XBiotech's stock plummets

XBiotech’s stock plummets premarket after poor review for cancer treatment

XBiotech Announces Outcome of EMA’s Oral Explanation Meeting

XBiotech's stock plummets

BUZ INVESTORS PRESS RELEASE XBiotech’s stock plummets   XBiotech Inc. (NASDAQ:XBIT) announced today that the European Medicines Agency (EMA) rendered a negative “trend” vote after meeting with the Company to discuss the “Day 180 List of Outstanding Issues” related to the Company’s marketing authorization application (MAA) for its candidate antibody for the treatment of colorectal cancer. A negative trend vote means it is unlikely that a positive Committee for Medicinal Products for Human Use (CHMP) opinion related to the Company’s MAA will be attained at the formal decision vote scheduled in May, and that additional steps would need to be taken to potentially gain marketing approval.

At the Oral Explanation meeting, per EMA protocol, the Company gave a 20 minute presentation and had a Q&A session with CHMP members regarding the MAA for its candidate therapy to treat advanced colorectal cancer (data presented by the Company will be filed with the SEC in a Form 8-K and will be available on the SEC’s website at www.sec.gov). The Oral Explanation format is intended to provide an opportunity for the Company to clarify data in support of marketing authorization.

The key outstanding issues are related to clinical relevance of the therapy in the indication and quality assurance related matters. The meeting, however, focused on outstanding clinical relevance issues.




XBiotech’s stock plummets

John Simard, President & CEO of the Company, stated, “We are disappointed by the outcome of the meeting. We believe that the data speak in a clear and resounding voice to clinical relevance of a new antibody therapy in advanced colorectal cancer. We believe that findings from our Phase III study show that we have developed an important endpoint and methodology to evaluate anti-cancer therapy in advanced stage disease and that our monoclonal antibody represents a breakthrough treatment in patients with advanced colorectal cancer. The EMA marketing authorization application procedure enables the appeal of negative decisions from the oral explanation. We may seek access to this process at the appropriate time.”

About True Human™ Therapeutic Antibodies

XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

About XBiotech
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com.

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Tesla Stock: Tesla’s Poor Results PROOF Investors Have Lost Their Minds

Tesla Stock: Tesla’s Poor Results PROOF Investors Have Lost Their Minds



Tesla Stock: Tesla’s Poor Results PROOF Investors Have Lost Their Minds

Tesla StockTesla Stock Needs a Correction

What else is new? Tesla Motors Inc (NASDAQ:TSLA) was trading only 0.5% lower yesterday morning, but it definitely could’ve been worse. After all, the American manufacturer of luxury electric cars continued to show losses in its second-quarter results. It also produced fewer vehicles than expected.

Tesla’s CEO, Elon Musk—who runs the car company, a solar panel company, and a space exploration company planning a mission to Mars by 2025—must be running on Tesla stock’s famous “Autopilot.” You would think that the chronic.

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To the credit of TSLA stock, revenue of $1.27 billion marked a 33% increase. However, adjusted revenue of $1.56 billion was below market expectations of $1.62 billion. Here’s the truly mindboggling number, though: Tesla reported an adjusted loss per share of $1.06. This was more than double what analysts expected (a $0.52 loss). This was also the 13th straight quarterly loss for Tesla, for those who keep track of such things. (Source: “Tesla posts another loss, but says on track for future deliveries,” Reuters, August 3, 2016.)

Battery technology is advancing rapidly and there’s no guarantee that lithium-ion (Li-ion) batteries will endure the test of time. There’s a good chance that, as many manufacturers start introducing electric cars, battery technology will evolve. For the record, Tesla didn’t invent electric cars. They’ve been around longer than internal combustion cars. Breakthroughs with aluminum-air (Al-air) batteries could blow Li-ion batteries out of the Nevada desert. (Source: “New aluminum air battery could blow past lithium-ion, runs on water,” Extremetech, January 28, 2015.)

Ultimately, though, the problem is not with electric cars at all. There’s nothing wrong with electric cars. Many car companies are introducing them and that’s actually the problem for Tesla. The established manufacturers, those that have confronted production issues when Elon Musk was in diapers, will make them more efficiently. They’re just not getting the cult-like shareholders that are flocking to Elon Musk’s company. Tesla has constantly failed to ramp up production, while it still enjoys a relative monopoly in the luxury electric car market, all because of Musk’s fan boys.

The post Tesla Stock: Tesla’s Poor Results PROOF Investors Have Lost Their Minds appeared first on Profit Confidential.

EURUSD to Stage Near Recovery on Poor NFP Report

EURUSD to Stage Near Recovery on Poor NFP Report



EURUSD to Stage Near Recovery on Poor NFP Report

EURUSD to Stage Near Recovery on Poor NFP Report

NFP Report Another 180K expansion in U.S. Non-Farm Payrolls (NFP) accompanied by a downtick in the jobless rate may boost the appeal of the greenback and trigger further losses in EURUSD as it puts pressure on the Federal Open Market Committee (FOMC) to further normalize monetary policy in 2016.

Even though Fed Funds Futures highlight a 12% probability for a September rate-hike, a further improvement in labor market dynamics may encourage central bank officials to adopt a more hawkish outlook for monetary policy as the U.S. economy approaches ‘full-employment.’ However, an unexpected slowdown in wage growth may keep the FOMC on the sidelines throughout 2016 as the central bank warns ‘market-based measures of inflation compensation remain low; most survey-based measures of longer-term inflation expectations are little changed, on balance, in recent months.’

However, U.S. firms may scale back on hiring amid slowing outputs paired with signs of a weaker-than-expected recovery, and a dismal labor report may drag on the greenback as market participants push out bets for the next Fed rate-hike.

 

Bullish USD Trade: NFP Increases 180K or More, Labor Force Participation Improves

  • Need red, five-minute candle following the NFP print to consider a short trade on EUR/USD.
  • If market reaction favors a bullish dollar trade, sell EUR/USD with two separate position.
  • Set stop at the near-by swing high/reasonable distance from entry; look for at least 1:1 risk-to-reward.
  • Move stop to entry on remaining position once initial target is hit; set reasonable limit.