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Press Release Source: La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company Reports Fourth Quarter and Year End 2003 Financial Results
Tuesday March 2, 7:30 am ET
SAN DIEGO, March 2 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company (Nasdaq: LJPC - News), reported a net loss for the fourth quarter ended December 31, 2003 of $8.4 million or $0.17 per share (on 51.0 million weighted average shares) compared to a net loss of $13.2 million or $0.31 per share (on 42.4 million weighted average shares) for the fourth quarter of 2002. The net loss for the year ended December 31, 2003 was $38.8 million or $0.85 per share (on 45.8 million weighted average shares) compared to a net loss of $43.3 million or $1.03 per share (on 42.0 million weighted average shares) for the same period in 2002.
ADVERTISEMENT
Research and development expenses decreased to $6.4 million for the three months ended December 31, 2003 from $11.3 million for the same period in 2002. This was primarily due to a decrease in expenses related to the Company`s Phase 3 clinical trial of Riquent® which was completed in December 2002, the open-label follow-on clinical trial of Riquent which was initiated in July 2002 and closed in April 2003, and the Phase 1/2 clinical trial of LJP 1082 which was completed in October 2002.
Research and development expenses decreased to $32.4 million for the twelve months ended December 31, 2003 from $37.7 million for the same period in 2002 primarily due to a decrease in expenses related to the completion of the Company`s clinical trials as discussed above. These decreases were partially offset by an increase in personnel costs, including the restructuring charges recorded in May 2003.
Cash, cash equivalents and short-term investments as of December 31, 2003 were $32.1 million compared to $52.7 million as of December 31, 2002. On February 25, 2004, the Company sold 8,695,653 shares of its common stock in a public offering for net proceeds of approximately $25.6 million. The Company anticipates that its existing cash and cash investments, including the net proceeds received by the Company from the February 2004 public offering, and interest earned thereon, will be sufficient to fund the Company`s operations as currently planned into the second quarter of 2005, assuming that the Company does not engage in any significant clinical trial or commercialization activities and further assuming that the Company does not enter into an agreement with a collaborative partner or engage in any other fundraising activities.
La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe. The Company is developing Riquent®, formerly known as LJP 394, for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also developing LJP 1082 for the treatment of antibody-mediated thrombosis, a condition in which patients suffer from recurrent stroke, deep-vein thrombosis and other thrombotic events, and is in the early stage of developing small molecules to treat various other autoimmune and inflammatory conditions. The Company`s common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit its Web site: http://www.ljpc.com .
Except for historical statements, this press release contains forward- looking statements involving significant risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from our current expectations. Forward-looking statements include those that express a plan, belief, expectation, estimation, anticipation, intent, contingency, future development or similar expression. Although our New Drug Application ("NDA") for Riquent® has been accepted by the United States Food and Drug Administration (the "FDA") for review, there is no guarantee that the FDA will approve Riquent in a timely manner, or at all. Our analyses of clinical results of Riquent, previously known as LJP 394, our drug candidate for the treatment of systemic lupus erythematosus ("lupus"), and LJP 1082, our drug candidate for the treatment of antibody-mediated thrombosis ("thrombosis"), are ongoing and could result in a finding that these drug candidates are not effective in large patient populations, do not provide a meaningful clinical benefit, or may reveal a potential safety issue requiring us to develop new candidates. The analysis of the data from our Phase 3 trial of Riquent has shown that the trial did not reach statistical significance with respect to its primary endpoint, time to renal flare. Although our NDA for Riquent has been accepted for review by the FDA, the results from our clinical trials of Riquent may not ultimately be sufficient to obtain regulatory clearance to market Riquent either in the United States or Europe, and we may be required to conduct additional clinical studies to demonstrate the safety and efficacy of Riquent in order to obtain marketing approval. There is no guarantee, however, that we will have the necessary resources to complete any additional trial, that we will elect to conduct an additional trial, or that any additional trial will sufficiently demonstrate the safety and efficacy of Riquent. Our blood test to measure the binding affinity for Riquent is experimental, has not been validated by independent laboratories and will likely be reviewed as part of the Riquent approval process. Our other potential drug candidates are at earlier stages of development and involve comparable risks. Analysis of our clinical trials could have negative or inconclusive results. Any positive results observed to date may not be indicative of future results. In any event, regulatory authorities may require additional clinical trials, or may not approve our drugs. Our ability to develop and sell our products in the future may be adversely affected by the intellectual property rights of third parties. Additional risk factors include the uncertainty and timing of: obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; the need for additional financing; our ability to pass FDA pre-approval inspections of our manufacturing facilities and processes; the increase in capacity of our manufacturing capabilities for possible commercialization; successfully marketing and selling our products; our lack of manufacturing, marketing, and sales experience; generating future revenue from product sales or other sources such as collaborative relationships; future profitability; and our dependence on patents and other proprietary rights. Readers are cautioned to not place undue reliance upon forward- looking statements, which speak only as of the date hereof, and we undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date hereof. Interested parties are urged to review the risks described in our Annual Report on Form 10-K for the year ended December 31, 2002, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time.
La Jolla Pharmaceutical Company
Condensed Financial Statements (in thousands, except per share data)
Summary of Operations
Three Months Ended Twelve Months Ended
December 31, December 31,
(unaudited)
2003 2002 2003 2002
Research and
development
expenses $6,415 $11,343 $ 32,385 $37,696
General and
administrative
expenses 2,096 2,087 6,908 6,944
Total expenses 8,511 13,430 39,293 44,640
Loss from operations (8,511) (13,430) (39,293) (44,640)
Interest income 131 300 665 1,373
Interest expense (60) (29) (210) (51)
Net loss $(8,440) $(13,159) $(38,838) $(43,318)
Basic and diluted
net loss per share $(0.17) $(0.31) $(0.85) $(1.03)
Shares used in
computing basic
and diluted net
loss per share 50,970 42,427 45,804 42,046
Balance Sheet Information
December 31, December 31,
2003 2002
Assets
Cash, cash
equivalents,
and short-term
investments $32,133 $52,725
Other assets 9,811 9,139
Total assets $41,944 $61,864
Liabilities
and Stockholders`
Equity
Liabilities $5,517 $8,065
Stockholders`
equity 36,427 53,799
Total liabilities
and stockholders`
equity $41,944 $61,864
Source: La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company Reports Fourth Quarter and Year End 2003 Financial Results
Tuesday March 2, 7:30 am ET
SAN DIEGO, March 2 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company (Nasdaq: LJPC - News), reported a net loss for the fourth quarter ended December 31, 2003 of $8.4 million or $0.17 per share (on 51.0 million weighted average shares) compared to a net loss of $13.2 million or $0.31 per share (on 42.4 million weighted average shares) for the fourth quarter of 2002. The net loss for the year ended December 31, 2003 was $38.8 million or $0.85 per share (on 45.8 million weighted average shares) compared to a net loss of $43.3 million or $1.03 per share (on 42.0 million weighted average shares) for the same period in 2002.
ADVERTISEMENT
Research and development expenses decreased to $6.4 million for the three months ended December 31, 2003 from $11.3 million for the same period in 2002. This was primarily due to a decrease in expenses related to the Company`s Phase 3 clinical trial of Riquent® which was completed in December 2002, the open-label follow-on clinical trial of Riquent which was initiated in July 2002 and closed in April 2003, and the Phase 1/2 clinical trial of LJP 1082 which was completed in October 2002.
Research and development expenses decreased to $32.4 million for the twelve months ended December 31, 2003 from $37.7 million for the same period in 2002 primarily due to a decrease in expenses related to the completion of the Company`s clinical trials as discussed above. These decreases were partially offset by an increase in personnel costs, including the restructuring charges recorded in May 2003.
Cash, cash equivalents and short-term investments as of December 31, 2003 were $32.1 million compared to $52.7 million as of December 31, 2002. On February 25, 2004, the Company sold 8,695,653 shares of its common stock in a public offering for net proceeds of approximately $25.6 million. The Company anticipates that its existing cash and cash investments, including the net proceeds received by the Company from the February 2004 public offering, and interest earned thereon, will be sufficient to fund the Company`s operations as currently planned into the second quarter of 2005, assuming that the Company does not engage in any significant clinical trial or commercialization activities and further assuming that the Company does not enter into an agreement with a collaborative partner or engage in any other fundraising activities.
La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe. The Company is developing Riquent®, formerly known as LJP 394, for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also developing LJP 1082 for the treatment of antibody-mediated thrombosis, a condition in which patients suffer from recurrent stroke, deep-vein thrombosis and other thrombotic events, and is in the early stage of developing small molecules to treat various other autoimmune and inflammatory conditions. The Company`s common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit its Web site: http://www.ljpc.com .
Except for historical statements, this press release contains forward- looking statements involving significant risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from our current expectations. Forward-looking statements include those that express a plan, belief, expectation, estimation, anticipation, intent, contingency, future development or similar expression. Although our New Drug Application ("NDA") for Riquent® has been accepted by the United States Food and Drug Administration (the "FDA") for review, there is no guarantee that the FDA will approve Riquent in a timely manner, or at all. Our analyses of clinical results of Riquent, previously known as LJP 394, our drug candidate for the treatment of systemic lupus erythematosus ("lupus"), and LJP 1082, our drug candidate for the treatment of antibody-mediated thrombosis ("thrombosis"), are ongoing and could result in a finding that these drug candidates are not effective in large patient populations, do not provide a meaningful clinical benefit, or may reveal a potential safety issue requiring us to develop new candidates. The analysis of the data from our Phase 3 trial of Riquent has shown that the trial did not reach statistical significance with respect to its primary endpoint, time to renal flare. Although our NDA for Riquent has been accepted for review by the FDA, the results from our clinical trials of Riquent may not ultimately be sufficient to obtain regulatory clearance to market Riquent either in the United States or Europe, and we may be required to conduct additional clinical studies to demonstrate the safety and efficacy of Riquent in order to obtain marketing approval. There is no guarantee, however, that we will have the necessary resources to complete any additional trial, that we will elect to conduct an additional trial, or that any additional trial will sufficiently demonstrate the safety and efficacy of Riquent. Our blood test to measure the binding affinity for Riquent is experimental, has not been validated by independent laboratories and will likely be reviewed as part of the Riquent approval process. Our other potential drug candidates are at earlier stages of development and involve comparable risks. Analysis of our clinical trials could have negative or inconclusive results. Any positive results observed to date may not be indicative of future results. In any event, regulatory authorities may require additional clinical trials, or may not approve our drugs. Our ability to develop and sell our products in the future may be adversely affected by the intellectual property rights of third parties. Additional risk factors include the uncertainty and timing of: obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; the need for additional financing; our ability to pass FDA pre-approval inspections of our manufacturing facilities and processes; the increase in capacity of our manufacturing capabilities for possible commercialization; successfully marketing and selling our products; our lack of manufacturing, marketing, and sales experience; generating future revenue from product sales or other sources such as collaborative relationships; future profitability; and our dependence on patents and other proprietary rights. Readers are cautioned to not place undue reliance upon forward- looking statements, which speak only as of the date hereof, and we undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date hereof. Interested parties are urged to review the risks described in our Annual Report on Form 10-K for the year ended December 31, 2002, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time.
La Jolla Pharmaceutical Company
Condensed Financial Statements (in thousands, except per share data)
Summary of Operations
Three Months Ended Twelve Months Ended
December 31, December 31,
(unaudited)
2003 2002 2003 2002
Research and
development
expenses $6,415 $11,343 $ 32,385 $37,696
General and
administrative
expenses 2,096 2,087 6,908 6,944
Total expenses 8,511 13,430 39,293 44,640
Loss from operations (8,511) (13,430) (39,293) (44,640)
Interest income 131 300 665 1,373
Interest expense (60) (29) (210) (51)
Net loss $(8,440) $(13,159) $(38,838) $(43,318)
Basic and diluted
net loss per share $(0.17) $(0.31) $(0.85) $(1.03)
Shares used in
computing basic
and diluted net
loss per share 50,970 42,427 45,804 42,046
Balance Sheet Information
December 31, December 31,
2003 2002
Assets
Cash, cash
equivalents,
and short-term
investments $32,133 $52,725
Other assets 9,811 9,139
Total assets $41,944 $61,864
Liabilities
and Stockholders`
Equity
Liabilities $5,517 $8,065
Stockholders`
equity 36,427 53,799
Total liabilities
and stockholders`
equity $41,944 $61,864
Source: La Jolla Pharmaceutical Company
Verlust im 4 Quartal von 2003 um 0,14 Cent pro Aktie verringert gegenüber dem Vorjahr.
Verlust pro Aktie für das Geschäftsjahr 2003 verringert gegenüber 2002 um 0,18 Cent.
Das kann man ja positiv beurteilen ,könnte heute mal wieder interessant werden.
joe
Verlust pro Aktie für das Geschäftsjahr 2003 verringert gegenüber 2002 um 0,18 Cent.
Das kann man ja positiv beurteilen ,könnte heute mal wieder interessant werden.
joe
danke für die Info, Joe
MFG
fiddi
MFG
fiddi
Dow Jones Business News
La Jolla Pharm 4Q Loss Narrows On Lower R&D
Tuesday March 2, 8:46 am ET
SAN DIEGO (Dow Jones)--La Jolla Pharmaceutical Co. (NasdaqNM:LJPC - News)`s fourth-quarter net loss narrowed as a result of a reduction in spending on research and development.
The company has completed three clinical trials since the start of the year- ago period.
For the fourth quarter ended Dec. 31, La Jolla reported a net loss of $8.4 million, or 17 cents a share, compared with a net loss of $13.2 million, or 31 cents a share, last year, according to a press release Tuesday.
A survey of four analysts by Thomson First Call (News - Websites) saw a loss of 14 cents a share.
La Jolla, which is developing products to treat autoimmune diseases, reported no revenue in the fourth quarter.
The improved financial results came from lower costs. Research and development expense fell to $6.4 million in the quarter from $11.3 million a year earlier.
Since October 2002, the company has completed two clinical trials for Riquent, a treatment for lupus kidney disease, and one for LJP 1082, a treatment antibody mediated thrombosis. The trials pushed up costs in the year-ago quarter.
La Jolla Pharmaceutical Co. - San Diego
4th Quar Dec. 31:
2003 2002
Net income (8,440,000) (13,159,000)
Avg shrs (diluted) 50,970,000 42,427,000
Shr earns
Net income (.17) (.31)
Year:
Net income (38,838,000) (43,318,000)
Avg shrs (diluted) 45,804,000 42,046,000
Shr earns
Net income (.85) (1.03)
Figures in parentheses are losses.
La Jolla, a development-stage drug company, did not report any revenue for 2003.
Last week, the company sold 8.7 million shares of common stock for $25.6 million to fund operations. On Aug. 13, 2003 it sold 8.2 million shares for $ 20.9 million.
Company Web site: http://www.ljpc.com
-Ian Salisbury; Dow Jones Newswires; 201-938-5400
La Jolla Pharm 4Q Loss Narrows On Lower R&D
Tuesday March 2, 8:46 am ET
SAN DIEGO (Dow Jones)--La Jolla Pharmaceutical Co. (NasdaqNM:LJPC - News)`s fourth-quarter net loss narrowed as a result of a reduction in spending on research and development.
The company has completed three clinical trials since the start of the year- ago period.
For the fourth quarter ended Dec. 31, La Jolla reported a net loss of $8.4 million, or 17 cents a share, compared with a net loss of $13.2 million, or 31 cents a share, last year, according to a press release Tuesday.
A survey of four analysts by Thomson First Call (News - Websites) saw a loss of 14 cents a share.
La Jolla, which is developing products to treat autoimmune diseases, reported no revenue in the fourth quarter.
The improved financial results came from lower costs. Research and development expense fell to $6.4 million in the quarter from $11.3 million a year earlier.
Since October 2002, the company has completed two clinical trials for Riquent, a treatment for lupus kidney disease, and one for LJP 1082, a treatment antibody mediated thrombosis. The trials pushed up costs in the year-ago quarter.
La Jolla Pharmaceutical Co. - San Diego
4th Quar Dec. 31:
2003 2002
Net income (8,440,000) (13,159,000)
Avg shrs (diluted) 50,970,000 42,427,000
Shr earns
Net income (.17) (.31)
Year:
Net income (38,838,000) (43,318,000)
Avg shrs (diluted) 45,804,000 42,046,000
Shr earns
Net income (.85) (1.03)
Figures in parentheses are losses.
La Jolla, a development-stage drug company, did not report any revenue for 2003.
Last week, the company sold 8.7 million shares of common stock for $25.6 million to fund operations. On Aug. 13, 2003 it sold 8.2 million shares for $ 20.9 million.
Company Web site: http://www.ljpc.com
-Ian Salisbury; Dow Jones Newswires; 201-938-5400
steht ein schönes Paket im BID ,würde er unlimitiert kaufen wären wir bei 3,70 US Dollar.
Joe
Joe
Sieht gut aus,der BID läuft dem ASK hinterher!!!!!!!!!!
joe
joe
Das grosse Paket wurde aufgeteilt ,er hatte wohl keine Hoffnung das er bedient wird .
Joe,
ich halte das teil eh bis die zulassung kommt das wird wohl im Herbst oder so sein. Ich glaub schon dran dass sie die bekommen.
MFG
fiddi
ich halte das teil eh bis die zulassung kommt das wird wohl im Herbst oder so sein. Ich glaub schon dran dass sie die bekommen.
MFG
fiddi
Ist ja auch okay.
Ob die Zulassung im Herbst kommt ist noch im Prinzip offen ,vielleicht schneller.
Hier noch ein Text .
Just because the FDA did not grant LJPC accelerated approval on NDA acceptance doesn`t mean Riquent still won`t be granted AA status. The stock got killed b/c a number of investors don`t want their money tied up in LJPC for the next 6-9 months under what would be a normal time frame for CDER approval. Add in the additional risks for follow-on offerings (already done), macro events, drug rejection, I can readily understand the short term notion to sell the stock.
However, keep in mind, the FDA can still grant Riquent accelerated approval under Subpart H, even weeks after their NDA acceptance. Under Subpart H, drugs in development for serious, life-threatening diseases with an unmet medical need can be approved on an accelerated basis if the FDA determines that the effect of the drug on a surrogate endpoint is reasonably likely to predict clinical benefit and that a post-marketing clinical trial can be successfully completed following drug approval which confirms the clinical benefit. A post-marketing clinical trial may need to be initiated prior to approval, but under Subpart H, such a trial would not need to be completed until after approval. The Company is currently in discussions with the FDA about the design and timing of a post-marketing clinical trial.
Subpart H offers an alternate pathway for potential approval of Riquent, and it also may enable an accelerated approval of Riquent, allowing patients to gain access to Riquent while an additional post-marketing study is ongoing.
Even if we don`t get accelerated approval, also very possible, Riquent will in some capacity be approved IMHO. Too much is on the line for the FDA to blow this. AS always, due your own diligence.
Ob die Zulassung im Herbst kommt ist noch im Prinzip offen ,vielleicht schneller.
Hier noch ein Text .
Just because the FDA did not grant LJPC accelerated approval on NDA acceptance doesn`t mean Riquent still won`t be granted AA status. The stock got killed b/c a number of investors don`t want their money tied up in LJPC for the next 6-9 months under what would be a normal time frame for CDER approval. Add in the additional risks for follow-on offerings (already done), macro events, drug rejection, I can readily understand the short term notion to sell the stock.
However, keep in mind, the FDA can still grant Riquent accelerated approval under Subpart H, even weeks after their NDA acceptance. Under Subpart H, drugs in development for serious, life-threatening diseases with an unmet medical need can be approved on an accelerated basis if the FDA determines that the effect of the drug on a surrogate endpoint is reasonably likely to predict clinical benefit and that a post-marketing clinical trial can be successfully completed following drug approval which confirms the clinical benefit. A post-marketing clinical trial may need to be initiated prior to approval, but under Subpart H, such a trial would not need to be completed until after approval. The Company is currently in discussions with the FDA about the design and timing of a post-marketing clinical trial.
Subpart H offers an alternate pathway for potential approval of Riquent, and it also may enable an accelerated approval of Riquent, allowing patients to gain access to Riquent while an additional post-marketing study is ongoing.
Even if we don`t get accelerated approval, also very possible, Riquent will in some capacity be approved IMHO. Too much is on the line for the FDA to blow this. AS always, due your own diligence.
La Jolla Pharmaceutical to Present at Lehman Healthcare Conference
March 03, 2004 07:30:00 AM ET
SAN DIEGO, March 3 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company LJPC today announced that Steven B. Engle, Chairman and CEO of La Jolla Pharmaceutical, will present today at 1:30 p.m. Eastern Time at the Lehman Brothers Seventh Annual Global Healthcare Conference in Miami, Florida. An audio webcast of the presentation will be available through the Company`s Web site http://www.ljpc.com .
La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe. The Company is developing Riquent(R), formerly known as LJP 394, for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also developing LJP 1082 for the treatment of antibody-mediated thrombosis, a condition in which patients suffer from recurrent stroke, deep-vein thrombosis and other thrombotic events, and is in the early stage of developing small molecules to treat various other autoimmune and inflammatory conditions. The Company`s common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit its Web site: http://www.ljpc.com.
Except for historical statements, this press release contains forward- looking statements involving significant risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from our current expectations. Forward-looking statements include those that express a plan, belief, expectation, estimation, anticipation, intent, contingency, future development or similar expression. Although our New Drug Application ("NDA") for Riquent(R) has been accepted by the United States Food and Drug Administration (the "FDA") for review, there is no guarantee that the FDA will approve Riquent in a timely manner, or at all. Our analyses of clinical results of Riquent, previously known as LJP 394, our drug candidate for the treatment of systemic lupus erythematosus ("lupus"), and LJP 1082, our drug candidate for the treatment of antibody-mediated thrombosis ("thrombosis"), are ongoing and could result in a finding that these drug candidates are not effective in large patient populations, do not provide a meaningful clinical benefit, or may reveal a potential safety issue requiring us to develop new candidates. The analysis of the data from our Phase 3 trial of Riquent has shown that the trial did not reach statistical significance with respect to its primary endpoint, time to renal flare. Although our NDA for Riquent has been accepted for review by the FDA, the results from our clinical trials of Riquent may not ultimately be sufficient to obtain regulatory clearance to market Riquent either in the United States or Europe, and we may be required to conduct additional clinical studies to demonstrate the safety and efficacy of Riquent in order to obtain marketing approval. There is no guarantee, however, that we will have the necessary resources to complete any additional trial, that we will elect to conduct an additional trial, or that any additional trial will sufficiently demonstrate the safety and efficacy of Riquent. Our blood test to measure the binding affinity for Riquent is experimental, has not been validated by independent laboratories and will likely be reviewed as part of the Riquent approval process. Our other potential drug candidates are at earlier stages of development and involve comparable risks. Analysis of our clinical trials could have negative or inconclusive results. Any positive results observed to date may not be indicative of future results. In any event, regulatory authorities may require additional clinical trials, or may not approve our drugs. Our ability to develop and sell our products in the future may be adversely affected by the intellectual property rights of third parties. Additional risk factors include the uncertainty and timing of: obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; the need for additional financing; our ability to pass FDA pre-approval inspections of our manufacturing facilities and processes; the increase in capacity of our manufacturing capabilities for possible commercialization; successfully marketing and selling our products; our lack of manufacturing, marketing, and sales experience; generating future revenue from product sales or other sources such as collaborative relationships; future profitability; and our dependence on patents and other proprietary rights. Readers are cautioned to not place undue reliance upon forward- looking statements, which speak only as of the date hereof, and we undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date hereof. Interested parties are urged to review the risks described in our Annual Report on Form 10-K for the year ended December 31, 2002, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time.
© 2004 PRNewswire
March 03, 2004 07:30:00 AM ET
SAN DIEGO, March 3 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company LJPC today announced that Steven B. Engle, Chairman and CEO of La Jolla Pharmaceutical, will present today at 1:30 p.m. Eastern Time at the Lehman Brothers Seventh Annual Global Healthcare Conference in Miami, Florida. An audio webcast of the presentation will be available through the Company`s Web site http://www.ljpc.com .
La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe. The Company is developing Riquent(R), formerly known as LJP 394, for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also developing LJP 1082 for the treatment of antibody-mediated thrombosis, a condition in which patients suffer from recurrent stroke, deep-vein thrombosis and other thrombotic events, and is in the early stage of developing small molecules to treat various other autoimmune and inflammatory conditions. The Company`s common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit its Web site: http://www.ljpc.com.
Except for historical statements, this press release contains forward- looking statements involving significant risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from our current expectations. Forward-looking statements include those that express a plan, belief, expectation, estimation, anticipation, intent, contingency, future development or similar expression. Although our New Drug Application ("NDA") for Riquent(R) has been accepted by the United States Food and Drug Administration (the "FDA") for review, there is no guarantee that the FDA will approve Riquent in a timely manner, or at all. Our analyses of clinical results of Riquent, previously known as LJP 394, our drug candidate for the treatment of systemic lupus erythematosus ("lupus"), and LJP 1082, our drug candidate for the treatment of antibody-mediated thrombosis ("thrombosis"), are ongoing and could result in a finding that these drug candidates are not effective in large patient populations, do not provide a meaningful clinical benefit, or may reveal a potential safety issue requiring us to develop new candidates. The analysis of the data from our Phase 3 trial of Riquent has shown that the trial did not reach statistical significance with respect to its primary endpoint, time to renal flare. Although our NDA for Riquent has been accepted for review by the FDA, the results from our clinical trials of Riquent may not ultimately be sufficient to obtain regulatory clearance to market Riquent either in the United States or Europe, and we may be required to conduct additional clinical studies to demonstrate the safety and efficacy of Riquent in order to obtain marketing approval. There is no guarantee, however, that we will have the necessary resources to complete any additional trial, that we will elect to conduct an additional trial, or that any additional trial will sufficiently demonstrate the safety and efficacy of Riquent. Our blood test to measure the binding affinity for Riquent is experimental, has not been validated by independent laboratories and will likely be reviewed as part of the Riquent approval process. Our other potential drug candidates are at earlier stages of development and involve comparable risks. Analysis of our clinical trials could have negative or inconclusive results. Any positive results observed to date may not be indicative of future results. In any event, regulatory authorities may require additional clinical trials, or may not approve our drugs. Our ability to develop and sell our products in the future may be adversely affected by the intellectual property rights of third parties. Additional risk factors include the uncertainty and timing of: obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; the need for additional financing; our ability to pass FDA pre-approval inspections of our manufacturing facilities and processes; the increase in capacity of our manufacturing capabilities for possible commercialization; successfully marketing and selling our products; our lack of manufacturing, marketing, and sales experience; generating future revenue from product sales or other sources such as collaborative relationships; future profitability; and our dependence on patents and other proprietary rights. Readers are cautioned to not place undue reliance upon forward- looking statements, which speak only as of the date hereof, and we undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date hereof. Interested parties are urged to review the risks described in our Annual Report on Form 10-K for the year ended December 31, 2002, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time.
© 2004 PRNewswire
La Jolla Pharmaceutical to Present at Lehman Healthcare Conference
March 03, 2004 07:30:00 AM ET
SAN DIEGO, March 3 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company LJPC today announced that Steven B. Engle, Chairman and CEO of La Jolla Pharmaceutical, will present today at 1:30 p.m. Eastern Time at the Lehman Brothers Seventh Annual Global Healthcare Conference in Miami, Florida. An audio webcast of the presentation will be available through the Company`s Web site http://www.ljpc.com .
La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe. The Company is developing Riquent(R), formerly known as LJP 394, for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also developing LJP 1082 for the treatment of antibody-mediated thrombosis, a condition in which patients suffer from recurrent stroke, deep-vein thrombosis and other thrombotic events, and is in the early stage of developing small molecules to treat various other autoimmune and inflammatory conditions. The Company`s common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit its Web site: http://www.ljpc.com.
Except for historical statements, this press release contains forward- looking statements involving significant risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from our current expectations. Forward-looking statements include those that express a plan, belief, expectation, estimation, anticipation, intent, contingency, future development or similar expression. Although our New Drug Application ("NDA") for Riquent(R) has been accepted by the United States Food and Drug Administration (the "FDA") for review, there is no guarantee that the FDA will approve Riquent in a timely manner, or at all. Our analyses of clinical results of Riquent, previously known as LJP 394, our drug candidate for the treatment of systemic lupus erythematosus ("lupus"), and LJP 1082, our drug candidate for the treatment of antibody-mediated thrombosis ("thrombosis"), are ongoing and could result in a finding that these drug candidates are not effective in large patient populations, do not provide a meaningful clinical benefit, or may reveal a potential safety issue requiring us to develop new candidates. The analysis of the data from our Phase 3 trial of Riquent has shown that the trial did not reach statistical significance with respect to its primary endpoint, time to renal flare. Although our NDA for Riquent has been accepted for review by the FDA, the results from our clinical trials of Riquent may not ultimately be sufficient to obtain regulatory clearance to market Riquent either in the United States or Europe, and we may be required to conduct additional clinical studies to demonstrate the safety and efficacy of Riquent in order to obtain marketing approval. There is no guarantee, however, that we will have the necessary resources to complete any additional trial, that we will elect to conduct an additional trial, or that any additional trial will sufficiently demonstrate the safety and efficacy of Riquent. Our blood test to measure the binding affinity for Riquent is experimental, has not been validated by independent laboratories and will likely be reviewed as part of the Riquent approval process. Our other potential drug candidates are at earlier stages of development and involve comparable risks. Analysis of our clinical trials could have negative or inconclusive results. Any positive results observed to date may not be indicative of future results. In any event, regulatory authorities may require additional clinical trials, or may not approve our drugs. Our ability to develop and sell our products in the future may be adversely affected by the intellectual property rights of third parties. Additional risk factors include the uncertainty and timing of: obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; the need for additional financing; our ability to pass FDA pre-approval inspections of our manufacturing facilities and processes; the increase in capacity of our manufacturing capabilities for possible commercialization; successfully marketing and selling our products; our lack of manufacturing, marketing, and sales experience; generating future revenue from product sales or other sources such as collaborative relationships; future profitability; and our dependence on patents and other proprietary rights. Readers are cautioned to not place undue reliance upon forward- looking statements, which speak only as of the date hereof, and we undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date hereof. Interested parties are urged to review the risks described in our Annual Report on Form 10-K for the year ended December 31, 2002, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time.
© 2004 PRNewswire
March 03, 2004 07:30:00 AM ET
SAN DIEGO, March 3 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company LJPC today announced that Steven B. Engle, Chairman and CEO of La Jolla Pharmaceutical, will present today at 1:30 p.m. Eastern Time at the Lehman Brothers Seventh Annual Global Healthcare Conference in Miami, Florida. An audio webcast of the presentation will be available through the Company`s Web site http://www.ljpc.com .
La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe. The Company is developing Riquent(R), formerly known as LJP 394, for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also developing LJP 1082 for the treatment of antibody-mediated thrombosis, a condition in which patients suffer from recurrent stroke, deep-vein thrombosis and other thrombotic events, and is in the early stage of developing small molecules to treat various other autoimmune and inflammatory conditions. The Company`s common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit its Web site: http://www.ljpc.com.
Except for historical statements, this press release contains forward- looking statements involving significant risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from our current expectations. Forward-looking statements include those that express a plan, belief, expectation, estimation, anticipation, intent, contingency, future development or similar expression. Although our New Drug Application ("NDA") for Riquent(R) has been accepted by the United States Food and Drug Administration (the "FDA") for review, there is no guarantee that the FDA will approve Riquent in a timely manner, or at all. Our analyses of clinical results of Riquent, previously known as LJP 394, our drug candidate for the treatment of systemic lupus erythematosus ("lupus"), and LJP 1082, our drug candidate for the treatment of antibody-mediated thrombosis ("thrombosis"), are ongoing and could result in a finding that these drug candidates are not effective in large patient populations, do not provide a meaningful clinical benefit, or may reveal a potential safety issue requiring us to develop new candidates. The analysis of the data from our Phase 3 trial of Riquent has shown that the trial did not reach statistical significance with respect to its primary endpoint, time to renal flare. Although our NDA for Riquent has been accepted for review by the FDA, the results from our clinical trials of Riquent may not ultimately be sufficient to obtain regulatory clearance to market Riquent either in the United States or Europe, and we may be required to conduct additional clinical studies to demonstrate the safety and efficacy of Riquent in order to obtain marketing approval. There is no guarantee, however, that we will have the necessary resources to complete any additional trial, that we will elect to conduct an additional trial, or that any additional trial will sufficiently demonstrate the safety and efficacy of Riquent. Our blood test to measure the binding affinity for Riquent is experimental, has not been validated by independent laboratories and will likely be reviewed as part of the Riquent approval process. Our other potential drug candidates are at earlier stages of development and involve comparable risks. Analysis of our clinical trials could have negative or inconclusive results. Any positive results observed to date may not be indicative of future results. In any event, regulatory authorities may require additional clinical trials, or may not approve our drugs. Our ability to develop and sell our products in the future may be adversely affected by the intellectual property rights of third parties. Additional risk factors include the uncertainty and timing of: obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; the need for additional financing; our ability to pass FDA pre-approval inspections of our manufacturing facilities and processes; the increase in capacity of our manufacturing capabilities for possible commercialization; successfully marketing and selling our products; our lack of manufacturing, marketing, and sales experience; generating future revenue from product sales or other sources such as collaborative relationships; future profitability; and our dependence on patents and other proprietary rights. Readers are cautioned to not place undue reliance upon forward- looking statements, which speak only as of the date hereof, and we undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date hereof. Interested parties are urged to review the risks described in our Annual Report on Form 10-K for the year ended December 31, 2002, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time.
© 2004 PRNewswire
15,5 % Plus vorbörslich
was ist da im busch
was ist da im busch
Es war nichts gutes,leider.
schauen wo der Kurs landet.
joe
schauen wo der Kurs landet.
joe
Oh Oh ,was sehe ich da!
bin ja schon lange Raus, scheint interessant mal wieder Einzusteigen.
War da nicht irgendwas im Herbst.
Mal nachforschen.
joe
bin ja schon lange Raus, scheint interessant mal wieder Einzusteigen.
War da nicht irgendwas im Herbst.
Mal nachforschen.
joe
Warum sind die so abgestürzt? Nur allgemeiner Markttrend oder steckt mehr dahinter?
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