RiverBabe's Baby Biotechs

[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

[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.

[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]

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

[edward]

Thanks for the great info. Could be worth keeping an eye on. I'd love a repeat of last spring's run-up!

[riverbabe]

River,
Any insight as to what's going on with Rexahn, RNN? I see it's on the rise again. Quite a big move today. Thanks!

The word is it's because of this article:

http://seekingalpha.com/article/247986-rexahn-pharma-is-considerably-undervalued-based-on-prospects-recent-developments?source=yahoo

I don't have any interest in it right now though.

[edward]

River,
Any insight as to what's going on with Rexahn, RNN? I see it's on the rise again. Quite a big move today. Thanks!

[riverbabe]

Affx

So that's what the article was all about! Fascinating billy.

[billyjoe]

AFFX again

River,

I found this article interesting. http://finance.yahoo.com/news/Affyme....html?x=0&.v=1

Several years ago I was heavily into the Fern and Hosta business. Many new varieties are patented but patent owners had problems when other companies would propagate the patented varieties, sell great quantities of them without paying royalties, and claim they had discovered the varieties, often as a mutated seedling. A company, perhaps AFFX, came up with a method of putting a genetic marker in the plants. You could say it was like checking DNA of the plant to see if it had been kidnapped. I don't know how this has developed over the past ten years but I've heard reports of greenhouses being raided and 10's of thousands of plants being destroyed, just like the old bootlegging days.

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

[billyjoe]

Affymetrix is a well established company I have liked for a long time. Its recent acquisition of Thermo Fisher is a definite positive catalyst. (Disclosure: my father-in-law worked for Fisher Scientific for years and years and years. I am also familiar with their products through my former research and hospital lab experience).

http://www.fool.com/investing/general/2011/01/12/affymetrix-shares-popped-what-you-need-to-know.aspx

The chart is beautiful with a good buy point of about 5.30. Congrats billy! And thank you for bringing it here!

River,
I'm all in now. Bought at 5.30 shortly before your post and again today at 5.08. Barchart has support at 4.97 and 4.84. Resistance 5.31 and 5.52. VV has a stop at 4.68.

----------billy

[riverbabe]

The FDA letter secrecy

Another example of what biotech investors are up against:

http://blogs.forbes.com/matthewherper/2011/01/20/mannkind-beconds-poster-child-for-dangers-of-fda-secrecy/?partner=yahootix

Best quote of the day:

matthewherper Matthew Herper
by adamfeuerstein
I think @aviksaroy's note has the best $MNKD headline. "A Giant Leap Backward For MannKind."

[riverbabe]

Mnkd

This is a link to the SEC filing (8-K) by Mannkind about the Complete Response Letter from the FDA:

http://www.investors.mannkindcorp.com/phoenix.zhtml?c=147953&p=IROL-sec

The second link is to Adam Feuerstein's article today at TheStreet.com

http://www.thestreet.com/story/10979582/1/mannkind-founder-loses-cult-status.html

[riverbabe]

Apparently the fat lady has sung for MNKD. FDA wants 2 more clinical trials for Afrezza. MNKD spokesman says that could take 2 years to complete. Shares fall over 44% in extended trading from 9.11 to 5.04. My newfound conservative investing has saved me.

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

ditto for me. Poorer Al Mann, who bot even more shares before this announcement, poorer Al. The latest video of his that I watched was not enthusiastic, for him the most enthusiastic of promoters. So I was not motivated to buy. Happy happy I didn't. Feel sorry for him. If it ever gets approved, it could be HUGE!!! But, his statement that the FDA spent TWO WEEKS looking at the facilities that did the comparative studies between the original device data and the new device data (instead of about two days) made me think there was going to be a problem. Sat on my hands, thank God.

[billyjoe]

Apparently the fat lady has sung for MNKD. FDA wants 2 more clinical trials for Afrezza. MNKD spokesman says that could take 2 years to complete. Shares fall over 44% in extended trading from 9.11 to 5.04. My newfound conservative investing has saved me.

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

[riverbabe]

River,
Here's one not mentioned for a long time......AFFX. A person I won't name that has an outstanding track record of stock picking likes it and I just bought quite a bit and am willing to hold for 6 months or more. Their business is genetic analysis, DNA chips, and reagents.

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

Affymetrix is a well established company I have liked for a long time. Its recent acquisition of Thermo Fisher is a definite positive catalyst. (Disclosure: my father-in-law worked for Fisher Scientific for years and years and years. I am also familiar with their products through my former research and hospital lab experience).

http://www.fool.com/investing/general/2011/01/12/affymetrix-shares-popped-what-you-need-to-know.aspx

The chart is beautiful with a good buy point of about 5.30. Congrats billy! And thank you for bringing it here!