CLVS Up After-Hours, ECYT On The Back Foot, IMMU Making News, NNVC Cashed Up

(RTTNews) - Clovis Oncology Inc. (CLVS) rose over 6 percent to $60.44 in after-hours on Monday following the receipt of breakthrough therapy designation for its investigational drug CO-1686.

CO-1686 is being studied in phase II expansion cohorts of Non-small Cell Lung Cancer patients with activating EGFR mutations who have failed initial EGFR-directed therapy and have developed the T790M resistance mutation.

Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.

Shares of Endocyte Inc. (ECYT) dropped nearly 5 percent to $6.17 in extended trading on Monday after the company announced that it is withdrawing the conditional Marketing Authorization Applications for Vintafolide and companion imaging components in Europe.

Endocyte has an exclusive worldwide agreement with Merck to develop and commercialize Vintafolide.

Vintafolide and companion imaging components Etarfolatide and Intravenous (IV) Folic Acid were being developed for the treatment of adult patients with folate receptor-positive, platinum-resistant ovarian cancer, in combination with pegylated liposomal doxorubicin, or PLD.

Earlier this month, the Data Safety Monitoring Board recommended that a phase III trial evaluating Vintafolide for platinum-resistant ovarian cancer be stopped because Vintafolide in combination with PLD versus PLD alone did not meet the pre-specified criteria for progression-free survival.

Immunomedics Inc. (IMMU) said that its investigational pancreatic cancer therapeutic, clivatuzumab tetraxetan labeled with yttrium-90 (90Y), in combination with low-dose gemcitabine, demonstrated increased survival advantage in a phase Ib study, according to updated results.

The company has also launched a phase III registration trial, dubbed PANCRIT-1, to confirm the encouraging results. Patient accrual in the trial is planned for completion by the middle of 2015, with top-line results expected in the first half of 2016.

IMMU closed Monday's trading 3.41% higher at $3.34.

OPKO Health Inc. (OPK) said study results have demonstrated that its 4Kscore Test, launched on March 31, 2014, is the most accurate, personalized predictor for risk of high-grade cancer.

The 4Kscore Test provides a patient with his personal risk for high-grade prostate cancer from a blood test.

OPK closed Monday's trading at $8.36, up 2.33%.

NanoViricides Inc. (NNVC) said that with cash of roughly $36.6 million, it is well-funded to perform initial human clinical trials of its injectable FluCide drug candidate and to advance its DengueCide orphan drug candidate towards initial human clinical trials.

NNVC closed Monday's trading at $3.22, up 0.31%.

StemCells Inc. (STEM) said that according to interim analysis of clinical data from a phase I/II chronic spinal cord injury trial with the HuCNS-SCcells, significant sensory gains have been observed in two additional patients.

In total, the company has now reported clinical updates on a total of eight of the twelve patients enrolled in its Phase I/II clinical trial of HuCNS-SC (purified human neural stem cells) platform technology for chronic thoracic spinal cord injury.

STEM closed Monday's trading at $1.41, up 1.44%.

Ventrus Biosciences Inc. (VTUS) plunged 16.83 percent on Monday to close at $0.88 after the company agreed to merge with privately-held Assembly Pharmaceuticals in an all-stock transaction. Upon completion of the merger, the combined company will be renamed Assembly Biosciences Inc. and trade on the Nasdaq Capital Market under the ticker "ASMB."