BOSTON ( TheStreet) -- We're less than two months from putting 2012 to bed but an astonishing number of biopharmaceutical firms still have significant stock-moving catalysts that have yet to play out.
Here's an alphabetized list of 21 biotech and drug companies with FDA drug approvals and significant clinical trial results expected before the end of 2012.
Acadia Pharmaceuticals (ACAD - Get Report): Top-line results from a phase III study of pimavanserin in patients with Parkinson's disease psychosis expected in November. Read more on the BioRunUp trade in Acadia and a deeper dive into previous pimavanserin studies.
Alexza Pharmaceuticals' (ALXA) Adasuve, an inhaled formulation of the antipsychotic medication loxapine, is expecting an FDA approval decision on Dec. 21. U.S. regulators have rejected Adasuve twice previously.When Amarin (AMRN - Get Report) reports third-quarter results on Thursday, Nov. 8, investors will be listening for an update on Vascepa's New Chemical Entity (NCE) status and plans for the drug's commercial launch. Amicus Therapeutics (FOLD) and partner GlaxoSmithKline (GSK) will announce top-line results from two phase III studies of migalastat (Amigal) in Fabry disease before the end of the year. Biogen Idec (BIIB) will complete a busy year of drug development when it announces results from a phase III study of dexpramipexole in amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease. Data expected before end of the year. Biomarin Pharmaceuticals (BMRN): Phase III study of GALNS for MPS IV also known as Morquio Syndrome before end of year. If the study is successful and the drug is approved, GALNS could double Biomarin's revenue over the next five years Catalyst Pharmaceutical Partners (CPRX)has promised results from a phase IIb study of CPP-109 (vigabatrin) in cocaine addiction before the middle of November. That means data this week or next. Celgene (CELG): Top-line results from the phase III study of Abraxane in pancreatic cancer before the end of the year. TheStreet contributor Nate Sadeghi predicts a win for Celgene from this important Abraxane study. Last May, Celldex Therapeutics (CLDX) reported interim results from a mid-stage study of its targeted cancer drug CDX-011 demonstrating superior response rates in patients with advanced metastatic breast cancer compared to single-agent chemotherapy. Updated results from this study will be presented at the San Antonio Breast Cancer Symposium in December.
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