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AFFY Mauled, BDSI On Track, GALE Blows, AVXL, INO, MACK On Watch


Affymax Inc. (AFFY) plunged more than 57% to $1.25 in extended trading on Monday after the company said it is reducing its workforce by 75% and may even consider bankruptcy proceedings.

The company's actions stem from the nationwide voluntary recall of anemia medication OMONTYS Injection due to reports of serious hypersensitivity reactions, including anaphylaxis last month.

Alnylam Pharmaceuticals Inc. (ALNY) has initiated a phase I clinical study for ALN-TTRsc, a subcutaneously administered RNAi therapeutic targeting transthyretin, for the treatment of TTR-mediated amyloidosis. Data from this trial is expected in mid-2013.

The company plans to start a phase II clinical study of ALN-TTRsc in familial amyloidotic cardiomyopathy patients by the end of 2013 and, assuming positive results, expects to start a pivotal trial for ALN-TTRsc in FAC patients in 2014.

Anavex Life Sciences Corp. (AVXL.OB) rose more than 10% to $0.75 following FDA's proposal to accelerate the approval of drugs that could slow down or prevent Alzheimer's disease.

Anavex is developing a drug for Alzheimer's disease. The compound known as ANAVEX 2-73 has successfully completed a phase 1 clinical trial.

BioDelivery Sciences International Inc. (BDSI) said it is on track to file BUNAVAIL NDA for opioid dependence in mid-2013. The company also noted that its two phase III efficacy studies evaluating BEMA Buprenorphine for chronic pain, conducted in conjunction with Endo Health Solutions, are scheduled to be completed in late 2013 or early 2014.

BDSI closed Monday's trading at $3.92, down 1.01%.

Galena Biopharma Inc. (GALE) added an FDA approved product to its portfolio following the acquisition of Abstral sublingual tablets in U.S., a treatment approved for breakthrough cancer pain, from Sweden-based Orexo AB.

Under the terms of the agreement signed on Monday, Galena will pay Orexo $10 million upfront and $5 million within the first twelve months of closing, plus low double digit royalties and one-time milestone payments based on pre-specified net sales.

GALE closed Monday's trading at $2.02, up 5.21%.

Hospira Inc. (HSP) on Monday announced that its drug for in-hospital sedation - Precedex, has been granted pediatric exclusivity by the FDA. The provision of pediatric exclusivity implies that the period during which a generic application may not be approved has been extended by a period of six months after patent expiry.

The granting of pediatric exclusivity does not mean that Precedex is approved for use in pediatric patients. Precedex is FDA-approved only for use in adults aged 18 and older.

Inovio Pharmaceuticals Inc. (INO) said interim data of a phase II clinical trial evaluating ChronVac-C, a therapeutic vaccine candidate for hepatitis C, is expected to be reported in 1Q 2013. ChronVac-C, developed by ChronTech Pharma, uses Inovio's delivery system called MedPulse.

INO gained 1.49% to $0.54 in after-hours on Monday.

Merrimack Pharmaceuticals Inc. (MACK) has completed enrollment in a phase II study of MM-121 in combination with Paclitaxel in patients with platinum-resistant or refractory advanced ovarian cancers. Top line results from this study are expected in the second half of 2013. Merrimack has an exclusive, global collaboration and licensing agreement with Sanofi for MM-121 that was signed in 2009.

MACK closed Monday's trading 1.16% higher at $6.10.

MusclePharm Corp. (MSLP.OB) rose over 3% to $7.30 on Monday following the launch of FitMiss, a new line of branded fitness supplements specifically designed for active women. The company said that its FitMiss line is now available at retail locations of GNC and Vitamin World, as well as online retailers BodyBuilding.com, VitaCost.com, and ProSource.net.

Quidel Corp. (QDEL) and Life Technologies Corp. (LIFE) have received FDA clearance for Clostridium difficile assay and Quantstudio DX and 7500 Fast DX Real-Time PCR instruments. The Quidel Molecular Direct C. difficile Assay is Quidel's first assay with a streamlined stool processing procedure.

Seattle Genetics Inc. (SGEN) has submitted a supplemental Biologics License Application to the FDA seeking approval of ADCETRIS for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma.

ADCETRIS was granted accelerated approval by the FDA for relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma in August 2011.

SGEN closed Monday's trading at $33.41, down 0.42%.

Thoratec Corp. (THOR) announced Monday that it has successfully completed the first human use of HeartMate PHP, or Percutaneous Heart Pump. Two additional patients were treated as part of this first-in-man series. The pilot study will be continued during the second quarter and a CE Mark study is expected to be initiated in the second half of 2013.

XOMA Corp. (XOMA) has appointed Tom Klein to the newly created position of Chief Commercial Officer. Klein joins XOMA from Genentech, where he was Vice President, Business Unit Head Virology and Specialty Care. At XOMA, Klein will be reporting to Chief Executive Officer John Varian.

by RTTNews Staff Writer

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