LabStyle Innovations Corp. (OTCQB: DRIO) saw its share volume continue to surge on June 4th with 441,560 shares exchanging hands, 6.5 times higher than its three month daily average volume of 67,910 shares.
LabStyle Innovations Corp., developer of the Dario™ Diabetes mHealth Solution, announced that its President and Chief Executive Officer, Mr. Erez Raphael, will present at RetailInvestorConferences.com on June 5th.
The company also announced some recent highlights:
- First shipments of the Dario(TM) Diabetes Management Solution in Italy, New Zealand and the United Kingdom, collecting initial positive feedback.
- Notice of Allowance from the U.S. Patent and Trademark Office for core patent claims covering the Dario(TM) Personalized Smart Meter.
- National and regional insurance reimbursement approval for the Dario(TM) Personalized Smart Meter in Italy. LabStyle is actively seeking reimbursement in other strategic territories.
- Work with FDA towards potential clearance of the Dario(TM) Personalized Smart Meter in the U.S. following a 510K filing made in late December 2013.
DRIO closed the day at $1.30 on June 4th, 16.67% lower than its previous close of $1.56.
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BrainStorm Cell Therapeutics Inc. Announces Interim Results From Phase II Clinical Trial
BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) saw its share volume soar on June 4th with 1,503,473 shares exchanging hands, double its three month daily average volume of 778,615 shares.
Earlier this week, BrainStorm Cell Therapeutics Inc. announced that interim results from the Company's Phase IIa ALS trial conducted at Hadassah Medical Center in Jerusalem, Israel were presented yesterday at the Joint Congress of European Neurology by Principal Investigator Professor Dimitrios Karussis. The positive safety and preliminary efficacy results observed in this study are consistent with results observed in the company's previous Phase I/II trial. Between these two studies, a total of 26 patients have been treated with NurOwn(TM), BrainStorm's stem cell therapy candidate for ALS.
Prof. Karussis noted, "Administration of NurOwn was well tolerated both intramuscularly and intrathecally. I am very encouraged by signs of disease stabilization and even improvement that we observed in a number of the treated subjects. Analysis of the complete dataset will be invaluable in helping BrainStorm optimize the analysis of its Phase II study, which is about to launch in the United States."
"We are very satisfied with the results observed so far in these two studies," commented Chaim Lebovits, BrainStorm's President. "The fact that some of the patients actually demonstrated clinical improvement surpassed our expectations of achieving stabilization or reduced rate of decline. We look forward to the completion of this trial and to building on these results in our double-blind, placebo controlled, multi-center study currently being launched in the USA."
BCLI closed the day at $.295 on June 4th.
IntelGenx Technologies Reports Positive Results From Comparitive Bioavailability Study
IntelGenx Technologies Corp. (OTCQX: IGXT) saw its share volume remain strong on June 4th with 491,533 shares exchanging hands, right on par with its three month daily average volume of 425,824 shares.
Last month, IntelGenx, a Canadian drug delivery company focused on oral drug delivery, reported together with RedHill Biopharma Ltd. (NASDAQ: RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, positive results from a comparative bioavailability study with their anti-migraine VersaFilm(TM) product, an oral thin film formulation of rizatriptan for acute migraines. The study compared the anti-migraine VersaFilm(TM) product to the European reference drug Maxalt(R) lingua, marketed in Germany by MSD SHARP & DOHME GMBH, to support the planned submission of a European Marketing Authorization Application ("MAA") for the anti-migraine VersaFilm(TM) product during the third quarter of 2014.
The results of the study are subject to final quality assurance and an independent study report by the Canadian clinical research organization ("CRO") that conducted the study. The final independent report from the CRO is expected in the coming weeks.
IntelGenx and RedHill previously conducted a successful bioavailability study which demonstrated the required U.S. Food and Drug Administration ("FDA") criteria for therapeutic bioequivalence between the anti-migraine VersaFilm(TM) soluble oral thin film product and the U.S. reference drug, Maxalt-MLT(R). Following the successful bioequivalence study, IntelGenx and RedHill announced in 2013 the submission to the FDA and acceptance for review of a New Drug Application ("NDA") seeking marketing approval of the anti-migraine VersaFilm(TM) product. Following a Complete Response Letter received from the FDA in February 2014, which raised questions primarily related to Chemistry, Manufacturing and Controls ("CMC"), IntelGenx and RedHill recently reported that they believe that FDA approval of the anti-migraine VersaFilm(TM) product NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Accordingly, the companies continue to work with the FDA in order to address and resolve all remaining CMC questions and to secure a compliant source of the raw material.
IGXT closed the day at $.69 on June 4th.
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