) -- 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.
: Top-line results from a phase III study of pimavanserin in patients with Parkinson's disease psychosis expected in November. Read more on the
and a deeper dive into
previous pimavanserin studies.
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.
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.
will announce top-line results from two phase III studies of migalastat (Amigal) in Fabry disease before the end of the year.
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.
: 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,
over the next five years
Catalyst Pharmaceutical Partners
has promised results from a phase IIb study of
before the middle of November. That means data this week or next.
: Top-line results from the phase III study of Abraxane in pancreatic cancer before the end of the year.
contributor Nate Sadeghi predicts a
from this important Abraxane study.
reported interim results from a
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.
: Top-line results from the phase III trial of
Thermodox in liver cancer
expected before the end of the year. The "HEAT" study compares Thermodox plus radiofrequency thermal ablation (RFA) versus RFA alone in patients with primary liver cancer. The primary endpoint of the study is improvement in progression-free survival.
: Top-line results from a phase III study of
expected before year's end. The "LEAP" study compares CO-011 versus gemcitabine in metastatic, chemo-naive pancreatic cancer patients whose tumors express low levels of hENT1, a protein which gemcitabine requires to enter cells. Survival is the study's primary endpoint.
brings its hepatitis B vaccine Heplisav in front of an FDA advisory panel on Nov. 14.
FDA will announce an approval decision for
medullary thyroid cancer drug cabozantinib on or before Nov. 29.
presents important new data on its all-oral hepatitis C combination regimens at the
beginning Saturday, Nov. 10.
An FDA advisory panel convenes Dec. 20 to review
will release results from a
in opioid-induced constipation before the end of the year. The "KODIAC" trials, consisting of two phase III placebo-controlled efficacy and an open-label, placebo-controlled long-term safety study, are designed to determine the efficacy and safety of NKTR-118, a once-daily tablet, for the treatment of constipation in patients taking prescription opioid medications.
is expecting an FDA approval decision for Gattex on Friday, Dec. 28. Gattex treats patients with short-bowel syndrome. An
last month to recommend the drug's approval.
awaits an FDA decision on Nov. 21 for tofacitinib, the first rheumatoid arthritis pill.
: Top-line results before the end of the year for the phase III melanoma study of Allovectin (injected directly into melanoma lesions) versus dacarbazine or temozolomide in patients with recurrent metastatic melanoma. The primary endpoint of the study is durable response rate at 24 weeks but the more important and necessary (for approval) secondary endpoint is overall survival.
reports third-quarter financial results on Tuesday, Nov. 6, including the
set to announced results from the phase III study of
. The "PICASSO III" study compares palifosfamide plus doxorubicin to doxorubicin alone in patients with front-line metastatic soft-tissue sarcoma. The study's primary endpoint is improvement in progression-free survival (for accelerated approval) and overall survival (for full approval.)
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