly 3.3 percent in Australian trading before the FDA report was released.
Summaries for both drugs were released on the FDA's website at www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4410B1-00-Index.html
Press Release Source: GTC Biotherapeutics, Inc.
FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn* (antithrombin [Recombinant])
Friday January 9, 6:30 pm ET
If approved, ATryn will be first recombinant human antithrombin available in the U.S.
ROCKVILLE, Md.--(BUSINESS WIRE)--GTC Biotherapeutics ("GTC", NASDAQ: GTCB) and OVATION Pharmaceuticals, Inc. announced today that the Blood Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted that ATryn is safe and efficacious for the prevention and treatment of venous thromboembolism in hereditary antithrombin deficient patients undergoing surgery or childbirth procedures. The FDA considers the recommendations of its Advisory Committees when making its determinations. If approved, ATryn will be the first recombinant human antithrombin available in the U.S.
"We are very pleased with the Advisory Committee's recommendation in support of the safety and efficacy of ATryn," said Geoffrey F. Cox, Ph.D., GTC's Chairman and Chief Executive Officer. "ATryn is the first transgenically produced therapeutic to achieve approval in Europe and undergo review by the FDA. ATryn is also a testament to our established strength in recombinant technology, and has the potential to provide an important new treatment option for patients with hereditary antithrombin deficiency."
In September 2008, the FDA assigned Priority Review to GTC's Biologic License Application, or BLA, for ATryn. Priority Review is granted to applications for products that, if approved, would provide significant advances in treatment or provide a treatment where no sufficient one already exists. Under Priority Review, the FDA's target date for action on the BLA is February 7, 2009. GTC has licensed ATryn to OVATION to develop and market it in the U.S.
"The committee's recommendation takes us a step closer to making ATryn available to people in the U.S. with hereditary antithrombin deficiency, a rare clotting disorder associated with severe complications for which there are few treatment options," said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. "Consistent with our overall focus on addressing unmet medical needs of small patient populations, bringing ATryn to market would give us the opportunity to make a meaningful difference in the lives of people suffering from this rare disorder."
Antithrombin works as a natural anticoagulant in the human body by regulating thrombin, which plays an important role in controlling the formation of blood clots. ATryn was developed with the key objective to provide the purity, safety and consistency of an unlimited supply of recombinant antithrombin. Purified recombinant antithrombin has the same amino acid sequence as antithrombin derived from human plasma.
People with hereditary antithrombin deficiency are at increased risk for venous blood clots, including pulmonary embolism and deep vein thrombosis. The prevalence of hereditary antithrombin deficiency in the general population is approximately one in 2,000 to one in 3,000. Half these patients may experience a thrombosis before 25 years of age and based on one study, up to 85 percent may suffer a thromboembolic event by age 50.
About ATryn* (antithrombin [Recombinant])
ATryn is the first recombinant antithrombin product approved in the world and the first antithrombin product that has been approved through the centralized European Medicines Agency (EMEA) procedure in the European Union.
ATryn is under review by the FDA for the prevention and treatment of peripartum and perioperative thromboembolic events in patients with hereditary antithrombin deficiency.
The most common adverse events listed in the approved European labeling that may occur during ATryn treatment include dizziness, headache, bleeding, nausea, bleeding at injection site and increased bleeding during treatment. As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
About GTC Biotherapeutics
GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. In addition to ATryn, GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factors VIIa, VIII, and IX, which are used for the treatment of hemophilia, and alpha-1 antitrypsin. GTC also has a monoclonal antibody portfolio that includes a monoclonal antibody to CD20 and a monoclonal antibody to CD137. GTC's intellectual property includes a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC's transgenic production platform is particularly well suited to enabling cost effective development of proteins that are difficult to express in traditional recombinant production systems as well as proteins that are required in large volumes. Additional information is available on the GTC web site, http://www.gtc-bio.com.
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the timing of the FDA's review of the BLA for ATryn. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K and its other periodic reports filed with the Securities and Exchange Commission, including the uncertainties associated with dependence upon the actions of regulatory agencies.
GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law.
About OVATION Pharmaceuticals
OVATION is a fast growing biopharmaceutical company that develops and commercializes medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients' lives through its focus on central nervous system (CNS), hematology/oncology, and hospital-based therapies. The three new launches the company expects over the next three years will be fueled largely by its late-stage CNS pipeline, which is one of the most robust in the industry. OVATION has been recognized for excellence in the global pharmaceutical and biotechnology industries with the 2006 and 2007 "Pharma Company of the Year" award from Scrip magazine for small to mid-sized enterprises. More information about the company, its products and full prescribing information may be found at www.ovationpharma.com.
* ATryn is a registered trademark of GTC Biotherapeutics
Contact:
GTC Biotherapeutics, Inc.
Thomas E. Newberry, 508-370-5374
Vice President, Corporate Communications and Government Relations
[email protected]or
OVATION Pharmaceuticals, Inc.
Sally Benjamin Young, 847-727-3265
Vice President of Communications
[email protected]--------------------------------------------------------------------------------
Source: GTC Biotherapeutics, Inc.
Things are shaping up for the better in this Small biotech.
This one hovers around a buck and dips below occasionally but not permanently. Once good news comes out, watch out above!
52wk Range: 0.11 - 1.19
Volume: 2,782,484
Avg Vol (3m): 855,097
Technicals
Percentage Gainer
Last Price Quote is:
38.99%above 13-day MA
104.39%above 50-day MA
RS Rating: 97
Fundamentals
Key Data:
Market Cap (M): $69.83
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 03/05/2009
Last Analyst Rating: Neutral
FRAMINGHAM, Mass., Jan 21, 2009 (BUSINESS WIRE) -- GTC Biotherapeutics, Inc. (GTCB, Trade) received notice from the Listing Qualifications Staff ("Staff") of The NASDAQ Stock Market indicating that GTC has regained compliance with the minimum market value of listed securities requirement for continued listing on The NASDAQ Capital Market, as set forth in Marketplace Rule 4310 (c)(3), by exceeding $35 million of market capitalization for 10 consecutive trading days. Based on NASDAQ's recent extension of the temporary suspension of Marketplace Rule 4450(a)(5), GTC has until at least July 20, 2009 to regain compliance with the minimum $1.00 bid price requirement for continued listing.
"We are pleased to have regained compliance with the minimum market capitalization listing requirement," stated Geoffrey F. Cox, GTC's Chairman of the Board and CEO. "We look forward to continuing to build on our strengths with expected near term news regarding ATryn's regulatory review and its commercial launch in the USA."
ATryn(R), GTC's recombinant form of human antithrombin, was recently recommended by the Blood Products Advisory Committee, or BPAC, to be safe and efficacious for the prevention and treatment of venous thromboembolism in hereditary antithrombin deficient patients undergoing surgery or childbirth procedures. The Food and Drug Administration, or FDA, instituted guidance last week regarding the review and approval of a New Animal Drug Application, or NADA, for animals that incorporate additional genetic information. GTC worked closely with FDA staff to present all relevant information and participated in all field inspections necessary to support the review of an NADA for the animals that produce recombinant human antithrombin in their milk. The FDA's preliminary review of this information was presented to the BPAC. Under the Priority Review process, the target action date for a decision by the FDA on the Biologics License Application for ATryn(R) is February 7, 2009. OVATION Pharmaceuticals, GTC's partner for development and commercialization of ATryn(R) in the United States, is planning for commercial launch of the product following FDA approval.
About GTC Biotherapeutics
GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. In addition to ATryn(R), GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factors VIIa, VIII, and IX, which are used for the treatment of hemophilia, and alpha-1 antitrypsin. GTC also has a monoclonal antibody portfolio that includes a monoclonal antibody to CD20 and a monoclonal antibody to CD137. GTC's intellectual property includes a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC's transgenic production platform is particularly well suited to enabling cost effective development of proteins that are difficult to express in traditional recombinant production systems as well as proteins that are required in large volumes. Additional information is available on the GTC web site, http://www.gtc-bio.com.
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the prospects for and timing of determinations by NASDAQ and the FDA, and the prospects for the commercial launch of ATryn(R). Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K and its other periodic reports filed with the Securities and Exchange Commission, including the risks and uncertainties associated with dependence upon the actions of NASDAQ and the FDA, as well as the actions of partners. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law.
SOURCE: GTC Biotherapeutics, Inc.
GTC Biotherapeutics, Inc.
Thomas E. Newberry, 508-370-5374
Vice President, Corporate Communications & Government Relations
[email protected] Copyright Business Wire 2009
52wk Range: 0.11 - 1.13
Volume: 3,005,262
Avg Vol (3m): 1,022,200
Technicals
Percentage Gainer
Last Price Quote is:
24.58%above 13-day MA
79.84%above 50-day MA
RS Rating: N/A
Fundamentals
Key Data:
Market Cap (M): $84.38
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 03/05/2009
Last Analyst Rating: Neutral
Nice day...Milestones are within reach and positive PR's will bolster the PPS.
Buy GTCB for a nice percentage gain.
Things are shaping up for the better in this Small biotech.
Healthy consolidation after the dip...Back above the 200-Day MA
52wk Range: 0.11 - 0.95
Volume: 2,956,591
Avg Vol (3m): 648,284
Technicals
Percentage Gainer
Last Price Quote is:
46.17%above 13-day MA
47.90%above 50-day MA
RS Rating: 7
Fundamentals
Earnings Expected on May 7
Key Data:
Market Cap (M): $44.86
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 05/07/2009
Last Analyst Rating: Neutral