BioPharma « Terug naar discussie overzicht

GTCB - GTC Biotherapeutics - Deel 11

2.656 Posts, Pagina: « 1 2 3 4 5 6 ... 125 126 127 128 129 130 131 132 133 » | Laatste

Omlaag ↓

Ghostly 3 oktober 2008 20:02

quote:
ronald76 schreef:
15% in de +,wie had dat nou gedacht.
Gr,

Prettig w end.

helaas bij een laag volume.

[verwijderd] 3 oktober 2008 21:25

quote:
ronald76 schreef:
15% in de +,wie had dat nou gedacht.
Gr,

Prettig w end.

Met weinig volume, en nu weer -3%

Dirk

Ghostly 3 oktober 2008 22:23

quote:
Dirk R. Wijnen schreef:
[quote=ronald76]
15% in de +,wie had dat nou gedacht.
Gr,

Prettig w end.
[/quote]

Met weinig volume, en nu weer -3%

Dirk

tja zoals gebruikelijk.

ludwig mack 4 oktober 2008 00:50

Last Trade: 0.33
Trade Time: 3:23PM ET
Change: 0.01 (2.94%)
Prev Close: 0.34
Open: 0.33
Bid: 0.28 x 5000
Ask: 1.25 x 100
1y Target Est: 4.00
Day's Range: 0.33 - 0.40
52wk Range: 0.17 - 1.19
Volume: 128,231
Avg Vol (3m): 192,546
Market Cap: 33.94M
P/E (ttm): N/A
EPS (ttm): -0.34
Div & Yield: N/A (N/A)

sappas 6 oktober 2008 14:07

FDA Accepts ATryn(R) BLA Filing
GTC Receives $2 Million in Milestone Payments

Last update: 8:00 a.m. EDT Oct. 6, 2008

FRAMINGHAM, Mass., Oct 06, 2008 (BUSINESS WIRE) -- The US Food and Drug Administration, or FDA, has accepted for review GTC Biotherapeutics, Inc.'s (GTCB:gtc biotherapeutics inc com
News, chart, profile, more
Last: 0.33-0.01-2.65%

3:23pm 10/03/2008

Delayed quote dataAdd to portfolio
Analyst
Create alertInsider
Discuss
Financials
Sponsored by:
GTCB 0.33, -0.01, -2.6%) Biologics License Application, or BLA, for ATryn(R). FDA's Blood Products Advisory Committee intends to review the BLA for ATryn(R) during a meeting that is being planned for January 2009. Based on the achievement of these milestones, GTC has received $2 million in additional milestone payments from OVATION Pharmaceuticals, Inc.
As previously announced, ATryn(R) has been designated an Orphan Drug and FDA has determined that the product fulfills the criteria for Fast Track status. The ATryn(R) BLA will also receive Priority Review. Priority Review is granted to only to those products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under Priority Review, the target date for FDA action on the BLA is February 7, 2009. This action date was affirmed by the FDA following preliminary review of the BLA performed in accepting the BLA.
ATryn(R) is GTC's recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The company seeks regulatory approval of ATryn(R) in the United States for the prophylactic treatment of deep vein thrombosis and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high risk surgical and childbirth procedures. There are no other recombinant forms of antithrombin available to treat this rare patient population. GTC has licensed ATryn(R) to OVATION Pharmaceuticals, Inc. to develop and market it in the United States.
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, 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 Advisory Committee meeting and target action dates for the ATryn(R) BLA. 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.
SOURCE: GTC Biotherapeutics, Inc.
GTC Biotherapeutics, Inc.
Thomas E. Newberry, 508-370-5374
Vice President, Corporate Communications
and Government Relations
tom.newberry@gtc-bio.com

Copyright Business Wire 2008

Groetjes,

Sappas

[verwijderd] 6 oktober 2008 15:06

Zijn nu mijn geitjes op het droge.?? Voor de zekerheid alvast een AB.

ludwig mack 6 oktober 2008 15:52

quote:
gideon1404 schreef:
Zijn nu mijn geitjes op het droge.?? Voor de zekerheid alvast een AB.

? wat

[verwijderd] 6 oktober 2008 15:54

quote:
gideon1404 schreef:
Zijn nu mijn geitjes op het droge.?? Voor de zekerheid alvast een AB.

Laatste koers Verschil

0.28 USD -0.05 (-15.15 %)

ludwig mack 6 oktober 2008 15:55

op naar de laatste fase ......
succes allen!
gr

ludwig mack 6 oktober 2008 15:59

Last Trade: 0.38
Trade Time: 9:36AM ET
Change: 0.05 (15.12%)
Prev Close: 0.33
Open: 0.3499
Bid: 0.35 x 4000
Ask: 0.37 x 500
1y Target Est: 4.00
Day's Range: 0.34 - 0.38
52wk Range: 0.17 - 1.19
Volume: 6,400
Avg Vol (3m): 192,457
Market Cap: 39.07M
P/E (ttm): N/A
EPS (ttm): -0.335
Div & Yield: N/A (N/A

[verwijderd] 6 oktober 2008 16:26

men is weer niet erg onder de indruk zo te zien.

[verwijderd] 6 oktober 2008 18:41

Hoeveel milestone payments krijgt gtcb bij goedkeuring (7/02/09) ook al weer?
Ik weet dat de vermarkting in de vsa veel sneller verloopt dan in Europa. Maar welke tijdspanne mogen we ook al weer verwachten?
Groetjes.

[verwijderd] 6 oktober 2008 18:54

quote:
janfj schreef:
Hoeveel milestone payments krijgt gtcb bij goedkeuring (7/02/09) ook al weer?
Ik weet dat de vermarkting in de vsa veel sneller verloopt dan in Europa. Maar welke tijdspanne mogen we ook al weer verwachten?
Groetjes.

When will Ovation pay milestones?

$9M of the $257M total potential milestones pertains to the HD indication:

• $3M already received on deal closing
• $1.5M on FDA acceptance of BLA for review
• $0.5M on granting of a priority review
• $1.0M on positive opinion from FDA advisory panel
• $3.0M* on FDA approval of BLA
[*Amount is $4.0M if no advisory panel was held or if FDA overrules a negative panel vote.]

The other $248M consists of undisclosed amounts triggered by three clinical/regulatory milestones for the DIC indication and undisclosed annual sales-based milestones on a nine-tier schedule that apply when sales in the preceding year exceed an undisclosed threshold. There are no clinical/regulatory milestones for the CABG/HR indication.

The three clinical/regulatory milestone triggers for the DIC indication are: i) establishment of a mutually agreeable clinical-development plan (including Leo if the development plan is global); ii) FDA acceptance for review of the sBLA; and iii) FDA approval of the sBLA.

sec.gov/Archives/edgar/data/904973/00...

[verwijderd] 6 oktober 2008 19:16

quote:
ludwig mack schreef:
op naar de laatste fase ......
succes allen!
gr

Eeeuuuhhh,laatste fase............

Is dat eeuuuhhh,de stekker eruit.

Vriendelijke groet.

[verwijderd] 6 oktober 2008 19:29

OVATION PR on ATryn® BLA
-------------------------------------
www.businesswire.com/portal/site/bios...

ATryn® (antithrombin alfa) BLA Filing Accepted by FDA

DEERFIELD, Ill.--(BUSINESS WIRE)--OVATION Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ATryn® (antithrombin alfa). OVATION acquired the exclusive U.S. license to ATryn in August from GTC Biotherapeutics, allowing the company to develop and commercialize the product in this country. The acceptance of the BLA comes just one month after the FDA assigned a priority review to the product, which has also been granted orphan drug designation. An action letter is expected in February, 2009.

ATryn is under review for the treatment of a rare disorder called hereditary antithrombin deficiency, or HD, involving people who do not have sufficient antithrombin in their bloodstream. Antithrombin is a protein that helps keep blood from clotting and has anti-inflammatory properties.

“We are excited about how well ATryn is progressing through the regulatory process and are particularly pleased that FDA has accepted the filing for review,” said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. “This is a key milestone that paves the way for FDA to consider its approval early next year following the Blood Products Advisory Committee meeting in January.”

ATryn is one of two product licensing agreements OVATION has completed in the last 60 days. With one of these products launching by the end of this year, and two more products – including ATryn – now under FDA review, the company is positioned to bring three new, orphan-designated products to market over the next year.

The most common adverse events listed in the approved European labeling that may occur during treatment with ATryn include dizziness, headache, bleeding, nausea, bleeding at injection site and increased bleeding during treatment.

About OVATION Pharmaceuticals

OVATION is a fast-growing biopharmaceutical company that develops, manufactures and markets 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, hematology/oncology, and hospital-based therapies. The four new launches the company expects over the next three years will be fueled 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.

[verwijderd] 6 oktober 2008 19:32

0.33 USD 0.00 (0 %)

[verwijderd] 6 oktober 2008 20:01

Weinig animo na het toch goede nieuws?

[verwijderd] 6 oktober 2008 21:03

quote:
ludwig mack schreef:
[quote=gideon1404]
Zijn nu mijn geitjes op het droge.?? Voor de zekerheid alvast een AB.

? wat

Misschien heb ik het verkeerd begrepen maar ik dacht dat ik medeeigenaar was van een geitenfarm
en dat die beestjes beter-sneller en meer medicinale stof produceerden dan de techniek van het ei. Wordt het overigens nog wat met dit aandeel.

sappas 6 oktober 2008 22:28

GTCB lager gesloten op 0,29.

Vreemd, zeer vreemd.

Groetjes,

Sappas

[verwijderd] 6 oktober 2008 22:30

quote:
sappas schreef:
GTCB lager gesloten op 0,29.

Vreemd, zeer vreemd.

Groetjes,

Sappas

Op het laatst he zo doet men dat.............

isht.comdirect.de/html/detail/ticklis...

2.656 Posts, Pagina: « 1 2 3 4 5 6 ... 125 126 127 128 129 130 131 132 133 » | Laatste

Aantal posts per pagina: 20 50 100 | Omhoog ↑

Direct naar Forum

Markt vandaag

AEX 920,67 +1,95 +0,21% 14:42


Germany40^	18.018,90	+0,09%
BEL 20	3.833,42	+0,00%
EURO50	4.855,90	+0,32%
US30^	38.485,20	-0,26%
Nasd100^	19.683,80	+0,10%
US500^	5.429,35	-0,06%
Japan225^	38.179,90	-0,86%
Gold spot	2.319,00	-0,59%
EUR/USD	1,0710	+0,05%
WTI	78,34	+0,40%