Echo Sounds Louder, PBMD Gets Prime Attention, Xmas Coming Early For CYCC

(RTTNews) - Cubist Pharmaceuticals Inc. (CBST) touched a new high of $72.64 on Monday before closing at $70.76, following positive top-line results from its phase III trial of investigational antibiotic Ceftolozane/Tazobactam in complicated urinary tract infections.

Ceftolozane/Tazobactam is also being studied in a phase III study for complicated intra-abdominal infections, and top-line data from this study are expected in late December.

Cyclacel Pharmaceuticals Inc. (CYCC) said it will be reporting primary endpoint data of a phase II study of its drug candidate Sapacitabine in older patients with myelodysplastic syndromes at the ASH conference in early December.

The company also noted that the Data Safety Monitoring Board has recommended the continuation of its phase III trial of oral Sapacitabine capsules in elderly patients with acute myeloid leukemia as planned without any modifications.

CYCC closed Monday's trading 5.99% higher at $4.60.

Echo Therapeutics Inc. (ECTE) jumped over 30 percent in extended trading to $3.51 as the company gets ready to announce top-line data from a CE Mark regulatory trial of its experimental device Symphony on Tuesday, November 26, 2013.

The company's Symphony CGM System is a non-invasive, wireless, continuous glucose monitoring system that is being developed for use in hospital critical care units and for people with diabetes.

Echo looks forward to initiate a pivotal study of Symphony to support regulatory submission in the U.S. next year.

Heat Biologics Inc. (HTBX) remains on track to commence patient enrollment in its phase 1/2 bladder cancer trial before year-end, now that the manufacture of the first GMP-grade batch of its investigational drug HS-410 has been successfully completed.

HTBX closed Monday's trading 8.32% higher at $8.72.

The FDA decision on Mallinckrodt's (MNK) investigational compound XARTEMIS XR for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate has been extended by 3 months to April 2014.

The NDA for XARTEMIS XR was accepted by the FDA on July 29, 2013, and was granted priority review, which meant a decision by Jan.29, 2013. Now the three-month extension of the decision date from the FDA is in response to additional data submitted by Mallinckrodt.

MNK closed Monday's trading at $50.60, down 1.25%.

Shares of Prima BioMed Ltd. (PBMD) rose more than 38 percent on Monday to close at $1.50 following the new attention that is being given to the company's phase II trial of its experimental drug CVac for treatment of epithelial ovarian cancer patients in first or second remission.

The company said that an expert panel will be discussing CVac clinical trial data on December 11, 2013.

According to recently reported results, in a small cohort of 20 patients, CVac conferred approximately a 50% increase in progression free survival.

Teva Pharmaceutical Industries (TEVA) and Mylan Inc. (MYL) have agreed to settle and dismiss pending patent litigation involving Teva's multiple sclerosis drug Copaxone in the United Kingdom, the Netherlands and France.

The case relates to Mylan seeking a court judgment that Teva's European Patent 762,888 expiring May 2015 for, COPAXONE be pronounced invalid.

Last month, the District Court of the Hague (Netherlands) ruled in Teva's favor for the Copaxone patent.

MYL touched a new high of $44.37 before closing at $44.22.

Ventrus Biosciences Inc. (VTUS) has completed patient enrollment and randomization in its second phase III clinical trial of Diltiazem Hydrochloride 2% Cream in patients with pain related to anal fissure. The data from this study are expected to be available in the first quarter of 2014.

The company reported positive results from its first pivotal phase III clinical trial of VEN 307 for the treatment of anal fissure last year.

If things pan out the way as planned, Ventrus expects to file a New Drug Application for VEN 307 in the second quarter of 2014.

VTUS closed Monday's trading at $2.83, down 0.70%.