) -- Here are some more top biotech stock trades for the second half of 2011.
listed on the following pages encompass pending FDA drug approval decisions and clinical trial results -- all of which have the potential to produce significant stock-price volatility in the next six months.
These biotech stock events/trades expected before 2011 finishes build on the list of
that I compiled and published last week.
Represented below are an additional five pending FDA drug approvals, four phase III clinical trials and five phase II clinical trials -- all of which should occur in the second half of the year.
The event: Phase III study of TC-5214 as add-on therapy for patients with major depressive disorder.
The timelines: Top-line results from one or more of the four phase III studies expected in the fourth quarter.
The stakes: Targacept partner
is conducting a large phase III study program for TC-5214 in major depressive disorder.
TC-5214 is a potential blockbuster depression drug
if the phase III studies are successful.
The event: Phase III study of tivozanib in kidney cancer.
The timeline: Top-line results expected in the fourth quarter.
The stakes: Tivozanib, Aveo's lead drug, is being compared against
Nexavar in first-line, advanced renal cell carcinoma, or kidney cancer. The study is designed to show that tivozanib can extend the time before tumors regrow or patients die compared to Nexavar.
The event: Phase II study of TH-302 in pancreatic cancer
The timeline: Top-line results expected in the fourth quarter.
The stakes: After a previous pancreatic cancer drug failed, Threshold is back developing another drug known as TH-302. The phase II study compares TH-302 plus the chemotherapy drug gemcitabine against gemcitabine alone in patients with first-line pancreatic cancer. The study is designed to show that the addition of TH-302 to gemcitabine can prolong the time before tumors start to grow.
The event: FDA approval decision for the migraine patch Zelrix.
The timeline: FDA is expected to make its approval decision on Aug. 29.
The stakes: If approved, Zelrix would be NuPathe's first commercially marketed product.
that pushes a steady stream of the commonly used migraine medicine sumatriptan through the skin and into the patient's bloodstream.
The event: Phase III study of orBec in graft-versus-host disease.
The timeline: Top-line results expected in the second half of the year.
The stakes: FDA rejected orBec in 2007, instructing
in graft-versus-host disease (GVHD). OrBec is an oral (pill) reformulation of a well-known topical steroid that can be delivered directly to the gut, where it's most needed to help patients with GI GVHD.
The event: FDA decision to remove the bioscan requirement for Zevalin.
The timeline: Nov. 20.
The stakes: The use of Zevalin as a therapy for non-Hodgkin's lymphoma is hindered by an FDA-mandated "bioscan" requirement that doctors perform to predetermine the distribution of Zevalin throughout the body. Spectrum is seeking FDA permission to remove the bioscan requirementfrom the Zevalin label, which the company believes will make the drug easier to use along and also accelerate sales growth.
The event: Phase III study of delayed-release cysteamine in patients with nephropathic cystinosis.
The timeline: Top-line results are expected by the end of July.
The stakes: Raptor is testing its every 12-hour formulation of cysteamine against an every sixhour version of the drug in patients with nephropathic cystinosis, a rare lysosomal storage disorder diagnosed in children that can cause kidney failure among other problems. Raptor developed its delayed release cysteamine to make dosing easier and alleviate gastrointestinal side effects associated with the more frequent, immediate-release versions of the drug.
The event: Phase II study results for the hepatitis C drug PSI-7977
The timeline: Data expected at the American Association for the Study of Liver Disease (AASLD) annual meeting, Nov. 4-8.
in development and a big reason for the huge run in Pharmasset's stock price so far this year. Investors are excited about PSI-7977's potential to eventually become a component in an all-oral therapy against the serious liver disease. Pharmasset expects to present new data on PSI-7977 from two closely followed midstage studies later this year, with presentation of data at the AASLD annual meeting.
The event: Phase II study of VX-509 in rheumatoid arthritis.
The timeline: Top-line results in the third quarter.
The stakes: Investors are rightly focused mostly on Vertex's newly launched hepatitis C drug Incivek, but the company's pipeline also includes VX-509, a potentially valuable, oral JAK 3 inhibitor.
, separately, are developing similar oral drugs which target the $12 billion-a-year rheumatoid arthritis market.
The event: FDA approval decision for ANX-530 (exelbine) in non-small cell lung cancer.
The timelines: FDA is expected to make an approval decision date on Sept. 1.
The stakes: ANX-530 is a reformulation of the generic chemotherapy drug vinorelbine. The FDA issued a refuse-to-file letter for ANX-530 in 2010.
The event: FDA approval decision for ruxolitinib for myelofibrosis.
The timeline: FDA is expected to make an approval decision on Dec. 6, assuming a six-month review from the submission date of June 6.
The stakes: The first approved drug from Incyte's lab and a new, first-in-class treatment for myelofibrosis.
The event: Phase III study of Thermodox in primary liver cancer.
The timeline: Interim efficacy analysis in the third quarter.
The stakes: The interim analysis will determine whether the
should continue to a final analysis, likely in the middle of 2012. The study could be stopped early if the interim analysis finds overwhelming evidence of a Thermodox benefit (a great outcome, obviously) or discontinuation of the study due to futility (a bad outcome.)
The event: Pivotal phase II "PACE" study of ponatinib in acute and chronic myeloid leukemia.
The timeline: Complete patient enrollment in the current quarter followed by interim data in December, most likely at the American Society of Hematology (ASH) annual meeting, Dec. 10-13.
The stakes: Ariad owns all the commercial rights to ponatinib, making it the most important and potentially valuable drug in the company's pipeline. Ariad intends to seek regulatory approval for ponatinib if final results from the pivotal phase II study are positive next year.
The event: Phase II study of capesaris in prostate cancer.
The timeline: Top-line results to be reported by end of the year, perhaps delayed into early 2012.
The stakes: GTx is developing capesaris, an experimental testosterone deprivation therapy for prostate cancer, to have equivalent efficacy to Lupron, the current standard of care, but with a better tolerability and side effect profile. The phase IIb study compares daily, oral capesaris to an every-three-month injection of Lupron.
The event: FDA approval decision for Iluvien in diabetic macular edema.
The timeline: FDA is expected to make an approval decision date on Nov. 11.
The stakes: Alimera was rejected initially in 2010.
, company and analyst reports, TheStreet research.
>>To see these stocks in action, visit the
portfolio on Stockpickr.
-- Written by Adam Feuerstein in Boston
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