21.06.2016 06:30:34
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GSK FULFILS Goals, CDXC Sinks On Short Seller Report, LPTN Up On Defense Grant
(RTTNews) - Biotricity Inc. (BTCY.OB) touched a new high on Monday, following the filing of a 510(k) for the company's flagship product bioflux solution with the FDA.
The company expects to receive a response from the FDA on its 510(k) submission by early Fall.
Upon final release, Biotricity's flagship product, the bioflux solution, will combine a proprietary mobile ECG monitoring device and an industry leading ECG viewer software package. The combination will enable physicians to remotely monitor and diagnose patients with cardiovascular disease and coronary heart disease by detecting arrhythmias, using an accredited 24 hour, 7 day per week, ECG monitoring facility, according to the company.
BTCY.OB touched a new high of $2.15 on Monday before closing the day's trading at $2.13, up 6.50%.
Shares of ChromaDex Corp. (CDXC) plunged over 42% on Monday, following a report by short seller Bleecker Street Research, which details allegations of stock promotion and fraud.
The report also claims that the profitability of the company for the quarter ended April 2, 2016, is likely fake and appears to be engineered.
Responding to the short attack, Frank Jaksch, Founder and CEO of ChromaDex said, "The report appears to be a blatant and transparent attempt by a shortseller or shortsellers to profit from an immediate and precipitous decline in the company's share price through the use of an opinion piece published anonymously and laden with misinformation, innuendo and the use of selective historical information".
CDXC closed Monday's trading at $2.84, down 42.97%.
Cellectis (CLLS) announced that the first patient has been treated in a phase I study of UCART19 in pediatric acute B lymphoblastic leukemia at the University College of London.
This UCART19 clinical trial is sponsored by French drug company Servier in close collaboration with Pfizer Inc. (PFE).
Cellectis will receive a milestone payment from Servier of an undisclosed amount.
CLLS closed Monday's trading 4.04% higher at $27.78.
GlaxoSmithKline plc (GSK) and Innoviva Inc.'s (INVA) phase III study of the investigational once-daily 'closed' triple combination therapy, in patients with chronic obstructive pulmonary disease has met its two co-primary endpoints.
The study, dubbed FULFIL, demonstrated statistically significant improvements compared with twice-daily Symbicort Turbohaler in both lung function and health-related quality of life at the end of the 24-week study period.
GlaxoSmithKline plans to make EU and US regulatory submissions for the closed triple combination therapy by the end of 2016.
The closed triple therapy is a combination of three medicines - fluticasone furoate (FF), an inhaled corticosteroid, umeclidinium (UMEC), a long-acting muscarinic antagonist and vilanterol (VI), a long-acting beta2-adrenergic agonist delivered once-daily in GSK's Ellipta inhaler.
Should the Closed Triple be successfully developed and commercialized, Theravance Biopharma Inc. (TBPH) is entitled to receive an 85% economic interest in the royalties paid by GlaxoSmithKline on worldwide net sales. Those royalties are upward-tiering from 6.5% to 10%. Additionally, GlaxoSmithKline is responsible for all development costs related to the Closed Triple with no costs being borne by Theravance Biopharma.
GSK closed Tuesday's trading at $41.49, up 2.88%.
Shares of Lpath Inc. (LPTN) soared over 43.75% on Monday on the company's receipt of a $1.45 million two-year grant awarded by the Defense Medical Research and Development Program, an agency of the U.S. Department of Defense.
The fund will support the study of Lpathomab for the treatment of neuropathic pain associated with traumatic brain injury.
The company reported favorable results from a phase I study of Lpathomab in healthy volunteers in April of this year.
LPTN closed Monday's trading at $2.99, up 43.75%.
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Aktien in diesem Artikel
Cellectis SA (spons. ADRs) | 1,86 | 3,91% | |
ChromaDex Corp | 7,10 | -1,39% | |
Innoviva | 17,90 | -1,10% |