La Jolla Shines, ETRM Gets New Decision Date, NWBO Going North, RGDO Explodes

(RTTNews) - BioLineRx (BLRX) investigational treatment for celiac disease, BL-7010, has successfully completed the single administration, dose-escalation stage of an on-going phase 1/2 clinical study. No serious adverse events were reported and no dose-limiting safety issues were found. Based on these positive safety and tolerability results, the company will proceed with the repeated administration stage of the study. Results are expected in mid-2014.

BLRX closed Monday's trading at $2.56, up 2.81%.

EnteroMedics Inc.'s (ETRM) Premarket Approval Application for Maestro System delivering VBLOC vagal blocking therapy as a treatment for morbid obesity is now set to be reviewed by an FDA panel on June 17, 2014. The Advisory Committee Meeting was originally scheduled for May 29, 2014.

ETRM closed Monday's trading 2.14% higher at $2.39.

Keryx Biopharmaceuticals Inc. (KERX) has submitted a Marketing Authorization Application to the European Medicines Agency, seeking the approval of Zerenex as a treatment for hyperphosphatemia in patients with chronic kidney disease (CKD), including dialysis- and non-dialysis dependent CKD.

Zerenex is currently under FDA review with a decision date set for June 7, 2014.

Zerenex, under the brand name Riona, was approved in Japan for the improvement of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD in January of this year.

KERX closed Monday's trading at $14.99, down 1.83%.

La Jolla Pharmaceutical Co. (LJPC) rose more than 62 percent to $17.70 in extending trading on Monday following news about its randomized, placebo-controlled phase II trial of GCS-100 in chronic kidney disease achieving the primary endpoint of improved kidney function.

According to the company, a dose of 1.5 mg/m2 of GCS-100 was associated with a statistically significant increase in estimated glomerular filtration rate compared to placebo between baseline and end of treatment. However, there was no statistically significant difference at a higher dose of 30 mg/m2 of GCS-100.

Northwest Biotherapeutics (NWBO) rose more than 29 percent to close Monday's trading at $7.85, following two regulatory approvals in Germany for its lead product candidate DCVax-L. One is the "Hospital Exemption" early access program with DCVax-L granted by Paul Ehrlich Institute, and the other is reimbursement eligibility for DCVax-L granted by German reimbursement authority (Institut Fur Das Entgeltsystem Im Krankenhaus, or InEK).

Under the Hospital Exemption, NW Bio may provide DCVax-L to patients for the treatment of any glioma brain cancers, both newly diagnosed and recurrent, outside of the company's clinical trial and charge full price. The patients may be from Germany or elsewhere. This approval has a term of five years, and can be re-applied for and re-issued at the end of that period.

DCVax-L is under phase III testing for Glioblastoma multiforme brain cancer.

Novavax Inc. (NVAX) is slated to release top-line data from an ongoing phase 2 clinical trial of its respiratory syncytial virus F-protein (RSV F) nanoparticle vaccine candidate in women of childbearing age in the second quarter of 2014. The company is also scheduled to report top-line data from the recently initiated phase 1/2 clinical trial of its H7N9 avian influenza VLP vaccine candidate with Matrix-M in the second half of 2014.

NVAX closed Monday's trading at $5.86, down 1.51%. In after-hours, the stock was up 4.10% to $6.10.

Shares of Regado Biosciences Inc. (RGDO) touched a new high of $11.50 on Monday before closing at $11.30 after the company cheered investors with the news about the receipt of FDA's Fast Track status for its investigational REG1 anticoagulant system.

The REG1 anticoagulant system is under a phase III trial for acute coronary syndrome patients undergoing percutaneous coronary intervention, dubbed REGULATE-PCI Trial.