ARAY On The Rise, AERI Catching Eyes, CORT Growing Big, SLXP Gets FDA Date

By RTT News, 
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( - Accuray Inc. ( ARAY ) surged more than 9 percent to $10.15, following strong Q2 fiscal 2014 results and upbeat revenue outlook for fiscal 2014.

The company's total revenue for the second quarter ended December 31, 2013 is $93.6 million, representing an increase of 20% from the prior year second quarter.

Looking ahead to fiscal 2014, the company revised its total revenue outlook to a range of $340 million to $350 million, up from its previous total revenue guidance range of $325 million to $345 million.

Aerie Pharmaceuticals Inc. ( AERI ) has initiated a phase 2b study of its experimental drug PG324 to treat patients with glaucoma or ocular hypertension. Topline results of this trial are currently expected to be released in mid-2014.

AERI closed Thursday's trading 7.05% higher at $17.91.

Amgen Inc.'s ( AMGN ) pivotal phase III study of Evolocumab in patients with heterozygous familial hypercholesterolemia has met its co-primary endpoints of LDL cholesterol reduction.

The trial, known as RUTHERFORD-2, is the fifth pivotal LDL-C lowering study in the phase III program. The data from all these studies will form the basis of the company's global filing plan and discussions with regulatory agencies.

AMGN closed Thursday's trading 1.44% higher at $120.89.

Avanir Pharmaceuticals Inc. ( AVNR ) has submitted a New Drug Application to FDA for approval of AVP-825, its investigational drug-device combination product, for the acute treatment of migraine.

The NDA has been submitted under the 505(b)(2) regulatory approval pathway that allows the company to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug.

AVNR closed Thursday's trading 13.83% higher at $3.95.

Shares of Corcept Therapeutics Inc. ( CORT ) rose more than 8 percent to $4.05 in extended trading on Thursday after the company reported that revenue of its lead product Korlym rose 56% in Q4, 2013. Korlym revenue for the full year of 2013 is $10.4 million.

Looking ahead to 2014, the company anticipates Korlym revenue to grow to a range of $24 million to $28 million, up from $10.4 million in 2013.

Salix Pharmaceuticals Ltd.'s (SLXP) New Drug Application for Budesonide 2 mg Rectal Foam has been accepted for review by FDA. The regulatory agency's decision date is set for September 15, 2014.

The company is seeking approval of Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

SLXP closed Thursday's trading 2.41% higher at $98.48.

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This article appears in: News Headlines

Referenced Stocks: AERI , AMGN , ARAY , AVNR , CORT

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