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Biotechnology

INSY Target $23 FDA Cannabidiol Fast trackFDA Grants INSYS Therapeutics ‘Fast Track’ Designation for Cannabidiol (CBD) Oral Solution as INSYS Therapeutics, Inc. (NASDAQ:INSY), announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s cannabidiol (CBD) oral solution for the treatment of Prader-Willi syndrome, a rare and complex genetic disorder characterized by insatiable appetite in children that often leads to obesity and type 2 diabetes. “FDA’s Fast Track designation will enable an expedited regulatory review process for our proprietary formulation of CBD in the treatment of pediatric patients with Prader-Willi syndrome, a debilitating condition which currently does not have any approved products available,” said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics. “We plan to start the clinical development program for this promising therapy in late first quarter of 2018.” The most common known genetic cause of life-threatening obesity in children, Prader-Willi syndrome has a prevalence of approximately 1 in 15,000, according to the Prader-Willi Syndrome Association, occurring in males and females equally and in all races. “We are very encouraged by the FDA’s decision to put CBD for Prader-Willi on the Fast Track and believe it is good news for these young patients, their families and clinicians,” said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. “This special regulatory designation represents a significant milestone in the company’s R&D program, which is focused on developing and delivering safe, effective and novel treatment options using cannabinoids and novel drug delivery technology for unmet medical needs.” About INSYS INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. Forward-Looking Statements This news release contains forward-looking statements including regarding (i) our belief that FDA’s Fast Track designation will enable an expedited regulatory review process for our proprietary formulation of CBD in the treatment of pediatric patients with Prader-Willi syndrome, (ii) our belief that Prader-Willi syndrome currently does not have any approved products available and that our proprietary CBD formulation has potential to be a viable treatment option and (iii) our plan to start the clinical development program for this promising therapy in late first quarter of 2018. These forward-looking statements are based on management’s expectations and assumptions as of the date of this news release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2016 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.
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by StockPicksNYC98
ITUS stock climbs after news of new patentItus Corporation, a company that develops, aquires, and licenses emerging technologies in the areas of biotechnology, is in the stages of developing technology that can detect cancer at an earlier rate through a blood test. The company saw its stock jump by 85 percent upon releasing news of the patent issuance of the new technology, this was on Sept. 18. The biotechnology industry has grown by 7 percent in the past three months, and in an expanding economy, I would think that this industry has room to continue growing. The S&P continues to grow, gaining 4 points (it is to note that this move was on lower than average volume) at the time of writing this. 90 percent of the market saw new highs today, showing good sentiment. However, the possibility of interest rate hikes still looms over the market, as well as climbing oil prices and President Trumps proposed tax reforms. ITUS has rebounded off support at the 2.50 level and could hit a target of 5.00. It currently sits at 3.33, 51 percent from its 52-week high. Volume is increasing and RSI is showing bullish strength. I am long, having entered at 2.75. Risk is controlled to 3 percent of my account, should the trade go the other way. With earnings coming out, a good report could send the stock up to its target very quickly. There is still a chance to jump in at 3.50 or better.
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by Brandon50115
CELGENE PULLBACK PROVIDES A GREAT LONG OPPORTUNITYCelgene is one of my top picks in the biotech sector, it is fundamentally strong, and the chart is providing a great potential breakout picture. I have entered half of my position around 127.50$ and looking to add around 123$ with a hard stop below 116$ below 115$ there is a chance that we get back to 100$ though i am not expecting this scenario right now. Targets are new all time highs around 150$. Notice this big sideway phase and the recent breakout, in my view this pullback could be a good chance to enter. I encourage everybody to make his own analysis. Blessings
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by IamJeanPaul
Gilead Biotech Aiming HighAlthough the ideas I share with you all revolve around currency pairs, I thought I'd share another specialty of mine: Biotech and pharma stock. If you're in the field, you may have already heard about Gilead having one of the best price to earning ratio of the major biotech companies. You may have also noticed the sharp decline that they experienced in the summer of 2015 which has largely been attributed to a loss in momentum due to the expiration of their patents and increased competition in the market. One could also argue that investors selling their stock contributed to the snowballing drop that seems to still be underway. Despite all this, there has been a lot of positive news recently with current projects that were once in the pipeline (such as Harvoni and Sovaldi) that have now been approved for the treatment of Hepatitis C. This puts them squarely back in competition with AbbVie and other similarly sized companies. In addition to other projects, the temptation of selling put options on Gilead at this very attractive price should yield dividends within the coming years. That said, the reversal is still not quite there yet but this is a very long term play that you should be ready for. As with currency pairs, this idea can turn on a dime so you should always take the necessary precautions!
NASDAQ:GILDLong
by Cohiba93
bottom of another possible cup and handle Being with this ticker for awhile I've been through the ups and downs. I outlined a few areas where we see run ups and blowoff tops. It's my estimation that we get a 15 10 20% haircut at times with the blowoff. That's the nature of runs maybe? Maybe even more so with spec bio. Anyway I am eyeballing the makings of the bottom of another possible cup and handle formation, we just went through one. PIRS is news driven and has nothing but good news for months. Value based asset that is proving itself, imo.
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by tradetraderson
Cash bleeding company on a bullish trend how far can this run?PLSE has been bleeding cash for a while now but it has attracted investments from two investors providing cash infusion to help it stay afloat on early February. This is when the stock broke out and has been trending up since then. Even though doom and gloom was predicted for PLSE here on Feb 23 2017 stock has moved up by $7 since then. Yesterday I was expecting a pull back to $18 or a $22 to hold and rip. Now some sort of consolidation would be necessary or else this will get shorted aggressively. Originally posted in : blog.buysellshortcover.com
NASDAQ:PLSE
by Saadey
Biotech's 40% Bear Market is OverThere is one useful way to determine when a trend is over and that is using a 50% "speedline" of a move. The decline from $400 in $IBB, the IShares Nasdaq Biotechnology Index Fund back in July 2015 and then tumbled 40% to $240 on February 9th, 2016 and later retested $240 on June 27, 2016. The mid-point of that decline is $320 and a line drawn from the top at $400 down through the $320 level on June 27th gives you a line that is now down below $275 and that line has been violated to the upside, retested and is turning back up again and THIS TIME it is with President Trump pushing for faster "time to market" in exchange for lower drug prices. Will the deal go through and will it make a difference? Time will tell. For now, the Yellen-Bubble-popping bear market has been dramatic since August 2015 as it tumbled a whopping 40%. But there might be signs of life here in Biotech Bubble land, even with fears of price gouging still lingering over these stocks . For now: Average in over the next 2-3 months and see if this story pans out. Tim 12:31AM EST February 2, 2017 280.42 last $IBB. Other symbols for Biotech $FBT, $XBI, $BBH
NASDAQ:IBBLong
by timwest
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