Dendreon released new data looking at PROVENGE’s ability to increase overall survival in a study that was targeted solely at evaluating this in African American men who suffer from advanced prostate cancer.

The news looks solid if there are no “issues” that will be taken with the data.  Dendreon said that the new analysis found that the African American population in its study had a median overall survival benefit of 45.3 months.  This is significant if you compare the results to only 14.6 months as a median overall survival benefit in the control arm.  In short, PROVENGE extended median survival for African American men by 30.7 months.

Dendreon is one of the feature companies at ASCO’s 2012 Annual Meeting this year that is out in less than two weeks.  We would expect more results, but the trick is whether or not other companies will trump Dendreon or not.  The case so far has been that Dendreon has been ineffective in generating sales to the point that it has expected and the numbers seem to keep softening.  Physician use and acceptance is supposed to be wider, but that $93,000 cost may be prohibitive.

Dendreon Corporation (NASDAQ: DNDN) is up 2.75% at $7.47, and its 52-week trading range is $6.46 to $42.87.

JON C. OGG

24/7 Wall St. has compiled a log of companies which have already signaled in press releases that they will be presenting data or that data will be presented on their behalf at the 2012 ASCO Annual Meeting.  We have previewed more than 25 companies so far and that is not even including Big Pharma names.  As of May 18, the total abstracts submitted were 5,264 and of those there have been 2,744 which have been accepted for presentation at ASCO.  Of those accepted for presentation, some 1,859 are going to be ‘ePublication only’ for viewers.  The breakdown for the Abstracts shows that the oral presentation is currently 257 presentations and 2,487 are listed as poster presentation only.

The most presentations accepted (203) so far are focused on Genitourinary Cancer, which covers urinary tract and male genital tract as follows: Prostate cancer; Bladder cancer; Kidney cancer; Testicular cancer; Penile cancer; Nonmalignant tumors of the urinary tract and male reproductive system; and Von Hippel Lindau disease.  As of today, the fewest accepted presentations (93) cover Pediatric oncology.

Amgen Inc. (NASDAQ: AMGN), the largest independent biotech that there is, recently showed updated results from a Phase 2 study showing that treatment with blinatumomab helped achieve a high-rate of complete response in 72% of adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia treated in the study. This blinatumomab is the first of a new class of agents called bi-specific T cell engagers antibodies, which are designed to harness the body’s cell-destroying T cells to kill cancer cells.  Blinatumomab targets cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas, such as ALL. Full results of the study will be presented during an oral abstract session on June 4 at the ASCO Annual Meeting.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) recently sold off but will will have updated clinical data from the pivotal PACE trial of ponatinib, its investigational pan-BCR-ABL inhibitor in patients with chronic myeloid leukemia (CML) on June 4.  The company said that the data will form the basis of its regulatory filings for marketing approval of Ponatinib for patients with chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblasatic leukemia.

ArQule, Inc. (NASDAQ: ARQL) and Daiichi Sankyo, Co., Ltd. (Japan) will have an oral presentation at the ASCO Annual Meeting featuring Phase 2 trial data with tivantinib as a single agent investigational second-line treatment in hepatocellular carcinoma. ArQule announced that this randomized, double-blind study met its primary endpoint in January and will now present the full results from this trial, including positive data in the pre-defined c-MET high population. Additional clinical data with tivantinib will be featured in two poster discussions and two general poster sessions.

Array BioPharma Inc. (NASDAQ: ARRY) has recently risen on its lung cancer and melanoma results.  The company has three oral presentations at the annual meeting after having already presented Phase 1 data on MEK162 in 28 patients with biliary tract cancer at the ASCO Gastrointestinal Cancers Symposium in January 2012 showing that it was well tolerated and showed evidence of clinical efficacy in this patient population, including a complete response and a partial response. Stable disease was observed in 12 patients. The company has licensed selumetinib to AstraZeneca (NYSE: AZN) and licensed MEK162 to Novartis (NYSE: NVS).

Johnson & Johnson (NYSE: JNJ) release positive data on its Zytiga medicine showing that the treatment helped high-risk patients.  Zytiga was approved in 2011 and the drug helped patients’ tumors when prostate cancer had not yet metastasized beyond the prostate gland.

What is happening is that Dendreon keeps having lower Provenge sales despite the hope that more reimbursement and more doctor recommendations are supposed to be helping.  This is the second big drop this month after a disappointing revenue figure was shown over a week ago. Analysts have a Thomson Reuters consensus target of just over $367 million in sales in 2012 and just over $513 million in sales in 2013.

Wednesday brought up more questions because the SEC probe may be tied to the company’s dropped sales projections for Provenge in earlier periods when shares were far higher. The reality is that this had been disclosed with earnings over a week ago, but investors are shooting first and asking questions later.

The only good news here for investors is that Dendreon’s stock chart may offer some support not too much lower than the current 10.6% drop to $7.70. Dendreon has four different presentations at ASCO this June and here is a Seeking Alpha transcript of the CFO presentation at a Bank of America Merrill Lynch health conference this week.

At $7.70, Dendreon’s 52-week range is $6.46 to $42.87.  Those old hopes of a Dendreon buyout now feel very dated.

The company’s market cap is now only $1.14 billion and Dendreon has over $500 million in cash and liquidity on hand.  The presentation at a conference this week currently shows no need to raise more capital until the company can reach a breakeven level.

JON C. OGG

Here is how the company describes itself: We are a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. Our objective is to develop first-in-class, prescription products using an approach that relies on the scientific rigor of biotechnology to address unmet needs in the rapidly-growing market for aesthetic medicine. Our initial focus is on the facial aesthetics market, which comprises the majority of the aesthetic medicine market. Our product candidate, ATX-101, is a potential first-in-class, injectable drug currently in Phase III clinical development for the reduction of submental fat, which commonly presents as an undesirable “double chin.”

KYTHERA notes that ATX-101 is a proprietary synthetic formulation of sodium deoxycholate, a well-characterized component of human bile that is naturally occurring in the body and promotes the breakdown of dietary fat.

The company is collaborating with Bayer outside the United States and Canada, and Bayer recently completed two pivotal Phase III trials with positive topline results.  KYTHERA initiated a Phase III clinical program with a planned enrollment of 1,000 patients in the United States and Canada in March 2012 and it expects to report results from these trials in 2013.

J.P. Morgan and Goldman Sachs are listed as the bookrunners, with other firms in the syndicate listed as Leerink Swann and Lazard Capital Markets.

FULL S-1 FILING

JON C. OGG

Shares hit a high of $7.84 as the top-tick on Wednesday and that was against a close of $1.62 the day before.  You have to keep in mind that things were so bad at Rosetta that the company completed a 1 for 15 reverse stock split to close at $2.10 on a split adjusted basis but shares had nominally been at $0.14 before that.  So raising $2.2 million does not sound out of line on the surface, but the offering was a direct share offering of 632,057 ordinary shares at a price of $3.50 per share.  That is a 30% discount, but it was after a gain of more than 200%.

Aegis Capital Corp. acted as the exclusive placement agent for the offering. Rosetta’s use of proceeds is primarily to fund its operations and for other general corporate purposes.  These uses include debt repayment or refinancing, working capital, intellectual property protection and enforcement, capital spending, investments, acquisitions or collaborations, research and development and product development.

Shares are indicated down close to 20% at $4.05 in active trading on what is usually a thin volume stock.  No good deed goes unpunished.

JON C. OGG

MiRview® mets² is said to accurately identify the primary tumor of origin in primary and metastatic cancer including Cancer of Unknown or Uncertain Primary.

Medicare coverage opens up a giant commercial opportunity as this test will now be made available to Medicare patients.  Medicare is the largest U.S. payor and the idea is that if Medicare starts covering a product then the private payor systems out there are likely to adopt reimbursement for medical insurance coverage as well.

Rosetta Genomics said that it launched its direct selling effort in the U.S. just one year ago.

As far as just how big this is… “The policy will cover the 45 million Medicare beneficiaries and will enable Rosetta to provide the miRview® mets2 assay for Medicare beneficiaries throughout the U.S. at no cost to the patient, thereby eliminating an adoption barrier for the physician ordering the test and for the patient.”

Teh company further noted about its test products, ” In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the miRview® mets and miRview® mets² test, 60,000 from miRview® squamous, 60,000 from miRview® meso, 54,000 from miRview® kidney and more than 1 million patients worldwide from miRview® lung.”

Shares were just at $1.62 on a split-adjusted basis Tuesday and this stock’s 1:15 reverse split has just taken place this week in the share price for what had been a penny stock.  Now shares are up some 295% at $6.40 against a split-adjusted trading range of $1.40 to $36.45 over the last 52-weeks.

JON C. OGG

The following ten securities will be added to the Index: Cerus Corporation (Nasdaq: CERS), Celldex Therapeutics, Inc. (Nasdaq: CLDX), Amicus Therapeutics, Inc.(Nasdaq: FOLD), Infinity Pharmaceuticals, Inc. (Nasdaq: INFI), Jazz Pharmaceuticals plc (Nasdaq: JAZZ), Omeros Corporation (Nasdaq: OMER), Orexigen Therapeutics, Inc. (Nasdaq: OREX), Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX), Raptor Pharmaceutical Corporation (Nasdaq: RPTP), and Trius Therapeutics, Inc. (Nasdaq: TSRX).

The following members will be booted from the NASDAQ Biotechnology Index: BioSante Pharmaceuticals, Inc. (Nasdaq: BPAX), China Biologic Products, Inc. (Nasdaq: CBPO), Columbia Laboratories, Inc. (Nasdaq: CBRX), Cardiome Pharma Corp (Nasdaq: CRME) and DURECT Corporation (Nasdaq: DRRX).

The NASDAQ Biotechnology Index tracks the performance of a set of NASDAQ-listed securities that are classified as either biotechnology or pharmaceutical and it is re-ranked twice a year (May/November).

The iShares Nasdaq Biotechnology (NASDAQ: IBB) ETF has more than $1.8 billion in assets and it aims to track the NASDAQ Biotechnology Index per its description.  SPDR S&P Biotech (AMEX: XBI) has more than $500 million in assets tracks the biotech members ranked by S&P, but there are some overlaps in the indexes. Market Vectors Biotech ETF (AMEX: BBH) has only just over $100 million in assets and tracks the  Market Vectors US Listed Biotech 25 Index.

JON C. OGG

The company issued a press release noting that it has received conditional marketing authorization from the European Commission for Pixuvri®.  This pertains to the company’s controversial pixantrone as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas. The company further noted that Pixuvri is the first approved treatment in the European Union in this patient setting.

Cell Therapeutics will get to market Pixuvri in the 27 Member States of the European Union but it will also get to market in Iceland, Liechtenstein and Norway.  The company also plans to make Pixuvri immediately available through a named patient program and the marketing and commercialization of Pixuvri will start with CTI’s own sales force in the EU starting in the second half of 2012.

Conditional approval is not an open-ended and endless approval.  On this front the company noted, “conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.”

Shares closed up almost 15% at $1.16 on more than 8 million shares today and the 52-week trading range of $0.95 to $2.40.  Even after the pop, this stock has a market value of $236 million.

JON C. OGG

24/7 Wall St. wanted to make a log of companies which have already signaled that they will be presenting data or that data will be presented on their behalf at the 2012 ASCO Annual Meeting.  The data below is as follows:

As of May 10, the total abstracts submitted were 5,264 and of those there have been 2,744 which have been accepted for presentation at ASCO.  Of those accepted for presentation, some 1,859 are going to be ‘ePublication only’ for viewers.  The breakdown for the Abstracts shows that the oral presentation is currently 257 presentations and 2,487 are listed as poster presentation only.

The most presentations accepted (203) so far are focused on Genitourinary Cancer, which covers urinary tract and male genital tract as follows: Prostate cancer; Bladder cancer; Kidney cancer; Testicular cancer; Penile cancer; Nonmalignant tumors of the urinary tract and male reproductive system; and Von Hippel Lindau disease.  As of today, the fewest accepted presentations (93) covers Pediatric oncology.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) will have updated clinical data from the pivotal PACE trial of ponatinib, our investigational pan-BCR-ABL inhibitor in patients with chronic myeloid leukemia (CML).

Array BioPharma Inc. (NASDAQ: ARRY) recently noted that it “presented Phase 1 data on MEK162 in 28 patients with biliary tract cancer at the ASCO Gastrointestinal Cancers Symposium in January 2012. MEK162 was well tolerated and showed evidence of clinical efficacy in this patient population, including a complete response and a partial response. Stable disease was observed in 12 patients.”

Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI) announced in early May that the new data from the BiovaxID® Phase II mantle cell lymphoma clinical trial conducted by the U.S. National Cancer Institute will be presented by the NCI at the 2012 American Society of Clinical Oncology Annual Meeting.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) previously noted that interim topline results of the Phase 2b EMERGE study of CDX-011 in patients with advanced breast cancer will be presented in a webcast on May 23, 2012 but it is not going to get in at ASCO as it noted, “Celldex anticipated presenting these topline results at the American Society of Clinical Oncology 2012 Annual Meeting. Due to a clerical error in which the incorrect submission category was inadvertently selected in the on-line ASCO submission form, the abstract for the EMERGE study was not considered for acceptance. Celldex attempted to rectify this clerical error but was informed that no exceptions are made to the submission policy.”  Call this the “ASCO-less ASCO presentation.”

CytRx Corporation (NASDAQ: CYTR) will present data from its Phase 1b/2 clinical trial in patients with advanced solid tumors, primarily soft tissue sarcomas.

Exelixis, Inc. (Nasdaq: EXEL) recently announced that cabozantinib will be the subject of nine presentations at the upcoming Annual Meeting… The company noted that cabozantinib encompasses phase 3 pivotal trials in medullary thyroid cancer (MTC) and metastatic castration-resistant prostate cancer (CRPC).

Galena Biopharma (NASDAQ: GALE) will present “Safety and Long-Term Maintenance of Anti-HER2 Immunity Following Booster Inoculations of the E75 Breast Cancer Vaccine” and it will host a panel called “HER2 Targeted Cancer Therapies” which includes NeuVax update from the Phase 2 and current Phase 3 PRESENT trials.

Generex Biotechnology Corporation (OTCBB: GNBT) will be presenting data on its breast cancer treatment ambitions.

Genomic Health, Inc. (NASDAQ: GHDX) recently announced that 18 abstracts were accepted for presentation at ASCO which will be highlighting Breast, Colon and Prostate progress.

ImmunoGen, Inc. (Nasdaq: IMGN) noted in late-April “At the upcoming ASCO meeting in June, we expect to see not only EMILIA Phase III data and new SAR3419 Phase I data, but also data from the Phase II trial evaluating the safety of trastuzumab emtansine in the adjuvant/neoadjuvant setting.”

Nektar Therapeutics (NASDAQ: NKTR) has two abstracts: one covering a Phase 3 study of NKTR-102 versus Treatment of Physician’s Choice in patients with locally recurrent or metastatic breast cancer previously treated with an anthracycline, a taxane and capecitabine; a second will be NKTR-102 in patients with platinum-resistant ovarian cancer.

NewLink Genetics Corporation (NASDAQ: NLNK) announced in April that data from its HyperAcute(R) Pancreas immunotherapy and its HyperAcute(R) Lung immunotherapy as well as its D-1MT IDO pathway inhibitor will be presented at the annual meeting.

Pharmacyclics, Inc. (NASDAQ: PCYC) will have two oral presentations and one poster discussion session: two oral presentations will highlight the first reporting on data from the ibrutinib (formerly PCI-32765) Phase II CLL single agent trial in treatment naïve patients and the ibrutinib Phase Ib/II CLL combination trial with ofatumumab in relapsed or refractory patients; the poster discussion session will highlight data from the ibrutinib Phase Ib CLL combination trial with bendamustine and rituximab in relapsed or refractory patients.

Seattle Genetics, Inc. (NASDAQ: SGEN) will show updated information on ADCETRIS for patients with relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).

Here was a recent list of other stocks to watch covered by an analyst in the Denver Post.

JON C. OGG

Dendreon Corporation (NASDAQ: DNDN) said that its total revenue rose almost 200% to $82 million, but that is almost in-line and shows no upside surprise for PROVENGE sales.  Despite still having some $559 million in cash and near-term liquidity, a drop of 21% to $9.17 is really not hurting the overall biotech sector anywhere close to as much as we feared it would.

VIVUS Inc. (NASDAQ: VVUS) is weak after earnings as well as the loss was wider than expected, but it now has some of $333.4 million in cash and short-term now that it raised cash via a secondary offering.  This is still in a holding pattern as the current Qnexa NDA final decision is still out to about July 17, 2012.  A surprise mover to the upside is Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) with a rally ahead of its FDA meeting for lorcaserin as a weight-loss pill.  Arena shares are up 15% at $3.14 against a 52-week range of $1.23 to $3.47 and the current market cap is $571 million.

Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) was up so much on Monday that you would have thought it was a takeover stock rather than a cystic fibrosis drug test that caused the pop.  Shares were up huge on Monday and Tuesday is seeing another day of bucking the trend as shares are up 5.3% at $61.20 at yet another 52-week high.  Its market cap is now magically almost $13 billion.  So far on Tuesday we have seen the following analyst rating changes: Raised to Equal-weight at Morgan Stanley; Raised to Outperform at Wells Fargo; and Raised to Buy at Needham.

Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) is one of the upside exception today as J.P. Morgan initiated coverage with an Overweight rating.  Shares are up almost 5% at $10.44 against a 52-week range of $5.88 to $13.75.

Amgen Inc. (NASDAQ: AMGN) is a mix somewhere between biotech and pharma and it is following the defensive stocks today with a gain of 0.6% to $70.04 against a 52-week high of $72.00.  That new 2.1% dividend yield is offering some cushion it appears.

Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) shows that investors will reward emerging pharma players merely for reaching agreements with creditors,  This stock is up 19% at $1.855 on only 2 million shares after it reached an agreement with some creditors to restructure a portion of its debt in a move anticipated to bring the equivalent of $44 million.  Its market cap is $131 million and the $1.86 compares to a 52-week range of $1.26 to $9.14.

JON C. OGG