By RTT News,
August 13, 2014, 12:22:00 AM EDT
(RTTNews.com) - BioTime Inc.'s ( BTX ) product Premvia has received FDA clearance as a Class II medical device. The product is indicated for the management of wounds including: partial thickness, full-thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh's surgery, post-laser surgery, podiatric wounds, wound dehiscence, abrasions, lacerations, second degree burns, skin tears and draining wounds.
BTX closed Tuesday's trading 0.70% higher at $2.86.
Cellular Biomedicine Group Inc. ( CBMG ) has treated the final patient in its phase IIb trial evaluating its proprietary adipose-derived mesenchymal precursor cell (haMPC)-based therapy for knee osteoarthritis. The results from the trial, dubbed ReJoin, are scheduled to be announced in the first quarter of 2015.
A phase I/IIa twelve-month follow-up MRI readout has been completed and the company expects the official report to be available by early fourth quarter of 2014.
CBMG closed Tuesday's trading at $21.73, down 7.10%.
Cutera Inc.'s ( CUTR ) enlighten laser platform has received FDA 510(k) clearance for the treatment of benign pigmented lesions. enlighten is the first and only dual wavelength (532 nm/1064 nm) and dual pulse duration picosecond laser system cleared for sale in the United States. Commercial shipments of the product are anticipated to commence in the fourth quarter of 2014.
CUTR closed Tuesday's trading 1.48% higher at $9.63.
Epizyme Inc. ( EPZM ) on Tuesday said that in an ongoing phase I dose escalation study of EPZ-6438 in patients with advanced solid tumors and B-cell lymphomas, the maximum tolerated dose has not been reached, meaning that the compound is well tolerated. The company also noted that there were no dose-limiting toxicities or adverse events-related treatment discontinuations.
The company expects to present more complete phase I data in late 2014.
EPZM closed Tuesday's trading at $35.02, up 2.61%. In after-hours, the stock shed 5.77% to 433.
Evoke Pharma Inc. ( EVOK ) has initiated a thorough ECG (QT) study of its lead product candidate, EVK-001, which is currently in a phase III clinical trial for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus.
The company expects to provide top-line data from the study in early 2015.
EVOK closed Tuesday's trading at $6.51, down 3.12%.
Shares of Exact Sciences Corp (EXAS) touched a new high of $19.15 on Tuesday before closing at $17.46, following FDA approval for the company's noninvasive, stool DNA colorectal cancer screening test Cologuard.
Cologuard, the first noninvasive screening test for colorectal cancer, works by identifying DNA changes, caused from cancerous tumors or precancerous polyps, in the cells that are shed from the lining of the colon into the stool. The test also includes a hemoglobin detection component which identifies the presence of blood in the stool, which is another possible indicator of colorectal cancer.
The list price of Cologuard in the U.S. is $599. The Centers for Medicare and Medicaid Services has proposed coverage memorandum for Cologuard, and a final National Coverage Determination is expected to be posted in October/November of this year after a public comment period.
Revance Therapeutics Inc. (RVNC), a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, expects to report data from its first U.S. phase III pivotal study of RT001 for use in the treatment of lateral canthal (crow's feet) lines by the end of 2014.
The company is also on track to report results from a phase II active comparator study for RT002 in the treatment of glabellar (frown) lines in 2015.
RVNC went public on February 6, 2014, offering its shares at a price of $16 each.
RVNC closed Tuesday's trading at $24.46, down 4.23%.
StemCells Inc. (STEM) expects to report final results of its phase I/II clinical trial of proprietary HuCNS-SC cells in spinal cord injury in mid-2015. This landmark study has enrolled twelve subjects with chest-level injury to the spinal cord, and the company has so far reported clinical updates on a total of eight of the twelve patients enrolled.
STEM closed Tuesday's trading at $1.65, down 1.79%. In after-hours, the stock further lost 3.03% to $1.60.
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