Breaks Categories: News

TuesdaySep 05, 2017 9:12 am

NetworkNewsBreaks – Global Payout, Inc. (GOHE) Looks to Achieve Fully Reporting Status within 60 Days

Payment solutions company Global Payout, Inc. (OTC: GOHE) this morning announced that it is currently in the process of completing its financial audit in preparation for the filing of Form 10-K, which the company expects will be completed within the next 60 days. “We are very pleased to have kicked-off the very important process of completing our audit and are optimistic in our ability to complete it within the next 60 days so that we enter a fully reporting status,” James Hancock, CEO of Global Payout, stated in the news release. “By becoming fully reporting, we are increasing our transparency…

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ThursdayAug 31, 2017 12:31 pm

NetworkNewsBreaks – Dextera Surgical, Inc.’s (NASDAQ: DXTR) MicroCutter 5/80™ Receives Expanded Indication Approval by FDA; Shares Higher

Dextera Surgical (NASDAQ: DXTR) shares are up 15% this morning after the company said it has received approval from the U.S. Food and Drug Administration (FDA) to use its MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads in combination with open solid organ parenchymal dissection techniques, including such organs as the liver, kidney, pancreas and spleen. “This expanded indication represents an additional 44,000 procedures in the United States annually, and we look forward to bringing the MicroCutter 5/80 to surgeons for these applications,” Dextera Surgical president and CEO Julian Nikolchev stated in the news release. To…

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ThursdayAug 31, 2017 12:29 pm

NetworkNewsBreaks – Apricus Biosciences, Inc.’s (NASDAQ: APRI) Vitaros™ Class 2 NDA Resubmission Acknowledged by FDA; PDUFA Goal Date Set

Apricus Biosciences (NASDAQ: APRI) this morning said that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its recently resubmitted New Drug Application (NDA) for Vitaros™ and considers it a complete, class 2 response to Apricus’ 2008 action letter. Additionally, the PDUFA (Prescription Drug User Fee Act) goal date for conclusion of the FDA’s review is set for the standard review period for NDA resubmissions of six months, falling on February 17, 2018. “The FDA has determined that the resubmission is a complete, class 2 response to our 2008 action letter.  Importantly, we believe that Vitaros, if approved, will…

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ThursdayAug 31, 2017 12:27 pm

NetworkNewsBreaks – SteadyMed (NASDAQ: STDY) Shares Plunge on Refusal to File Letter from FDA for Trevyent® NDA

SteadyMed (NASDAQ: STDY) shares are down 35% this morning after the company said it has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application (NDA) for Trevyent®. The Trevyent NDA was submitted in June 2017 for the treatment of Pulmonary Arterial Hypertension (PAH). Upon preliminary review of the NDA, the FDA determined that it was not adequately complete to permit a substantive review. The FDA has requested more details regarding certain device specifications and performance testing. The FDA also requested further design verification and validation testing on the final,…

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ThursdayAug 31, 2017 9:19 am

NetworkNewsBreaks – Lexaria Bioscience Corp. (CSE: LXX) (OTCQB: LXRP) Announces Clinical Study of High Absorption TurboCBD™ Product

Lexaria Bioscience Corp. (CSE: LXX) (OTCQB: LXRP), a company engaged in licensing proprietary technology for the delivery of bioactive compounds, this morning announced the world’s first clinical study on human volunteers of cannabidiol (CBD) within Lexaria’s TurboCBD™ product. The study, which aims to evaluate the effects of TurboCBD™ on both cardiovascular health and cognitive function, will have a double-blind and placebo controlled cross-over design measuring effects after a single dose, as well as seven days of daily dosing, in 24 volunteers. “Lexaria is proud to be advancing our collective knowledge of the benefits of CBD specifically showcasing the benefits of…

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WednesdayAug 30, 2017 1:12 pm

NetworkNewsBreaks – Otonomy, Inc. (NASDAQ: OTIC) Misses Primary Endpoint in AVERTS-1 Phase 3 Trial; Shares Hit New 52-Week Low

Shares of Otonomy, Inc. (NASDAQ: OTIC) plummeted 81% to a new year-low of $3.80 this morning, a drastic fall below its previous low of $11.30, as investors reacted to news that the company reported negative results for its AVERTS-1 phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease. The clinical trial missed the primary endpoint and all key vertigo secondary endpoints. Shares of OTIC now trade in a 52-week range of $3.80-$21.15. “Based on these results, we are immediately suspending all development activities for OTIVIDEX including the ongoing AVERTS-2 trial. In addition, the company is undertaking a review…

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WednesdayAug 30, 2017 10:37 am

NetworkNewsBreaks – ProBility Media Corp. (PBYA) Pledges Donation to Hurricane Harvey Relief Efforts

EdTech innovator ProBility Media Corp. (OTCQB: PBYA) this morning announced that it has committed a portion of its profits – as realized from its initiative to deliver the American Society of Mechanical Engineers (ASME) Boiler Pressure Vessel Code (BPVC) – to victims that have suffered losses as a result of Hurricane Harvey. The company’s donations will be distributed through the Jewish Federation of Greater Houston. “The Jewish Federations of North America have opened an emergency relief fund to support communities and individuals in Houston, San Antonio, Galveston, Corpus Christi and other areas of Texas that have been hammered by Hurricane Harvey,” Noah…

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WednesdayAug 30, 2017 9:48 am

NetworkNewsBreaks – PotNetwork Holding, Inc. (POTN) Retains PCAOB-Registered East West Accounting Services, LLC to Initiate Audit

PotNetwork Holding, Inc. (OTC: POTN) this morning announced that it has officially retained the auditing services of East West Accounting Services, LLC, a Public Company Accounting Oversight Board (PCAOB) registered CPA firm based in South Florida. Moving forward, East West will review and analyze PotNetwork’s recently announced financial results, providing credible verification of the company’s second quarter and year-to-date operating performance. “We believe that the timing for this action is now,” Gary Blum, chief executive officer of PotNetwork Holding, stated in the news release. “In consideration of the amount of momentum built up over the past 6 months, coupled with…

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TuesdayAug 29, 2017 11:45 am

NetworkNewsBreaks – LiNiu Technology Group (NASDAQ: LINU) Shares Soar on Strategic Cooperation Agreement with Shou Guang Agriculture Logistic Park

LiNiu Technology Group (NASDAQ: LINU) shares are up 73% after the company this morning said it has signed a strategic cooperation agreement with Shou Guang Agriculture Logistic Park ("SGALP"), a company approved by the China National Development and Reform Commission and one of the largest vegetable distribution, pricing, information exchanges and logistic centers throughout Asia. Per the agreement, the companies will collaborate regarding product offerings, information resources, consumers, management of the logistic park and more. Additionally, Guangzhou LiNiu will provide SGALP with access to internet sales channels through its LiNiuYang trading platform, while SGALP permits Guangzhou LiNiu access to its…

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TuesdayAug 29, 2017 11:41 am

NetworkNewsBreaks – Moleculin Biotech, Inc. (NASDAQ: MBRX) Files Annamycin IND with FDA for Acute Myeloid Leukemia

Shares of Moleculin Biotech (NASDAQ: MBRX) are trading 7% higher this morning following the company’s news that it has filed an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to study Annamycin in the treatment of relapsed or refractory acute myeloid leukemia (AML). The company expects the FDA will allow the IND to go into effect, which normally occurs within 30 days and would permit Moleculin to begin additional clinical trials of Annamycin. If the IND goes into effect as the company anticipates, it intends to begin clinical trials in the fourth quarter of 2017. "Now that we…

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