Posts related to ‘FDA’

Potential Breakthrough in Esophagus Cancer (CTIC)

Cell Therapeutics, Inc. (NASDAQ: CTIC) has announced what may be a large breakthrough in the fight against cancer.  This is a combined test rather than as a standalone treatment, but the result may be a huge step in cancer of the lower esophagus.  As many of the ties of one cancer are made to others, you can imagine that the hope might be that this would have other possibilities as well in the fight against other or related cancers.

The company said that a study from Brown University to be presented in the proffered oral session at the Annual Meeting of the International Society of Gastrointestinal Oncology in Philadelphia patients with cancer of the lower esophagus showed a high rate of complete remission when given OPAXIO(TM).  This is paclitaxel poliglumex, which is a biologically enhanced paclitaxel.  This result was shown when OPAXIO was administered in combination with standard cisplatin and concurrent radiation.

Cell Therapeutics noted that the phase II study was led by Dr. Safran and enrolled 40 patients with pathologically-confirmed and locally-advanced adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-esophageal junction with no evidence of distant metastasis. These 40 patients received weekly paclitaxel poliglumex and cisplatin for six weeks with concurrent radiation. Of the first 28 patients undergoing surgery, all 8 of the 28 with adenocarcinoma have achieved a pathologic complete remission. No patients required a feeding tube, which differs from historical studies using the standard regimen where the large majority of patients require a feeding tube.

The company said that Paclitaxel poliglumex’s selective radiation enhancement preclinical profile is being validated by the high rates of pathologic complete remission, and by low rates of severe regional side effects observed in this phase 2 study. It also noted that the results justify proceeding to a randomized, controlled trial to definitively prove the clinical benefit observed.  It also plans to speak with the FDA regarding a potential phase III registration strategy for this indication.  Further noted is that this would ‘be the first registration study for a radiation sensitizing agent in this indication.’

As this is a $1.23 stock and has a 52-week trading range of $0.05 to $2.28, you can imagine there will be a lot of trading around this small cap name on Thursday.  Additional results and safety data is offered below.
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Posted on: October 1, 2009 – 6:31 am in Biotech, Drug companies, FDA, Trading Alert,

The Unusual Suspects (ATVI, AIG, ALTH, TREE, GOOG, PAY, EXPO, WIRE, AXYS)

bull-and-bear-image2We have almost a whole new slate of stocks in this week’s round of “The Unusual Suspects” for key stocks traders need to keep an eye on for the week ahead.  Activision Blizzard Inc. (NASDAQ: ATVI) was singled out by Barron’s.  We ran a bit noting $100 as a possible target for American International Group Inc. (NYSE: AIG), and let’s just say that it was widely read.  Allos Therapeutics Inc. (NASDAQ: ALTH) has a key FDA ruling this coming week.  Tree.com, Inc. (NASDAQ: TREE) may have its model crushed by none other than Google Inc. (NASDAQ: GOOG).  And troubled VeriFone Holdings, Inc. (NYSE: PAY) has earnings due this coming week, right at a key stock inflection point.  Exponent Inc. (NASDAQ: EXPO) and Encore Wire Corp. (NASDAQ: WIRE) are S&P index additions as new entrants.  Axsys Technologies Inc. (NASDAQ: AXYS) also has a shareholder proxy date this week, and some think a higher buyout price may be in the works.  We have run key details and previews for all of these to watch in the coming week.

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Posted on: August 29, 2009 – 12:00 pm in Activist Investor, Analyst Calls, Biotech, Calendar, Charts, Earnings, Editor's Picks, FDA, Financial Stocks, Index, Internet, Mergers and Buy Outs, Rumors, Technology Companies, The Week, Video Games, , , , , , , , ,

The War On Diabetes Heats Up (NVO, AMLN, LLY, MNKD, PFE, VVUS, BMY, AZN, ARNA, GERN, STEM, OREX, GNBT, SPEX, ORMP, HDIX, PODD)

Biotech ImageDiabetes is becoming an epidemic in the U.S. and the Western World.  The ties to obesity are often direct, so the potential treatments are often directly tied as well.  We did a recent dig down for the next $170 billion opportunity for eight different major diseases and conditions, and now we have conducted a much deeper dig down specifically in the field of diabetes over at BioHealthInvestor.com.  We have recent and upcoming FDA action and data being presented from Novo Nordisk (NYSE: NVO), MannKind Corp. (NASDAQ: MNKD), Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN), Eli Lilly (NYSE: LLY), Alkermes Inc. (NASDAQ: ALKS), Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca (NYSE: AZN).  There is a mini-race going on between some of the later stage studies from obesity and diabetes candidates from Arena Pharmaceuticals, Inc. (NASDAQ: ARNA), VIVUS, inc. (NASDAQ: VVUS), Orexigen Therapeutics, Inc. (NASDAQ: OREX) and Amylin Pharmaceuticals Inc. (NASDAQ: AMLN).  Geron Corporation (NASDAQ: GERN) and StemCells Inc. (NASDAQ: STEM) were noted as two of the stem cell hopes, although stem cells may later rather than sooner.

Generex Biotechnology Corporation (NASDAQ: GNBT), Spherix Incorporated (NASDAQ: SPEX) and Oramed Pharmaceuticals Inc. (OTCBB: ORMP) were all noted in the much smaller or emerging plays.  Home Diagnostics, Inc. (NASDAQ:HDIX) and Insulet Corporation (NASDAQ: PODD) have both recently had key events as the interest in test equipment companies continues to remain high.

FULL STORY with much more detail at BioHealthInvestor.com.

Posted on: August 10, 2009 – 10:56 am in Biotech, Drug companies, FDA, Healthcare, Medical, , , , , , , , , , , , , , , , ,

Biotech Business Daily (RIGL, BIIB, ARRY, ALNY, FOLD, HALO, AOB, STEM)

Here are some of the top stories affecting key drug and biotech stocks that have links through to more in-depth coverage and analysis today at the website BioHealthInvestor.com:

Rigel Pharmaceuticals Inc.’s (NASDAQ: RIGL) Phase IIb trial results Thursday morning of its rheumatoid arthritis candidate R788, is boosting its stock on speculation it may help the company attract a clinical partner.

Biogen Idec Inc. (NASDAQ: BIIB) is enjoying a second day of gains after its new PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis (RMS) received an FDA Fast Track designation.  This might be a game-changing event for the company with some risks as well.

Array BioPharma Inc. (Nasdaq: ARRY) now says it will discontinue development of ARRY-797 in chronic inflammatory diseases. Attention may now turn to Array’s ARRY-162, another anti-inflammatory that showed much more promising efficacy.

Also, see our in-depth feature this week on five fast-growing biotechs with improving analyst estimates: Alnylam Pharmaceuticals Inc. (Nasdaq: ALNY), Amicus Therapeutics Inc. (Nasdaq: FOLD), Halozyme Therapeutics Inc. (Nasdaq: HALO), American Oriental Bioengineering Inc. (NYSE: AOB), and Stemcells Inc. (Nasdaq: STEM).

-The 24/7 Wall St. Team

Posted on: July 9, 2009 – 11:09 am in Biotech, Drug companies, FDA, Medical, , , , , , , ,

BioHealth Business Daily (AMGN, NVS, AMLN, LLY, ALKS, NVO, LLY, VICL, SCLN, ARNA)

These are some of the top stories affecting key drug and biotech stocks that are covered with more in-depth details and analysis this morning at BioHealthInvestor.com:

Amgen Inc’s (Nasdaq: AMGN)’s osteoporosis drug did so well in a head-to-head Phase III trial vs. the current standard drug from Novartis Inc. (NYSE:  NVS) that the Amgen’s drug may become the new standard for patients with breast cancer.

Amylin Pharmaceuticals Inc. (Nasdaq: AMLN), along with partners Eli Lilly & Co. (NYSE: LLY) and Alkermes Inc. (Nasdaq: ALKS), announced its new drug application for a once-weekly version of Byetta will be reviewed by the FDA, which may  help invigorate growth for the franchise.

Vical Inc. (Nasdaq: VICL) announced a positive four-month interim analysis for what is arguably its second-largest market opportunity, taking potentially another small step toward the goal of attracting a partner for its herpes vaccine program.

SciClone Pharmaceuticals Inc. (Nasdaq: SCLN) shares are down more than 7 percent on revenue and secondary offering fears. And Arena Pharmaceuticals Inc. (Nasdaq: ARNA) shares are falling after another dilutive offering.

Also, see our in-depth feature this week on five of the fastest-growing biotechs with improving analyst estimates: Alnylam Pharmaceuticals Inc. (Nasdaq: ALNY), Amicus Therapeutics Inc. (Nasdaq: FOLD), Halozyme Therapeutics Inc. (Nasdaq: HALO), American Oriental Bioengineering Inc. (NYSE: AOB), and Stemcells Inc. (Nasdaq: STEM).

-The 24/7 Wall St. Team

Posted on: July 8, 2009 – 9:47 am in Biotech, Drug companies, FDA, Medical, , , , , , , , ,

BioHealth Business Daily (CI, AET, MYL, JAZZ, PTIE, GSK, ALNY, FOLD, HALO, AOB, STEM)

Here are some of the top stories affecting key drug and biotech stocks that are covered in-depth today at BioHealthInvestor.com:

Cigna corp. (NYSE: CI), Aetna Inc. (NYSE: AET), and other managed care companies are rising despite making health care reform concessions, as shareholders see they have a seat at the bargaining table.

Mylan Inc. (NASDAQ: MYL) has received FDA approval for a generic version of an AstraZeneca (AZN) prostate cancer drug — a rather unusual new generic.

Jazz Pharmaceuticals Inc. (Nasdaq: JAZZ) shares are up more than 25 percent after the company took steps to ease a cash crunch that had curtailed drug development.

King Pharmaceuticals (KG) and Pain Therapeutics (PTIE) said  they expect to resubmit a new drug application in mid-2010, slightly later than anticipated.

GlaxoSmithKline (NYSE: GSK) announced a positive study on its Cervarix vaccine, although it’s unclear if the company can play catch-up to Merck & Co.’s (NYSE: MRK) Gardasil.

See our in-depth feature this week on five fast-growing biotechs with improving analyst estimates: Alnylam Pharmaceuticals Inc. (Nasdaq: ALNY), Amicus Therapeutics Inc. (Nasdaq: FOLD), Halozyme Therapeutics Inc. (Nasdaq: HALO), American Oriental Bioengineering Inc. (NYSE: AOB), and Stemcells Inc. (Nasdaq: STEM).

-The 24/7 Wall St. Team

Posted on: July 7, 2009 – 11:03 am in Biotech, Drug companies, FDA, Medical, Trading Alert, , , , , , , , , , ,

The Best Short-Selling Opportunities Of The Year (C)(GE)(F)(SBUX)(SIRI)

angrybearThere is still some conversation about the federal government restricting short-selling activity in certain stocks. The counterargument to these restrictions is that short selling plays an important role in the valuation of securities by efficiently allowing investors to bet that a stock will fall as readily as they can bet that it will rise. Short sellers have the reputation, whether deserved or not, for trying to manipulate information about public companies with the hope of driving their prices down. That may be true.

24/7 Wall St. has come up with a list of the best short-selling opportunities between now and the end of the year. The list was chosen based on: 1) trading volume, 2) the total short position in the stock over the first half of the year, 3) a history of the short position in these stocks rising or falling rapidly, and 4) stocks in companies that tend to move on news throughout the year and not just on earnings information. Read More »

Posted on: July 5, 2009 – 5:54 pm in Airlines, Analyst Calls, Autos, Banking, Biotech, Casinos, Conglomerates, Consumer Electronics, Dividend, Drug companies, Editor's Picks, FDA, Green Biz, Hardware, Healthcare, Infrastructure, Internet, Large Cap Stocks, Medical, PC Companies, Pharmaceuticals, Private Equity, Retail, Short Interest, Software, Technology, Turnarounds, Wireless, , , , , , , , , , , , , , , , , , , ,

Media Digest 7/2/2009 Reuters, WSJ, NYTimes, FT, Bloomberg

newspaperReuters:   California declared a financial emergency.

Reuters:   An SEC attorney raised concern about a Madoff report in 2004.

Reuters:   Auto parts supplier Lear filed for bankruptcy.

Reuters:   NYC apartment sales are down more than 50%.

Reuters:   Beijing Automotive will bid for Opel.

Reuters:   GM told a judge asset sales was its only option. Read More »

Posted on: July 2, 2009 – 3:04 am in Autos, Banking, China, Compensation, Economy, Emerging Markets, FDA, Internet, Metals, Oil & Gas, Press Digest, , , , , , , , , , , , , , , , ,

Media Digest 7/1/2009 Reuters, WSJ, NYTimes, FT, Bloomberg

newspaperReuters:   California raced to approve a state budget its cutting deficit.

Reuters:   Ten more people may face charges in Madoff case.

Reuters:   Gannett (GCI) is laying off 1,000 more people.

Reuters:   China will delay a web filter for PCs sold in the country.

Reuters:   B of A’s (BAC) asset management unit got low bids.

Reuters:   Monster’s June job index fell.

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Posted on: July 1, 2009 – 2:54 am in Autos, Banking, Biotech, China, Commodities, Compensation, Conglomerates, Drug companies, Entertainment, FDA, Internet, Management Change, Metals, Pharmaceuticals, Press Digest, Turnarounds, , ,

Generic Biotech Drug Approval in Japan, Implications in U.S. and Abroad (NVS, PFE, AZN, AMGN, GENZ, GILD, CELG)

Novartis AG (NYSE: NVS) shares are at session highs and well of the lows of the day in the early afternoon Thursday after Japan okayed one of the company’s human growth hormones, the first approval in Japan of a generic biotech drug.  With the recent talks of President Obama wanting generic biologics, the approval process in Japan is probably not an isolated event and should not be ignored for broader implications.
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Posted on: June 25, 2009 – 11:31 am in Biotech, Drug companies, FDA, Medical, Politics, , , , , , ,

Palomar’s Chance To Take Away from BOTOX (PMTI, JNJ, AGN)

Money Stack ImagePalomar Medical Technologies Inc. (NASDAQ: PMTI) is seeing shares surge to new heights not seen in 18-months.  The company is the first to receive FDA approval for over-the-counter clearance for a new, patented home use laser device that for the treatment of periorbital wrinkles (for eyes, like crows feet). The beauty of this, no pun intended, is that it is part of a Johnson & Johnson (NYSE: JNJ) partnership and that may lead to much greater use.  This one will not exactly kill the entire Botox market for Allergan, Inc. (NYSE: AGN), but even for one such possible replacement the idea of a home-use laser has to be a bit more enticing than getting stuck with a needle full of Botulinum toxins.
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Posted on: June 5, 2009 – 11:49 am in Entertainment, FDA, Healthcare, Luxury, Medical, Product Review, , ,

Analyst Projecting 50% Upside in Dendreon (DNDN)

Money Stack ImageDendreon Corporation (NASDAQ: DNDN) was started with a Buy rating and a $36.00 target at Deutsche Bank.  The call’s positive expectations are mixed near-term, but the assumption is that Provenge will become a blockbuster product in the fight against metastatic Prostate cancer. After looking through all the notes, it appears that this may be the second highest price target from all of the analysts out there.

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Posted on: June 5, 2009 – 6:39 am in Analyst Calls, Biotech, Drug companies, FDA,

Media Digest 6/2/2009 Reuters, WSJ, NYTimes, FT, Bloomberg

newspaperReuters:   Global consumer confidence is improving.

Reuters:   GM (GM) filed for Chapter 11 and expects a quick exit.

Reuters:   Most US retailers probably had sales drop in May.

Reuters:   China gave Geithner backing for the US programs to stimulate the economy. Read More »

Posted on: June 2, 2009 – 2:58 am in Autos, Banking, China, Compensation, Economy, FDA, Financial Stocks, Hardware, Mergers and Buy Outs, Press Digest, Retail, Semiconductor, Semiconductors, , , , , , , , , , , , ,

Full 2009 ASCO Cancer & Oncology Primer (ABII, AEZS, ALTH, AMGN, APPA, ARQL, BMY, CLDX, CELG, CTIC, CGRB, LLY, EXEL, GHDX, GSK, IMGN, MEDX, MDVN, MITI, OGXI, OSIP, PPHM, PFE, ROSG, SNTA, TRBN, ZIOP, ZGEN)

We have compiled an updated lengthy 2009 American Society of Clinical Oncology, or ASCO, document showing many company cancer data presentations slated to start this weekend.   This is broken down in drug and biotech companies with share values, ranges, and recent developments for the following drug and biotech companies:  Abraxis BioScience, Inc. (NASDAQ:ABII), AEterna Zentaris Inc. (NASDAQ: AEZS), Allos Therapeutics, Inc. (NASDAQ: ALTH), Amgen Inc. (NASDAQ: AMGN), A.P. Pharma, Inc. (Nasdaq: APPA), Arqule Inc. (NASDAQ: ARQL), Bristol-Myers Squibb (NYSE: BMY), Celldex Therapeutics (NASDAQ: CLDX), Celgene Corporation (NASDAQ: CELG), Cell Therapeutics (NASDAQ: CTIC), Cougar Biotechnology, Inc. (NASDAQ: CGRB), Eli Lilly and Company (NYSE: LLY), Exelixis (NASDAQ: EXEL), Genomic Health, Inc. (NASDAQ: GHDX), GlaxoSmithKline (NYSE: GSK) , Immunogen (NASDAQ: IMGN), Medarex (NASDAQ: MEDX), Medivation, Inc. (NASDAQ: MDVN), Micromet, Inc. (NASDAQ: MITI), OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), OSI Pharmaceuticals (NASDAQ: OSIP), Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), Pfizer Inc. (NYSE: PFE), Rosetta Genomics (NASDAQ:ROSG), Synta Pharmaceuticals (NASDAQ: SNTA), Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN), ZIOPHARM Oncology (NASDAQ: ZIOP), and ZymoGenetics, Inc. (NASDAQ: ZGEN).

The full presentation can be seen at BioHealthInvestor.com.

JON C. OGG
May 27, 2009

Posted on: May 27, 2009 – 1:34 pm in Biotech, Drug companies, FDA, Medical, Pharmaceuticals, , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Many Biotechs Barely On Life Support (BPAX, CEGE, EPIX, IDMI, LJPC, NRGN, NFLD, TPTX)

Burning Money PicWe have run a watch list of companies under their own strategic review, and the number of biotech (or grouped with biotech) stocks under this description is just staggering.   We published a full review of this over at BioHealthInvestor.com.  The list includes Biosante Pharmaceuticals, Inc. (NASDAQ: BPAX), Cell Genesys, Inc. (NASDAQ: CEGE), EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX), IDM Pharma, Inc. (NASDAQ: IDMI), La Jolla Pharmaceutical Co. (NASDAQ: LJPC), Neurogen Corporation (NASDAQ: NRGN), Northfield Laboratories Inc. (NASDAQ: NFLD) and TorreyPines Therapeutics, Inc. (NASDAQ: TPTX) are all under strategic reviews and their futures are probably questionable at best.

You can read that full report here at the BioHealthInvestor.com website.

Jon C. Ogg
May 13, 2009

Posted on: May 13, 2009 – 11:31 am in Accounting, Biotech, Drug companies, FDA, Medical, Mergers and Buy Outs, Pharmaceuticals, Trading Alert, , , , , , , ,

FDA Attacks Cheerios Over Claims as a Drug (GIS)

Cheerios LogoGeneral Mills, Inc. (NYSE: GIS) maybe facing the same types of battles many supplement and diet product companies have seen  with the FDA over advertising claims.  The good news is that this is not a direct safety issue, but it is an issue over the claims of the long-lasting Cheerios whole-grain oat cereal.
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Posted on: May 12, 2009 – 9:54 am in Agriculture, FDA, Food, Regulation,

Another Legal Medical Marijuana Company Now Public (GFON, CVIV)

Cannabis Science, Inc. (OTCBB: GFON), or Gulf Onshore, Inc. (GFON), is yet another public stock company which is going after the field of legalized medical marijuana.  Just last week the company was called  Gulf Onshore and it just changed its name to Cannabis Science, Inc. after acquiring the assets of Cannex Therapeutics LLC about 10 days ago.  Last week the company also announced that it had selected its first pharmaceutical cannabis product for FDA testing.  It was not even two weeks ago that a company called Medical Marijuana, Inc. (OTC: CVIV) had pursued a similar strategy in coming public after formerly being called Club Vivanet.

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Posted on: April 14, 2009 – 6:10 pm in Biotech, Commodities, Consumer Goods, Cult Stock, Drug companies, Entertainment, FDA, IPOs, Medical, OTC, Pharmaceuticals, Politics, Regulation, Tobacco, ,

Dendreon Set To Re-File PROVENGE (DNDN)

Dendreon Corporation (NASDAQ: DNDN) has announced that its pivotal Phase 3 IMPACT study of PROVENGE in men with advanced prostate cancer data.  While the data is incomplete, Dendreon said that the IMPACT study met its primary endpoint of improving overall survival compared to a placebo control.  Dendreon intends to file an amendment to its existing Biologic License Application (BLA) in the fourth quarter of this year to gain licensure of PROVENGE.

PROVENGE is Dendreon’s candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies specifically designed to engage the patient’s own immune system against cancer.
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Posted on: April 14, 2009 – 8:01 am in Biotech, FDA

MS Setback for Acorda (ACOR, BIIB)

burning-money-pic42Acorda Therapeutics, Inc. (NASDAQ: ACOR) is taking it right on the chin this morning.  The company announced that it has received a “refuse to file letter” from the FDA regarding its New Drug Application for Fampridine-SR.  Unfortunately, this is supposed to be for a novel therapy being developed to improve walking ability in people with multiple sclerosis.
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Posted on: March 31, 2009 – 8:54 am in Biotech, FDA, Trading Alert, ,

Pfizer’s Sutent Scores Another Pancreatic Tumor Win (PFE)

pfizer-logo1Pfizer Inc. (NYSE: PFE) is stopping its Phase III clinical trial of Sutent early.  This is generally a scare over adverse events, but not in this case.  Sutent apparently has shown such a significant benefit in patients with advanced pancreatic islet cell tumors that an independent data monitoring committee has recommended halting the trial after concluding that Sutent demonstrated greater progression-free survival compared to placebo.
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Posted on: March 12, 2009 – 7:46 am in Drug companies, FDA,