REPH Implodes, MRK's Keytruda Gets FDA Nod, New Entrant In Ebola Drug Study

(RTTNews) - Cellectar Biosciences Inc. (CLRB) plans to initiate a phase I/II proof-of-concept trial of I-131-CLR1404, a highly-selective, cancer-targeting radiopharmaceutical, in patients with relapsed or refractory multiple myeloma, an incurable cancer of plasma cells during the fourth quarter 2014.

Earlier in the year, the company initiated a phase II diagnostic imaging trial of its lead compound, I-124-CLR1404, in glioblastoma.

CLRB closed Thursday's trading at $3.03, down 3.50%.

Kamada Ltd. (KMDA) plunged more than 18 percent to $5.82 on Thursday after the company announced that its European phase 2/3 clinical study of inhaled Alpha-1 antitrypsin (AAT) therapy for the treatment of Alpha-1 antitrypsin deficiency (AATD) failed to meet the primary and secondary endpoints.

Merck's (MRK) humanized monoclonal antibody KEYTRUDA has been granted accelerated approval by FDA for the treatment of melanoma patients who have not responded to prior therapies.

Keytruda, formerly known as MK-3475, becomes the first anti-PD-1 (programmed death receptor-1) therapy to be approved in the United States.

Merck is conducting ongoing phase II and III clinical studies in advanced melanoma, which are designed to provide further confirmatory evidence for Keytruda in this indication. The drug is expected to be made available within one week.

MRK touched a new high of $61 on Thursday before closing at $60.08.

Nanosphere Inc. (NSPH) has engaged Jefferies LLC as its financial advisor to assist it in the development and evaluation of a full range of potential strategic alternatives for the company.

NSPH closed Thursday's trading at $0.65, down 14.28%. In after-hours, the stock was up 10.01% to $0.72.

NewLink Genetics Corp. (NLNK) has been granted permission by FDA to proceed with phase I clinical trials of its Ebola vaccine candidate. The vaccine was initially developed by the Public Health Agency of Canada, and is under an exclusive licensing arrangement with BioProtection Systems, a wholly-owned subsidiary of NewLink Genetics.

The company is working with the U.S. Department of Defense's Defense Threat Reduction Agency (DTRA) and the Walter Reed Army Institute of Research (WRAIR) to launch the initial phase 1 safety trial.

The death toll from the Ebola epidemic in West Africa has surpassed 1,900 people, according to Margaret Chan, the World Health Organization's chief. NLNK closed Thursday's trading at $25.55, down 1.62%.

OncoMed Pharmaceuticals Inc. (OMED) is all set to resume enrollment and dosing of new patients in phase I trials of Ipafricept, now that the FDA has removed the partial clinical hold on the phase I trials.

OncoMed is conducting three phase 1b clinical trials of Ipafricept - one in pancreatic cancer (Abraxane +gemcitabine + ipafricept), one in hepatocellular carcinoma (sorafenib + ipafricept), and one in platinum-sensitive ovarian cancer (carboplatin/paclitaxel + ipafricept).

OMED closed Thursday's trading at $17.68, down 5.56%. In after-hours, the stock gained 4.07% to $18.40.

Shares of Recro Pharma Inc. (REPH) plunged 28 percent to $4.10 in extended trading on Thursday, following the company's decision to close its phase II trial evaluating intranasal dexmedetomidine, Dex-IN, for postoperative analgesia following bunionectomy (surgery to treat deformed bones of the big toe and foot).

The company's decision was based on findings from a prespecified interim analysis conducted on the initial half of patients who completed enrollment in the phase II trial which indicated that the study may not reach statistical significance in its current design.

A revised phase II study of Dex-IN is expected to be launched starting in Q4 2014, and top line results are anticipated mid-year 2015.

Stereotaxis Inc. (STXS) rose over 13 percent to $3.24 on Thursday, following FDA clearance for its Vdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator in the U.S.

Employed in conjunction with the company's Niobe ES magnetic navigation system, the Vdrive with V-Loop system is designed to remotely control the advancement, retraction, rotation, tip deflection and loop size of a compatible circular mapping catheter, which is used in approximately 60,000 complex electrophysiology procedures worldwide each year.

Veracyte Inc. (VCYT) is accelerating its entry into pulmonology market by acquiring Allegro Diagnostics Corp., a privately held company focused on developing genomic tests to improve the preoperative diagnosis of lung cancer.

Veracyte has agreed to pay $21.0 million, comprised of $7.8 million in cash and $13.2 million in stock, as purchase price. Veracyte plans to commercially launch Allegro's lead lung cancer test in the second half of 2015, with meaningful revenue expected in 2017.

VCYT closed Thursday's trading at $12.42, down 0.40%.