12:00 AM
 | 
Sep 02, 2013
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Allenex AB (SSE:ALNX) gained SEK1.03 (48%) to SEK3.19 on Thursday after saying Mexico approved XM-ONE to detect human leukocyte antigen (HLA) and non-HLA antibodies between donor and recipient in organ transplantations.

XM-ONE is an endothelial crossmatch test kit that detects anti-endothelial cell antibodies (AECA) as well as antibodies to major histocompatibility complex (MHC) class I and II HLA antigen. The test is already marketed in the U.S. and Europe.

Allenex finished the week up SEK1.10 (48%) to SEK3.40.

Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) lost $0.61 to $17.45 last week after FDA extended by three months the PDUFA date for an sBLA to expand the label for Xiaflex collagenase clostridium to treat Peyronie's disease.

The new date is Dec. 6; it was Sept. 6. Auxilium said the delay was due to the company's submission of revisions to its proposed REMS and label.

Auxilium markets Xiaflex in the U.S., Canada and the EU, where it is known as Xiapex, to treat Dupuytren's contracture in adult patients with a palpable cord. The company has worldwide rights to Xiaflex from BioSpecifics Technologies Corp. (NASDAQ:BSTC), which was down $0.83 to $18.28 last week.

bioMerieux S.A. (Euronext:BIM) slipped €0.39 to €77.36 the week of Aug. 19 after FDA approved Vitek MS for the automated identification of bacteria and yeasts that are known to cause serious illness in humans. The system can identify 193 different microorganisms associated with skin infections, pneumonia, meningitis and bloodstream infections.

Catalyst Pharmaceutical Partners Inc. (NASDAQ:CPRX) gained $0.59 (42%) to $2.01 on Tuesday after FDA granted breakthrough therapy designation to Firdapse amifampridine to treat Lambert-Eaton myasthenic syndrome (LEMS). Firdapse, which is approved for LEMS in the EU, is in Phase III testing in the U.S., with data expected in 2Q14 and an NDA submission planned for late 2014 or early 2015.

Catalyst finished up $0.67 (53%) to $1.94 on the week. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), which granted Catalyst exclusive, North American rights to Firdapse, was up $0.73 to $65.47 on the week.

MorphoSys AG (Xetra:MOR; Pink:MPSYF) was up €2.74 to €59.24 the week of Aug. 19 after Novartis AG (NYSE:NVS; SIX:NOVN) said FDA granted breakthrough therapy designation for bimagrumab (BYM338) to treat sporadic inclusion body myositis. The human HuCAL antibody against activin receptor type 2B (ACVR2B) is in Phase II testing for the indication. Novartis developed it in collaboration...

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