RiverBabe's Baby Biotechs

[riverbabe]

Nymx

Sorry I'm late on this, peanuts. Didn't check my mail for days (took time off).
Anyway, looks like much good news for NYMX, what with a $13M deal with Recordati for EU+ distribution of anti-enlarged prostate drug. http://finance.yahoo.com/news/Nymox-....html?x=0&.v=1 and also $15M in equity financing from institutions.
Increased volume today, with some profit taking at the close. Hit 8.00 at one point, closed at 7.59. Hope you got in at the open, around 7.00, if you got in at all. Love Canadian companies, especially this one's strong tie with McGill University (one of the biggies). Their product is in Phase 3 clinical studies, looks like it requires only one treatment for at least 5 years of benefit. http://www.sec.gov/Archives/edgar/da...xhibit99-1.htm In a way, that's a detriment, eh? No daily pills or anything. But as long as the population (male) keeps aging, there should be a steady flow of customers. (Imagine the surprise of all the old guys here on MrM when they find out they won't have to pee "urgently" or to get up two or three times a night to pee any more.) It sounds like a really great product. Couldn't find any information on an NDA filed in the US yet, or on how long the Phase 3 studies will be going on.

I actually like this company. Some analyst has 14.50 target on it.

Hey Hey. Safety Committee just found the treatment 100% safe! Stock up 10% right now. Happy are we who have a few shares. http://finance.yahoo.com/news/Januar....html?x=0&.v=1

[billyjoe]

River,
What are your thoughts on CELG? It's either a great buy at around 50 or something is wrong with their product line.

-----------billy

[riverbabe]

River,
What are your thoughts on CELG? It's either a great buy at around 50 or something is wrong with their product line.

-----------billy

Picked these up on twitter yesterday (from Reuters):
http://www.reuters.com/article/2011/...7128UL20110203 AND

http://www.reuters.com/article/2011/02/04/us-celgene-idUSTRE7135HJ20110204

iT'S EITHER A BUY OR IT'S NOT depending on your point of view as to whether or not management deceived investors. Worth watching, at least the volume. But remember, for every buyer there's a seller.

Celgene shares fall on drug malignancy concerns

Celgene Corp
CELG.O
$51.29
+1.79+3.62%02/04/2011
By Toni Clarke

BOSTON | Thu Feb 3, 2011 4:58pm EST

BOSTON (Reuters) - Shares of Celgene Corp (CELG.O) fell as much as 8 percent on Thursday amid growing concerns that its most important cancer drug, Revlimid, could cause secondary malignancies in some patients with the blood cancer multiple myeloma. Revlimid is approved to treat multiple myeloma in patients who have received prior treatment, but the company is seeking to win approval for it as a maintenance therapy -- to be used earlier in the disease and for longer periods of time.

Celgene recently said it had suspended dosing in one of its three pivotal maintenance therapy trials, known as IFM 2005-02, due to a higher rate of secondary malignancies. "This difference in malignancies has resulted in the suspension of dosing in the trial (IFM) and the suggestion by investigators that the duration of Revlimid maintenance should be limited to 12, 18 or 24 months," said Geoffrey Porges, an analyst at Sanford Bernstein, in a research note.

Celgene recently filed for marketing approval of Revlimid in Europe for newly diagnosed patients and as a maintenance therapy. The company expects to file for approval in newly diagnosed patients in the United States later this year. Sales of Revlimid rose 42 percent in the fourth quarter to $707.5 million, driven by increased use of the drug for longer periods. Investors are banking on the momentum continuing.

"Celgene's management have damaged their credibility with investors by their incomplete disclosure about this issue," said Porges, who interviewed at least one clinical trial investigator on Thursday. "The big disparity between what we learned today and what we and investors had learned from Celgene is that the observation bias alluded to by Celgene does not appear to explain the difference in cancer cases in the IFM study." Greg Geissman, a spokesman for Celgene, declined to comment in detail, but noted that the company did mention the issue on a recent earnings conference call.

According to a transcript of the call, the company mentioned that the IFM was considering amending the trial's protocol to discontinue Revlimid maintenance therapy for the roughly 70 patients still in the study. "This amendment would enable Celgene and the IFM to fully explore all potential variables associated with the small number of second primary malignancies reported in the IFM-0502 trial," said Robert Hugin, the company's chief executive officer. Hugin also said Celgene was working with the IFM to investigate the benefit of retreatment in those patients who stopped maintenance therapy and whose disease then progressed.

But Porges believes the company downplayed the importance of the findings. "The risk benefit of Revlimid maintenance still seems overwhelming, and sufficient to justify approval, reimbursement and use, but the trickle-out disclosure that is contrary to Celgene's statements is concerning," Porges said.

Celgene's shares closed down 6.9 percent at $49.50 on Thursday. Earlier in the day they fell as low as $49.

(Reporting by Toni Clarke, editing by Matthew Lewis)

AND

Analysis: Celgene's new CEO faces first challenge of tenure

Stocks
Celgene Corp
CELG.O
$51.29
+1.79+3.62%02/04/2011
By Toni Clarke

BOSTON | Fri Feb 4, 2011 1:52pm EST

BOSTON (Reuters) - The CEO of Celgene Corp (CELG.O), Robert Hugin, is facing his first major challenge since taking the helm of the biotechnology company last June.

The company's shares have fallen more than 10 percent since December 6, when it revealed a potential connection between its cancer drug Revlimid and the risk of developing a second primary malignancy. Revlimid, which is approved in combination with the steroid dexamethasone to treat patients with the blood cancer multiple myeloma who have received at least one prior treatment, is Celgene's most important product.

Over the past few weeks, investors have grown increasingly concerned about the potential for Revlimid's sales to be hurt, and on Thursday its shares fell as much as 8 percent. Geoffrey Porges, an analyst at Sanford Bernstein, said in a research note that Celgene's management "have damaged their credibility with investors by their incomplete disclosure about this issue." The controversy relates to a decision by the Intergroupe Francophone Du Myelome (IFM) -- which is running a trial known as IFM 2005-02, to suspend dosing for the roughly 70 patients still in the trial in order to further evaluate safety.

Porges argues that the company downplayed the significance of the second primary malignancy findings. In its defense, Celgene points to the fact that Hugin told investors about the suspension on its fourth-quarter earnings call, and said it "would enable Celgene and the IFM to fully explore all potential variables associated with the small number of second primary malignancies reported in the IFM-0502 trial." Celgene said Porges was an exception and that "a majority" of analysts is defending the company.

The company hopes to win approval for the use of Revlimid in newly diagnosed patients and for longer, maintenance therapy. Investors are banking on longer usage to fuel growth. Sales of Revlimid rose 42 percent in the fourth quarter to $707.5 million.

On Friday, however, some analysts jumped in to defend Celgene, helping the stock bounce back as much as 3.4 percent. Shares were up 2.4 percent at $50.68 on Friday afternoon. Analysts at J.P. Morgan surveyed physicians and found that 68 percent believed the data about second primary malignancies would not impact their practice, according to slides from a J.P. Morgan call released by Celgene. "Even if a direct association was found between Revlimid and SPMs, 70 percent of physicians would not consider taking patients off maintenance therapy due to a very favorable view of the overall risk/benefit profile," the analysts said. "It does not appear the rate of second primary malignancy will have a fundamental impact on Revlimid maintenance use, in our view."

The IFM trial is one of three pivotal trials that will determine whether the drug wins approval for earlier and longer usage. Celgene has already filed for approval in Europe and expects to file in the United States later this year.

[riverbabe]

Celg

billy, I know you do great DD, so you probably saw this "it's the best biotech bargain around" article. GLTY. http://seekingalpha.com/article/2509...h?source=yahoo

[billyjoe]

River,
Thanks for the article. I had not seen it. These biotechs drive me crazy. Beth has had VGHCX for years and it's just caught up to its price of 3 years ago but still a ways to go to match 2007. With health care prices going up constantly, the money seems to be going into a black hole. The hospital workers aren't getting it, the stock prices don't reflect the increases, it's a real mystery to me.

----------billy

[riverbabe]

River,
Thanks for the article. I had not seen it. These biotechs drive me crazy. Beth has had VGHCX for years and it's just caught up to its price of 3 years ago but still a ways to go to match 2007. With health care prices going up constantly, the money seems to be going into a black hole. The hospital workers aren't getting it, the stock prices don't reflect the increases, it's a real mystery to me.

----------billy

They drive me crazy too. The baby biotechs rely on catalysts to boost them and if it's nay instead of yea they lose big time. Most of the time, it's a coin toss, called a "binary event." Most of them are very thinly traded so when quite a few people pile in (like subscribers following their guru's tip) the price move up is quite spectacular. Same goes for a nay decision. Just try to sell your shares at that point! The down move is also spectacular. So, 2011 is my year for being conservative on these.

The big biotechs have different problems, but not too different. Like CELG, e.g. Spreading the risk, like Beth's fund, is some protection but tends to even things out so the price movements are smaller, but you have to be more patient, and when biotechs are out of favor, even more patient.

The best luck I have had in the past is owning the right one at the precise time of the big buyout. This has happened at least four times (in the last ten or so years. ouch) At least my grandkids college fund benefitted so well from AstraZeneca's buyout of Medimmune (my so-called broker named MEDI my sacred cow because I refused to sell it hoping for buyout) that they (all 8 of them) are funded for 1+ years. The oldest is graduating this year and will have enough to pay off all his student loans and a load of cash besides, in spite of the $400 a month for living expenses he's gotten for two years already.

[riverbabe]

FWIW, the only biotechs I own now are AFFX, BMRN, DNDN, GENZ (BO candidates?), NYMX (I like it, speculative) and NVS (for the divi 4.17% yield and possible growth). I am currently red in AFFX, BMRN, DNDN, green in GENZ and NYMX, up 7.3% in NVS (excl. divis). Not spectacular, but I'm patient.

[riverbabe]

Required reading!

This article should be required reading for anyone thinking about investing in baby biotechs! Fair warning!

http://www.reuters.com/article/2011/02/05/us-drugs-fda-idUSTRE7135FR20110205

[billyjoe]

River,
Now you've got me scared ! I do own a bunch of AFFX also.

--------------billy

[riverbabe]

River,
Now you've got me scared ! I do own a bunch of AFFX also.

--------------billy

Actually, I don't consider AFFX a baby bio. It actually has some revenue. I am holding it only as a possible TO target. Remember BEC? This link is to some comments on the zoo board. If it doesn't get bot soon, I'm out.

http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=te&bn=51280&tid=3024&mid=3024&tof=1&frt=2#3024

[Peter Hansen]

River

River check out this article from Forbe's Magazine .....my brother read about PYMX while sipping coffee at Borders Reading the magazine , which he deftly returned to the rack. I said no wonder Borders is Bankrupt LOL

http://blogs.forbes.com/robertlangreth/2011/01/28/the-genius-chemist-and-his-assault-on-mutant-killer-bacteria/

Looks interesting ......but we have been down this road before.....only consolation is that all the sellers appear to have been wrung out!

[riverbabe]

VERY interesting...

River check out this article from Forbe's Magazine .....my brother read about PYMX while sipping coffee at Borders Reading the magazine , which he deftly returned to the rack. I said no wonder Borders is Bankrupt LOL

http://blogs.forbes.com/robertlangreth/2011/01/28/the-genius-chemist-and-his-assault-on-mutant-killer-bacteria/

Looks interesting ......but we have been down this road before.....only consolation is that all the sellers appear to have been wrung out!

Wow. Sounds like they're on to something very original. They're still in clinical trials, mostly Phase 2. I wonder how they will address the concerns (i.e. have clinical data that passes muster at the FDA) about safety...

"Wall Street remains skeptical. PolyMedix shares hover around a dollar. A key question is whether the drug will be able to distinguish bacteria from host as it goes about its killing business. PolyMedix Chief Executive Nicholas Landekic is optimistic--there have been no showstopper safety problems so far--but only big human trials can tell for sure." A good one to watch for results. Thank you!

[riverbabe]

Mnkd

Looks like we were right not to take the risk for a change. Comments on yesterday's earnings release and CC.

http://www.thestreet.com/story/11004597/1/mannkinds-founder-shuts-his-wallet.html

[billyjoe]

River,
Some nice action today in AFFX. I'm not worried anymore.........at least for today.

----------billy

[Louetta]

Would you care to opine on AMRN? 'Preciate any input you may have...