NetworkNewsBreaks

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 1:15 pm

NetworkNewsBreaks – Top 10 Mid-day Percentage Gainers on August 30, 2017

Here is a list of stocks shaking up the markets today, with particular focus on NASDAQ and OTC small caps. The top gainers based on percentage: NBEV 19.24% – News: Expands Marley yerba Mate™ with distribution partners throughout the US FTEK 14.14% – News: Receives multiple APC contracts totaling $6.9M SUMR 6.47% – News: Names new member to board of directors CRME 5.60% – News: Presents new data regarding BRINAVESS at European Society of Cardiology Congress 2017 EVLV 5.21% – News: Agrees to sell WWDP for $13.5M ICAD 3.91% – News: Obtains approval of Xoft Axxent balloon applicators from the…

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WednesdayAug 30, 2017 1:14 pm

NetworkNewsBreaks – SeeThruEquity Updates Coverage, Increase PT on FTE Networks, Inc. (FTNW)

SeeThruEquity has updated its coverage and increased its price target to $3.20 on shares of FTE Networks, Inc.’s (OTCQX: FTNW) stock following the company’s recent report of financial results for the second quarter of 2017. FTE completed the acquisition of Benchmark Builders, Inc. in April, which contributed to its reported revenues of $50.2 million for the second quarter, a massive increase compared to $3.2 million for the same period of 2016. In addition to contributing to revenues, the company’s acquisition of Benchmark also expands its service capabilities and almost doubles its sales backlog. For more information, visit www.ftenet.com About FTE…

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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 11:49 am

NetworkNewsBreaks – Top 10 Mid-day Percentage Gainers on August 29, 2017

Here is a list of stocks shaking up the markets today, with particular focus on NASDAQ and OTC small caps. The top gainers based on percentage: ALPE 8.57% – News: Enters joint research program with Mercedes-Benz Research, Development North America and Princeton University OESX 8.14% – News: Receives award notifications from two long-standing automotive customers WNDW 7.12% – News: Enters agreement with Triview Glass Industries, LLC for the fabrication of SolarWindow™ products MICT 5.88% – News: Enertec Systems 2001 subsidiary receives a $650,000 purchase order EARK 4.92% – News: Issues details regarding its open house on September 27 WRIT 4.76%…

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TuesdayAug 29, 2017 11:47 am

NetworkNewsBreaks – SeeThruEquity Initiates Coverage on Nexeon MedSystems, Inc. (NXNN)

SeeThruEquity has initiated coverage and a price target of $2.40 on shares of Nexeon MedSystems, Inc.’s (OTCQB: NXNN) stock. The analyst noted that there are several potential upcoming catalysts for Nexeon, such as the company’s capital raise in the form of issuing a $3 million private placement with price protection and 50% warrant coverage. Additionally, the company plans to commence commercial activities in the second quarter of 2018 for its lead product, NNS, a neurostimulation and recording platform for deep brain stimulation (DBS) that has previously received a CE Mark. The development stage medical device company believes NNS has the…

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