LLY Adds New Drug To Portfolio, GILD Faces FDA Decision, IMUC Catches Eyes

(RTTNews) - Cubist Pharmaceuticals Inc. (CBST) has submitted a New Drug Application to FDA seeking approval of its investigational antibiotic ceftolozane/tazobactam for the treatment of Complicated Urinary Tract Infections and Complicated Intra-Abdominal Infections.

The company expects to submit a Marketing Authorization Application for ceftolozane/tazobactam to the EMA in the cUTI and cIAI indications during the second half of 2014.

CBST closed Monday's trading 1.86% higher at $65.14.

The FDA has approved Eli Lilly and Co.'s (LLY) Cyramza to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma.

In clinical trials, participants with unresectable or metastatic stomach or gastroesophageal junction cancer treated with Cyramza experienced a median overall survival of 5.2 months compared to 3.8 months in participants receiving placebo, experienced a delay in tumor growth and also showed an improvement in overall survival.

The National Cancer Institute estimates that 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die from the disease, this year. Cyramza enjoys orphan product designation for this indication.

LLY closed Monday's trading at $60.86, up 0.71%.

Gilead Sciences Inc.'s (GILD) resubmitted New Drug Applications for Cobicistat, a boosting agent for HIV therapy, and Elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults have been accepted for review by FDA.

The FDA's decision date for Cobicistat is set for October 3, 2014 and that of Elvitegravir is scheduled for October 4, 2014.

Cobicistat is approved under the tradename Tybost, and Elvitegravir is approved under the tradename Vitekta in Europe, Canada and Australia.

Last April, the FDA issued complete response letters for Elvitegravir and Cobicistat citing deficiencies in documentation and validation of certain quality testing procedures and methods.

GILD closed Monday's trading at $71.60, up 2.29%.

ImmunoCellular Therapeutics Ltd. (IMUC) rose 10 percent in extended trading on Monday to $1.31 after the company announced that it will be presenting updated overall survival results from a phase II trial of dendritic cell-based cancer vaccine ICT-107 in newly diagnosed glioblastoma on June 1, 2014 at the 2014 at the American Society for Clinical Oncology annual meeting.

Rexahn Pharmaceuticals Inc.'s (RNN) investigational product RX-21101 has demonstrated complete tumor growth inhibition, enhanced tumor regression, and extended survival in preclinical study with mouse xenograft models without significant changes in body weight compared to intravenously administered docetaxel.

The preclinical study was conducted by Rexahn in collaboration with the University of Maryland and Ohio State University.

RNN closed Monday's trading at $1.00, up 2.04%.