Several health-care stocks moved higher on Canadian, European and U.S. regulatory action Thursday, and one of the biggest moves came from
, which recently was climbing 33%.
The Food and Drug Administration
confirmed it would accept either a positive interim or final analysis of survival from Dendreon's latest trial to approve its prostate-cancer vaccine Provenge. Shares were up $2.48 to $9.23.
got the FDA's approval to market a new orally disintegrating tablet formulation of its antipsychotic drug clozapine, marketed as FazaClo. Previously the drug was available in 25-mg and 100-mg dosage strengths in blister packaging, but the company will now additionally market bottle packaging and a 12.5-mg dosage strength.
Avanir said the bottles will be available in pharmacies shortly and it expects health care professionals and patients will find them more convenient. Shares were up 10%, or 33 cents, to $3.55 midday, after rising 16 percent to $3.70 in early trading.
( ENCY) was higher by 45 cents, or 12.3%, at $4.03 on an announcement late Wednesday that the Canadian health authority approved Thelin for treatment of pulmonary artery hypertension in that country.
( WYE) and
said Wednesday the FDA will review Progenics' new-drug application and European regulators will review Wyeth's marketing authorization application for subcutaneous methylnaltrexone, a treatment for constipation in patients receiving painkillers. The FDA expects to complete review of the NDA by Jan. 30, 2008.
Progenics will receive a $5 million milestone payment from Wyeth for the acceptance of the NDA submission, in addition to the $4 million milestone it received for the European Medicines Agency review.
Under a 2005 agreement, Wyeth has worldwide rights to commercialize the drug and Progenics has an option to co-promote it in the U.S. Wyeth will pay Progenics royalties on worldwide sales and co-promotion fees within the U.S.
With regard to methylnaltrexone, the companies are conducting two phase III trials in prolonged dysfunction of the gastrointestinal tract following surgery, targeting an NDA submission in early 2008. They're also developing an oral formulation with a targeted NDA submission of late 2009 or early 2010.
Wyeth was up 60 cents, or 1%, to $58.10, and Progenics was up 39 cents, or 1.8%, to $21.66.
Avanir, Encysive and Progenics are components of the Nasdaq Biotechnology Index, which was up 0.1% to 832.16.
climbed 5.3% after announcing it will provide quantitative gene expression services to the Immune Tolerance Network. The research effort develops and assesses products and strategies for organ transplants, autoimmune diseases, allergies and asthma. Financial terms of the agreement weren't disclosed. Shares of the San Francisco-based biotechnology company were up 22 cents at $4.40.