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Last $17.87 USD
Change Today -1.10 / -5.80%
Volume 99.8K
LJPC On Other Exchanges
Symbol
Exchange
NASDAQ CM
Stuttgart
As of 8:10 PM 04/17/15 All times are local (Market data is delayed by at least 15 minutes).

la jolla pharmaceutical co (LJPC) Key Developments

La Jolla Pharmaceutical Company Appoints Dennis Mulroy as Chief Financial Officer

La Jolla Pharmaceutical Company announced that Dennis Mulroy will join the company as Chief Financial Officer, effective April 6, 2015. Prior to joining La Jolla, Mr. Mulroy served as Chief Financial Officer of Taxus Cardium Pharmaceuticals Group Inc.

La Jolla Pharmaceutical Co. Announces Initiation of Phase 3 Clinical Trial of LJPC-501 in Catecholamine-Resistant Hypotension

La Jolla Pharmaceutical Company announced that it has initiated its ATHOS (Angiotensin II for the Treatment of High-Output Shock) 3 trial, a Phase 3 clinical trial of LJPC-501for the treatment of catecholamine-resistant hypotension (CRH). In February 2015, the company reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA), in which it was agreed that the primary efficacy endpoint for the trial would be increase in blood pressure. CRH is an acute, life-threatening condition in which blood pressure drops to dangerously low levels in patients who respond poorly to current treatments. In accordance with the SPA, the ATHOS 3 trial is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial of LJPC-501 in patients with CRH. The ATHOS 3 trial is designed to enroll approximately 315 patients. Patients will be randomized 1:1 to receive either LJPC-501 plus standard-of-care vasopressors or placebo plus standard-of-care vasopressors. Randomized patients will receive their assigned treatment via continuous IV infusion for up to 7 days. The primary efficacy endpoint of the ATHOS 3 trial is to compare the change in mean arterial pressure between the two groups in the trial. Secondary endpoints include comparison of changes in Sequential Organ Failure Assessment scores and the safety and tolerability of LJPC-501 in patients with CRH. The company has reached agreement with the FDA that an adequately sized Phase 3 trial comprised of 200-300 patients would provide a sufficient safety database to support FDA review and consideration for marketing approval. The prognosis for patients suffering from CRH is very poor, and current treatment options are limited.

La Jolla Pharmaceutical Company Announces Initiation of Phase 2b Clinical Trial of GCS-100 in Advanced Chronic Kidney Disease

La Jolla Pharmaceutical Company announced that it has initiated its Phase 2b clinical trial of GCS-100for the treatment of advanced chronic kidney disease (CKD) caused by diabetes. CKD is a condition characterized by a gradual loss of kidney function over time that may eventually lead to kidney failure, requiring dialysis or a kidney transplant to maintain life. The Phase 2b clinical trial is a double-blind, multi-center, placebo-controlled, randomized trial of GCS-100 in diabetic patients with Stage 3b or 4 CKD. The clinical trial is designed to enroll approximately 375 patients. Patients will be randomized 1:1:1:1 to receive fixed doses of GCS-100 (1, 3 or 9 mg) or placebo. Randomized patients will receive their assigned treatment via IV injection once a week for 8 weeks and then once every other week for an additional 16 weeks. The primary endpoint of this Phase 2b clinical trial is to compare the change in kidney function, as measured by estimated glomerular filtration rate (eGFR), from baseline to week 26, which is 2 weeks after the last injection, between patients receiving GCS-100 or placebo. Secondary efficacy endpoints include a responder analysis based on pre-specified percentage changes in eGFR and an analysis on progression to renal replacement therapy. Other secondary endpoints are focused on the long-term safety and tolerability of GCS-100, including an evaluation of the incidence of major cardiac events.

La Jolla Pharmaceutical Company Announces Unaudited Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2014

La Jolla Pharmaceutical Company announced unaudited earnings results for the fourth quarter and full year ended December 31, 2014. For the quarter, the company reported loss from operations of $6,863,000 against $6,398,000 a year ago. Net loss attributable to common shareholders was $6,849,000 or $0.45 basic and diluted per share against $6,397,000 or $1.45 basic and diluted per share a year ago. Cash used in operating activities was $5.4 million compared to $2.0 million for the same period in 2013. The increase in cash used in operating activities and comprehensive net loss attributable to common shareholders was primarily due to increases in research and development expenses related to the Phase 2 clinical trial of GCS-100 in advanced CKD, the Phase 1/2 clinical trial of LJPC-501 in hepatorenal syndrome (HRS), preclinical work on LJPC-1010 and LJPC-401 and intellectual property in-licensing costs related to LJPC-501 and LJPC-401. For the year, the company reported loss from operations of $21,340,000 against $17,941,000 a year ago. Net loss attributable to common shareholders was $21,313,000 or $2.00 basic and diluted per share against $18,736,000 or $12.16 basic and diluted per share a year ago. Cash used in operating activities was $12.9 million compared to $4.7 million for the same period in 2013. The increase in cash used in operating activities and comprehensive net loss attributable to common shareholders was primarily due to increases in research and development expenses related to the Phase 2 clinical trial of GCS-100 in advanced CKD, the Phase 1/2 clinical trial of LJPC-501 in hepatorenal syndrome (HRS), preclinical work on LJPC-1010 and LJPC-401 and intellectual property in-licensing costs related to LJPC-501 and LJPC-401.

La Jolla Pharmaceutical Company Announces Special Protocol Assessment for its Phase 3 Trial of LJPC-501

La Jolla Pharmaceutical Company announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assesment (SPA) for its Phase 3 clinical trial of LJPC-501 for the treatment of catecholamine-resistant hypotension (CRH). In accordance with the SPA, the primary efficacy endpoint for this Phase 3 registration trial will be increase in blood pressure. La Jolla plans to initiate this multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial pursuant to the approved SPA in the first quarter of 2015.

 

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