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Monday, January 31, 2011

Manhattan Pharmaceuticals: Another Pop, Legitimacy Next?

VNDA Files Shelf, Acquisition in the Works?

Vanda Pharmaceuticals announced on Monday that it had filed a shelf registration with the SEC that would allow the company to sell up to $50 million worth of common and/or preferred stock as well as debt securities and warrants in one or more future offerings. 

The registration is not yet active, but according to a press release Monday, the intent of the filing is to allow Vanda "greater flexibility to take advantage of acquisition, financing and other business opportunities when and if such opportunities arise."

The key take-away from the above quote is the mention of an acqusition. 

Since Vanda is already tied to Titan Pharmaceuticals in the way of an 8-10% royalty rate that Titan grabs from Fanapt sales, speculation has it on Monday that Vanda is possibly looking to offer a buyout of Titan that would net Vanda not only the royalty rate on Fanapt sales, but also the pipeline prospects of Probuphine and the ProNeura drug delivery technology. 
The fifty million outlined in the SEC filing is not near enough for Vanda to consider a buyout of any company, let alone Titan, but Vanda is still sitting on a chunk of cash from the $200 million up-front payment that Novartis shelled out in 2009 for the US and Canadian rights to Fanapt.

The shelf offering could supplement the cash on hand for a buyout of Titan, which would put first estimates at an offering price of right around $3/share - roughly double where Titan trades today.

Any link between Monday's announcement by Vanda and a possible Titan buyout is purely speculation at this point, but a binding deal to consumate a marriage between the two companies does make sense, hence the speculation.

It's also commonly believed that Titan has been aligning itself more as a buyout candidate than as a stand-alone company, which only adds fuel to the speculative fire. 

A recent run looked a lot like a methodical accumulation of the TTNP stock before a retracement off the high took place, but shares were trading 10% higher on Monday, with no news - from Titan, at least - having been released.

Whether it's Vanda or not, I still see a buyout of Titan in the works, although three dollars/share would be a little on the cheap side of an offer given the assumed success of Probuphine, but at the same time, you can't argue with a double as a premium.

TTNP isn't disappointing as a 'Stock to Watch' this week, and there may be more to come.

Disclosure:  Long TTNP, no position VNDA.

Zecco Holdings

Weekly Stock Watch: Titan Due For News; MedClean Still Moving; Clinical Data Climbs Higher; Cytosorbents;


TTNP:  It's been a volatile month for shares of Titan Pharmaceuticals, as a rise to $1.75 has been followed by a dip to back below $1.50, but the company is due for a press release, and one may come this week as investors await Titan's take on the expected royalty share for fourth quarter sales of Vanda's schizophrenia drug, Fanapt, which is being marketed by Novartis.

Novartis also made headlines last week when the company's CEO Joe Jimenez not-so-subtly hinted that there may be some acquisitions in the works; acquisitions that he labeled as "bolt-on", meaning for about a billion dollars or less.

Titan, with an already established link to Novartis through Fanapt, certainly fits that "bolt-on" description and has already been identified as a probably acquisition target by biotech speculators who have also been following the Probuphine story

TTNP could be a newsworthy stock throughout 2011, and the news just might start flowing this week - keep an eye on it.

Disclosure:  Long TTNP.

MCLN:  Last weekend it was MCET that we were watching as a penny stock on the run, and MultiCell ran for a couple of days into the new trading week before pulling back when news failed to materialize.  This week MedClean is a penny play worth watching after another big day on Friday saw MCLN close another thirty percent to the upside with still no news being announced. 

MedClean's green technology for disposing of medical waste could also be looked at for long term potential as well as short term trading, but those invested for the long term are counting on a turnaround with the latest run.  That said, the amount of time this one spent in the .002 range has given long shareholders the opportunity to pick up some shares that have already more than doubled.

It's quite possible that this run may peter out as MCET's did, so I'm always a fan of taking profits during a significant run, but Friday's close has investors and traders alike awaiting the bell on Monday morning to get a feel for what could be coming next.

Stay tuned...

Disclosure:  Long MCLN.

CLDA:  Clinical Data continued to climb late last week, closing another couple of percentage points higher, just a week after the FDA approved its antidepressant drug Vilibyrd.

Many analysts expect big numbers from Vilibyrd and its favorable side-effect profile, but its talk and speculation of a buyout that is keeping this one on the front burner for the time being. 

As shares approach the thirty dollar level, it's worth keeping CLDA on the watch list, as I wouldn't rule out a pullback if no acquisition news is announced.

Congrats to the longs who were able to sell into last week's run, however.

Disclosure:  No Position.

CTSO:  Last week saw shares of Cytosorbents push through the seventeen cent barrier before falling back a little, but as time edges on to the expectation of a data release from the European sepsis trial, CTSO could approach the current 52-week high of thirty cents. 

The last update from the company regarding enrollment had the number at 90, leaving many to speculate that full enrollment would be announced within the first couple of months of 2011.

With no effective treatment for severe sepsis currently on the market, Cytosorbents could land a gold mine if CytoSorb works in treating the indication, and that would also mean that CTSO could experience a monumental run.  On the flip side, there's no reason that this stock wouldn't drop to a couple of pennies should the trial results be announced as unsuccessful - but that's the name of the high risk/high reward game.

Keep this one on the watch list until we hear news one way or the other.

Disclosure:  Long CTSO.

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Thursday, January 27, 2011

Briefs: CTSO, MCLN Continue Higher, MCET Down, VNDA, SIGA Rebound


CTSO:  As mentioned yesterday in 'Penny Play on the Move', shares of Cytosorbents have embarked on a run that may or may not lead us to results of the ongoing CytoSorb-sepsis trial in Europe, but speculation could be taking over after CTSO shares touched sixteen cents on Wednesday after breaking through the barrier at fifteen cents early in the trading day.

CytoSorb has the potential to become a huge blockbuster if the European trial is successful and the product is ultimately approved, as there is no effective treatment for severe sepsis on the market.  Further on down the road the technology would be able to be geared towards treating other indications, according to previous reports by the company.

It's still not sell time - not even for any trading shares - just yet, but the run is worth watching as it's expected that trial enrollment could be announced as complete on any given day during the current quarter.

The last major run saw CTSO fly to over forty cents, and I don't thing that a repeat run to those prices are out of the question, barring any bad news from Europe.

Could be an exciting year for investors of Cytosorbents, but a failure in the ongoing trial will send the stock plumetting - always keep the flipside in mind, since stock investing isn't all sunshine and rainbows.

It's also worth noting that volume is picking up a bit along with the price.

Disclosure: Long CTSO.

MCLN:  Like CTSO, MCLN also continued its run higher on Wednesday, although while CytoSorbents' run may have been significant because the fifteen cent barrier was punctured, it was still no competition for the 50%-plus increase that MedClean realized.

No news accompanied MedClean's continued run, although like MCET over the previous few trading days, this run could breach the penny mark before retreating, although significant news on the earnings front may be able to ensure that the price stays above a penny, should the stock make it that far.

I was sceptical with MCET's run after a few days of price increases without news, and the same will be said for MCLN, but I didn't take advantage of 'sell time' on Wednesday because the big volume and close at the high has me believing that Thursday could return more of the same.

MedClean's 'green' business plan makes it an intriguing long term pick, but for the short term we're still dealing with a highly speculative penny stock that is suseptible to significant price swings, whether warranted by news or not.

Keep an eye on this run, but don't forget to take some profits if your personal comfort level is breached.  Remember, it's worse to have not sold when you had the chance only to watch a retracement than it is to sell a few shares for some profit only to watch the stock go higher.

All just my opinion.

Disclosure:  Long MCLN.

MCET:  When no news revealed itself for MCET after days flying higher to the upside, the stock retreated off the recent highs and closed down by over thirty percent.  There's still a chance that news could be released - volume has been off the charts - but it's also likely that this run will end up like most of them before it - nice while it lasted.

That's why it's tough to recommend holding all shares into any MCET runs.

Thursday will offer a look as to whether just how serious this run is, a further sub-penny retreat could drop it back down to the .004 level.

Regardless of playing with the trading shares, there's enough there with this company to make it worth holding a core position for the long term, in my opinion.

Disclosure:  Long MCET. 

SIGA:  SIGA had been dipping back towards the ten dollar mark over the past few trading days as the PIP trial heated up and fears of a government freeze had investors pulling some cash to the sidelines, but a slight rebound on Wednesday could be an indication that President Obama quelled some fears that SIGA would not receive its BARDA money because of the said freeze.

There's still a lot of speculation around Siga for a company that just landed a huge government contract, and any dip to ten dollars should be used to add shares, in my opinion and barring any negative news, but there's still room for a move up from the current position if the lawsuit turns out even remotely favorable to Siga and the BARDA contract ends up being fully paid out after the appeal filed by a Siga competitor get sorted.

A big winner for 2010, Siga will still be one to watch for 2011.

Disclosure:  No position.

VNDA:  It's certainly no secret that TheStreet.com's biotech blogger Adam Feuerstein has a personal itch in his pants when it comes to Vanda Pharmaceuticals and that company's schizophrenia drug Fanapt, but that point was reiterated in a recent article about Clinical Labs approval of Vilibyrd where AF seemingly went out of his way to throw in a negative comment about Vanda.

Vanda had been on the downswing for a week or so, and Feuerstein's comment was convenient as many speculate that there are motives behind that guy's actions and words.

In reality, his vendetta against Vanda may result from the fact that he had Vanda - and Titan Pharmaceuticals (if he ever mentioned that company) - completely written off before the FDA approved the drug in 2009

With TheStreet's approval or not, Fanapt sales have increased through 2010 and it's expected that the trend will continue through 2011. 

Because Titan Pharmaceuticals receives an expense-free royalty rate from Fanapt and also has Probuphine in the final stages of a confirmatory Phase III trial, I still see TTNP as the better buy & hold, but VNDA does look pretty actractive also while hanging out in the vicinity of seven dollars.

VNDA rebounded by five percent on Wednesday, while TTNP closed up a couple of pennies after dipping to the $1.50 mark following the latest run.

Quarter Four Fanapt sales results could be released any day.

Disclosure:  Long TTNP, No position VNDA.

Posted yesterday at VFC's NEW Stock House.




Activity From Generex - Cash Raising, AE37 Enrollment & Valuation, But Where is Oral-Lyn In All Of This?


After a period of relative silence from Generex, aside from a late day 8k announcement on Friday, a couple of press releases issued on Tuesday show that the lights are on in Worcester.

It was first announced that the company had agreed to monetary terms with "certain institutional investors" that would put at least three million dollars in the Generex coffers, but the deal could bring in up to six million, if the "certain" investors were to purchase the full allotment of shares and warrants offered. 

Generex will use the proceeds to fund ongoing trials and - of course - for general corporate purchases, which covers just about everything from electric bills and salaries to business meeting at Scores.

Also on Tuesday it was announced that Generex will increase the amount of patients enrolled in the ongoing Phase II trial testing AE37 for breast cancer.  According to the release, the increase in enrollment will ensure that all patient groups are well represented in this trial before consideration shifts to the planned Phase III trial. 

If this move validates the Phase II trial any more than it would have been anyway, then good on Antigen Express - the Generex subsidiary who is bringing AE37 through development - but it's a little premature to be looking towards Phase III.  Let's make sure Phase II turns out as planned, which the boost in enrollment may be a move to do just that.

That said, the fact that the enrollment boost is coming mid trial will have some speculating as to why the move was needed now and not planned in originally?

Generex offered another nugget in that AE37 release on Tuesday by announcing that an independent valuation firm, one that specializes in pharmaceuticals, had put a $300 million value on AE37 at its current stage in development.  Not surprisingly, the company thought that this value was conservative, although investors may disagree as the current market cap for GNBT is still under 75 million.

It's tough to place too high a value on a Phase II company, in my opinion (never was a fan of GERN when it was trading with a market cap of closer to a billion than to half a billion), no matter how promising a product candidate may be, but I'll buy the fact that this stock should be trading significantly higher if anyone were taking Oral-lyn and/or AE37 seriously. 

It's still my opinion that Generex is looking to sell or partner AE37, hence the "independent" valuation thrown out there, but investors are more intent on hearing news regarding Oral-lyn.  THAT is the flagship product and the short term catalyst for which investors are awaiting an update.

All this talk about AE37 over the past few months while nothing has been mentioned about Oral-lyn will no doubt have investors believing that the company is leading them towards the bright, shiny object and away from where the attention should be.

This company can have quite the flair for the dramatic when need be, even when things get a little ridiculous, but it's all ho-hum right now until we get an Oral-lyn update.

For twenty six cents, however, couldn't resist picking up a few shares because if Oral-lyn does kick back solid results, then GNBT will be trading much, much higher in no time.

Disclosure:  Long GNBT.

Posted Yesterday at VFC's NEW Stock House.

Zecco Holdings

Tuesday, January 25, 2011

Penny Plays on the Move: Where Do They Stand?

MOVED TO:

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Briefs: CLDA, Opens the Week Running; MCET, Another One Running; BDSI, Lawsuit News; RNN, Big Buys By Teva; DDSS, Approval in Canada

Posted earlier at VFC's NEW Stock House:

CLDA:  After announcing last week that the FDA had approved Clinical Data's Vilibyrd - an antidepressant whose claim to fame will be that it doesn't interfere with the sex drive - it was off to the races on Monday morning as shares of CLDA traded up by over ten dollars, closing nearly seventy percent higher than Friday's closing price.

The company itself some and analysts predict that Vilibyrd's favorable side-effect profile gives the product a chance to make an immediate impact in an already competitive market.

While the long term still gives Clinical Data some fairly significant room to the upside, in my opinion, I'm always a fan of enjoying some of the profits to be had in price swings like this one over the short term, so congrats to shareholders of CLDA who were along for the ride and are booking nice vacations at this time.

Speculation of a buyout or partnership has also surrounded this stock over the past week, and with a product that could eventually bring in up to two billion dollars annually, there's sure to be a lot of buzz surrounding this one.

Keep an eye out for news and enjoy the profits, for those who were playing this one based on the pending FDA news.

I'm not a big fan of chasing stocks, and the most significant have already been had for the short term, so any entry here would be one with an eye towards the long term commercializiation of Vilibyrd. Any premium on a buyout may not be as much as it would have been before approval, after the already significant run-up in price.

Disclosure: No position.

MCET: After having given off indications of a pending run late last week, shares of Multicell Technologies closed the day on Monday up by nearly 50% while having spiked even higher shortly after the opening bell.
 
No news has yet to accompany the run - a run built on huge volume - which has inclined many (including myself) to sell a few trading shares into the upside volume in order to lock in profits just in case this is a run not built on the foundation of solid news.

MCET has realized significant runs such as this one on many occasions over the years, although each time it has retraced back to previously traded levels, hence the inclination to ensure that a few shares are sold to bank in some profits.

That said, MCET is also a penny play with potential, therefor it's worth keeping a core base of shares in the event the company announces solid news regarding the pipeline. The two candidates far enough along to create buzz are MCT-125, a treatment for fatigue in MS patients (a Phase II product) or the Ideal BioStent, which was recently purchased by Multicell's majority-owned subsidiary Xenogenics.

MCET could be setting a new bottom at just around a penny right now, but with this current run having led to a double in a very short amount of time, it's worth being aware that the run may not be sustained without news, especially if it was sparked by a mention in a penny stock news letter.

Keep an eye on this one, and congrats to those who realized some nice profit.

Disclosure:  Long MCET.

BDSI:  BioDelivery Sciences issued a press release last week refuting the claims of a recent lawsuit filed by MonoSol RX alleging patent infringement and false marketing against BioDelivery, Meda and Aveva Drug Delivery Systems.

If the BioDelivery rebuttal is to be worth its words, then MonoSol's claims are baseless and the pipeline is going to move forward without distraction. It is up to the courts, however, to decide whose argument deserves merit or not, bur for the time being I don't think that this lawsuit is a factor, until it becomes one.

BioDelivery has a promising drug delivery technology in BEMA and a promising pipeline and is still worth the look as a long term investment.

Disclosure: Long BDSI.


RNN: Shares of Rexahn saw a twenty percent jump on Monday after it was disclosed that Teva Pharmaceutical Industries purchased nearly four million dollars worth of RNN common stock in a private offering.

The shares were bought at a significant premium over the current RNN trading price, fueling Monday's run. With this offering, Teva now owns over six percent of Rexahn.

Rexahn has stated that the raised funds will be used to fund the anit-cancer compound, RX-3117, which is still in the preclinical stages of development.

Aside from 3117, Rexahn has a robust pipeline of product to potentially treat various indications, including cancer, depression and Parkinson's Disease, and is a solid long term 'Phase II' pick, in my opinion.

Any dips back towards the one dollar mark would maintain RNN as a solid buy, although it's worth noting that many 'Phase II companies' are always at threat of having to conduct a cash raising event. That said, any cushy deals like the one worked with Teva - where the offering is at a premium - should keep shareholders happy for the short term.

Disclosure: No position.


DDSS:  Labopharm announced last week that the Canadian regulatory authorities had granted the approval of OLEPTRO in the Canadian market. OLEPTRO is a once daily formulation of the antidepressant trazodone, which is intended to treat major depressive disorder (MDD).

DDSS has traded sideways for quite some time now as OLEPTRO has been slow to make headway in the market, and the Canadian approval news had little effect on the share price. Any immediate gains were instantly wiped out as Labopharm has not been drawing much interest or attention of late.

Labopharm has a solid drug delivery technology in CONTRAMID and the company has offered some promising news releases over the course of the past year, however, earnings and news have not been enough to spark a spike in price, leading to the extended period of time at or near the one dollar mark for DDSS.

Although stagnant for a while, when stocks like this one move, they move quick, so I'm still a fan of some accumulation at the dollar mark.

Disclosure: Long DDSS.















Monday, January 24, 2011

MCET: On The Run


Friday's Trading action for Multicell Technologies could have offered a hint for what the new week would bring, as late day trading saw the both price and volume pick up at a pace fast enough to have speculators expecting news come Monday morning.  News never came, but MCET shares were on the move regardless, hitting highs of over 50% the previous trading day's close shortly after the opening bell.

The recent run makes Multicell a smoothe double in just under two weeks time, and there is still the potential that news could push this one higher.

On the other hand, this penny play has been known to return quick doubles before, so the possibilities exist that a retracement to back under a penny could also materialize in quick fashion, so it's always wise - in my opinion - to flip a few trading shares into signficant runs like this one.

Multicell's most advanced product is MCT-125, a therapeutic treatment for fatigue in MS patients that has completed a Phase II trial.  Additional products intended to treat various cancers are in the preclinical or developmental stages of development and are far from being considered potential market moving products.

However, a majority owned subsidiary of Multicell, Xenogenics Corporation, recently purchased all assets relating to Ideal BioStent and Xenogenics then licensed certain intellectual properties of the BioStent to Rutgers University.  Should Xenogenics bring that product to commercialization, then even a small dent in the multibillion dollar market could prove highly lucrative to both Multicell and Xenogenics.

It's been a few months of crickets from the Multicell printing presses, but 2011 has certainly started off with a New Years bang after realizing a quick double.  Speculative penny plays are always a threat to retrace quickly after sudden spikes, but it's also possible that there's still news that has yet to be released. 

Enjoy a few bucks of profit taking, I'd say, but it's probably also worth keeping some base shares in place in case something actually is in the works.

Disclosure:  Long MCET.




Stock Watch: GNBT, Gluskin Out; CLDA, Vilibyrd Approval; Vivus, Delayed


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GNBT:  Might be worth watching the wires for Generex news this coming week.  Shortly after it was announced that Mannkind's Afrezza received another setback from the FDA, Generex put out an 8K on Friday revealing that former CEO Anna Gluskin had effectively resigned from her standing positions at Generex and all associated subsidiaries. 

Gluskin had been removed from her  position as CEO back in late December when all eyes were on the then-pending vote for a reverse split of the GNBT common stock.  Since that time the Executive Vice President of Generex, Mark Fletcher, has been filling in as the interim CEO while a search for a permanent replacement took place. 

Friday's filing announcing the effective removal of Gluskin's association with the company has led to speculation that Generex, a company that has been slim on the news and updates this year, may be ready to issue a more significant announcement - such as the appointment of a new CEO. 

As I mentioned last week, with Afrezza development now relegated to the backburner for the time being, this could be a chance for Generex and Oral-lyn to grab some headlines, and the fact that Anna is out could be an indication that some fresh headlines are on the way.

That said, investors would be wise to keep expectations tempered; it's been a while since a relevant update regarding the Oral-lyn Phase III trial has been released and Generex could really do with a deep-pocketed partner coming on board and boosting the cash position, although the agreement (which is on hold until June now) to acquire a majority ownership of Global Medical Direct hints that the company may decide to go-it-alone in distributing its products.

The FDA's most recent rejection of Afrezza most certainly sets the stage for Generex to make up some ground in terms of timeline if the Oral-lyn trials are advancing as promised, but it also brings to light the fact that the FDA is hesitant to move away from the current standard of insulin delivery, which continues to be the needle. 

Just something to keep in mind.

For the short term, the Gluskin departure has some wondering if some other news is set to follow, which makes the sideways-trading GNBT a stock to watch this week.

Disclosure:   Long GNBT.

Posted Sunday at VFC's NEW Stock House.

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CLDA:  Shares of Clinical Data Inc jumped by over two dollars (a 15% rise) in the after-hours on Friday when a late day press release announced that the FDA had approved the antidepressant vilazodone - brand name Vilibyrd - a potential billion-dollar product since its an antidepressant that does not affect the sex drive of the patient, as most antidpressants do; nothing depressing about that, hey?

Vilibyrd also did not lead to weight gain during trials, another side effect of already-approved antidepressants, but most would probably deal with a little weight gain anyway as long as their was no subdued desire involved.

Nonetheless, Clinical Data and analysts see the preferable side effect profile as potentially placing Vilibyrd ahead of the competition in the antidepressant class with some estimating peak sales of above $2 billion annually, pending additional approvals.

CLDA enjoyed a solid week of attention and volatility, and there could be more to come during the coming week.  If the after hours trading is a precursor, there could be some drastic price increases due come Monday, but it's always a good idea to at least be prepared for any eventuality in the biotech sector.  Recent trading patterns have actually seen shares fall after companies announce positive approval news.  The potential of Vilibyrd may keep that from happening here, but it's happened to company's with bigger products - Dendreon and Provenge come to mind - so an all-out chase of the rising price might not be the best course of action if the price spikes early in the week.

Of course, if follow-up news hits the wires, then all bets are off.

Worth watching.

Disclosure:  No position. 

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VVUS:  Back in October Vivus, Inc made headlines when stocks jumped on news that the FDA had requested additional information regarding the company's weight loss product, Qnexa.  Just three months later, shares took a sharp dive when the FDA again requested additional data for the same product.

In October it was looked at as a positive that the FDA seemed willing to approve Qnexa and did not outright refuse approval, however, this time the FDA is keying in on data surrounding the potential for birth defects for the offspring of those treated with Qnexa. 

Investors or traders looking to play the news in the now-term may have bailed out on Friday because it's possible that it could take Vivus up to five or six months to compile the data that was requested by the FDA, although the encouraging sign is that the FDA did not ask for additional trials.

The longer term prospects for Vivus are for the most part unchanged by the news, but any FDA delay will certainly bring in the sceptics, so the dip in price should have come as no surprise to the news.

Any further dip in price may spark some speculative buying by investors betting that the product will ultimately be approved, but weight-loss products could be a risky play these days as recent history has shown that they could potentially produce severe long term health risks.

Could be a volatile week for VVUS.

Disclosure:  No position.













Wednesday, January 19, 2011

Briefs: BIEL, BDSI, CELH

BioElectronics Actipatch Back Square Healing Recovery Patch, $29.99

BIEL:  BioElectronics' first investor update of 2011 keyed in on updates from the international market, fitting since the company's efforts to receive over-the-counter clearances for its products in the United States has thus far failed, reports on the international front continued on Tuesday as it was announced that the RecoveryRX patch is now fully reimbursable under all insurance providers in the Netherlands.

With no traction being gained to win approvals with the US FDA, expect BioElectronics to continue to highlight the international news, but investors will have to hope it gets a little more exciting than a distribution deal in Iran and reimbursable coverage in the Netherlands.

Sales, sales, sales - it's there the good news needs to originate to have a significant impact on share price.

Disclosure:  Long BIEL. 

Allay Menstrual Pain Kit, BioElectronics

BDSI:  Shares of BioDelivery Sciences received a 10% haircut on Tuesday after the company announced that a patent infringement filed by MonoSol Rx, LLC against BioDelivery, ONSOLIS partner MEDA and Aveva Drug Delivery Systems, Inc this past November has been amended to include a 'false marketing' charge.

It's arguable whether or not the drop in the BDSI stock was justified on this news, but compared to where shares were trading just a short time ago - just over $2 - the dip should not be considered very significant; in fact, a ten percent move to the downside in the biotech sector is barely a blip on the radar on any given day.

The potential of BioDelivery lies in the future of ONSOLIS sales both in the US and abroad, and even moreso in the pipeline products that are being developed using the BEMA drug delivery technology. 

The lawsuit is a factor to take into consideration, most certainly, but it's not likely, in my opinion, that the suit will amount to much other than a slap on the wrist, with a modest settlement sum or royalty rate being awarded to MonoSol as an outcome.

I'm more interested in the development of BioDelivery's pipeline than this lawsuit, at least for the time being, but I'm always a fan of selling some trading shares into any significant spikes just to cover all bases. 

BDSI is no different.

Worth watching.

Disclosure:  Long BDSI.

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CELH:  Volume picked up fairly significantly for shares of Celsius Holdings on Tuesday, with well over 200,000 shares trading hands before the clock ticked three.  No news - positive or negative - was issued in conjunction with the twenty percent drop in price, but it really can't get much worse for Celsius after the company missed sales targets by a margin larger than what Green Bay put up over Atlanta this past weekend.

Until this company can put together a couple of quarters with sales in even the same zip code as the guesstimates, then the riff-raff will do what they want with the stock.  If speculation is your game and you believe that there's still room in the beverage market for a product like Celsius, then playing the volatility may be the way to go.

Interest is low, volume is up and price is down - with the fate of the company hinging on rebounding sales, things could get exciting either way for Celsius Holdings and its shareholders.

A dip below thirty cents late day Tuesday made for a nice speculative buy, in my opinion.

Will be watching, after the volume spike.

Disclosure:  Long CELH.

Posted Tuesday at VFC's NEW Stock Watch.


Tuesday, January 18, 2011

Stock Watch: MNKD

MNKD: Mannkind is going to be on many - if not all - biotech watch lists until the FDA's approval decision for Afrezza is announced. It's expected that the decision will come within weeks, according to the delay announcement released at the end of December, the original d-day for the FDA.

If Afrezza is approved as an inhaled alternative to insulin-by-injection, then Mannkind could have an instant blockbuster on its hands, as diabetics could then start to toss the needle to the wayside.

Of note, Generex is developing another insulin spray product, Oral-lyn; the difference being that Oral-lyn absorbs the insulin through the inner lining of the cheek while Afrezza's insulin is absorbed through the lungs.

There's been speculation in the medical and investor circles as to which method of delivery is better, but there has been just as much speculation surrounding the approvals of each product as well.

We'll know Afrezza's fate before too long now, but Oral-lyn is still wrapped up in Phase III trials and has some ground to make up, barring another delay for Afrezza.

Mannkind's CEO, Alfred Mann, has much invested - to say the least - in his company and its lead product, and he recently used the term "cautiously optimistic" to support his feelings and monetary position towards a potential Afrezza approval. That's a pretty good way to put it from the perspective of a CEO, especially when other CEOs, such as BioElectronics' Andy Whelan, practically promise investors that their products will be approved.

With the FDA - ya just never know. It's a government agency in Washington succept to heavy lobbying and lawmakers, so it's irresponsible at best to expect any consistency.

For instance, Washington is all about regulating this and that, but little attention is paid to the chemicals and the such that are put into the foods we eat (especially the fast foods) that can end up doing more damage to the liver than a night of boozing it up on Grey Goose at European night club.

Back to the topic at hand, the Afrezza decision is looming, and what's good for MNKD and Afrezza should also be good for Generex and Oral-lyn, at least at this point. A positive FDA decision will indicate that the administration is ready to accept spray insulin products into the market place.

MNKD continues to be a stock to watch.

Disclosure: No position MNKD, long GNBT.

Posted Tuesday AM at VFC's NEW Stock House.

Stock Watch: TTNP

TTNP: It's been a nice ride up for shares of Titan over the past week, and the true cause behind the run has still yet to reveal itself. Speculation has it that the continued increased sales of Fanaptthrough the last quarter of 2010 have led to the quick increase in TTNP price, although Probuphine news is also close enough to possibly be a factor behind the speculative rise.

Regardless, Titan has been loaded with potential since the approval of Fanapt in 2009 sparked a run from mere pennies to over two dollars, and it's my opinion that the company is being positioned more towards partnership and acquisition than for its potential as a stand-alone.

Titan's week-long run faltered on Friday - expectedly, as momentum players and profit takers do their thing - but it'll be one to watch for the coming weeks as the possibility exists that the run will be accompanied by some news.

Vanda Pharmaceuticals will also be one to watch, as any positive Fanapt news that affects Titan will also be relevant to VNDA. Titan receives 8-10% in royalties on sales of Fanapt, Vanda's drug which is partnered with Novartis.

Disclosure: Long TTNP, no position VNDA.

Posted Tuesday AM at VFC's NEW Stock House.

Friday, January 14, 2011

PPHM: New Trials for Peregrine

PPHM:  It's been a few months since I last mentioned Peregrine Pharmaceuticals, a company I've long liked as a Phase II accumulation play, but PPHM is in the news again as 2011 opened with news of the initiation of new trials for one of the company's lead products, Bavituximab.

The two newly-initiated trials will measure the effectiveness of Bavituximab in treating pancreatic cancer and hepatitis C, respectively.

News of the trial commencement was enough to have PPHM trading up by over a dollar since late December, although it's worth keeping in mind that Peregrine is essentially still a 'Phase II play' and additional dilution should be expected as the trials move into Phase III and beyond. 

That said, the potential of Bavituximab and Cotara both could be attractive assets to potential big pharma partners or buyers.

Definitely one worth watching into 2011, and a favorite 'Phase II' pick of mine; let's just be realistic and take some profits when available.

Disclosure:  Long PPHM.

Originally posted Wednesday at VFC's NEW Stock House.

Thursday, January 13, 2011

TTNP: The Run Continues, but the Flame Has Yet to Reveal Itself

TTNP:  The rapid run of Titan Pharmaceuticals is almost becoming redundant day after day, but it's worth keeping a continued eye on TTNP as heavier-than-usual volume again spurred a significant move to the upside, as shares reached the $1.70 mark during Wednesday's trading.

Again, no news has been released in conjunction with the run - nor has any been yet released by the company this year, for that matter - so investors are left to assume that either increased Fanapt sales by Vanda and Novartis is the cause of the run, or pending news on the Probuphine front.

The confirmatory Phase III Probuphine trial has been fully enrolled since September of last year, and it's expected that the results will be known early this year.  Positive results could be accompanied by news of a major partnership or buyout, as I've long speculated would be the end result for Titan. 

Regardless of what's going on behind the scenes to fuel the recent run, TTNP is providing another example of how quickly 'long term' (that's a relative term depending on the patience levels of individual investors) accumulation can pay off when a nice speculative biotech play starts to move.

If the first two weeks of the year are an indication, 2011 could bring much prosperity for Titan and its shareholders.

Again - definitely worth keeping an eye on during the coming weeks.  The true cause of the spike has yet to reveal itself.

Disclosure:  Long TTNP

Originally posted on Wednesday at VFC's NEW Stock House.


EZTrader.com

AMRN: Encouraging News Continues Into the New Year

MOVED TO:  http://vfcsstockhouse.com/blog/article/-amrn-encouraging-news-continues-into-the-new-year

Wednesday, January 12, 2011

TTNP: Titan on a Roll

TTNP:  After highlighting the nice trading from this past Friday, I couldn't let Monday's action go unnoticed as shares of Titan closed the day up eleven cents at $1.47.  Volume has also picked up fairly significantly since the afternoon hours on Friday, leading to speculation that news might be pending or accumulation could be in the works by a bigger player than just your average retail guy.

As I mentioned previously, the rise could be due to an increase in fourth quarter sales numbers for Fanapt which would lead to a larger royalty check for Titan - and we'll know soon enough if that is actually the case - but with the latest Probuphine trial having completed full enrollment in September of last year, trial results should be forthcoming before the end of the second quarter.

Positive announcements on either front could lead to a continued run in the TTNP share price and also provide more ammo for the argument that Titan is a candidate for a partnership deal or acquisition.

It's worth adding on any dip back towards a buck, in my opinion, and let's watch the wires for the Q4 Fanapt sales numbers.

Disclosure:  Long TTNP.

Originally posted on Tuesday at VFC's NEW Stock House.

Covestor Investment Management

MHAN: The Penny Plays Run Quick, Hey?

MOVED TO:  http://vfcsstockhouse.com/blog/article/-mhan-the-penny-plays-run-quick-hey-

Originally posted on Tuesday at VFC's NEW Stock House.Zecco Holdings



BIEL: Year's First Investor Update

BIEL:   BioElectronics closed out the year in 2010 with news that the company had reached a 12-month agreement with MUNCmedia to communicate the BIEL story to retail investors, of which MUNC claims to have a network consisting of 90 million.

The push to attract retail investors, however, will indicate to many, in my opinion, that the company has failed to attract the quality and/or quantity large investors that should be preferable.

While this deal may pay off, revenue growth and resolving the FDA situation should be the primary means for attracting new investors, not MUNCmedia who might play the BIEL game about as well as Joe Noel.

Another item that diminishes the impact and credibility of the MUNC press release is that a report by ING Direct USA/Sharebuilder is cited in the press release as justification for a push into the promotional retail market.  Problem is, you can't purchase shares of BIEL with Sharebuilder, so what does that say?  Why reference a report by Sharebuilder that doesn't find it fit

This company does not need to be expending resources on stock promotion, it needs all resources geared towards growing sales numbers and receiving over the counter approval in the US - if those items materialize, then that would be promotion that even MUNCmedia couldn't provide.

BioElectronics Actipatch Back Square Healing Recovery Patch Actipatch Knee Pain Swelling, Bruising & Scarring Therapy Kit
 From the late-December MUNCmedia press release, let's move to the first Investor Update of 2010 on the BIEL website, which emphasizes an additional push on the international front.  Moves into both Iran and Russia forefront the report, with expanded distribution into Hong Kong also mentioned.

This news can be received in two lights.  While Iran and Russian are two of the more legitimate and non-corrupt governments that we can think of (sarcasm intended), it's also ironic that BioElectronics was able to push an American-made product through those bureaucracies with more speed and efficiency than with the US FDA.

On the FDA front, the issues discussed in the update regarding the RecoveryRX submission should come as no surprise, for while the US has a reputation of being the best place there is for the little guy to succeed, that only goes so far unless you're carrying a boatload of cash and a whole bunch of lobbyists with you to Washington.  As I've mentioned on numerous occasions, a product from a small company such as BioElectronics with products in competition to those of the big boys should not be expected to be high on the FDA's list of priorities.

2011 could be a year of significant international growth for BioElectronics, but the most signficant potential catalyst for the short term continues to be the over-the-counter clearance in the  United States.

BIEL closed Monday at just under a penny, so the stock is still highly speculative, but does hold a good deal of potential if the products catch on overseas and are allowed to be marketed in the US.

Disclosure:  Long BIEL.

Actipatch Wrist / Ankle or Foot Pain Therapy - Bioelectronics

Originally posted on Tuesday at VFC's NEW Stock House.

Monday, January 10, 2011

TTNP: Nice Friday Action

TTNP:  Shares of Titan Pharmaceuticals enjoyed a late day price and volume surge on Friday, closing the day at $1.36. 

With ongoing Probuphine trials offering the company indigenous potential for the future, the shorter-term catalyst could relate to increased sales of Fanapt, Vanda Pharmaceuticals' schizophrenia drug which has realized significant sales growth for the duration of 2010.  Titan receives an 8-10% royalty on sales due to a long-existing licensing agreement.

Since flying from a penny to $2.50, Titan spent most of 2010 retracing its steps to the one dollar mark, but that may end up haveing been a bargain of a re-entry price with all that's on the table for this company.

Growing royalty revenue from Fanapt sales could become a side-note to the Probuphine show, as it's expected that results from the trial will be announced early this year.  The ProNeura subcutaneous drug delivery technology behind Probuphine should also not be ignored for its potential applications for other indications.

Additionally, in light of this potential, Titan could be lined up by big pharma as a potential target for a partnership or acquisition.

TTNP could turn into a nice success story for 2011 - stay tuned - although don't expect a repeat of the percentage gains that shareholders enjoyed on the major run of 2009.

Disclosure:  Long TTNP.

Posted earlier at VFC's NEW Stock House.

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CVM: Trial Approved in Russia

CVM:  After recently announcingthat the long awaited Phase III Multikine trial for head and neck cancer was a go, Cel-Sci Corp issued a press release last week announcing that the Russian medical authorities have given the company approval to commence the trial in its Russian locations.

This tid bit is a nice piece of ancillary information, but keep an eye out for news of enrollments - that's what really matters right now in terms of a relevant next step after it was announced in the last week of December that the trial had commenced.

Aside from a quick spike on the day the trial start was announced, CVM has traded relatively flat since settling in the eighty cent range after climbing to near a dollar from fifty cents over the past couple of months.

If Multikine ends up becoming an approved success, these prices will be looked back upon as quite the bargain, which leads me into the 'Readers Respond' portion of this post:

From an anonymous reader of VFC's Stock House:

Why is this stock so cheap. Whats wrong.....VFC's Take:  Let's first address the "so cheap" aspect of the Cel-Sci stock.  I may be off base, but I believe that the reader is associating CVM's sub-$1 share price with being a cheap stock, but the trading price does not tell the whole story.  The amount of shares trading in relation to price is what's important, and CVM's shares times price give us a market cap of roughly 170 million - that is what is important when assessing whether a stock is cheap or not.

Cel-Sci Corp. only just recently commenced its Phase III trial for Multikine, so essentially CVM is what I'd call a 'Phase II' stock, which - to be honest - the current market cap could arguably be justified for a Phase II company.  On the other hand, Multikine holds a lot more potential than many other Phase II/III products out there if only because we saw with Dendreon (DNDN) how the market reacts to approved cancer immunotherapies.  That said, Multikine is still a long way from market, so that's all Multikine and CVM are right now - potential.

So, each individual investor must come to his or her own conclusions about whether or not CVM is cheap, expensive or right where it should be based on the sub-$1 share price - but don't forget to take market cap into consideration. 

Price is not the only factor that determines whether or not a stock is cheap.

In the meantime, trial enrollment numbers are what investors should have their eyes on now.

Disclosure:  Long CVM. 

Posted earlier at VFC's NEW Stock House.


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Tuesday, January 4, 2011

Long Awaited Trial Is A Go

"Finally!" At least that's what long time investors of Cel-Sci Corp were saying during the last week of 2010 when it was announced that the long-awaited Phase III head and neck cancer trial for Multikine had finally commenced.

Titled "IT MATTERS" (ImmunoTherapy Multikine Anti Tumor Treatments), the trial is expected to be enrolling patients at all 48 clinical sites within just a few months, according to Mr. Eyal Talor, Cel-Sci's Chief Scientific Officer.

As has been mentioned on numerous occassions, this trial is expected to be the largest ever conducted for a head and neck cancer treatment and will span three continents and nine countries.

Although announcements of a trial commencement do not give indications of success, rather it's an indication of progress, this trial - that for years has been more of a tease than Jenny McCarthy on 'Singled Out' - is significant in the fact that Multikine is being tested as a first line treatment. Additionally, Multikine could usher in the new wave of cancer vaccines since Cel-Sci will not need cells from the patient in order to produce the treatment, unlike other cancer vaccines such as Dendreon's Provenge that need a patient sampling before producing the vaccine in the laboratory.

Cel-Sci has methodically prepared for the launch of this trial for years, including the dedication of all available resources and assets to a top-line Multikine production facility near Baltimore, Maryland that also offers the company the possibility of revenue streams from contracting and leasing agreements. The true - and only relevant potential, at least for the time being - is Multikine.

The trial completion date is still far off in the future, the potential significance of this product as a first line treatment for head and neck cancer should keep CVM at or near the top of the 'Possible Next Dendreon' list.

Cel-Sci also has LEAPS in its back pocket, but unless another opportune situation arises - like an H1N1 epidemic - all resources will most likely be geared towards bringing Multikine to market.

The CVM share price, after receiving an initial spike on the news, has traded relatively flat on the Phase III start announcement.

Disclosure: Long CVM.

Posted earlier at VFC's NEW Stock House.

MNKD and GNBT, Game Changers for 2010?

Mannkind heard from the FDA regarding an approval for its inhaled insulin product, Afrezza, although no final decision was made as the regulatory agency declared that it would need another four weeks before rendering the highly anticipated decision.

Shares of Mannkind responded positively to the announcement of a delay, as many probably expected an outright denial of Afrezza based on past interactions, but the delay may be an indicator that the FDA is taking the product seriously and could be on the verge of issuing an approval.

In actuality, it's also possible that the FDA is just backlogged - as usual - and needed the additional time to get over the holiday hangovers before getting down to business; after all, Washington does come to a standstill during the winter holiday season.

The Mannkind/Afrezza story continues to be one worth following, as any product for insulin delivery that does not use a needle should be considered a potential blockbuster.

As we know, Generex is also working on such a product, Oral-lyn, although O-L utilizes the inner lining of the cheek to deliver the insulin, where Afrezza uses the lungs.

Generex, in the meantime, announced that an agreement had been reached to extend the closing date of its majority purchase of Global Medical Direct, LLC to June 1, 2011. The company had previously been counting on raising the necessary funds for the acquisition through - in part - a reverse split that never materialized.

Both Mannkind and Generex could become game-changers in 2011, and will be worth watching.

Disclosure: Long GNBT, no position MNKD.

Posted earlier at VFC's NEW Stock House.

CELH: 2011 Opens Back on the OTC

CELH: 2011 started off for Celsius Holdings in an almost 180 degree reversal from 2010. In 2010, the company spoke of the promise of trading on the Nasdaq while management offered sales projections that, in retrospect, were about as far off the mark as you can be while still maintaining a shred of credibility.

After the calamity that became of the time that CELH spent trading on the Nasdaq, Celsius opened the new year trading right back on the OTC with expectations a lot less enthusiastic than those of the previous year.

The marketing and advertising of 2010 has done little (in terms of sales) to persuade investors that the products are catching on like the company says they are, but a couple of strong quarters to open the year could turn things around quick, fast and in a hurry. The key is to see two consecutive strong quarters of growth consistent with company projections; that's something that we have not yet seen, and something that needs to be seen for the company to garner new found confidence.

There's still a lot of potential here - the products are good, novel and the trend is right, but the returns have just not been there. You almost have to wonder if Mario Lopez actually hurt sales more than he helped them.

2011 opens with a clean slate for the company. The current market cap in total is less than the amount of two quarters worth of sales, at least according to the projections of management, so a quick rebound could be in store. However, another quarter of sliding backwards could signal the beginning of the end, if it hasn't been signalled already.

The new products and new flavors may speak of renewed optmism, but the sales numbers need to show it. Investors have been forced to disregard estimations provided by the company.

It's the product that keeps this one alive, in my opinion, because the product is good; Cola (with ice, terrible warm) being the favorite and the Green Teas close behind.

Disclosure: Long CELH.

Posted earlier at VFC's New Stock House.

ACTC: Volatility and News to Open the New Year

MOVED TO:  http://vfcsstockhouse.com/blog/article/-actc-volatility-and-news-to-open-the-new-year

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