RiverBabe's Baby Biotechs

[riverbabe]

River,

OPTR positive news on anti diarrhea drug. How much more would good April panel results add? Maybe another quick 10%?


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

It may be the panel is already priced in. But with positive PDUFA price increase should be stunning, but may be transient. This is the only alternate antibiotic to vancomycin for C. diff. and performs better with far fewer relapses. FDA sees nothing wrong with the reported results, regardless of the (serious adverse effects) SAEs which were no worse than vancomycin. The benefit/risk ratio is in favor of OPTR approval. Even if there is no buyer for the company (unlikely) immediately, this should be a blockbuster drug worthy of a major pharma. (disclosure: I personally knew 3 little old ladies (mothers of friends/relatives) who have died of C. diff. in nursing home. It is so dreadful I don't even care to describe it). (ask your expert)

[riverbabe]

Optimer

Adam Feuerstein from TheStreet.com doing live blog on OPTR FDA panel. Watch here to see how these things work:

(OPTR halted pending results) Panel concludes by 4PM, possible repopen in AH or earlier?

http://www.thestreet.com/story/11071489/1/optimer-pharma-fda-panel-live-blog.html

[billyjoe]

"analyses favor fida over vanco" sounds good so far

---------billy

[peanuts]

DNDN - medicare approved for $90K+ treatment cost

NYMX - technically ripe

Both moved nicely today... DNDN has been especially strong lately

[riverbabe]

Both moved nicely today... DNDN has been especially strong lately

Go DNDN! Some analyst looking for $100 eventually. (yeah, yeah, but a long way to go)

NYMX reported good trial results. you're right, chart looks good.

[Louetta]

Here is an interesting article from a source I am familiar with: http://biotechinvestmentparadigm.com/?p=954
FWIW, here's another one: http://investorshub.advfn.com/boards...e_id=59379471#
I'll try to some more looking at this one. No time today.

CORT today announced that it has submitted its New Drug Application for the use of CORLUX in Cushing's Syndrome to the U.S. FDA plus a request for priority review which I gather takes 6 months.

[Louetta]

Hi Louetta! Welcome back! I am holding some AMRN on all the takeover rumors. But you know what those rumors are worth. http://seekingalpha.com/article/2520...ce=marketwatch
It has an apparently fantastic drug to lower triglycerides when taken with a statin. Since Lipitor is coming off patent soon, it is thought that maybe GSK or PFE are interested. The CEO keeps bragging that the company has more suitors than the 17 staff they have. Get a load of the institutional ownership! http://whalewisdom.com/stock/amrn
ALSO from 2/11/11: Posted: Mon Feb 14, 2011 2:01 pm
ronpopeil Share Monday, February 14, 2011 12:29:17 PM
Re: Biorunner post# 40142 Post # of 40153

AMRN - From Maffais.com (off the yahoo board)

WOW! Instituitional Activity is picking up Nicely!

These were filed on 2-11-11

Levin Capital Strategies L P added 76,000
Knott David M Sold all -516,213
Suttonbrook Capital Management Lp new holding 449,700
Susquehanna International Group Llp new holding45,605
Renaissance Technologies Corp added 486,444
Knight Capital Group Inc added 22,279
Franklin Resources Inc added 83,000
Duquesne Capital Management L L C new holding 700,000
Bank Of New York Mellon Corp added more 3,223,400

Previous Shares Held By Institutions 31,636,393 Net Shares Changed (Pct): 6,446,975 (20.37%)
Current Shares Held By Institutions "Don't worry about the world coming to an end today. It's already tomorrow in Australia"

http://www.amarincorp.com/products/amr101-for-reducing-cardiovascular-risk.html

The MARINE phase 3 trials have met the primary endpoint and an NDA is expected soon in 2011. http://investor.amarincorp.com/relea...leaseID=533361
The ANCHOR phase 3 trials are underway. If successful NDA and good ANCHOR results, the drugs could be block busters and pose a threat to any generic Lipitor. http://clinicaltrials.gov/ct2/show/N...=amarin&rank=2
I don't know, anybody's guess at this point. It could be a long wait. But the price is right and I'm willing to wait a while but bail at bad news.

AMRN up 70% in the premarket. May not hold that thru the day but a good start.

Happy marathon day. Watch Kim Smith.

[riverbabe]

AMRN up 70% in the premarket. May not hold that thru the day but a good start.

Happy marathon day. Watch Kim Smith.

WOW! thanks for the heads up! Triple the daily av. vol. already in pre-market. I'll be taking profits here! (no oinks) (in @ 8.20, current ask 16.10!)

P.S. Sold, av 16.21 YES! Happy marathon to you! Hope you have the day off. Enjoy!

[Louetta]

WOW! thanks for the heads up! Triple the daily av. vol. already in pre-market. I'll be taking profits here! (no oinks) (in @ 8.20, current ask 16.10!)

P.S. Sold, av 16.21 YES! Happy marathon to you! Hope you have the day off. Enjoy!

Sometimes it pays to be lucky. Went to the marathon, have no blackberry type device so was cut off from the world. Just got back and sold for 16.99 otherwise would have sold earlier.

[toxo]

Optr

Hi Babe, time to bail on OPTR or should I hang for the what May brings? Thanks for your insite!

[riverbabe]

Hi Babe, time to bail on OPTR or should I hang for the what May brings? Thanks for your insite!

I'm hanging on for the end of May decision, even though slightly in the red. Have a full position, but might still consider buying more with my lucky ICO $$. This is going to be a block buster drug if approved, and there doesn't seem to be any reason not to approve. If there are labeling restrictions, it will still be block buster. Can't guarantee a sure thing, but the odds are looking very good. River

[toxo]

Optr

Thank-you!

[Louetta]

RB, I'd be interested in any thoughts you may have on ANTH. They appear to have a couple of late stage studies in progress.

Thanks.

[riverbabe]

Anth

RB, I'd be interested in any thoughts you may have on ANTH. They appear to have a couple of late stage studies in progress.

Thanks.

I don't see any near term catalysts. The current Phase III clinical trial (A-002) just completed enrolment, with an estimated completion date of Feb 2012 with analysis of data after that, prior to filing NDA if applicable.

http://www.clinicaltrials.gov/ct2/show/NCT01130246?term=vista-16&rank=1

It seems pricey to me at this time (6.92 - 7.00 ish). The IPO price was 7.00 and then it dropped back to 4.14 by 2/4/11 after some dilution. The recent financial report indicates quite an increase in expenses.

http://finance.yahoo.com/news/Anthera-Pharmaceuticals-prnews-2887053945.html?x=0&.v=1

There hasn't been much blatant interest in it lately, as far as I can see.

FYI, the following is an analysis by one of my sources as of Feb this year. (biorunup.com) (it's all public data)
Posted: Fri Feb 04, 2011 Overview of pipeline and lead product candidates with pending clinical trial catalyst events…

http://www.anthera.com/products_overview.asp

Pivotal Phase 3 (VISTA-16) Clinical Trial under SPA

A-002 (varespladib methyl) (once-daily, oral inhibitor of sPLA2 enzyme)

ClinicalTrials.gov ID NCT01130246 with estimated final study data during 1H12 in combo with statin drug therapy for treatment of acute coronary syndrome (ACS), scheduled interim futility analysis after at least 1,000 patients complete treatment expected by mid-2011

Phase 2b (PEARL-SC) Clinical Trial

A-623 (Sub-cutaneous Dual Inhibitor of BAFF or BLyS)

On 12/14/10, reported Merck Bio-Manufacturing will supply A-623 for testing and resumed pt enrlmt in JAN 2011 following resolution of product vial issues, ClinicalTrials.gov ID NCT01162681 w/ expected top-line efficacy data during 1H12 and bio-marker (B cell) interim data expected during 1H11 for patients w/ lupus

On 11/2/10, reported 3Q10 quarterly financial results, including…

- total operating expenses during 3Q10 of $8.4 million (M) and $22.8M for the first nine months of 2010

- ended 9/30/10 with approx. $73.1M in cash / equivalents and short-term investments – was awarded $1M in federal grants on 11/1/10

- as of 11/10/10 has 32.8M shares of common stock outstanding, zero debt, and market cap of approx. $135M w/ stock price at $4.14 on 2/4/11

Below is the history of capital raises and stock sale history from the time of the IPO…

- On February 26, 2010, the Company’s Registration Statement on Form S-1 was declared effective for its initial public offering (“IPO”), pursuant to which the Company sold 6,000,000 shares of its common stock at a public offering price of $7.00 per share. The Company received net proceeds of approximately $37.1 million from this transaction. On April 6, 2010, the Company sold 604,492 shares of common stock pursuant to the exercise of the underwriters’ over-allotment option in connection with the Company’s IPO and received net proceeds of approximately $4.0 million.

- On September 24, 2010, the Company closed a private placement transaction with certain accredited investors pursuant to which the Company sold an aggregate of 10,500,000 units at a purchase price of $3.00 per unit, with each unit consisting of one share of common stock and a warrant to purchase an additional 0.40 shares of common stock. Each warrant is exercisable in whole or in part at any time until September 24, 2015 at a per share exercise price of $3.30, subject to certain adjustments as specified in the warrant. The Company received net proceeds of approximately $29.1 million.

[Louetta]

I don't see any near term catalysts. The current Phase III clinical trial (A-002) just completed enrolment, with an estimated completion date of Feb 2012 with analysis of data after that, prior to filing NDA if applicable.

http://www.clinicaltrials.gov/ct2/show/NCT01130246?term=vista-16&rank=1

It seems pricey to me at this time (6.92 - 7.00 ish). The IPO price was 7.00 and then it dropped back to 4.14 by 2/4/11 after some dilution. The recent financial report indicates quite an increase in expenses.

http://finance.yahoo.com/news/Anthera-Pharmaceuticals-prnews-2887053945.html?x=0&.v=1

There hasn't been much blatant interest in it lately, as far as I can see.

... snip ...

Thank you !!!