AVNR's PRIME Flops, BG Medicine Tastes Sweet, CYTR Awaits Data, ENTA Shines

(RTTNews) - Avanir Pharmaceuticals Inc. (AVNR) fell more than 12 percent to $3.75 in extended trading on Tuesday following the failure of a phase II trial of its investigational drug AVP-923 (dextromethorphan / quinidine) for the treatment of central neuropathic pain in patients with multiple sclerosis, dubbed PRIME, to meet the primary efficacy endpoint.

Baxter International Inc. (BAX) has submitted a biologics license application to the FDA for the approval of OBI-1, a recombinant antihemophilic porcine sequence factor VIII, in patients with acquired hemophilia A. OBI-1 has been granted orphan-drug designation for acquired hemophilia A by the U.S. regulatory agency.

BAX closed Tuesday's trading at $67.26, down 0.78%.

BG Medicine Inc. (BGMD), which surged more than 86 percent on Tuesday to close at $1.08, continued its rally in extended trading too, rising another 15 percent, following the revised Medicare national limitation for its galectin-3 blood test.

The 2014 Medicare national limitation amount for the galectin-3 blood test will be $30.01 compared to $17.80 that was effective in 2013.

The company's BGM Galectin-3 test is a novel blood test, which is cleared by the U.S. Food and Drug Administration for use as an aid in assessing the prognosis of patients with chronic heart failure.

CytRx Corp. (CYTR) will issue a news release at 8:00 a.m. Eastern time tomorrow announcing top-line results of its global phase 2b clinical trial comparing its experimental Aldoxorubicin as a first-line treatment for advanced soft tissue sarcomas versus the widely used chemotherapeutic agent Doxorubicin.

CYTR closed Tuesday's trading at $2.39, down 9.47%. In after-hours, the stock fell further 13% to $2.07.

Echo Therapeutics Inc. (ECTE) surged more than 21 percent to $3.56 in extended trading on Tuesday after the medical device company announced that it has entered into a strategic collaboration agreement with Medical Technologies Innovation Asia Ltd., or MTIA, of Hong Kong.

As per the agreement, Echo, which is developing Symphony CGM System, a non-invasive, wireless continuous glucose monitoring system, is entitled to receive a $10 million cash investment from MTIA.

MTIA will be responsible for development costs, as well as manufacturing and marketing costs, relating to the Symphony CGM System for the Chinese market, and for obtaining regulatory approval for the product in Peoples' Republic of China, Hong Kong, Macau and Taiwan.

Enanta Pharmaceuticals Inc. (ENTA) touched a new high of $38.48 on Tuesday before closing at $38.14, following impressive results of a phase III study, dubbed SAPPHIRE-II, which is using a regimen containing the company's drug candidate ABT-450 for the treatment of hepatitis C virus genotype 1 infection.

ABT-450 is being developed in collaboration with AbbVie Inc. In clinical studies, ABT-450 is co-administered with ritonavir, a commonly used boosting agent to increase the blood concentrations of many protease inhibitors.

ABT-450/r in combination with ABT-333, AbbVie's investigational non-nucleoside polymerase, and ABT-267, an investigational NS5A inhibitor of AbbVie, is currently in six phase III clinical trials, dubbed Sapphire I and II, Pearl II, III, IV and Turquoise II.

PDL BioPharma Inc. (PDLI) expects revenue for the fourth quarter ending December 31, 2013 to be approximately $109 million, which is above the analysts' consensus estimate of $107.6 million. The company reported revenue of $86 million in Q4, 2012.

PDLI closed Tuesday's trading at $8.23, down 0.60%.

Raptor Pharmaceutical Corp. (RPTP), which is seeking to explore additional indications for its marketed nephropathic cystinosis drug Procysbi, submitted an investigational new drug application to the FDA for the clinical development of the drug as a potential treatment for Leigh syndrome and other mitochondrial disorders.

The company expects to initiate the Leigh syndrome trial in Q1 2014.

RPTP closed Tuesday's trading at $14.46, up 0.42%.

Spectrum Pharmaceuticals Inc. (SPPI) has submitted a New Drug Application to the FDA for approval of Belinostat for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. The company has sought priority review for Belinostat. Whether or not the FDA accepts Belinostat filing for review will be known in 60 days.

SPPI closed Tuesday's trading at $9.39, down 0.21%.

Biotech stocks can be risky as their fortunes depend on two key events namely clinical trial results and FDA decisions. Nevertheless, the returns can be impressive when the stocks are bought and sold at the right time. So far, 36 of our 2013 stock picks have delivered triple-digit returns, including ENTA, which reported impressive trial results today.

Visit Emerging Biostocks (http://www.rttnews.com/Products/EBSService.aspx) for a complete list of our biotech stock picks.