ACRX At FDA Altar, Orphan Drug Status Lifts CNAT, LCI Moves To NYSE

(RTTNews) - AcelRx Pharmaceuticals Inc.'s (ACRX) New Drug Application for Zalviso for the management of moderate-to-severe acute pain in adult patients in the hospital setting has been accepted for review by the FDA. The FDA's decision is likely to be in July 2014, based on a 10-month review cycle.

ACRX closed Monday's trading 1.84% higher at $9.96.

BioDelivery Sciences International Inc. (BDSI) is planning to initiate a placebo controlled phase III study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy in the first quarter of 2014. If the results of the trial, which could be available as early as the end of 2014, are positive, the company will be initiating the second placebo controlled study in 2015. If things pan out the way as planned, a New Drug Application for Clonidine Topical Gel is expected to be submitted in 2016.

BDSI closed Monday's trading 3.12% higher at $4.95.

Shares of Conatus Pharmaceuticals Inc. (CNAT) were up more than 27 percent to $7.80 in extended trading on Monday, following the company's experimental drug Emricasan receiving FDA's Orphan Drug Designation.

Emricasan is being developed for the treatment of liver transplant recipients with reestablished fibrosis to delay the progression to cirrhosis and end-stage liver disease.

A phase II trial of Emricasan in patients with chronic liver disease caused by alcohol and contraindicated to receive corticosteroid therapy for their alcoholic hepatitis was initiated in September of this year.

Forest Laboratories Inc. (FRX) touched a new high of $56.77 on Monday before closing the day's trading at $56.32 as the company added a new drug to its portfolio. The company is acquiring exclusive rights in the United States for Saphris sublingual tablets, a treatment for adult patients with schizophrenia or acute bipolar mania, from Merck & Co. Inc. (MRK) for an upfront payment of $240 million and additional payments defined as sales milestones.

Saphris logged net sales of $150 million in the 12-month period ended September 2013.

Isis Pharmaceuticals Inc. (ISIS) has earned a $2 million milestone payment from GlaxoSmithKline (GSK) related to the advancement of the ongoing phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy.

ISIS-TTRRx is an antisense drug in development with GlaxoSmithKline for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues.

ISIS closed Monday's trading at $38.42, down 0.88%.

Lannett Co. Inc. (LCI) will transfer the listing of its common stock to the New York Stock Exchange from NYSE MKT. The company's shares are expected to begin trading on the NYSE on December 13, 2013, under its current ticker symbol LCI.

LCI touched a new high of $32.59 before closing Monday's trading at $32.10.

Synageva BioPharma Corp. (GEVA) expects to report top-line results of its global phase III trial with sebelipase alfa in children and adults with lysosomal acid lipase deficiency during the second half of 2014. The trial, dubbed ARISE, has met the enrollment target of 50 patients.

Lysosomal acid lipase deficiency is an underappreciated cause of cirrhosis and accelerated atherosclerosis.

GEVA closed Monday's trading at $60.42, up 0.02%.