Aastrom Biosciences Inc.'s (ASTM) ixCELL-DCM phase IIb clinical trial is recommended for continuation without modification by the independent Data and Safety Monitoring Board, following an interim review.
The ixCELL-DCM phase 2b clinical trial is evaluating ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy. The company expects enrollment to be completed in the second half of 2014.
ASTM closed Wednesday's trading at $4.28, up 3.38%.
Aegerion Pharmaceuticals Inc. (AEGR) has initiated a phase III trial in Japan to evaluate lomitapide as an adjunct treatment to reduce low-density lipoprotein cholesterol in patients with homozygous familial hypercholesterolemia.
Last year, Aegerion received orphan drug designation from Japan's Ministry of Health, Labour and Welfare for lomitapide. The company hopes to submit the filing for marketing approval of Lomitapide in Japan as early as mid-2015.
AEGR closed Wednesday's trading 5.66% higher at $44.21.
AngioDynamics Inc. (ANGO) has turned a profit in its fiscal 2014 third quarter as sales grew 8 percent, reflecting continued market acceptance of its innovative products.
Looking forward to fiscal year 2014, the company now expects sales to range between $351 million to $355 million, up from its prior forecast of $349 million to $353 million.
ANGO closed Wednesday's trading 3.39% higher at $15.85. In after-hours, the stock gained another 2.52% to $16.25.
DelMar Pharmaceuticals Inc. (DMPI.OB) said Wednesday that new data from its ongoing phase I/II clinical trial with VAL-083 in the treatment of refractory glioblastoma multiforme has revealed that the compound is well tolerated, with no drug-related serious adverse events have been detected in 26 patients treated to date in the study.
The company noted that dose limiting toxicity has not been reached after fifth cohort and that the sixth cohort has been fully enrolled.
DMPI.OB closed Wednesday's trading at $1.28, down 3.03%.
The FDA has placed a clinical hold on Halozyme Therapeutics Inc.'s (HALO) ongoing phase II trial evaluating PEGPH20 in patients with pancreatic cancer. The regulatory agency's action follows the company's recent decision to temporarily halt enrollment and dosing of PEGPH20 in the trial.
The stock has lost nearly 30% of its value since the company broke news of the temporary halt of the trial on April 4.
HALO closed Wednesday's trading at $8.12, down 2.05%.
Vanda Pharmaceuticals Inc.'s (Vanda) circadian rhythm disorder drug HETLIOZ (tasimelteon), which was approved by FDA in January 2014, is now available through specialty pharmacies in the U.S.
The drug is indicated for Non-24-Hour Sleep-Wake Disorder (Non-24), a serious chronic circadian rhythm disorder that affects up to 70 percent of people who are totally blind.
The company is also preparing to file a Marketing Authorization Application for tasimelteon with the European Medicines Agency during 2014.
VNDA closed Wednesday's trading at $15.78, up 5.41%.
by RTT Staff Writer
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