Back to School: How biopharma can reboot drug development. Access exclusive analysis here

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

Read the full 1994 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE