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).

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

Alexza Pharmaceuticals Inc. (NASDAQ: ALXA) is getting crushed after the FDA declined approval for its anti-psychotic drug: NDA review cycle is complete and the application is not ready for approval in its present form.  Shares are down 47% at $1.60 on over 700,000 shares.

AllianceBernstein Holding L.P. (NYSE: AB) is indicated up less than 1% after Barron’s gave it a cover story as “A Deep Value Play.”

Allied Irish Banks plc (NYSE: AIB) is not seeing news, but the notion that it was up this morning almost seems like a reason for celebration… AIB shares are up 1% at $1.17.

Canadian Solar Inc. (NASDAQ: CSIQ) is up 0.6% at $15.59 and the indications were higher based upon a new CFO appointment after an SEC inquiry.  It backed prior guidance and said shipments would be at the mid-point to higher-end of guidance.

Chesapeake Energy Corporation (NYSE: CHK) is trading up after CNOOC from China is investing $2.16 billion in Chesapeake for one of its large shale projects.  Shares are up 5% at $24.28.

China New Borun Corporation (NASDAQ: BORN) is trading like ‘born to run’ after being given the #1 position in the IBD 100 this weekend.  Shares are up 4.5% at $16.80, a new all-time high above the prior high from last week of $16.14.

CIT Group, Inc. (NYSE: CIT) is trading up about 1.5% at $41.35 after Barron’s reported that Thain is turning it around.

Generex Biotechnology Corp. (NASDAQ: GNBT) is up 20% at $0.52 ahead of key data being presented today.

Harbin Electric, Inc. (NASDAQ: HRBN) received a going-private proposal from its CEO for $24.00 per share in cash.  Volume is light but so far shares are up over 27% at $25.50, above the offer.

Immunogen Inc. (NASDAQ: IMGN) is trading up by 9% at $7.75 as a carry-on trade from Friday after it gave new cancer trial data this morning.

LDK Solar Co., Ltd. (NYSE: LDK) raised guidance on revenue and shipment estimates.  Shares are up 9.3% at $10.71.

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JON C. OGG

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.

New short-interest data suggest traders are now increasing their directional bets against biotech stocks. Pfizer Inc. (NYSE: PFE) and Merck & Co. (NYSE: MRK) are in the top 10 of all large-cap stocks with the greatest increase in the number of shares shorted.

Eli Lilly has the FDA’s OK to market its Effient blood thinner, but the black-box warning on its label is so strong that it’s hard to believe it can dent the market share of the Sanofi Aventis (NYSE: SNY)/ Bristol Myers Inc. (NYSE: BMY) drug Plavix.

OSI Pharmaceuticals Inc. (Nasdaq: OSIP) announced new data from its Phase III Saturn study of Tarceva, and it’s likely an incremental positive for the cancer drug over rival Eli Lilly & Co.’s (NYSE: LLY) drug Altima.

-The 24/7 Wall St. Team

Generex Biotechnology Corp. (NASDAQ: GNBT) was up 18% today at $0.438; shares peaked at $0.70 last week and were at $0.27 before the swine flu scare came out.

BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) rose 14% to $3.24; shares peaked at $4.89 last week and were at $1.75 before the swine flu scare came out.

Pure Bioscience (NASDAQ: PURE) was down 1.2% at $2,40; shares peaked at $3.19 last week and were at $1.75 before the swine flu scare came out.

Vical Inc (NASDAQ: VICL) fell by 7% to $2.09; shares peaked at $3.30 last week and were at $2.40 before the swine flu scare came out.

Meridian Bioscience Inc. (NASDAQ: VIVO) were up barely above flat at $17.69; shares peaked at $18.30 last week and were at $16.13 before the swine flu scare came out.

AVI BioPharma Inc. (NASDAQ: AVII) was flat at $0.76; shares peaked at $1.29 last week and  were at $0.74 before the swine flu scare came out.

Jon C. Ogg

As you will see below, Novavax, Inc. (NASDAQ: NVAX), Generex Biotechnology Corp. (NASDAQ: GNBT), BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX), Pure Bioscience (NASDAQ: PURE), Vical Inc (NASDAQ: VICL), Meridian Bioscience Inc. (NASDAQ: VIVO), and AVI BioPharma Inc. (NASDAQ: AVII) have all begun their overbought roll-over.

Novavax, Inc. (NVAX) is down 13% at $2.75; shares were at $0.81 last Thursday and closed at $1.42 last Friday (and hit $3.88 Monday).

Generex Biotechnology Corp. (GNBT) is down 22% at $0.44; shares were at $0.27 last Thursday and closed at $0.34 last Friday (and hit $0.70 yesterday).

BioCryst Pharmaceuticals Inc. (BCRX) is down 18% at $3.41; shares were at $1.75 last Thursday and closed at $2.21 last Friday (hit $4.89 Monday).

Pure Bioscience (PURE) is down 10% at $10.58; shares were at $1.75 last Thursday and closed at $1.85 last Friday (hit $3.19 Monday).

Vical Inc (VICL) is down almost 7% at $2.27; shares were at $2.40 last Thursday and closed at $2.53 last Friday (hit $3.30 Monday).

Meridian Bioscience Inc (VIVO) are flat today at $17.80; shares were at $16.13 last Thursday and closed at $16.24 last Friday (and hit $18 on Monday).

AVI BioPharma Inc. (AVII) is down 10% at $0.878; shares were at $0.74 last Thursday and closed at $0.89 last Friday (and hit $1.29 Monday).

We sent a notice to our newsletter subscribers that these moves have been seen before, and these same moves are usually followed by a move back down that often takes the stocks  lower than where they started.  Some of these shares moved higher on Friday, so we wanted to show how much some of these have run up since last Thursday even with today’s pullback.

We stand by our prediction of earlier this week, despite the seriousness of this issue and despite the unfortunate deaths and illnesses that have been reported as a result.  Swine flu will soon be the brunt of jokes no different than the “Squeal like a pig!” notorious movie line.  The most dangerous things in Mexico remain the crime and violence, and of course Montezuma’s Revenge.

Jon C. Ogg

Of the tier-two stocks, you have BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) and Novavax, Inc. (NASDAQ: NVAX).  Of the tier-three stocks you have Generex Biotechnology Corp. (NASDAQ: GNBT), Vical Inc. (NASDAQ: VICL), AVI Biopharma, Inc. (NASDAQ: AVII), and Crucell NV (NASDAQ: CRXL).  More descriptive data has been provided for each move.   On another scale, Smithfield Foods Inc. (NYSE: SFD), the iShares MSCI Mexico Investable Market Index (NYSE: EWW), and The Mexico Fund, Inc. (NYSE: MXF) have exposure here as well.

BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) was up big Friday as it is a maker of drugs that block key enzymes in viral diseases like the flu, shares are indicated over $3.00 after a $2.21 close on Friday.  Novavax, Inc. (NASDAQ: NVAX) is another clinical stage company using its virus-like particle platform technology for flu treatments; stock is indicated north of $2.50 after closing up some 75% at $1.42 Friday.

Generex Biotechnology Corp. (NASDAQ: GNBT) is being passed around as a penny stock flu player with shares indicated around $0.40 after closing up 25% at almost $0.34 Friday.  Vical Inc. (NASDAQ: VICL) closed up 3% Friday at $2.53 and shares are indicated up around $3.00.  AVI Biopharma, Inc. (NASDAQ: AVII) rose over 20% to $0.89 Friday and shares are indicated up marginally as a result.  Crucell NV (NASDAQ: CRXL) has a faster way of making flu vaccines. This closed up 1% on Friday and is hardly moving.

This could have an impact on food stocks and even an ETF and a closed-end fund that each track Mexico.  Smithfield Foods Inc. (NYSE: SFD) is deemed as the big pork play among the U.S. food companies.  There are also two plays on the fund side with a closed-end fund and an ETF.  The iShares MSCI Mexico Investable Market Index (NYSE: EWW) may be taking a hard hit this morning because of the Mexico-tied swine flu being the source of the disease.  There have been more than 1,300 suspected cases and roughly 100 deaths from swine flu.  This is the key ETF that traders use to trade exposure to Mexico.  The Mexico Fund, Inc. (NYSE: MXF) is a closed-end mutual fund that may also take a hard hit this morning because of the Mexico-tied swine flu being the source of the disease.

Those who believe that the sky is falling will point back to the flu scare of 1918 that decimated populations.  Keep in mind that there was little communication and the treatment at the time was generally bed rest and no hygiene was practiced by the bulk of the population.   You can probably bet that you will be hearing “squeal like a pig!” jokes sooner rather than later.

As a reminder, these huge gap-ups can last more than a day, but historically we have seen each successive move usually being less than the first.  As with issues such as SARS and bird flu, the world did not end and it was only the SARS scare which actually caused real damage.  We also had the great Mad Cow disease craze and even teh Hoof & Mouth scare, all of which created initial moves but ultimately had zero net impact on sectors and the economy as a whole.

JON C. OGG

The offering consists of up to 22,527,275 shares of commonstock issuable upon conversions of a $20,650,000 principal amount of 8% SecuredConvertible Notes due September 2009, and up to 51,198,347 shares of commonstock issuable upon the exercise of warrants.  

The company itself will not receive any proceeds fromthe offering.

Generex is up almost 1% to $1.07 in early morning trading.The market cap sits at $119.3 million and the 52-week range is $0.81 to $2.14.

You can join our open email distribution list to hear about previews for other mergers, spin-offs, break-ups, IPO’s, special financings, and other special situations.

Rachel Lopez
May 1, 2008

Cadence Pharmaceuticals Inc. (NASDAQ: CADX) up over 8% today on no new developments to $6.74 off a 52-week range of $4.84 to $20.67. Cadence Pharmaceuticals is a development stage biopharmaceutical company with two products in Phase III testing, Acetavance and Omigard.

CV Therapeutics (NASDAQ: CVTX) down today despite FDA approval for its coronary artery treatment, Lexiscan, granted last Friday. The drug is injected into patients during heart tests that cannot exercise to increase blood flow in their arteries. The drug will be marketed by OTC company Astellas Pharma US Inc. and will pay CV Therapeutics $12 million now that drug has been approved. CV Therapeutics is down over 5% to $7.57 on a 52-week range of $5.41 to $13.74.

Mannkind Corp. (NASDSQ: MNKD) still slipping today on Pfizer’s insulin scare earlier this month. Pfizer markets an inhaled insulin product, Exubera, that recently studies showed it be connected with lung cancer in its users. Despite the failings of Pfizer’s inhaled insulin product and other developers of similar treatments (including Alkermes above), Mannkind intends to continue developing its similar product, Technosphere. Shares are down almost 7% to $2.33 today on a 52-week range of $2.15 to $15.65. Pfizer (NYSE: PFE) up marginally today to $20.53 on a 52-week range of $20.19 to $27.73.

Generex Biotechnology Corp. (NASDAQ: GNBT) could benefit from Pfizer’s and Mannkind’s struggles with inhaled insulin treatments. Generex’s product Oral-lyn is viewed as a competing oral insulin product that is safe and effective. Shares are up over 2% to $1.18 today on a 52-week range of $0.81 to $2.14.

Peregrine Pharmaceuticals Inc. (NASDAQ: PPHM) down almost 11% today after they announced that the pre-clinical study of their anti-PS Vascular Targeting Antibodies showed a broad range of potential for cancer treatment at the American Association of Cancer Research annual meeting. Shares are down to $0.44 on a 52-week range of $0.35 to $1.40.

Rachel Lopez
April 14, 2008