AMBI To Take A Long Route, ETRM Recharged, EXAS Gets Panel Date, OMED Flies High

(RTTNews) - Ambit Biosciences (AMBI) dropped more than 22 percent to $9.89 in extended trading on Tuesday, following the company's decision of not to submit a NDA for accelerated approval of its lead drug candidate for the treatment of relapsed/refractory acute myeloid leukemia, Quizartinib, based on phase II and IIb clinical trial data.

The company has decided to conduct a randomized, controlled phase III clinical trial in relapsed/refractory FLT3-ITD positive acute myeloid leukemia patients with an overall survival endpoint as the basis for the potential initial approval of Quizartinib.

Acceleron Pharma Inc. (XLRN) will be presenting new interim clinical data from a phase II trial of Sotatercept in patients with beta-thalassemia at the American Society of Hematology Annual Meeting in New Orleans on December 9th.

The company plans to initiate a phase II study of its experimental drug Dalantercept in combination with Bayer's cancer drug Nexavar in patients with hepatocellular cancer in the early part of 2014.

Acceleron went public on the Nasdaq as recently as September of this year at $15 per share. The stock closed Tuesday's trading at $23.28, up 5.39%.

Durata Therapeutics Inc. (DRTX) has submitted a Marketing Authorization Application to the European Medicines Agency for Dalbavancin for the treatment of patients with complicated skin and soft tissue infections (cSSTI). The company anticipates a decision in the first half of 2015. The drug candidate is also under FDA review with a decision date set for May 26, 2014.

DRTX closed Tuesday's trading at $11.06, down 2.21%.

EnteroMedics Inc. (ETRM) rose as much as 63.50 percent on Tuesday to close at $2.24, following the announcement of 18 month efficacy and safety results from its 5 year ReCharge Pivotal Trial of VBLOC vagal blocking therapy for the treatment of obesity.

According to the trial results, patients in the VBLOC group achieved excess weight loss of 25%, or 10% total body weight loss compared to 12% EWL, or 4% TBL for sham control group patients.

The VBLOC Therapy is delivered by a pacemaker-like device called the Maestro Rechargeable System. The Maestro system is approved in the E.U. and Australia but is yet to be approved in the U.S.

Exact Sciences Corp.'s ( EXAS) premarket approval application for its Cologuard stool-DNA-based, non-invasive colorectal cancer screening test is tentatively scheduled to be reviewed by an FDA panel on March 26, 2014.

Cologuard employs a relatively new approach of stool DNA testing. The test works by identifying DNA changes, caused from cancerous tumors or precancerous polyps, in the cells that are shed from the lining of the colon into the stool. The test also includes a hemoglobin detection component which identifies the presence of blood in the stool, which is another possible indicator of colorectal cancer.

EXAS closed Tuesday's trading at $12.24, down 1.45%.

Navidea Biopharmaceuticals Inc. (NAVB) has initiated one of the two pivotal phase III clinical trials of NAV5001, an investigational imaging agent in the differential diagnosis of Parkinsonian Syndromes from non-Parkinsonian tremor.

The NAV5001 phase III program consists of two similar clinical trials that will run in parallel and enroll approximately 550 total subjects who exhibit early stage tremor.

NAVB closed Tuesday's trading 2.47% higher at $1.66.

Shares of OncoMed Pharmaceuticals Inc. (OMED) more than doubled to $31.99 on Tuesday before closing at $27.70, following the company's strategic collaboration with Celgene Corp. (CELG).

As per the terms of the agreement, Celgene will be investing in six anti-cancer stem cell product candidates from OncoMed's biologics pipeline, including Demcizumab.

Demcizumab is under a phase 1b/2 clinical trial in ovarian cancer.

OncoMed will receive an upfront payment of $155 million, and Celgene will also purchase roughly $22.25 million in a private placement of newly issued shares of OncoMed's common stock at a price of $15.13 per share.