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Teva, BioSante Win FDA Approval to Sell Men’s Testosterone-Replacement Gel
Teva Pharmaceutical Industries Ltd. (TEVA)and BioSante Pharmaceuticals Inc. (BPAX) won U.S. clearance to sell Bio-T-Gel, a testosterone replacement therapy for men.
The Food and Drug Administration approved the transdermal gel, the agency said today in an e-mail. Teva, of Petach Tikva, Israel, will market Bio-T-Gel for men with low testosterone. The condition, known as hypogonadism, can cause erectile dysfunction, infertility, osteoporosis and muscle loss, according to the Mayo Clinic in Rochester, Minnesota.
BioSante, the original developer of Bio-T-Gel, estimates the market for male testosterone products is more than $1.2 billion in the U.S., where hypogonadism affects as many as 5 million men. BioSante, of Lincolnshire, Illinois, licensed the gel to Teva, the world’s largest generic-drug maker, and will receive milestone payments and royalties when the drug is commercialized.
Abbott Laboratories (ABT) won FDA approval in April for a testosterone product known as AndroGel and later sued Teva, alleging that Bio-T-Gel infringed the product’s patent. Abbott, of Abbott Park, Illinois, and Teva settled the litigation in December without disclosing the terms, BioSante said Jan. 31 in a statement.
BioSante’s other experimental testosterone product, LibiGel, is a topical treatment applied to the arm for female sexual dysfunction. The company fell 77 percent, the most in 12 years, on Dec. 15 after the drug failed to work better than a placebo in two trials. BioSante said Jan. 31 that it would decide within 90 days whether to continue studying LibiGel.
To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net
It’s FDA Madness! BioSante Pharmaceuticals (Nasdaq:BPAX) And Columbia Laboratories (Nasdaq: CBRX)!
Good morning Roachland and Happy Valentine’s day!
I’m featuring 2 stocks today that have immediate FDA catalysts. Let’s kick this off with BioSante Pharmaceuticals (Nasdaq: BPAX) since today is the day that the FDA will show Bio-T Gel the love, or give them a, “Dear John” letter. In other words yay or nay to Bio-T Gel a transdermal testoserone treatment for male hypogonadism which is a $1.2 BILLION market in the U.S alone.
Male hypogonadism effects nearly 5 million men in the U.S. and can cause depression, hairloss, lowered sperm count, muscle loss and all sorts of problems that can even lead to infertility in the more severe cases.
So good luck to everyone that is holding shares of BioSante today! I am still in it to win it.
BioSante’s CEO Stephen M. Simes will be holding a conference and corporate update at 10:30am EST and the live feed can be found here: http://www.veracast.com/webcasts/bio/ceoinvestor2012/76206341.cfm
Should BPAX get the nod from the FDA today, the share price should in my roachy opinion go over $1 and stay there this time around. Should BPAX get denied approval or a delayed approval then we are most likely looking at .50-60 cents. This is only my opinion, and not definites on what will happen to the share price either way.
I’ll get to the next hot bio-tech after this brief REMINDER:
SIGN UP TODAY and start proudly calling yourself a Stockroach! Does everyone here remember the StockRoach motto? We do all the work, and YOU rake in the PROFITS! Click “Right Here” and then don’t forget you have to confirm the “activation” link in your email or you will just be wasting your time waiting for the next winner while the rest of us cash in. Once you confirm your FREE subscription you can also download your very own FREE copy of our e-Book, “A bottom feeder’s guide to surviving penny stocks.”
Don’t forget to follow us on Twitter for intraday plays, and for a heads up tweet when things get HOT at the StockRoach!
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Columbia Laboratories (Nasdaq: CBRX) was a twitter only alert last week on the 7th where it did a little pop for a few cents and then it was relentlessy walked down where a lot of traders started loading up in the mid .70s to low .80s. There’s a lot of accumulation in that price range and CBRX is holding above it’s support level of .70 with a lower support level coming in at .65. Resistance lies ahead at .85, .90 and $1.
CBRX did release news yesterday that they transferred the NDA for their progesterone 8% (Prochieve) to Watson Pharmeceuticals (NYSE: WPI) while maintaining full financial interest, and at no cost to Columbia labs. Procheive is a joint venture with Watson pharma that helps to prevent miscarriages in women and has shown a 44% reduction in early term births in women that used Prochieve under 33 weeks of gestation.
A 44% reduction is of course statistically significant, and for any woman that is at risk for early term births or miscarriages knows just how heartbreaking that can be and a product such as Prochieve is a Godsend. The FDA will review the NDA for Procheive by Feb. 26th so keep your eyes and ears open!
The news you may have missed courtesy of Yahoo finance: http://finance.yahoo.com/news/Columbia-Laboratories-prnews-1363429208.html?x=0
Senorita “All I want for Valentine’s is FDA approvals!” Roachita
BioSante Pharma (Nasdaq: BPAX) Still On HIGH Alert!
Hola mi amors!
Happy Thursday, today I will be updating BioSante Pharmaceuticals (Nasdaq: BPAX)
BioSante Pharmaceuticals (Nasdaq: BPAX) has been driving Wall st. crazy with the volatility and those without the stomachs for it have been crying uncle. It all comes down to this mi amors,the closer a stock gets to a MAJOR catalyst such as PDUFA on Feb. 14th (which means if their Bio-T Gel gets PDUFA approved by the FDA it goes full commercial), the more people are going to try and shake you down for shares. This has definitely become a Balls of steel club stock, and only those with the big brass ones will win at this point. Many roaches have already raked in some massive gains from BPAX, but the balls of steel club roaches are going for MORE!
That my darlings is what is causing this volatility, it’s a share grab where hedgies, fundies, techies, traders, investors and everyone else under the sun is pulling out all stops (literally) to get as many shares of BPAX for as cheap as possible.
The ask is being walked down relentlessly, the bid is being pinged like crazy, BPAX has been on Nasquack’s forced short cover list for 2 days in a row which will also have an impact in the way it trades. The shorts want to cover for as much profits as possible, or they want to minimize losses since with shorting those losses can be endless.
On a positive note, BPAX did release news today that the DMC report (Independant Data Monitoring Committee) for BPAX’s Libigel cardiovascular and breast health safety studies show signs of positive data and they have recommended that BPAX continue on with their Libigel tests without any further modifications. In laymen’s terms Libigel does not seem to cause any breast or heart problems.
Now they just need to work out that placebo trial thing out. Libigel is the holy grail of the medical world, since the dawn of time man has been looking for a magic potion that will make women more randy for sexy time and so far BPAX’s Libigel is the closest to making that happen.
The reason the placebo trial failed was due to the women on the placebo saying that they too felt just as randy as the women on the actual treatment. I want to get a look at the researcher that was handing out the placebo and monitoring the placebo group. It sounds to me like he was young and cute, especially in a labcoat haha.
Women! How do we work?
Today’s BPAX libigel news courtesy of Yahoo finance: http://finance.yahoo.com/news/BioSante-Pharmaceuticals-bw-885355718.html?x=0
I’ll get to your techs after this brief reminder, especially since Papi Roachy has a mega hot alert on deck for tomorrow!
SIGN UP TODAY and start proudly calling yourself a Stockroach! Does everyone here remember the StockRoach motto? We do all the work, and YOU rake in the PROFITS! Click “Right Here” and then don’t forget you have to confirm the “activation” link in your email or you will just be wasting your time waiting for the next winner while the rest of us cash in. Once you confirm your FREE subscription you can also download your very own FREE copy of our e-Book, “A bottom feeder’s guide to surviving penny stocks.”
Don’t forget to follow us on Twitter for intraday plays, and for a heads up tweet when things get HOT at the StockRoach!
The StockRoach Twitter feed: http://twitter.com/#!/TheStockRoach
Support for BPAX comes in at .80, and resistance lies ahead at .95 and $1.
Senorita “Balls of steel club member” Roachita
Atrinsic, Inc. (Pink: ATRN) Brings In Gains Of Almost 1,000%!
Hola Roacheros!
Atrinsic, inc. (Pink: ATRN) is our first “almost” 10 bagger of the year! Are you really going to give me crap over a few ticks when the stock ran from my original alert on Jan. 4th at a PPS of .013, where it hit an amazing early HOD today of .135 for some ASS KICKING, MOUTH WATERING, HOLY GUACAMOLE gains upwards of 938% in a month?
There were also updates after updates on this roachy gem, just go to the search bar and you will see that we nailed ATRN each and every time! Here’s a link for everytime ATRN was updated: http://www.stockroach.com/?s=atrn
Chalk another one up for the StockRoach, nail it to the bedpost and tell the story to your grandchildren current or future!, The best part is that this is only the beginning mi amors, between Papa Roach and I, we will be bringing you some of the hottest stocks, the biggest pumps, and $$$ flowing into your accounts to the point where even Las Vegas will want some peanut butter with their JELLY (jealous) by the time this fiscal year ends.
Want some more HOT alerts before the chaff comes sniffing around for our scraps?
SIGN UP TODAY and start proudly calling yourself a Stockroach! Does everyone here remember the StockRoach motto? We do all the work, and YOU rake in the PROFITS! Click “Right Here” and then don’t forget you have to confirm the “activation” link in your email or you will just be wasting your time waiting for the next winner while the rest of us cash in. Once you confirm your FREE subscription you can also download your very own FREE copy of our e-Book, “A bottom feeder’s guide to surviving penny stocks.”
Don’t forget to follow us on Twitter for intraday plays, and for a heads up tweet when things get HOT at the StockRoach!
The StockRoach Twitter feed: http://twitter.com/#!/TheStockRoach
Senorita “BOOYAH and a bucket full of cash!” Roachita
BioSante Pharmaceuticals (Nasdaq: BPAX) Goes HAM! Breaks $1, Wall St. goes wild!
Just a quick BPAX update for mi amors.
Shares of BioSante (Nasdaq: BPAX) goes wilder than a drunken frat boy on spring break.
With their highly anticipated Feb. 14th date where their Bio-T Gel a transdermal testosterone booster for men with low test. levels goes up against the FDA for full approval it’s no surprise that BPAX is a stock that has Wall St. screaming it’s praises!
So it’s time for a quick technical update on Senorita’s favorite bio-tech trading that is now trading at $1.05 that has brought gains upwards of 133% since my original alert at .45.
Support comes in at $1.00 with a lower level support at .92, and the new resistances lies ahead at $1.12 and $1.20 on the daily charts. Should $1.20 break and hold then the next level of resistance is $1.50.
Chart courtesy of stockcharts.com: http://stockcharts.com/h-sc/ui?s=BPAX&p=D&b=5&g=0&id=p24951525252
Papa Roach has a muy caliente alert heading your way tomorrow morning at the bell, and I have a nice tech trade bottom bouncer coming out pre-market.
So what are you waiting for?
SIGN UP TODAY and start proudly calling yourself a Stockroach! Does everyone here remember the StockRoach motto? We do all the work, and YOU rake in the PROFITS! Click “Right Here” and then don’t forget you have to confirm the “activation” link in your email or you will just be wasting your time waiting for the next winner while the rest of us cash in. Once you confirm your FREE subscription you can also download your very own FREE copy of our e-Book, “A bottom feeder’s guide to surviving penny stocks.”
Don’t forget to follow us on Twitter for intraday plays, and for a heads up tweet when things get HOT at the StockRoach!
The StockRoach Twitter feed: http://twitter.com/#!/TheStockRoach
Senorita “Never fall in love with a stock unless it is BPAX haha” Roachita.
Roachy Roundup Time! 5 Hot Stocks, 5 big wins!
Just a quick roundup on my 5 for 5 blog from this morning.
Link if you missed the pre-market 5 for 5. http://www.stockroach.com/tgif-its-senoritas-hot-stock-roundup-mnel-atrn-bpax-motr-and-mvis/
Atrinsic, inc. (Pink: ATRN) brings yet another round of wins if you were late to the party. It gapped down at open allowing for some very nice cheaps in the .055 range and hit an intraday high of .085 for some fast track gains upwards of 54.5 %. I would still keep my eyes peeled on this puppy because the money is flowing nicely, and it appears to be consolidating at higher levels.
Mission NewEnergy (Nasdaq: NMEL) gapped up nicely at open today to hit a high of $1.25 from yesterday’s alert price of .83 for an overnight quickie that brought in gains upwards of 50% for very saavy roaches. Unfortunately this one turned into a stinker midday and some dilution might be occuring because it broke supports on heavy volume and just was not trading in a very healthy manner. This is why we always lock in those gains darlings!
BioSante Pharmaceuticals (Nasdaq: BPAX) finally broke it’s 1st major resistance at .70 and closes up 8% over the previous day at a very respectable power hour last second push at .74 , and with their FDA catalyst coming soon aren’t you glad I let you all know about BPAX when it was all you could buy .45s? I’m sure they look cheaper than anything on the McDonald’s $1 menu right about now haha. Even those of you that bought the .60s are starting to sound less morose. Lot less crying and much more buying going on at BPAX. Good times, and dollarland… you can almost smell it from here.
Microvison, inc. (Nasdaq: MVIS) my little chart play opened nicely with all you could grab .42s-.43s where it took off running to hit a high of .5198 for nice 24% snipe trade.
Let’s finish this roundup with this week’s El SUPERBEASTO Motricity, inc. (Nasdaq: MOTR) that was alerted when shares were abundant at .77 last week, and it is dazzling Wall St. with a mega 2 day rally that sent shares soaring to an intraday high of $1.29 for HOLY GUACAMOLE gains upwards of 67.5%!
Papa Roach’s rocking alerts have also brought in cumulative gains well into the triple digits this month as well, and he has another hottie on deck for Monday. Teasers will be sent out via e-mail over the weekend so:
SIGN UP TODAY and start proudly calling yourself a Stockroach! Does everyone here remember the StockRoach motto? We do all the work, and YOU rake in the PROFITS! Click “Right Here” and then don’t forget you have to confirm the “activation” link in your email or you will just be wasting your time waiting for the next winner while the rest of us cash in. Once you confirm your FREE subscription you can also download your very own FREE copy of our e-Book, “A bottom feeder’s guide to surviving penny stocks.”
Don’t forget to follow us on Twitter for intraday plays, and for a heads up tweet when things get interesting HOT at the StockRoach!
The StockRoach Twitter feed: http://twitter.com/#!/TheStockRoach
Senorita “This is easier than taking candy from a baby!” Roachita!
TGIF! It’s Senorita’s Hot Stock Roundup! MNEL, ATRN, BPAX, MOTR, and MVIS
Happy Friday everyone!
I just wanted to give everyone a quick Friday update on a few of the hottest stocks of the week.
Mission NewEnergy (Nasdaq: MNEL) which was alerted yesterday PRE-market was an all you could buy buffet of shares at .82, and boy did this sucker start retracing hard. After what seemed like a pretty boring morning with some decent volume and buying pressure, someone unleashed the Krakken on the shorts and had them chasing to cover and it hit a power hour high of $1.15 for some lip smack-a-r00 gains upwards of 40%!
***New support for MNEL comes in at $1, and resistance lies ahead at $1.40, but there is also a gap that could get filled from the $1.42 – $1.50 areas, and this low floater might just squeeze some more shorts and take this up towards the 50 DMA which lies ahead at $2.40. $2.25 is the key area to break for MNEL if it’s going for the 50 yard line.***
Atrinsic, Inc. (Pink: ATRN) Everyone’s favorite pink that keeps on giving seems to have momentarily stopped giving due to a delay in their web crawler Atrinsic Spyder. The company has assured investors that Spyder is definitely a go and there’s just a glitch in the Matrix that needs to be solved. Even the largest companies have delays in product launches so it’s not entirely unexpected or a “scam” as some are saying haha.
***Support for ATRN comes in at .05 with a lower level support of .045, resistance lies ahead at .075, and the 50 DMA of .083.***
BioSante Pharmaceuticals (Nasdaq: BPAX), just a reminder to all that they do have a major FDA catalyst on Feb 14th. where their Bio-T Gel a treatment for low testosterone levels goes up for FDA approval. It’s been churning the mid to high .60s nicely with small stairstepping price increments.
***Support for BPAX comes in at .62 with resistances at .70 and .75.***
Motricity, Inc. (Nasdaq: MOTR) a stock that was alerted here LAST WEEK at .77, I even put up the BIG RED ALERT picture up, so you can’t say that you missed it, was another one that rocked Wall St. socks yesterday as it smashed every resistance below $1 to suddenly bust loose and close at a roachy .98, but it just kept on going into after hours tading where it hit a high of $1.05 for some NOW THAT’S WHAT CALL GAINS upwards of 36%. What made this “Carl ICahn” stock take off running like a scalded mutt? Well a Form 3 filing hit the newswires right after the bell showing that an insider has been buying shares of Motricity, and with the mobile marketing sector being red hot who can blame him amirite? There’s a lot of people rumor mongering that MOTR will become a crucial part of Facebook or Google for mobile advertising, so we’ll keep our ears to the ground for that since the rumor mongers can be right twice a day haha.
***Support for MOTR comes in at .96 with a lower level support of .85, and resistance lies ahead at $1.10 and $1.25***
I’ll get to a new stock that I have been eyeing right after this reminder to you lurking FREELOADERS to:
SIGN UP TODAY and start proudly calling yourself a Stockroach! Does everyone here remember the StockRoach motto? We do all the work, and YOU rake in the PROFITS! Click “Right Here” and then don’t forget you have to confirm the “activation” link in your email or you will just be wasting your time waiting for the next winner while the rest of us cash in. Once you confirm your FREE subscription you can also download your very own FREE copy of our e-Book, “A bottom feeder’s guide to surviving penny stocks.”
Don’t forget to follow us on Twitter for intraday plays, and for a heads up tweet when things get interesting HOT at the StockRoach!
The StockRoach Twitter feed: http://twitter.com/#!/TheStockRoach
Last but not least keep an eye on Microvision (Nasdaq: MVIS) as this one has been seeing some major accumulation in the high .30s to the low .40 cent ranges for quite some time now and could get ready to bust loose with some nice double digit gains. This is a pure tech play based on the charts due to the RSI being in that nice trader “buy” area of the 50s with the MACD slowly starting to creep up, and the accumulation line is showing signs of life as well. The support and resistances are as follows:
***Support for MVIS comes in at .39 with resistance ahead at .45***
Papa Roach has a hot stock alert coming out Monday, so you won’t want to miss that and there will be a teaser e-mail going out over the weekend so if you are not signed up, you might want to do so right now.
Senorita “Yaaaay, I love Fridays!” Roachita
The Roach is WINNING!
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