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$ATPT, BERKSHIRE AGENT Member Level Monday, 10/23/17 10:45:20 AM
Re: Mean Weimaraner post# 9491
Post # of 9509
INSIDER OWNERSHIP by CEO (1.7BIL (57.1%)) is huge + $80K INVESTED= HUGE DEAL COMING $$$$$$$$$$$
Good morning Curly and $ABVG, Great things happening here!
NEWS (close watch, $EVOK 3.44 0.00 0.00 65,808 4.22 4.26
Evoke Pharma Announces Positive Topline Results from Comparative Exposure Pharmacokinetic Study for Gimoti(TM)
28 minutes ago - DJNF
Evoke Pharma Announces Positive Topline Results from Comparative Exposure Pharmacokinetic Study for Gimoti(TM)
505(b)(2) NDA on track for FDA submission in Q1 2018
SOLANA BEACH, Calif., Oct. 23, 2017 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced positive topline results from the Company's comparative exposure pharmacokinetic (PK) study. The trial was designed to demonstrate that a proposed dose of Gimoti, the Company's patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis, has similar systemic exposure to that of the referenced listed drug (RLD), Reglan Tablets. Based on the results, the Company will submit a 505(b)(2) New Drug Application (NDA) with a selected Gimoti dose to the U.S. Food and Drug Administration (FDA) in the first quarter of 2018.
The PK study was an open label, 4-way crossover and enrolled 108 male and female healthy volunteers who were each to receive one Reglan Tablet dose and three different doses of Gimoti in a random sequence. Following discussions at pre-NDA meetings with FDA, Evoke planned to select a Gimoti dose based on criteria that includes a 90% confidence interval for the ratio of area under the plasma concentration curve (AUC) falling within the bioequivalence range of 80-125% of the RLD. Two of the three doses tested met the selection criteria. The maximum observed plasma concentration (C(max) ) for Gimoti was slightly lower than the bioequivalence range, which had been previously discussed with FDA as a likely outcome given the different route of administration and prior Gimoti PK study results. Additionally, data showed the AUC and C(max) increased in a dose related manner across all three strengths tested. Relative to safety, all Gimoti doses were well--tolerated with no clinically significant adverse events reported following any of the doses.
"We are very pleased this study has met our objective of demonstrating bioequivalence on the measure of AUC to identify a Gimoti dose," said Dave Gonyer, Evoke Pharma's CEO. Mr. Gonyer continued, "In the first quarter of 2018, we will submit the NDA with these PK data, as well as safety and efficacy data from five prior Evoke clinical studies in healthy volunteers and patients with diabetic gastroparesis. We believe Gimoti has the potential to become the new standard of care for patients suffering from this debilitating disease and we look forward to providing further updates regarding the NDA as we move quickly toward submission."
About Gimoti
Gimoti has been in development for over a decade to provide a non-oral, outpatient alternative to treat the symptoms of gastroparesis in patients. Non-oral treatment is optimal as gastroparesis, also known as gastric stasis, results in erratic absorption of oral medications. Metoclopramide, the active ingredient in Gimoti, has been approved as a tablet and an injection to treat gastroparesis in the US since 1980. Approximately 4 million prescriptions of oral metoclopramide are written per year in the US.
Evoke has conducted a number of clinical trials that will be submitted with data from the comparative exposure pharmacokinetic trial. These include a Phase 1 PK bioavailability study, a Phase 1 thorough ECG cardiac safety trial, a Phase 2b efficacy and safety trial, a Phase 3 efficacy and safety trial in women and a companion efficacy and safety trial in men.
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing Gimoti, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. Gimoti is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through nasal administration. Visit www.EvokePharma.com for more information.
Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate, " "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negatives of these terms or other similar expressions. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: Evoke's beliefs about the study data, including that the objective of the PK study has been met on the measure of AUC and that the topline results demonstrate comparable bioequivalence between the oral Reglan Tablets and Gimoti's nasal delivery; beliefs that the AUC measurement is the most clinically relevant PK parameter for this study; the timing of the submission of the NDA to the FDA; Evoke's expectation that the PK trial will be the final clinical trial for Gimoti prior to NDA submission; Evoke's believe that Gimoti may become the new standard of care for patients suffering from gastroparesis; and Evoke's belief that there is a large unmet need for an effective treatment for diabetic gastroparesis. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke's business, including, without limitation: the topline data Evoke has reported from the PK study is based on preliminary analysis of key data, and such data may change following a more comprehensive review of the data related to the PK study and such topline data may not accurately reflect the complete results of the study, and the FDA may not agree with Evoke's interpretation of such results, including risks associated with C(max) falling below the bioequivalence range; later developments with the FDA that may be inconsistent with the already completed pre-NDA meetings, including inconsistent conclusions reflected in the official meeting minutes from the FDA; risks that the FDA may require additional efficacy or safety studies prior to submission or approval of the NDA; the inherent risks of clinical development of Gimoti; Evoke is entirely dependent on the success of Gimoti, and Evoke cannot be certain that it will be able to submit an NDA for Gimoti or obtain regulatory approval for or successfully commercialize Gimoti; Evoke's dependence on third parties for the manufacture of Gimoti as well as the submission of the NDA; Evoke may require additional funding to submit the NDA and conduct any additionally required studies, and will require substantial additional funding to commercialize Gimoti, and may be unable to raise capital when needed, including to fund ongoing operations; and other risks detailed in Evoke's prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor Contact:
The Ruth Group
Tram Bui
Tel: 646-536-7035
tbui@theruthgroup.com
(END) Dow Jones Newswires
October 23, 2017 07:30 ET (11:30 GMT)
$ATPT,
CHIEFS-TECH-ANALYSIS Member Level Thursday, 10/19/17 06:38:39 PM
Re: zsweet1 post# 9171
Post # of 9223
ATPT, BYOC, and CWIR Chart Comparison]>>>>>
ATPT DAILY CHART>>>https://www.barchart.com/stocks/quotes/ATPT/interactive-chart
BYOC DAILY CHART>>>https://www.barchart.com/stocks/quotes/BYOC/interactive-chart
CWIR DAILY CHART>>>>https://www.barchart.com/stocks/quotes/CWIR/interactive-chart
All 3 of these charts are an absolute thing of a beauty! I included a few indicators with each chart. The 4 indicators in order are the accumulation/dist line, ADX (14), Momentum, and Volume.
The 1 thing I want viewers to get out of comparing these 3 charts is how much more EXPLOSIVE the ATPT Chart is compared to the BYOC and CWIR Chart. Look at the MONSTER Candles ATPT is posting daily. We are all here to make money and I am telling you this chart is building itself to make much quicker gains than BYOC and CWIR. If you like to make quick money in what seems like a solid play to go long on it does not get better than ATPT! Every seller has been a chaser here.
The 24 filings posted in 4 days is a huge reason for this explosiveness. Most Companies have trouble getting 1 filing completed not to mention 24 filings audited by a CPA with 18 years of experience and his image/reputation on the line. These filings are FULLY AUDITED and REPORTED through the SEC folks! To me this feels like a safe buy and hold with everything we know imho!!
ATPT!!!
I know, I'm getting really excited also. lol
Go $ATPT
Its ATPT GM26
I bought a summer cottage (really cheap) in RI, we just got back.
Love it up there. Trying to get a winter place in florida!
Hey how you been? Hope all is well!
$STAF,
Staffing 360 Solutions Pre-Announces Third Quarter 2017 Results
6 hours 49 minutes ago - DJNF
Staffing 360 Solutions Pre-Announces Third Quarter 2017 Results
Forecasted Highlights:
-- Revenue growth of 9% to $50 million
-- Gross Profit growth of 11% to over $9 million
-- Gross Margin strengthened to 18%
-- Adjusted EBITDA growth of 25% to $2 million
-- Net Loss, after $5.6 million of non-cash and acquisition related charges,
of $5.3 million
-- Recent acquisitions included for only a few weeks in fiscal third quarter
NEW YORK, Oct. 19, 2017 (GLOBE NEWSWIRE) -- Staffing 360 Solutions, Inc. (Nasdaq:STAF), a public company executing an international buy-and-build strategy through the acquisition of staffing organizations in the United States and in the United Kingdom, today pre-announced its unaudited financial results for the fiscal third quarter ended September 30, 2017.
Subject to the completion of the review of Staffing 360 Solutions' full financial statements and filing with the Securities and Exchange Commission, the results for its fiscal third quarter 2017 are expected to be as follows:
-- Revenue of $50 million, an approximately 9% increase from $46 million in
the 2016 third quarter, including $6 million from acquisitions. On a
sequential quarterly basis, revenue is expected to improve by $8 million,
or over 18% compared to the fiscal second quarter of 2017. For the nine
months ended September 2017, revenue is expected to decrease by $2.2
million, including $1.8 million attributable to unfavorable foreign
currency translation and the acquisition revenue discussed above, to $133
million from $135 million for the comparable period in fiscal 2016;
-- Gross profit of over $9 million, an 11% increase over $8.4 million in the
fiscal third quarter of 2016. On a sequential basis, gross profit is
expected to improve by $1 million, or 18% compared to the fiscal second
quarter of 2017. For the nine months ended September 2017, gross profit
is expected to increase by over 3% from $23.6 million to $24.5 million
for the comparable period in fiscal 2016;
-- Gross margins continued to remain strong, increasing from 18.3% in the
prior year third quarter to 18.5% in the third quarter of fiscal 2017.
For the nine months ended September 2017, the gross margin is expected to
be 18.5%, an improvement from 17.4% for the comparable period in fiscal
2016;
-- The two acquisitions completed in September, CBS Butler Holdings Limited
in the U.K. and firstPRO Georgia in the U.S. are included in these
results for only a few weeks. The full impact of these acquisitions will
be reflected in the fiscal fourth quarter of 2017;
-- Including $5.6 million of non-cash charges, (relating to the refinancing
of the balance sheet as well as depreciation and amortization of
intangible assets, and approximately $0.9 million of acquisition-related
and other non-recurring expenses) the net loss attributable to common
stock is expected to be approximately $5.3 million for the fiscal third
quarter of 2017 compared to $0.9 million for the comparable period in
fiscal 2016. For the nine months the net loss attributable to common
stock is expected to be approximately $9.4 million, including $10.8
million of non-cash charges (relating to the refinancing, depreciation
and amortization of intangible assets, and $1.2 million of
acquisition-related and other non-recurring expenses) against
approximately $6.3 million for the comparable period in fiscal 2016;
-- Adjusted EBITDA is expected to be $2 million, a 25% increase over $1.7
million in the fiscal third quarter of 2016. For the nine months Adjusted
EBITDA, is expected to be $5.8 million, an increase of 7% over $5.4
million for the comparable period in fiscal 2016.
"The third quarter was a transformational period in the history of Staffing 360 Solutions," stated Brendan Flood, Executive Chairman of Staffing 360 Solutions. "We completed two acquisitions bringing our annualized revenues to $265 million and materially refinanced our balance sheet, improving our working capital position and ability to generate positive operating cash flow. More importantly, our trailing twelve months' pro-forma Adjusted EBITDA is now $11 million, up from $5.4 million in the comparable trailing twelve months of 2016."
Mr. Flood continued, "Looking forward, we are now positioned to see further growth as we utilize operating cash flow for investment in people and services in 2018 and beyond."
The Company expects to file its full results for the fiscal first quarter ended September 30, 2017 on Form 10-Q before the SEC filing deadline in mid-November and will host an earnings conference call around the same time to discuss the results.
For more information about Staffing 360 Solutions and complete investor materials such as investor presentations, white papers and webcasts of past earnings calls, please visit: www.staffing360solutions.com/res.html.
About Staffing 360 Solutions, Inc.
Staffing 360 Solutions, Inc. (Nasdaq:STAF) is a public company in the staffing sector engaged in the execution of an international buy-and-build strategy through the acquisition of domestic and international staffing organizations in the United States and in the United Kingdom. The Company believes that the staffing industry offers opportunities for accretive acquisitions that will drive its annual revenues to $500 million. As part of its targeted consolidation model, the Company is pursuing acquisition targets in the finance and accounting, administrative, engineering, IT, and Light Industrial staffing space. For more information, please visit: www.staffing360solutions.com.
Follow Staffing 360 Solutions on Facebook, LinkedIn and Twitter.
Non-GAAP Financial Measures
The Company uses financial measures which are not calculated and presented in accordance with US generally accepted accounting principles ("GAAP") in evaluating its financial and operational decision making regarding potential acquisitions, as well as a means to evaluate period-to period comparison. The Company presents these non-GAAP financial measures because it believes them to be an important supplemental measure of performance that is commonly used by securities analysts, investors and other interested parties in the evaluation of companies in our industry. We refer you to the reconciliations below.
The Company defines Adjusted EBITDA as earnings (or loss) from continuing operations before interest expense, income taxes, depreciation and amortization, and amortization of non-cash stock-based compensation, non-recurring acquisition and restructuring expenses and goodwill impairment charges.
Forward-Looking Statements
This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate," "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although Staffing 360 Solutions, Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein, including the goal of achieving annualized revenues of $500 million, due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, to consummate additional acquisitions, to successfully integrate newly acquired companies, to organically grow its business, to successfully defend potential future litigation, changes in local or national economic conditions, the ability to comply with contractual covenants, including in respect of its debt, as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. Staffing 360 Solutions does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.
Corporate Investor Contact:
Staffing 360 Solutions, Inc.
Brendan Flood, Executive Chairman
+1.646.507.5715
brendan.flood@staffing360solutions.com
Financial Contact:
Staffing 360 Solutions, Inc.
David Faiman, Chief Financial Officer
+1.646.507.5711
info@staffing360solutions.com
Staffing 360 Solutions, Inc. and Subsidiaries
Reconciliation of Net Loss Attributable to Common
Stock
to Adjusted EBITDA
(All Amounts in Millions)
For the For the
Period For the Period For the Period Period
July 2, 2017 July 3, 2016 January 1, January 3,
to to 2017 to 2016 to
September 30, October 1, September 30, October 1,
2017 2016 2017 2016
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Net Loss
Attributable to
Common Stock $ (5.3) $ (0.9) $ (9.4) $ (6.3)
Adjustments:
-------------------
Interest
Expense $ 0.7 $ 0.6 $ 1.8 $ 2.0
Provision for
Income Taxes 0.1 (0.5) 0.1 0.1
Depreciation
and
Amortization 2.0 1.3 4.8 3.9
EBITDA (2.5) 0.5 (2.7) (0.3)
Acquisition,
Capital
Raising and
Other
Non-Recurring
Expenses 0.9 0.9 1.2 3.6
Other Non-Cash
(MORE TO FOLLOW) Dow Jones Newswires
October 19, 2017 02:38 ET (06:38 GMT)
Staffing 360 Solutions Pre-Announces Third -2-
Charges 0.7 0.2 1.7 0.8
Debt
Extinguishment
Costs 2.8 - 4.2 -
Dividends --
Series A
Preferred
Stock 0.1 0.1 0.2 0.2
Other Income /
(Expense) - - - (0.5)
Adjusted EBITDA $ 2.0 $ 1.7 $ 4.6 $ 3.8
Trailing Twelve
Months (TTM)
Adjusted EBITDA $ 5.8 $ 5.4 $ 5.8 $ 5.4
Pro Forma Trailing
TTM Adjusted
EBITDA $ 11.0 $ 5.4 $ 11.0 $ 5.4
(END) Dow Jones Newswires
October 19, 2017 02:38 ET (06:38 GMT)
Check out $ATPT, I bought @ .0009 its @ .0015
I think this is the real deal. Over 23 filings the other day!
$MGTI 2.195 0.00 0.00 0 2.19 2.21
Monday reported,
Value of Cryptocurrencies Break Into Record Territories
2 days 23 hours 47 minutes ago - DJNF
FinancialBuzz.com News Commentary
NEW YORK, October 16, 2017 /PRNewswire/ --
Bitcoin continued its rally on Friday and hitting yet another all-time high. During last Friday's morning trading session, the price of the digital currency rose above $5,800 for the first time ever according to data from CoinDesk. Increasing investor's interest in the cryptocurrency market attributed to the surge in bitcoin price. The price of bitcoin jumped about 30 percent last week and has gained 480 percent year-to-date. Recent fear on a crackdown in digital currency trading in China sent the bitcoin price to fall sharply in mid-September. However, the price of bitcoin has bounced back quickly as other Asian countries such as Japan and South Korea showed support in cryptocurrencies trading. Chineseinvestors.com, Inc. (OTC: CIIX), Digatrade Financial Corp. (OTC: DIGAF), Global Arena Holding Inc. (OTC: GAHC), MGT Capital Investments, Inc. (OTC: MGTI), Riot Blockchain Inc. (NASDAQ: BIOP).
The cryptocurrency market is experiencing rapid growth this year. According to data from CoinMarketCap, the total market capitalization for all cryptocurrencies reached $174 billion. Bitcoin has a market value of $95 billion, accounting for over 54 percent of the total market. Other cryptocurrencies have also been trading higher this year. Ethereum, the second largest cryptocurrency by market cap, jumped 12.22 percent to $341.51 during last Friday's trading session. Ethereum has gained nearly 3900 percent this year.
Chineseinvestors.com, Inc. (OTCQB: CIIX) announced on October 11th announced that "the Company has launched the first cryptocurrency daily video newscast in the Chinese language, entitled Bitcoin Multimillionaire, broadcast from the NYSE. The video newscast covers timely information and analysis regarding all aspects of the emerging digital currency world, including specific cryptocurrencies, such as Bitcoin and Ethereum, industry trends, price movement, blockchain technology, and sector-related stocks and ETFs listed on major exchanges and the OTC market."
"Many Chinese investors are seeking information and education related to the cryptocurrency sector," says Warren Wang, Founder and CEO of CIIX. "Moreover, in response to the growing popularity of cryptocurrencies and ICOs, governments around the world, including but not limited to, the United States, China, Japan, South Korea and Switzerland are weighing in and/or enacting regulatory policies regarding cryptocurrencies and ICOs. In the United States, Goldman Sachs Group Inc. recently announced that it is considering a new trading operation dedicated to bitcoin and other digital currencies."
In addition, CIIX also has plans to launch a new cryptocurrency website under the domain name newcoin168.com to serve Chinese cryptocurrency investors. The site, expected to launch next month, will endeavor to be a leader in digital media and cryptocurrency and blockchain technology education providing straightforward explanations of cryptocurrency basics, trading guidelines, real-time market commentary and analysis regarding currency mining, blockchain technology, industry hotspots, sector-related stock trends and ETFs, and other strategies and opportunities to capitalize on the bitcoin market.
"After the recent launch of our Bitcoin Multimillionaire daily video newscast, the Company has decided to further expand its presence in the digital currency sector," says Wang. "Similar to U.S. stocks, as the price of digital currency, such as Bitcoin, continues to increase, Chinese people all over the world are taking notice and seeking access to timely information regarding market trends, news, and analysis. We look forward to being the premier source for this information."
Digatrade Financial Corp. (OTCQB: DIGAF) is a digital asset exchange, blockchain development and fintech advisory services company. On September 28, 2017, the company announced the execution of a Letter of Intent "LOI" for its Initial Coin Offering "ICO" with No Limits Consulting Limited based in Hong Kong. As previously announced Digatrade is currently integrating the Ethereum Coin "ETH" onto the Digatrade platform to enable Digatrade customers and shareholders first access to register for the token release. Interested subscribers for the ICO would be able to purchase ETH paired with BTC and subsequently subscribe for the Digafund (ERC20) token on an already established, safe and secure trading platform. Brad Moynes, CEO of Digatrade stated, "We are very pleased to have executed a digital corporate finance LOI agreement with the ANX group who recently completed the OpenANX token release with total token sales equivalent to US$18.5m".
Global Arena Holding Inc. (OTC: GAHC) is a holding and technology development company. The company focused on acquiring technologies, patents and companies having the ability to leverage the blockchain crypto technology. On August 17, 2017, the company announced that after months of development and testing, the Company's subsidiary, Global Election Services, Inc., is proud to announce the implementation of new proprietary software and hardware to utilize in ballot scanning during the tabulation process.
MGT Capital Investments, Inc. (OTCQB: MGTI) ranks as one of the largest U.S. based Bitcoin miners. Further, the Company continues to focus on an expansion model to grow its crypto assets materially. Recently, the company announced that it has executed a new purchase order with Bitmain Technologies for an additional 2,000 S9 Antminer mining rigs, with shipment expected by the end of fourth quarter 2017. Funds for the large order were provided by institutional investors though agreements whereby MGT will manage the mining operations and receive a management fee as well as a share of the profits. This financial arrangement creates downside protection for the Company while still providing strong economic upside leverage. Stephen Schaeffer, President of MGT Crypto-Capital Strategies, stated, "We believe having a mix of fully-owned and investor-owned mining rigs will allow us to appreciably expand our crypto currency footprint with less equity dilution. We plan to shortly update the investment community and shareholders with further details."
Riot Blockchain Inc. (NASDAQ: BIOP) leverages its expertise and network to build and support blockchain technology companies. Recently, the company announced it has made a strategic investment in Coinsquare Ltd., one of Canada's leading exchanges for trading digital currencies. This investment into a blockchain-focused company is indicative of similar opportunities Riot Blockchain plans to pursue, including possible acquisitions of businesses serving the blockchain ecosystem. "At Riot Blockchain, our team has the insight and network to effectively grow and develop blockchain assets," said Michael Beeghley, Chief Executive Officer of Riot Blockchain.
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(MORE TO FOLLOW) Dow Jones Newswires
October 16, 2017 09:00 ET (13:00 GMT)
Value of Cryptocurrencies Break Into Record -2-
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(END) Dow Jones Newswires
October 16, 2017 09:00 ET (13:00 GMT)
$PVCT news,
Provectus News
Provectus Announces Preliminary Results from Phase 1B Trial of Intralesional PV-10 in Combination with KEYTRUDA® (Pembrolizumab) for the Treatment of Stage IV Melanoma
- Adverse events consistent with established patterns for each drug; no unexpected toxicities observed
- 50% overall objective response rate; 10% complete response; highest responses observed in M1c patients; assessment via RECIST 1.1
Wednesday October 18, 2017
KNOXVILLE, TN., /GlobeNewswire/ -- Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com), ("Provectus" or the "Company"), a clinical-stage biotechnology company leading the development of the first small molecule oncolytic immunotherapy, intralesional ("IL") PV-10, as a single agent for locally advanced disease as well as in combination with another agent for widely metastatic disease, both for multiple cancer indications, today announced that results from the Company's ongoing Phase 1b/2 study of IL PV-10 in combination with KEYTRUDA® (pembrolizumab), Merck's systemic anti-PD-1 (programmed death receptor-1) antibody agent, were presented at the Society for Melanoma Research 2017 Congress, held in Brisbane, Australia from October 18-21. IL injection of PV-10 induces immunogenic cell death that results in tumor-specific reactivity in circulating CD8+ T cells.
The Phase 1b portion of the study continues to enroll patients with metastatic melanoma at clinical sites in the U.S. and Australia (NCT02557321); Stage IV patients with at least one injectable lesion who are candidates for KEYTRUDA are eligible. A total of up to 24 patients would receive the combination of IL PV-10 and KEYTRUDA every three weeks for five cycles (i.e., for up to 12 weeks, with no further PV-10 administered after week 12), followed by only KEYTRUDA every three weeks for up to 24 months. The primary endpoint for the Phase 1b trial is safety and tolerability; objective response rate and progression-free survival are key secondary endpoints (both assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter).
IL PV-10 Results from the Phase 1b Trial Presented at SMR:
Baseline characteristics (safety population, N=12): 92% men; median age of 71.5 years (range 28-81), 67% > 65 years; 67% Stage IV M1b/c.
Subject characteristics (safety population): 2.5 median number of cutaneous/subcutaneous lesions (range 1-40); patients had substantial non-injected systemic disease burden in addition to their injectable cutaneous and/or subcutaneous lesions; patients received a median of 5 cycles of PV-10 (mean 3.8, range 1-5); PV-10 was not administered after week 12.
Preliminary safety (safety population): adverse events were consistent with the established patterns for each drug; there were no unexpected toxicities or evidence of compounded toxicity.
Preliminary target lesion efficacy (efficacy evaluable population, N=10): 50% complete response; 80% objective response; maximum response.
Preliminary overall efficacy (efficacy evaluable population): 10% complete response; 50% objective response; 60% clinical benefit; highest responses observed in M1c patients; per RECIST 1.1.
Dominic Rodrigues, Chairman of the Company's Board of Directors, said, "These preliminary results highlight the safety characteristics of the combination of intralesional PV-10 and checkpoint inhibition. The data confirm an almost complete absence of correlation of adverse events between the two drugs, which we refer to as ‘orthogonality.' This outcome is very different from when oncolytic viruses or other biologics are used in combination with checkpoint inhibitors."
Mr. Rodrigues added, "There also was promising clinical benefit after minimal PV-10 intervention, especially in those patients with Stage IV M1c disease. These data support the advancement of the combination of PV-10 and checkpoint inhibition in the clinical study of metastatic melanoma."
A copy of the poster presentation is currently available on Provectus' website at http://provectusbio.com/media/docs/publications/SMR-2017-Poster-P15-1_18-Oct-2017.pdf.
The complete press release is available at http://www.provectusbio.com/news/press-releases/provectus-pr-20171018-1 on the Provectus website
Possible dip & rip, $OPTT 2.00 0.00 0.00 135,451 1.40 1.41
On News, $ONCS 1.80 0.52 +40.62 478,451 1.48 1.50
OncoSec Presents Positive Phase 2 Data for ImmunoPulse(R) IL-12 in Combination with Pembrolizumab Demonstrating a Best Overall Response Rate (BORR) of 50% in Predicted Anti-PD-1 Non-Responder Melanoma Patients
1 hour 51 minutes ago - DJNF
Data from Recently Completed Phase 2 Monotherapy and Combination Therapy Studies Presented at the 2017 9th World Congress of Melanoma - A Joint Meeting with the Society for Melanoma Research
SAN DIEGO, Oct. 19, 2017 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec" or "Company") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced updated Phase 2 clinical and immune monitoring data from patients treated with its investigational therapy, ImmunoPulse(R) IL-12 as a monotherapy versus the combination of ImmunoPulse IL-12 and the approved anti-PD-1 therapy pembrolizumab. These data were presented today in an oral presentation at the 2017 9th World Congress of Melanoma -- A Joint Meeting with the Society for Melanoma Research, and continue to support the rationale for the Company's recently initiated global, open-label, Phase 2b registration directed trial, PISCES/KEYNOTE-695.
The Phase 2 OMS-I100 monotherapy and Phase 2 OMS-I102 combination with pembrolizumab studies included 51 and 22(*) patients, respectively, with metastatic melanoma. The combination study patients were selected based on their baseline biomarker data, which predicted that patients would not respond to anti-PD-1 therapy. Monotherapy patients were treated with ImmunoPulse IL-12 alone and patients in the combination study also received pembrolizumab every 3 weeks per protocol. Fewer than 10% of patients in both studies reported treatment related serious adverse events (9.8% in the monotherapy and 8.7% in the combination studies). Data also demonstrate that ImmunoPulse IL-12 can trigger key immunologic events driving a cellular response leading to an inflamed tumor with increased TIL frequency whether as a monotherapy or combined with pembrolizumab, converting "cold" tumors to "hot", which were further enhanced with the addition of an anti-PD1 antibody.
*Includes one CR with non-evaluable RECIST lesions
Key Findings
OMS-I102 Combination with Pembrolizumab
50% (11/22) BORR observed at 24 weeks (42.9% [9/21] achieved RECIST v1.1 BORR).
41% (9/22) complete responders (CR), 9% (2/22) partial responders (PR), and 9% (2/22) stable disease (SD) for a total disease control rate of 59% (38.1% [8/21] achieved RECIST v1.1 durable CR).
Data demonstrate that the combination of ImmunoPulse IL-12 and pembrolizumab prime a coordinated innate and adaptive immune response, suggesting a synergistic relationship with anti-PD-1.
OMS-I100 Monotherapy
25-34.6% best overall response rate (BORR) by a modified "skin" RECIST.
Favorable safety profile (no life threatening or grade 4 AE).
In patients (n=26) treated with ImmunoPulse IL-12 on a 90-day cycle, there were 19.2% (5/26) complete responders (CR), 15.4% (4/26) partial responders (PR), and 34.6% (9/26) stable disease (SD) for a total disease control rate of 69.2%.
In the protocol addendum where patients (n=20) were treated with ImmunoPulse IL-12 on a 6-week cycle, there were 0 complete responders (CR), 25% (5/20) partial responders (PR), and 40% (8/20) stable disease (SD) for a total disease control rate of 65%.
"We are encouraged by the data from these analyses, which continue to show that ImmunoPulse IL-12 can prime the immune system to help improve patient response to anti-PD-1," said Dr. Alain Algazi, Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center. "The complete response rates observed in the Phase 2 study assessing the combination of ImmunoPulse IL-12 and pembrolizumab in the predicted anti-PD-1 non-responder patient population provide compelling early evidence that the combination could lead to a clinically meaningful impact on patient outcomes."
"Collectively, these study findings reinforce the combination of ImmunoPulse IL-12 and pembrolizumab to address a significant unmet medical need in melanoma patients who are unlikely to respond to anti-PD-1 therapies," said Punit Dhillon, CEO and President of OncoSec. "We look forward to presenting additional data from our ongoing Phase 2 combination study at the upcoming 2017 Society for Immunotherapy of Cancer Annual Meeting, in addition to our global, open-label, registration directed phase 2b clinical trial, PISCES/KEYNOTE-695, which we anticipate reporting initial data in mid-2018."
The full-text abstract is available and can be viewed on the World Melanoma Congress -- Joint Meeting with the Society of Melanoma Research website at https://worldmelanoma2017.com/. The presentation is available in the Publications section of OncoSec's website.
About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)
PISCES is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse(R), for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12 (tavokinogene telseplasmid [pIL-12] or "tavo"). In Phase 1 and 2 clinical trials, ImmunoPulse(R) IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec's lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program's current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements about OncoSec's business strategies, including advancement of its lead melanoma program and its broader clinical portfolio and plans to pursue collaborations with industry partners, as well as the potential contributions and impact of new directors on these strategies. Forward-looking statements can be identified by words such as "can," "may," "will," "suggest," "look forward to," "potential," "understand," and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management's current preliminary expectations and are subject to risks and uncertainties, which may cause OncoSec's results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the substantial time, costs and unpredictability of such studies and trials, the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; OncoSec's ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec's filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended April 30, 2017.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
CONTACT:
Investor Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
investors@oncosec.com
Media Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
media@oncosec.com
View original content with multimedia:http://www.prnewswire.com/news-releases/oncosec-presents-positive-phase-2-data-for-immunopulse-il-12-in-combination-with-pembrolizumab-demonstrating-a-best-overall-response-rate-borr-of-50-in-predicted-anti-pd-1-non-responder-melanoma-patients-300539506.html
SOURCE OncoSec Medical Incorporated
/Web site: http://www.oncosec.com
(END) Dow Jones Newswires
October 19, 2017 06:00 ET (10:00 GMT)
Thanks buddy, Will be fine. Go $ABVG!
Don't chase any,On no news. We will find more $$$
Yep, Thanks Berk
On news, $TROV 0.79 0.00 0.00 235,545 0.89 0.90
Trovagene's PLK1 Inhibitor (PCM-075) Demonstrates Synergy with Zytiga(R) (abiraterone acetate) in Castration Resistant Prostate Cancer Tumor Cells
44 minutes ago - DJNF
PCM-075 enhances activity of abiraterone in mCRPC tumors cells and may represent a novel treatment option to extend the benefit of anti-androgen therapy
SAN DIEGO, Oct. 18, 2017 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, today announced positive data from preclinical research demonstrating synergy of PCM-075, its oral, highly-selective Polo-like Kinase 1 (PLK1) Inhibitor, in combination with abiraterone (Zytiga(R) - Johnson & Johnson). Abiraterone is a potent and irreversible inhibitor of CYP17, a critical enzyme in androgen biosynthesis and is indicated for the treatment of mCRPC in combination with prednisone. This research was performed in collaboration with a major cancer research institution.
"The synergy observed when we combined PCM-075 with abiraterone appears to work through a novel mechanism that may modulate a signaling pathway previously unknown to be associated with this combination," said Dr. Mark Erlander, Chief Scientific Officer of Trovagene. "This unique combination appears to enhance the PCM-075 mechanism of action of arresting cells during mitosis with subsequent tumor cell death."
Metastatic Prostate Cancer is the third leading cause of cancer death in men. Approximately 25,000 men progress to metastatic Castration-Resistant Prostate Cancer (mCRPC) annually and receive anti-androgen therapy with a mean progression-free survival of less than two years. Abiraterone is the leading global anti-androgen therapy, marketed by Centocor Ortho Biotech, Inc., a member of the Johnson & Johnson family of companies, with 2016 sales in excess of $2.0 billion. Even with the broad adoption of abiraterone there continues to be a large medical need to extend the benefit of response to abiraterone in mCRPC.
"We are encouraged by the preclinical data of PCM-075 in mCRPC," said Bill Welch, Chief Executive Officer of Trovagene. "We previously completed a Phase 1 trial in metastatic solid tumor cancers, which provided a recommended Phase 2 dose and dosing schedule for PCM-075 in a combination regimen. We are working closely with key investigators to develop a Phase 2 clinical trial protocol with oral dosing of PCM-075 and abiraterone utilizing our existing solid tumor IND."
About PCM-075
PCM-075 is a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple hematologic and solid tumor cancers. Studies have shown that inhibition of polo-like-kinases can lead to tumor cell death, including a Phase 2 study in Acute Myeloid Leukemia (AML) where response rates up to 31% were observed when used in conjunction with a standard therapy for AML (low-dose cytarabine-LDAC) versus treatment with LDAC alone with a 13.3% response rate. A Phase 1 open-label, dose escalation safety study of PCM-075 has been completed in patients with advanced metastatic solid tumor cancers, and published in Investigational New Drugs. Trovagene is initiating a Phase 1b/2 clinical trial with PCM-075 in AML that was accepted by the National Library of Medicine (NLM) and is now publicly viewable on www.clinicaltrials.gov. The NCT number assigned by clinicaltrials.gov for this study is NCT03303339. PCM-075 has been granted Orphan Drug Designation by the FDA for the treatment of patients with AML.
PCM-075 only targets PLK1 isoform (not PLK2 or PLK3), is oral, has a 24-hour drug half-life with reversible on-target hematologic toxicities. Trovagene believes that targeting only PLK1 with reversible on-target activity and an improved dose/scheduling protocol can significantly improve on the long-term outcome observed in previous studies with a PLK inhibitor in AML.
PCM-075 has demonstrated synergy in preclinical studies with over 10 chemotherapeutic and target agents used in hematologic and solid tumor cancers, including FLT3 and HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the combination of its targeted PLK-1 inhibitor, PCM-075, with other compounds has the potential for improved clinical efficacy in Acute Myeloid Leukemia (AML), Castration-Resistant Prostate Cancer (CRPC), Non-Hodgkin Lymphoma (NHL), Triple Negative Breast Cancer (TNBC) and Adrenocortical Carcinoma (ACC).
About Castration-Resistant Prostate Cancer (CRPC)
Castration-Resistant Prostate Cancer (CRPC) is defined by disease progression despite androgen-deprivation therapy (ADT) and may present as one or any combination of a continuous rise in serum levels of prostate-specific antigen (PSA), progression of pre-existing disease, or appearance of new metastases. Prognosis is associated with several factors, including performance status, presence of bone pain, extent of disease on bone scan, and serum levels of alkaline phosphatase. Bone metastases will occur in 90% of men with CPRC and can produce significant morbidity, including pain, pathologic fractures, spinal cord compression, and bone marrow failure. Paraneoplastic effects are also common, including anemia, weight loss, fatigue, hypercoagulability, and increased susceptibility to infection. Institution of treatment and the choice of systemic or local therapy depend on a number of factors.
About Trovagene, Inc.
Trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring(R) (PCM) technology in tumor genomics. Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies. Trovagene offers its PCM technology at its CLIA/CAP -- accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics. For more information, please visit https://www.trovagene.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Trovagene's expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene's strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Trovagene's Form 10-K for the year ended December 31, 2016, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Trovagene Contact:
Vicki Kelemen
VP, Corporate Communications
858-952-7652
vkelemen@trovagene.com
View original content with multimedia:http://www.prnewswire.com/news-releases/trovagenes-plk1-inhibitor-pcm-075-demonstrates-synergy-with-zytiga-abiraterone-acetate-in-castration-resistant-prostate-cancer-tumor-cells-300538611.html
SOURCE Trovagene, Inc.
/Web site: http://www.trovagene.com
(END) Dow Jones Newswires
October 18, 2017 08:00 ET (12:00 GMT)
Volume alert, $GFI $HMY $IAG $NG $NGD $SFUN
Nice, $NEOT 1.72 0.00 0.00 245,668 1.91 1.92
??? $OPTT 2.02 0.58 +40.28 112,408 1.89 1.92
Thanks buddy, Hope i'm finally getting back in the groove!
Two for two this week, $NEOT 1.641 1.1216 +215.94 42,238,058 1.64 1.65
The rest did me well!
$NEOT 1.33 0.8106 +156.06 22,901,964 1.32 1.33
$TRXC 4.8801 2.0701 +73.67 69,115,160 4.88 4.89
Up over 100% from yesterdays low,$TRXC 4.4035 1.5935 +56.71 47,188,351 4.40 4.41
$TRXC 3.82 1.01 +35.94 25,109,343 3.82 3.83
$TRXC 3.655 0.845 +30.07 22,060,345 3.64 3.65
$TRXC 3.44 0.63 +22.42 5,896,397 3.41 3.45
News, $NEOT 1.17 0.6506 +125.26 1,626,717 0.90 0.916
Neothetics Inc. (NEOT) filed a Form 8K - Changes in Company Control - with the U.S Securities and Exchange Commission on October 17, 2017.
The completion of the Merger will constitute a change in control of the Company. The Merger is described in Item 1.01 of this Current Report on Form 8-K, which is incorporated by reference into this Item 5.01.
The full text of this SEC filing can be retrieved at: http://www.sec.gov/Archives/edgar/data/1618835/000119312517311376/d475961d8k.htm
Any exhibits and associated documents for this SEC filing can be retrieved at: http://www.sec.gov/Archives/edgar/data/1618835/000119312517311376/0001193125-17-311376-index.htm
Public companies must file a Form 8-K, or current report, with the SEC generally within four days of any event that could materially affect a company's financial position or the value of its shares.
(END) Dow Jones Newswires
October 17, 2017 08:26 ET (12:26 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
Alerted yesterday, $TRXC 2.81 0.00 0.00 1,006,643 3.09 3.10
Price Open 2.78
Previous Close 2.81
Day High 3.05
Day Low 2.15
High today 52 degrees, Getting cooler.
Yep, 20 minutes south. Ski country.
Are you still in $ONCI ?
Thats were i live, near lake erie!
Thank you, I didn't go fishing. I'm going in the next week or two local. Steelhead and Salmon
Very relaxing time camping, It was awesome. Northern RI.
On news, $TRXC 3.00 1.54 +105.48 2,246,509 2.63 2.65
TransEnterix Shares Soar On FDA Clearance Of Robotic Surgery Device -- MarketWatch
2 days 15 hours 4 minutes ago - DJNF
TransEnterix Inc. (TRXC) shares soared in the extended session Friday after the Food and Drug Administration gave marketing clearance to the company's robotic surgery device. TransEnterix shares jumped 63% to $2.38 on after-hours volume of more than 1 million shares. Late Friday, the FDA announced it had granted marketing clearance to TransEnterix's Senhance System that gives surgeons a 3-D high-definition view of the surgical field and remote control of three robotic arms to perform procedures.
-Wallace Witkowski
For more from MarketWatch: http://www.marketwatch.com/newsviewer
(END) Dow Jones Newswires
October 13, 2017 17:06 ET (21:06 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
Nice, $ABVG going current!
Ty, Hope to do some fishing!
I'm going camping tomorrow for a week.
Can't wait!
Person marked!