ALKS Moves Forward, KBIO Craters, GILD Opens Wallet, TRVN For The Long Haul

(RTTNews) - Shares of Alkermes plc (ALKS) touched a new high of $62.85 on Tuesday after the company announced that a supportive study in its pivotal phase III program of ALKS 5461 for the treatment of major depressive disorder showed statistically significant improvements in depression scores.

In the supportive study, dubbed FORWARD-1, ALKS 5461 was generally well tolerated in both of the two titration schedules evaluated - one-week and two-week dose escalation schedules, noted the company.

ALKS closed Tuesday's trading 2.61% higher at $60.93.

BioLineRx Ltd. (BLRX) has completed the dose escalation stage of a phase 1 trial of BL-8040 in healthy volunteers for the mobilization of stem cells from the bone marrow to the peripheral blood circulation. The company expects results from the phase I study of BL-8040 during the first quarter of 2015.

BL-8040 is being developed along multiple tracks for the treatment of hematological malignancies and other hematological indications.

BLRX closed Tuesday's trading at $1.77, unchanged from the previous day's close.

Celsion Corp. (CLSN) has submitted its phase I clinical trial protocol to the FDA for GEN-1 to establish a safe dose and biological activity of the compound in newly diagnosed ovarian cancer patients who will be undergoing neoadjuvant chemotherapy.

The protocol has been submitted to the FDA for its 30 day review and comment period. Pending this review, the company expects to initiate enrollment in the second half of 2015.

CLSN closed Tuesday's trading at $2.37, down 2.07%.

CytRx Corp. (CYTR) rose more than 15 per cent on Tuesday following interim results from its on-going phase II trial of Adoxorubicin showed a complete response, tumor shrinkage, prolonged stable disease and a favorable tolerability in patients with recurrent glioblastoma multiforme.

The company expects to have more definitive data in the first half of this year, which it intends to submit for possible presentation at American Society of Clinical Oncology (ASCO) 2015.

CYTR closed Tuesday's trading at $3.30, up 15.79%. In after-hours, the stock was up another 2.12% at $3.37.

Globus Medical Inc. (GMED) expects sales for full year 2014 to be $474 million or 9.1% over the prior year, exceeding its previous guidance range of $462-$467 million.

The company anticipates fourth quarter 2014 sales to increase 11.5% to roughly $128.5 million compared to year-ago quarter.

Globus Medical is slated to report its fourth quarter and full year 2014 financial and operating results in late February.

GMED closed Tuesday's trading 1.55% down at $23.45.

Gilead Sciences Inc. (GILD) has acquired a development program for non-alcoholic steatohepatitis and other liver diseases from privately-held Phenex Pharmaceuticals AG for $470 million.

The acquisition of Phenex's FXR program represents an important opportunity to accelerate Gilead's efforts to develop new treatment options that address fibrotic liver diseases, said Norbert W. Bischofberger, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer.

GILD closed Tuesday's trading at $97.65, up 0.89%.

Shares of KaloBios Pharmaceuticals Inc. (KBIO) cratered over 63% in extended trading on Tuesday after the company announced that a phase II study of its drug candidate KB001-A to treat Pseudomonas aeruginosa lung infections in subjects with cystic fibrosis failed to meet the primary endpoint.

Although the study showed KB001-A was generally safe and well-tolerated, it did not demonstrate a clinically significant effect on Pseudomonas aeruginosa infections in the cystic fibrosis patients.

KBIO closed Tuesday's trading at $1.83, down 1.08%. In after-hours, the stock was down 63.88% at $0.66.

Trevena Inc. (TRVN) has initiated a phase 2b clinical trial of TRV130 for acute postoperative pain in patients following abdominoplasty surgery.

The study is designed to enrol 200 patients who will be assigned randomly to a post-operative regimen of TRV130, placebo, or morphine, in a 2:1:2 ratio respectively, for 24 hours after surgery, beginning when post-operative pain becomes moderate or severe in intensity.

The company expects top-line data from this phase 2 study in mid-2015.

TRVN closed Tuesday's trading down 6.46% at $5.36. In after-hours, the stock was up 2.61% at $5.50.

Ultragenyx Pharmaceutical Inc. (RARE) intends to initiate a phase 2 study of KRN23 in tumor-induced osteomalacia patients in the first half of this year. Interim safety and efficacy data from this study are anticipated by the end of 2015.

Tumor-induced osteomalacia results from typically benign tumors that produce excess levels of fibroblast growth factor 23 (FGF23), which can lead to severe osteomalacia, fractures, bone and muscle pain and muscle weakness.

RARE closed Tuesday's trading at $47.10, down 0.84%.