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Ampligen Spurned, BLRX Clarifies, IDIX Pulls Plug On Drugs, MDCO, NAVB In News

Ampligen Spurned, BLRX Clarifies, IDIX Pulls Plug On Drugs, MDCO, NAVB In News
2/5/2013 4:19 AM ET

BioLineRx Ltd. (BLRX: Quote) clarified that any media reports or comments by those outside of the company regarding the outcome of the interim results of the phase II/III CLARITY clinical trial of BL-1020 in schizophrenia are merely based on speculation. The company added that as previously disclosed the results from the interim analysis of the CLARITY trial are expected to be reported during the week of March 18, 2013.

The interim analysis that will be performed by a fully independent, external Data Monitoring Committee will provide the company with an estimate of the total number of patients required in the study in order to achieve statistical significance on the cognitive endpoints of the study.

Celldex Therapeutics Inc. (CLDX: Quote) on Monday announced a $75 million proposed public offering of its common stock. The actual size or terms of the offering are yet to be revealed.

CLDX was down 3.37% to $7.17 in after-hours trading on Monday.

NewLink Genetics Corp. (NLNK: Quote) said it has received net proceeds of approximately $49.0 million from the public offering of common stock that closed on Monday. The underwritten public offering was priced at $11.40 per share.

NLNK closed Monday's trading 0.99% higher at $12.30.

Hemispherx Biopharma Inc.'s (HEB: Quote) new drug application seeking approval of Ampligen for chronic fatigue syndrome has once again been rejected by the FDA. In its complete response letter, the regulatory agency has requested the company to complete various nonclinical studies and perform a number of data analyses, in addition to conducting at least one additional clinical trial.

The company said it intends to request an end-of-review conference with the FDA as a precursor to submitting a formal appeal to the Office of New Drugs in the FDA's Center for Drug Evaluation and Research regarding the regulatory agency's decision on Ampligen.

HEB dropped more than 19% to $0.21 in after-hours trading.

Idenix Pharmaceuticals Inc. (IDIX: Quote) has pulled the plug on a phase IIb trial of its investigational hepatitis C drug IDX184, and discontinued the development of a second hepatitis C drug candidate IDX-19368. The two drug candidates were placed on hold by the FDA last August due to serious cardiac-related adverse seen in a competitor's phase II clinical trial of BMS-986094. Both IDX184 and IDX19368 share the same active metabolite as BMS-986094.

IDIX dropped more than 7% to $4.37 in extended trading on Monday.

The Medicines Co. (MDCO: Quote) on Monday said it has obtained an exclusive global license to advance Alnylam Pharmaceuticals Inc.'s (ALNY) ALN-PCS RNAi therapeutic program for the treatment of hypercholesterolemia. In return, Alnylam will receive $25 million in upfront payment in addition to milestone payments and royalties on product sales.

Navidea Biopharmaceuticals Inc. (NAVB: Quote) is all set collaborate with Maimonides Medical Center to investigate the utility of Lymphoseek Injection in lymphatic mapping procedures for colorectal cancer. Lymphoseek is under FDA review for use in Intraoperative Lymphatic Mapping, or ILM, which is performed primarily for patients with breast cancer and melanoma with a decision date set for April 30, 2013.

NAVB was up 1.52% to $3.34 in after-hours on Monday.

Stem Cell Therapeutics Corp. (SSS.V: Quote) and Trillium Therapeutics Inc. of Toronto are to be merged by way of a three-cornered amalgamation or plan of arrangement with a newly-created subsidiary of Stem Cell Therapeutics. The proposed merger would create Canada's only public company advancing cancer stem cell technologies, said Stem Cell Therapeutics' Executive Chairman David Allan.

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by RTT Staff Writer

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