|Healthcare Review: Dynavax Technologies, Apricus Biosciences, ACADIA Pharmaceuticals, Celldex Therapeutics, Avanir Pharmaceuticals|
|By Staff and Wire Reports|
|Monday, 10 June 2013 13:38|
Dynavax Technologies Corporation (NASDAQ:DVAX) shares decreased 27.17% to $1.80. The company, on June 10 reported that it recently concluded a meeting with the U.S. Food and Drug Administration (FDA or Agency) regarding its Biologic License Application (BLA) for HEPLISAV, an investigational adult hepatitis B vaccine. The meeting followed recommendations expressed in November 2012 by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) regarding the size of Dynavax's safety database.
Apricus Biosciences Inc. (NASDAQ:APRI) shares climbed 12.10% to $2.87. The company on June 10 announced that its marketing application for Vitaros®, indicated for the treatment of patients with erectile dysfunction ("ED"), has been approved through the European Decentralized Procedure ("DCP").
Under the DCP, Apricus Bio filed its application for marketing approval designating Netherlands as the Reference Member State ("RMS") on behalf of nine other European Concerned Member States ("CMS") participating in the procedure.
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) shares climbed 10.58% to $18.81. The company, on June 3, announced that Allergan, Inc. (NYSE: AGN) has advanced an additional product candidate as a potential new treatment for glaucoma. The novel small molecule resulted from joint research conducted by the companies under their recently concluded research collaboration focused on new therapies for glaucoma and related ophthalmic conditions.
Celldex Therapeutics, Inc. (NASDAQ:CLDX) shares increased 4.32% to $15.20. The company released its earnings data on May 2. The company reported ($0.23) earnings per share for the quarter, missing the analysts' consensus estimate of ($0.22) by $0.01. The company had revenue of $2.41 million for the quarter, compared to the consensus estimate of $2.65 million.
Avanir Pharmaceuticals, Inc. (NASDAQ:AVNR) shares jumped 4.24% to $3.93. The company on June 5 announced that the U.S. Food and Drug Administration (FDA) has agreed to an expedited development pathway for their next-generation compound, AVP-786, requiring only a limited pre-clinical package as part of the Investigational New Drug (IND) application. Upon completion of these preclinical studies the company intends to proceed directly into human clinical trials.