ADXS In Focus, EGLT Soars, NEO Boosts Outlook, RMD Hits Record High

(RTTNews) - Advaxis Inc. (ADXS) has received permission from FDA to conduct a phase I clinical study of ADXS-HER2 (ADXS31-164) for the treatment of patients with metastatic HER2 expressing solid tumors.

The clinical trial is expected to begin patient enrollment in the first half of 2015. ADXS-HER2 in osteosarcoma was granted orphan drug designation by the FDA last May.

Shares of Advaxis have lost more than 36% of their value in the last 3 days after an article dated January 21, 2015 alleged that in a recent presentation, the company overstated the effectiveness of its ADXS-HPV compound in shrinking tumors.

The company has completed a phase II study of ADXS-HPV in patients with recurrent cervical cancer in India.

ADXS closed Thursday's trading at $7.43, down 11.23%.

Egalet Corp. (EGLT) surged more than 23 per cent on Thursday after the company announced positive top-Line results from a Category 3 human abuse liability study of Egalet-001.

Egalet-001 is an abuse-deterrent, extended-release, oral oxycodone product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.

The Category 3 human abuse liability study compared the relative abuse potential of intact and manipulated formulations of Egalet-001 versus manipulated MS Contin, a currently approved oral morphine formulation.

The company plans to begin enrollment in a phase III study of Egalet-001 this quarter.

EGLT closed Thursday's trading 23.94% higher at $6.11.

NeoGenomics Inc. (NEO) has raised its outlook for the fourth quarter of 2014 based on continued strength in its underlying business.

Accordingly, the company now expects earnings per share of $0.01 to $0.02 on revenue of approximately $25 million for the fourth quarter of 2014. Previously, the company was expecting earnings per share of $0.00 - $0.01 and revenue of $23.0 to $24.5 million.

NeoGenomics is scheduled to report fourth quarter and full year 2014 financial results on February 24, 2015.

NEO closed Thursday's trading at $3.58, up 0.56%.

Novo Nordisk A/S (NVO) has received positive opinion from the European regulatory authorities for Saxenda for the treatment of obesity as an adjunct to a reduced-calorie diet and increased physical activity.

The drug was approved by the FDA on December 23, 2014, and is expected to be launched in the US in the first half of 2015.

NVO closed Thursday's trading at $44.25, down 2.08%.

ResMed Inc. (RMD) touched a new high on Thursday, following better-than-expected Q2 fiscal 2015 results.

The company's net income for the quarter ended December 31, 2014 was $91.2 million or $0.64 per share and revenue was $423.0 million, both of which were well above analysts' consensus. This compared with net income of $86.7 million or $0.60 per share and revenue of $384 million in the year-ago quarter.

The company has declared a quarterly dividend of $0.28 per share, which will have a record date of February 12, 2015, payable on March 19, 2015.

RMD closed Thursday's trading 2.93% higher at $61.86.