The Short-Seller Who Got Amylin Right

Image via WikipediaNEW YORK (TheStreet) -- Not all investors are shocked and upset about the decision by U.S. regulators to reject Amylin Pharmaceuticals' (AMLN) diabetes drug Bydureon. Short-sellers -- investors who bet that Amylin shares would fall -- are positively giddy and making money.

Amylin shares are down $10.35, or 50%, to $10.14 in Wednesday trading.

How did the shorts get Amylin right when a majority of investors believed Bydureon was going to be approved? I spoke with one Amylin short early Wednesday about his bear thesis. This hedge fund manager asked to remain anonymous because the rules of his fund forbid him to speak publicly about his investments.

"I always believed that Amylin and Eli Lilly (LLY) were taking shortcuts to get Bydureon through the FDA" and the agency was going to have problems with this approach, said this short seller.

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Big Gains For Pain Therapy Stocks Today: KG, PTIE, WPI, ENDP

So Pfizer is increasing their portfolio with King Pharmaceuticals, a maker of veterinary meds and pain therapies.  In addition to this news, another company came into the spotlight for pain management therapies.  This company is Pain Therapeutics (PTIE).  Pain Therapeutics is in clinical trials now in collaboration with King Pharmaceuticals so look for Pfizer to kick in some clinical trial expertise with Pain Therapeutics (PTIE).  Additional companies involved in pain therapies is Endo Pharmaceuticals.  I highly suggest buying Endo as a buy right now.  Since June 2010 Endo's stock has risen form 20.22 to its current trading at 34.99.  I suggest a limit order to buy at some discount.  Another Pain therapies stock is Watson Pharmaceuticals, a generic drug maker. 

My opinion on this is that Pain Therapeutics could be slightly overvalued on the hyped news, and although it may seem attractive to buy right now, I suggest waiting for the pullback as it will be years before these clinical trials are actually approved by the FDA.  Also, I am a little cautious placing a buy on Pfizer right now as they will be losing patents on Lipitor next year and other brand name drugs will become available as generics.  I might actually place Pfizer's stock right now on hold or sell, as earnings could be lower than expected.  Just because everyone is doing it does not make it a buy in my opinion. I actually do not necessarily see King Pharmaceuticals as such a hot buy with only 4.85% profit margin and 18M in profits on 380M in revenue.  But given that layoff will presume who knows. 

Stick to your guns and remain a cautious investor and good things will come.  I apply Warren Buffett's principles to the BioPharma Stock World and like purchasing stocks at a discount.  You should be searching for the next Pfizer and not chasing after something that is overly hyped.  Just my opinion.

Stocks mentioned in this article

Pfizer--(PFE)
King Pharmaceuticals --(KG)
Endo Pharmaceuticals --(ENDP)
Pain Therapeutics --(PTIE)  Up 18.56% today on the news
Watson Pharmaceuticals--(WPI)

Disappointing Day For Alexza Pharmaceuticals

Image via CrunchBaseI quietly predicted today's FDA outcome on Alexza and Jazz Pharma's CRL, last week in my FDA Calendar prediction.  Here were My Predictions which stated that investor's should be shorting Alexza last week.  That would have netted a huge profit on Alexza's demise.  I think that shorting stocks or place put call options on FDA catalyst events can be profitable if done properly.  Although Jazz did not go down today, I do not see good things for their future

You really have to know what you are doing though when you make projections like this as is the drugs are approved then you will not be too happy with the results.  It's really a difficult line to cross but I see the value of Shorting Stocks under the Obama FDA panel.  The panel has rejected 4 drugs so far in October. 

That doesn't mean that you should have shorted Hospira or Human Genome Sciences (HGSI) because these are large and mid cap stocks that are affected less by these FDA decisions.  Human Genome has an upcoming drug approval in December for their Lupus therapy and I actually like the stock right now and consider it a buy.  Alexza and Jazz just had too many red flags for me for approvals.  You have to do your homework and look through the clinical trial data available.  Or just follow BioPharma Investor and let me give you helpful advice on these decision. 

Wikinvest--Alexza Pharmaceuticals (ALXA)  Closed:  1.35 Down 1.65 for a 54.46% Loss

Wikinvest--Jazz Pharmaceuticals (JAZZ)  Jazz will probably will be going down with today's CRL.

Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia


FDA O-Fer October Drug Approvals

BOSTON (TheStreet) -- U.S. regulators have to approve at least one new drug in October, right?


The U.S. Food and Drug Administration has a perfect 0-4 record so far this month -- four drug approval decisions, four drug rejections. Monday, Alexza Pharmaceuticals(ALXA) and Jazz Pharmaceuticals(JAZZ) received the bad news. Last week, it was FDA rejections for Human Genome Sciences(HGSI) and Hospira(HSP).

Perhaps the best shot for more positive news will come Tuesday when Alkermes(ALKS) is expecting FDA to rule on its drug for opioid addiction.

The Street's FDA Drug Approval Contest: October's FDA Calendar

Image via CrunchBase Here is Ocotber's FDA Calendar. Along with the Calendar I have put my recommendation for each stock. Some you should really be buying, like Alkermes, others you should be shorting, like Arena, Vivus, and Jazz Pharma.

The poll has 3 results:
1. Full Approval
2. Complete Response Letter (aka delayed approval or no approval)
3. No Decision (more time, the FDA has a lot of approvals in such a given short period)

Oct. 1: Hospira's(HSP) Dyloject for acute moderate to severe pain in adults. (CRL)---Big Company so no big deal, still a buy

Oct. 4: Human Genome Sciences'(HGSI) Zalbin for hepatitis C. (CRL--Lupus drug approval set for December so still a buy)

Oct. 11: Alexza Pharmaceuticals'(ALXA) AZ-004 for agitation in patients with schizophrenia or bipolar disorder. (I'm going with No Decision, short this stock, as this is their first FDA decision for the Staccato technology) Slightly leaning toward CRL but I will say No Decision as my final answer.

Oct. 11: Jazz Pharmaceuticals'(JAZZ) JZP-6 for fibromyalgia. (CRL--FDA panel killed this drug, it works but the FDA isn't approving a GHB type drug right now. Short this stock)

Oct. 12: Alkermes'(ALKS) Vivitrol for opioid addiction. (Full Approval--Jim Cramer would say Buy, Buy Buy)

Oct. 16: ISTA Pharmaceutical (ISTA) XiDay is simply aonce daily version of twice daily solution, and avoid generic competition (FDA Approval)

Oct 22: Arena Pharmaceuticals'(ARNA) lorcaserin for obesity. (No way in he##, CRL) I would recommend shorting this stock.

Oct 22: Amylin Pharmaceuticals(AMLN) (Partnered with Alkermes and Eli Lilly) Once weekly Diabetes Shot exenatide or Bydureon---This is a delay from CRL in March so I expect Full Approval this time around.

Oct 28: Vivus'(VVUS) Qnexa for obesity. (Give me a break, CRL) I don't care what data they have come up with, I would recommend Shorting this stock.

Oct 29: Avanir Pharmaceuticals'(AVNR) Zenvia for pseudobulbar affect. (I'm going to go with Full Approval although it's a toss-up)

Forest Labs(FRX) ceftaroline for Community Acquired Pneumonia. I can't find this on the FDA calendar---But I will say Full Approval even though I can't find it.

Oct 30: Biodel's(BIOD) Linjeta for diabetes. (No Decision, short this stock) Again on the fence, possible CRL.

Stock Mailbag, Generex, Sequenom, MELA Sciences, Cardium Therapeutics, Biodel

Image via CrunchBase Another great article from The Street's Adam Feuerstein in his Biotech Stock Mailbag. Mostly on stocks NOT to invest in, or stocks to short, and biopharma stocks for Put Options. Adam's a downer to most parties but he speaks the truth. Whether you like it or not. Sometimes I haven't liked it but if you are looking for long term growth Biotech Stocks you might want to take some of his advice. Plus, you can enter his FDA Drug Approval Contest for October. See what people think about the FDA Drug Approvals Contest.

Biotech Stock Mailbag: Generex

Novartis Gains FDA Approval For Oral MS Drug

Image via WikipediaNovartis is now a game changer in MS market. Novartis is usually known for their vaccines, is the first in the oral pill MS drug market. Top News from Novartis as MS drug, Gelenya was approved from the FDA Monday.

Wikinvest: Novartis AG (NVS)

Rodman & Renshaw: Promising Biotechs from TheStreet

I was really impressed by Adam Feuerstein's article in TheStreet today. The Rodman Investor's Conference showcases promising upcoming Biotech and Pharmaceutical companies.
Stocks mentioned in this article are: AVII, BDSI, DNDN, RXII, ATHX, NEOL, PYMX

Rodman Rambles: Promising Biotechs

NEW YORK (TheStreet) -- I saw some promising, small biotech companies at this week's Rodman & Renshaw Annual Global Investment Conferences. The confab wasn't all about the biotech dreck---i.e. Biotech losers.

The Street's Equity Top Rated Stocks: Life Sciences Tools & Services

Image via CrunchBase

Every day TheStreet Ratings produces a list of the top rated stocks. Every day we will publish several lists to provide you with some stock buying (or selling) ideas.

Equity Top: Life Sciences Tools & Services
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