ANIK Needs Your Attention, DARA Gets A Double Blessing, ITMN ASCENDs So High

(RTTNews) - Anika Therapeutics Inc. (ANIK) rose over 33 percent to $46 in after-hours on Tuesday, following receipt of FDA approval for MONOVISC to treat pain and improve joint mobility in patients suffering from osteoarthritis of the knee.

MONOVISC is comprised of a sterile, clear, biocompatible, resorbable, viscoelastic fluid composed of partially cross-linked sodium hyaluronate (NaHA) in phosphate buffered saline. The product was commercially launched in Europe in 2008 and is distributed in 18 countries including, Canada and Middle Eastern nations.

Anika has a license agreement with DePuy Synthes Mitek Sports Medicine, under which Anika will receive a milestone payment of $5 million upon first commercial sale of MONOVISC in the market. The agreement also calls for potential additional payments contingent on achieving certain performance and sales threshold milestones, in addition to product transfer and royalty fees.

BioCryst Pharmaceuticals Inc. (BCRX) touched a new high of $13.33 in intraday trading on Tuesday before closing at $12.83, following positive regulatory news. The company's New Drug Application seeking approval of intravenous Peramivir to treat influenza that was submitted to the FDA in December 2013 has been accepted for review, with a decision date set for December 23, 2014.

The FDA has informed BioCryst that at this time, it does not plan to hold an Advisory Committee review of the NDA.

Cerus Corp. (CERS) fell more than 11 percent in extended trading on Tuesday to $7.05 as investors were spooked by the company's lackluster revenue guidance for 2014.

For 2014, the company expects revenue to range between $38 million and $40 million, which is well below analysts' consensus estimate of $51.71 million.

The company, which filed the last module for INTERCEPT plasma with FDA, last December, anticipates a possible approval decision as early as second-half of 2014.

Depomed Inc. (DEPO) said its product revenue is roughly $18.8 million for the fourth quarter of 2013 and $58.3 million for full-year of 2013. This compares with product revenue of $12.5 million for the fourth quarter of 2012 and $27.5 million for 2012.

The company has 4 marketed products namely Gralise, Zipsor, Lazanda and CAMBIA. The company is scheduled to report Q4 and full-year 2013 financial results on March 4, 2014.

DEPO closed Tuesday's trading at $12.75, down 1.09%.

Dyax Corp.'s (DYAX) phase 1a study of its investigational drug DX-2930 has met all objectives of assessing safety, tolerability and pharmacokinetics. DX-2930 is being developed for the prevention of hereditary angioedema (HAE) attacks.

A phase 1b study of DX-2930 in HAE patients is expected to be initiated by the company in mid-2014.

DYAX closed Tuesday's trading at $10.14, up 0.10%. The stock was up 3.55% to $10.50 in after-hours.

It was a double blessing for DARA BioSciences Inc. (DARA) on Tuesday with the company regaining compliance with the minimum $1.00 bid price per share requirement, and its investigational drug KRN5500 receiving orphan drug status from FDA.

KRN5500 is currently in phase II clinical development for parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy.

DARA rose 23.11% to close Tuesday's trading at $3.09. In extended trading, the stock gained another 1.29% to $3.13.

InterMune Inc.'s (ITMN) phase III trial of Pirfenidone in patients with idiopathic pulmonary fibrosis, dubbed ASCEND, has met primary endpoint and two key secondary endpoints, sending the stock soaring more than 177% to a high of $38.73 on Tuesday.

According to the trial results, Pirfenidone significantly reduced idiopathic pulmonary fibrosis disease progression as measured by change in percent predicted forced vital capacity (FVC) from Baseline to Week 52. The trial also met the secondary endpoints of exercise tolerance and progression free survival.

Based on the strength of the ASCEND results, InterMune is preparing a resubmission of its New Drug Application for Pirfenidone to the FDA, which is expected to be submitted by early third quarter of this year.

The company initially submitted the NDA for Pirfenidone seeking approval of the compound in the treatment of patients with idiopathic pulmonary fibrosis to reduce the rate of decline in lung function in November 2009. However, Pirfenidone was sent back to the drawing board by the FDA in May 2010, and the company was asked to conduct an additional clinical trial to support the efficacy of Pirfenidone in IPF. Accordingly, the ASCEND phase III study was initiated in July of 2011.

Pacira Pharmaceuticals Inc. (PCRX) touched a new high of $83.41 in intraday trading on Tuesday before closing at $78.14 as investors cheered the company's financial performance in the fourth quarter.

In Q4, 2013 net loss narrowed to $12.0 million or $0.36 per share on revenues of $33.6 million. This compared with a net loss of $16.3 million or $0.50 per share and revenues of $10.5 million in the fourth quarter of 2012.