Camaro1093 Stocks!

[Camaro1093]

Picked up some RNN here @ $2.31...

[Camaro1093]

14 Biotech Stocks Facing FDA Approval:

http://www.thestreet.com/story/10719163/1/14-biotech-stocks-facing-fda-approval.html

[Camaro1093]

We called DCTH (Delcath Systems, Inc.) @ $5.32 in February. Today, it's trading @ $9.33

Link back for original DCTH post...

[Camaro1093]

Potential BioShocker - QCOR (Questcor Pharmaceuticals, Inc.)

Upcoming advisory panel meeting and PDUFA date.

Drug: Acthar for infantile spasms

PDUFA date: June 11

An FDA advisory panel will review the safety and efficacy of Acthar on May 6. The FDA's review of Acthar is expected to post to the agency's web site on May 4 or May 5.

[Camaro1093]

Will be re-doing the iBOX this week... Time to get this board up and running!

[Camaro1093]

Nope... I sold on the CRL news, it'll be a while before they resubmit their NDA, so from this point, it's more of a longer term hold, IMO.

[mlkrborn]

098 NOW AFTER SET BACK on march 18 2010. Anyone in?
Biopharma Stock Alert for A.P. Pharma Inc. Issued by StockPreacher

DALLAS, March 22, 2010
GLOBE NEWSWIRE
StockPreacher.com announces an investment report featuring A.P. Pharma Inc. (Nasdaq:APPA). The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

The full report is available at: http://www.stockpreacher.com/n/APPA

Get our alerts BEFORE the rest of the market. Follow us on Twitter: http://twitter.com/StockPreacher

A.P. Pharma Inc. (APPA) is a specialty pharmaceutical company focused on developing pharmaceutical products using its Biochronomer polymer-based drug delivery technology. The Company's primary focus is on its lead product candidate, APF530, which completed a pivotal phase III clinical trial for the prevention of chemotherapy-induced nausea and vomiting (CINV) during the year ended December 31, 2008.

Message Board Search for APPA: http://www.boardcentral.com/boards/APPA

In the report, the analyst notes:

"APPA's net loss for the fourth quarter of 2009 was $1.9 million, or $0.05 per share, compared with a net loss of $3.9 million, or $0.13 per share, for the fourth quarter of 2008. For the full year 2009, the Company's net loss was $10.0 million, or $0.31 per share, versus a net loss of $23.1 million, or $0.75 per share, for 2008. The improved operating results in both the quarter and the year ended December 31, 2009, were principally due to APPA's decision to suspend, for the time being, development of its other product candidates in order to focus its resources on the submission and approval of the NDA for APF530, as well as other cost containment initiatives undertaken by the Company.

"APPA recently said U.S. health regulators did not approve its experimental drug for the treatment of nausea and vomiting induced by chemotherapy (CINV), citing concerns regarding the drug's administration system, and asked for more studies. The specialty pharmaceutical Company does not expect the commercial launch of the drug, APF530, in 2010, based on the expected time needed for a resubmission."

To read the entire report visit: http://www.stockpreacher.com/n/APPA

See what investors are saying about APPA at penny stock forum

StockPreacher.com is a small-cap research and investment commentary provider. StockPreacher.com strives to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in their research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on StockPreacher, please visit: http://www.stockpreacher.com

StockPreacher.com Disclosure

StockPreacher.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. StockPreacher.com is a Web site wholly owned by BlueWave Advisors, LLC. StockPreacher.com nor its affiliates have a beneficial interest in the mentioned company; nor have they received compensation of any kind for any of the companies listed in this communication. Please read our report and visit our Web site, StockPreacher.com, for complete risks and disclosures.

CONTACT: StockPreacher.com

Nic Lesmeister

(469)-252-3505

[e-mail]

[Camaro1093]

ABIO issued a PR today... Today they're up over 200%

ARCA biopharma Announces Patent Issued for Treating Heart Failure Patients with Bucindolol Based on Genetic Testing
Revised Request for FDA Special Protocol Assessment for GencaroTM Development in Genotype-defined Heart Failure Population Submitted

BROOMFIELD, Colo.--(BUSINESS WIRE)--ARCA biopharma, Inc. (Nasdaq: ABIO - News), a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent on methods of treating heart failure patients with bucindolol based on genetic testing. The patent (USP# 7,678,824) entitled “Methods for Treatment with Bucindolol Based on Genetic Targeting,” provides protection in the United States for this novel approach to treating patients with heart failure, one of the largest health care problems in the United States and the rest of the world. ARCA had previously announced the notice of allowance of this patent. Industry sources estimate that approximately 5.7 million Americans have heart failure and nearly 670,000 new patients are diagnosed annually. In addition, heart failure is the underlying reason for approximately 12 to 15 million annual visits to physicians, 6.5 million annual hospital days and over $37 billion in direct and indirect healthcare costs in the United States.

“We are obviously pleased with the USPTO’s issuance of this patent which we believe will extend our pharmacogenetic intellectual property protection around bucindolol and, if approved for marketing, provide Gencaro market exclusivity into 2025,” said Michael R. Bristow, President and Chief Executive Officer of ARCA. “Chronic heart failure continues to be a major health care problem, and among the challenges to improving care is the uncertainty of patient responses to drug treatment. We believe that a new heart failure therapy that includes a simple test to identify a substantial subpopulation of patients more likely to benefit has the potential to help alleviate some of the problems encountered with the current standard of practice.”

On March 25, 2010, ARCA submitted a revised clinical study protocol for review under the U.S. Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. An SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. Any proposed trial protocol must be reviewed and agreed upon with the FDA and the final trial protocol may be significantly different from the Company’s SPA submission. If ARCA obtains sufficient funding and FDA approval of the SPA, ARCA currently expects it could begin the proposed clinical trial approximately one year after such funding and approval. The FDA has previously designated as a Fast Track development program the investigation of Gencaro for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population.

About GencaroTM

GencaroTM (bucindolol hydrochloride) is a pharmacologically unique beta-blocker and mild vasodilator being developed for the treatment of chronic heart failure (HF). Gencaro is an oral tablet formulation, dosed twice daily. Gencaro is considered part of the beta-blocker class because of its property of blocking beta-1 as well as beta-2 receptors in the heart, preventing these receptors from binding with other molecules that would otherwise activate the receptor. Because of its mild vasodilator effects, the Company believes Gencaro is well-tolerated in patients with advanced HF.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for heart failure and other cardiovascular diseases. The Company's lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for heart failure. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted heart failure treatment. ARCA is collaborating with Laboratory Corporation of America to develop the companion genetic test for Gencaro. For more information please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.arcabiopharma.com&esheet=6228727&lan=en_US&anchor=www.arcabiopharma.com&index=1&md5=d32001ccd8aec6a2c6b59a2011b69a9b.

Safe Harbor Statement


This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the issuance of, and protection provided by, U.S. Patent 7,678,824 entitled “Methods for Treatment with Bucindolol Based on Genetic Targeting” and statements regarding the timing and outcome of the Company’s SPA submission; regulatory review and potential approval of the Company’s New Drug Application for Gencaro; the prospects for ARCA’s providing sufficient information in a timely manner as requested in the FDA’s Complete Response Letter; and the Company’s ability to fund future operations. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company's financial resources and whether they will be sufficient to meet the Company's business objectives and operational requirements; the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2009 and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

[Camaro1093]

BNVI is getting cheap here, might be a good time to add, or open a position if you haven't already, IMO.

GLTA.

[Camaro1093]

Picked up some ISCO.OB (International Stem Cell Corp.). Lots of potential with this one, IMO.

GLTA.

[Camaro1093]

Got your PM... Everything is going pretty well, what about you?

[Camaro1093]

Picked up some APPA @ $1.56, PDUFA date is 3/18...

[mlkrborn]

ANX: Adventrx Pharma Gets FDA OK For Exelbine Name >ANX
Last update: 3/12/2010 8:00:48 AM
(MORE TO FOLLOW) Dow Jones Newswires (212-416-2400)
March 12, 2010 08:01 ET (13:01 GMT)

[10bags]

Thursday , March 11, 2010 16:15ET

QUARTER RESULTS
XOMA LTD (XOMA) reported Q4 results ended December 2009. Q4 Revenues were $21.60M; -41.50% vs yr-ago; BEATING revenue consensus by +50.73%. Q4 EPS was 1c; -85.71% vs yr-ago; BEATING earnings consensus by +125.00%.

http://www.knobias.com/story.htm?eid=3.1.5c034089a6cfe609f381f5fc3c6f0cb018ddf0e5d2c1c3ef48fe91ceec1d5a18

[mlkrborn]

Taking A Shot At AP Pharma


(RTTNews) - The FDA decision on AP Pharma Inc.'s (APPA) lead product candidate APF530 for chemotherapy-induced nausea and vomiting is only a month away, scheduled for March 18.

A majority of patients receiving chemotherapy experience nausea and vomiting. Since CINV (chemotherapy-induced nausea and vomiting) can lead to patients discontinuing chemotherapy, prevention and control of CINV is important in the treatment of cancer patients.

Acute onset CINV occurs within the first 24 hours following chemotherapy treatment, while delayed onset CINV occurs more than 24 hours after treatment and may persist for several days. Based on the strength or degree to which chemotherapy treatments cause vomiting, or emesis, they can be classified as moderately emetogenic or highly emetogenic.

The current treatment options for CINV include 5-HT3 antagonists such as palonosetron (Eisai Co.'s Aloxi), ondansetron (GlaxoSmithKline plc's (GSK) Zofran), dolasetron (Sanofi-Aventis' (SNY) Anzemet) and granisetron (Roche's Kytril), as well as aprepitant (Merck & Co. Inc.'s (MRK) Emend), an NK1 antagonist, which is always used in combination with a 5-HT3 antagonist.

Of the above mentioned treatment options, ondansetron and granisetron have lost patent protection.

APF530 that is delivered by a single subcutaneous injection contains 5-HT3 antagonist, granisetron and is designed to provide five days of continuous relief from CINV. Injections and oral tablets containing granisetron are approved for the prevention of acute onset CINV, but not for delayed onset CINV. The unmet need is the greatest with patients receiving highly emetogenic chemotherapy, particularly delayed onset CINV.

AP Pharma submitted its New Drug Application for APF530 in May of 2009 under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the company can rely on the significant clinical data for safety and efficacy of APF530's active ingredient, granisetron.

In a pivotal late-stage study, APF530 was shown to be equally as effective as Aloxi in the prevention of both acute onset and delayed onset CINV.

Aloxi has been available in the United States for intravenous administration since 2003 for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with highly emetogenic chemotherapy.

Similarly, AP Pharma's APF530 has demonstrated that it can prevent acute onset CINV for both moderately and highly emetogenic chemotherapy, and to prevent delayed onset CINV in moderately emetogenic chemotherapy. However, no drug has been approved by the FDA for the prevention of delayed onset CINV in patients receiving highly emetogenic chemotherapy.

The global annual sales of Aloxi are reportedly estimated to be about more than $400 million.

As of September 30, 2009, AP Pharma's cash, cash equivalents and marketable securities were $1.6 million. Last October, the company strengthened its cash position by raising $8.1 million through private equity placement and as recently as January 11, received a final milestone payment of $2.5 million related to the sale of its royalty rights to two dermatological products - Retin-A Micro and Carac. The two dermatological products were sold by AP Pharma to an affiliate of the Paul Royalty Fund in 2006.

AP Pharma regained compliance with the $1.00 minimum closing bid price requirement for continued listing on the Nasdaq last month. Shares touched a two-year intraday high of $2.05 on Wednesday before closing the day's trade at $1.94.

[peewee]

NVLT CHART ! (BOTTOM FISHING !!!)

http://stockcharts.com/c-sc/sc?s=NVLT&p=D&yr=0&mn=3&dy=0&i=t24152714327&r=701

[Camaro1093]

Just picked up some SNT in the mid-.38s

GLTA.

[Camaro1093]

Nice day... Most of the biotechs we're following were up.

GLTA.

[Camaro1093]

HSKA on fire today... Picked up some more @ 0.87

GLTA.

[Camaro1093]

RxNews Recap for Monday 03-01-10. Ariad granted Orphan Drug status. Biodel up on NDA acceptance. Enzo soars on patent ruling.

http://biomedreports.com/articles/most-popular/30673-rxnews-recap-for-monday-03-01-10.html

[Camaro1093]

ETF Update: Is Biotech the Future of Healthcare?

http://seekingalpha.com/article/191148-etf-update-is-biotech-the-future-of-healthcare

[Camaro1093]

APPA after hours:

http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx?selected=APPA&mkttype=after&symbol=BNVI&symbol=INHX&symbol=HSKA&symbol=HRBR&symbol=APPA

[Camaro1093]

APPA rallied into the close... May be setting up to break thru $2 and stay there, IMO.

GLTA.

[Camaro1093]

HRBR presenting at an ASCO conference on Saturday... May be a good time to pick some up, IMO.

Do your own DD before investing!

GLTA.

[Camaro1093]

Picked up some HSKA... Undervalued here, IMO.

GLTA.

[peewee]

DARA


WEDNESDAY, JUNE 16

11:50 KRN5500 Demonstrates Significant Reduction in Neuropathic Pain in Patients with Cancer

Linda Jett, MSN, Clinical Director, Drug Development, DARA BioSciences

KRN5500, a novel spicamycin-derived, analgesic agent was provided to 19 patients in a Phase 2a clinical trial for patients with end-stage cancer and neuropathic pain. In this multicenter, randomized study, the KRN5500 group demonstrated a statistically significant median decrease of 23.6 % from baseline Numeric Rating Scale scores compared to a median change of zero in the Placebo arm (p=0.03).

12:20 pm End of Conference

http://www.worldpharmacongress.com/wpc_content.aspx?id=96755

[peewee]

BNVI lookie good !

[Camaro1093]

BNVI on the move...

[Camaro1093]

Sold SOMX in the low 3.90s and picked up some INHX.

GLTA.

[Camaro1093]

Nice call on it earlier when it was in the 6s!

GL

[mlkrborn]

Closed 8.20 after hitting $10.00sfew days ago cause of short squeeze. More to go it seems!

[Camaro1093]

SOMX having another good day.

GLTA.

[Camaro1093]

SOMX up again today, in the 3.60s at the moment. Could possibly hit $4+ by EOW, IMO.

GLTA.

[Camaro1093]

HRBR up 20%+

[Camaro1093]

APPA having a good day today... Should continue it's upward movement into the PDUFA date in mid-March.

GLTA.

[Camaro1093]

Picked up some SOMX today in the 3.50s... Added some more HRBR.

GLTA.

[DrHarleyboy]

Ohh yeah, sorry :) Go DARA!

[peewee]

Do not paint my picture black man..lol
Hope the coming cash of that IPO will be enough to not do that...

[DrHarleyboy]

Or, they will just R/S like ASTM did....

[peewee]

DARA will see 1$ because the need of the 1$ boogie to stay on the NASDAQ...company leaders reduced their salary to 1$/year so i believe no problem with that...LOL !

[mlkrborn]

ACTC.OB May be? Many bullish? around 010 below 096 52 weeks level!
U.S. 'tweaks' stem cell policy
Fri Feb 19, 2010 4:15pm EST

By Maggie Fox, Health and Science Editor

WASHINGTON, Feb 19 (Reuters) - The U.S. government broadened the definition of a human embryonic stem cell on Friday, helping qualify several corporate and academic experiments for federal funding.

Dr. Lana Skirboll, director of the Office of Science Policy of the National Institutes of Health, called the change technical and said it would be posted in the federal register for comment.

Human embryonic stem cells are the body's master cells, taken from very early stage embryos when they are just a ball of cells.

The current definition describes them as cells taken from the inner layer of a blastocyst -- a days-old hollow ball of cells. Skirboll said the new definition will include earlier stage embryos.

"We are making what I think is a relatively small technical change to the definition of human embryonic stem cells," Skirboll said in a telephone interview.

"This changes none of the ethical requirements in the guidelines."

U.S. President Barack Obama lifted some restrictions on the federal funding of human embryonic stem cell research soon after he took office last year but the NIH imposed strict ethical requirements and a review process for funding.

Dr. Robert Lanza of Massachusetts-based Advanced Cell Technology, one of the companies seeking federal funding for its research, said the decision was important.

His company is working with cells taken from embryos when they only have eight cells, with the aim of making it possible to implant the remaining seven-celled embryo into a woman to develop into a fetus.

"It would have been a disaster to exclude these valuable human embryonic stem cell lines from consideration for federal funding, especially since the leftover embryos used to generate them meet all the NIH requirements," Lanza said by e-mail.

"In fact, it could be strongly argued that these human embryonic stem cell lines are more ethical since they can be derived without embryo destruction."

Opponents of human embryonic stem cell research believe it is wrong to destroy a human embryo for any reason and some oppose any research at all involving human embryos. (Editing by Alan Elsner)

[Camaro1093]

HRBR (Harbor BioSciences, Inc) is on high alert!

Website: http://www.harborbiosciences.com/

Here are some excerpts from last co. PR (before co. name change):

Apoptone (HE3235) is a novel steroid analog of a dihydrotestosterone metabolite that has been found to stimulate cell death (apoptosis) in hormone-dependent prostate tumors. Preliminary results of the company’s ongoing Phase I/IIa clinical trial with Apoptone (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC) were presented on November 16, 2009 at the Molecular Targets and Cancer Therapeutics Conference. These data will be updated later in Q1/2010.

Harbor BioSciences is a development-stage company with two product candidates in clinical trials: Apoptone (HE3235), in the cohort expansion portion of a Phase I/IIa trial of patients with late-stage prostate cancer, and Triolex®, in a Phase IIa trial in obese type 2 diabetes mellitus patients. The Triolex study will be completed in Q1/2010, with data expected in Q2/2010. Apoptone and Triolex represent the lead candidates from Harbor BioSciences small molecule platform based on metabolites or synthetic analogs of endogenous steroid hormones.

Do your OWN DD before investing!

GLTA.

[Camaro1093]

Yeah, I agree. Hopefully it can close somewhere in the .80s as well!

GL.

[TH_Stockhunter]

DARA - Should see .80's today! IMO

[TH_Stockhunter]

GNVC News:

GenVec Announces Contract With The Department of Homeland Security
prnewswire

Press Release Source: GenVec, Inc. On Friday February 19, 2010, 7:24 am

GAITHERSBURG, Md., Feb. 19 /PRNewswire-FirstCall/ -- Today GenVec, Inc. (Nasdaq:GNVC - News) announced a new contract with the Department of Homeland Security (DHS) to continue the development of adenovector-based vaccines against foot-and-mouth disease (FMD) based on research and development done in collaboration with USDA-ARS and DHS S&T scientists at the Plum Island Animal Disease Center. Under this new agreement, GenVec will receive $3.8 million in program funding the first year and an additional $0.7 million if DHS exercises its renewal option under the contract.

Under this contract, GenVec will use its adenovector technology to develop additional FMD-serotype candidate vaccines. GenVec will also explore methods to increase the potency and simplify the production process of FMD vaccines developed under this contract as well as its previous contract with the DHS announced in 2007.

"This contract expands our ongoing efforts to develop adenovector-based FMD vaccines," said Dr. Paul Fischer, GenVec's President and Chief Executive Officer. "This new contract with the DHS will support new vaccine discovery and technology improvement for this important threat."

About GenVec

GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec's lead product, TNFerade™, is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer. TNFerade has also been and is currently being evaluated for its potential use in the treatment of several other cancers, including esophageal cancer, rectal cancer, and head and neck cancer. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and HSV-2. Additional information about GenVec is available at www.genvec.com and in the company's various filings with the Securities and Exchange Commission.

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues and operating expenses, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of GenVec's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.

Investor Contact:


Media Contact:


GenVec, Inc.


Tiberend Strategic Advisors, Inc.


Danielle M. DiPirro


Andrew Mielach


[phone]


[phone]


[e-mail]


[e-mail]

[peewee]

around that i got in...
:-´)

[Camaro1093]

Thanks bbb, I've been watching DARA for some time now, bought back in today in the .56s.

GL.

[mlkrborn]

XNPT Got hit hard down $13 to 6.70s. Seems bottom and momentum /swing traders and long term investors are buyers.. heavily shorted.. XNPT has 630 m worth of licencing deal with Glaxo and has other trials in its pipeline with both success and failure news--two steps backward one step forward type of progress..
DD
JMFHO

[peewee]

DARA CHART

[mlkrborn]

HNAB; I keep reading about it too. posted here bu CAMARO didnt like it nor the Alpha author pushing it since he was wrong in several positions he advocated..Let me know more to be convinced..