Acorda Therapeutics Inc. (ACOR) touched a new 52-week high of $35.75 on Monday before closing at $35.50 after the company announced that its marketed drug Ampyra approved for the improvement of walking in people with multiple sclerosis, also improved walking in people with post-stroke deficits. The company said it plans to continue clinical development in post-stroke deficits.
Boston Scientific Corp. (BSX) has commenced a clinical trial to evaluate the next generation ImageReady MR Conditional pacing system in the magnetic resonance imaging environment. The trial, dubbed SAMURAI, is a prospective, open-label, two-group randomized, multi-center, global clinical study designed to enroll approximately 363 patients at 45 centers in seven countries.
BSX closed Monday's trading at $7.47, down 2.48%.
BSD Medical Corp. (BSDM) has completed the previously announced $5.0 million registered direct offering of common stock and warrants. About 4 million shares of the common stock were sold at $1.23 per share to two institutional investors in the registered direct offering.
BSDM closed Monday's trading at $1.15, down 3.36%.
GTx Inc. (GTXI) announced that its two pivotal phase III clinical trials of Enobosarm for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer will continue as planned, following review by an independent Data Safety Monitoring Board. The company expects topline data from the studies to be released during the third quarter of 2013.
GTXI shed 6.07% to close Monday's trading at $4.02.
Merrimack Pharmaceuticals Inc. (MACK) has completed enrollment of one cohort in a phase II clinical trial of its experimental drug MM-121 combined with Paclitaxel in neoadjuvant setting of HER2-negative breast cancer. Final results from this cohort are expected in the second half of 2013.
MACK closed Monday's trading down 0.82% at $6.03.
Sarepta Therapeutics Inc. (SRPT) announced Monday that the FDA will consider accelerated approval for its experimental drug Eteplirsen after further review of additional information, namely the surrogate endpoint of dystrophin and clinical outcomes from the existing Eteplirsen dataset.
Eteplirsen is Sarepta's lead drug candidate for Duchenne Muscular Dystrophy and the company reported positive results from a phase IIb study last December.
The company is preparing to submit the dystrophin and clinical outcomes summaries and will be requesting a follow-up meeting with the FDA to discuss the data later this quarter. As a result, the End-of-Phase II CMC (Chemistry, Manufacturing and Controls) meeting with the FDA is now expected to occur in the third quarter.
SRPT closed Monday's trading at $39.24, down 2.41%. In after-hours, the stock lost 6.52% and was at $36.68.
For comments and feedback: editorial@rttnews.com