NPSP files NDA short bowel syndrome + CLDX CLSN AVEO ANTH IDRA ANX

Dec 02, 2011 No Comments by

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that it has launched a pivotal, randomized, double-blind, controlled Phase 3 trial of rindopepimut in patients with surgically resected epidermal growth factor variant III (EGFRvIII)-positive glioblastoma, the “ACT IV Study.”

Celsion Corporation (NASDAQ: CLSN) today announced that it has received commitments from investors to purchase an aggregate of $15 million of the its securities in a private placement. It will sell an aggregate of 6,486,488 shares of common stock at a price of $2.3125 per share along with warrants to purchase an additional 3,243,244 shares of common stock at an exercise price of $2.36 per share.

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), today announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for GATTEX (teduglutide) for Short Bowel Syndrome.

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) today announced positive interim biomarker data from the PEARL-SC phase 2b clinical study in patients with systemic lupus erythematosus, resulting in statistically significant reductions of B-cells.  Elevations in these B-cells have been associated with an increased risk of disease activity in lupus patients. It remains blinded to primary efficacy data. Final results from the PEARL-SC clinical study are expected in the 2Q  2012.  It had previously guided of a release during “mid-2012”.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) and Boehringer Ingelheim today announced that they have entered into an agreement for large-scale process development and clinical manufacturing of ficlatuzumab, AVEO’s novel HGF inhibitory antibody that is currently in Phase 2 clinical development in patients with non-small cell lung cancer (NSCLC). Boehringer Ingelheim will produce ficlatuzumab for clinical trials at its biopharmaceutical site in Fremont, USA. AVEO retains all rights to the development and commercialization of ficlatuzumab. Financial terms of the agreement were not disclosed.

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it met with the FDA to review development plans for ANX-188 (purified poloxamer 188) for sickle cell patients experiencing vaso-occlusive crisis. It hopes to initiate a Phase 3 study can be initiated in 2012.

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced the receipt of verbal notification from the Food and Drug Administration (FDA) that the company may proceed with a Phase 2 clinical trial of IMO-3100 in patients with psoriasis and plan to initiate it during 1H 2012

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About the author

Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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