12:00 AM
Jul 29, 2013
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Forest Laboratories Inc. (NYSE:FRX) was up $0.42 to $44.41 on Friday after FDA approved Fetzima levomilnacipran to treat major depressive disorder (MDD) in adults. The company said the product will be available in the U.S. next quarter. Forest has exclusive rights to develop and commercialize Fetzima in the U.S. and Canada from Laboratoires Pierre Fabre S.A.

On the week, Forest was up $0.65 to $44.41.

Gentium S.p.A. (NASDAQ:GENT) surged $4.85 (50%) to $14.61 on Friday after EMA's CHMP backed approval of Defitelio defibrotide to treat severe hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem cell transplantation therapy, reversing a prior negative recommendation. The committee said Defitelio should be approved under EMA's exceptional circumstances clause.

In March, CHMP recommended against approval of Defitelio to both treat and prevent VOD. Gentium requested a reexamination and submitted a revised MAA that focused on treating severe VOD and preventing VOD in high-risk patients. The company subsequently withdrew the prevention indication.

Gentium closed the week up $5.77 (65%).

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) gained $1.38 to $269.21 on Friday after EMA's CHMP recommended expanding the label of Eylea aflibercept from partner Bayer AG (Xetra:BAYN) to include treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Eylea is approved in Europe to treat wet age-related macular degeneration (AMD). Bayer has ex-U.S. rights from Regeneron, which was down $5.65 on the week.

Sarepta Therapeutics Inc. (NASDAQ:SRPT) fell $8.75 (19%) to $37.68 on Wednesday after the company said FDA "would not commit to declaring dystrophin an acceptable surrogate endpoint" for accelerated approval of eteplirsen to treat Duchenne muscular dystrophy (DMD). The company plans to submit an NDA in 1H14 based on Phase IIb data.

Sarepta closed the week off $7.39 (17%) to $36.96.

Prosensa Holding N.V. (NASDAQ:RNA), which is developing a competing DMD compound with partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), was up $3.96 (15%) to $29.61 last week, while PTC Therapeutics Inc. (NASDAQ:PTCT), which has a DMD compound in Phase III, was off $1.18 to $16.57.

Vectura Group plc (LSE:VEC) was up 8p (10%) to 92p on Friday after EMA's CHMP recommended approval of Ultibro Breezhaler (QVA149) from partner...

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