BioHealth Business Daily (ARQL, APPY, BPAX, BMY, CLDX, CELG, DCTH, JAV, KERX, PCYC, TLCR, VVUS)

Today’s edition of the BioHealth Business Daily is going to be very cancer-dominated due to the American Society of Clinical Oncology (ASCO) 2010 meeting that started this last weekend.  There are many other stocks on the move in the land of drugs and biotech as well.  Today’s key movers are ArQule Inc. (NASDAQ: ARQL), AspenBio Pharma Inc. (NASDAQ: APPY), BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), Bristol-Myers Squibb Company (NYSE: BMY), Celldex Therapeutics, Inc. (NASDAQ: CLDX), Celgene Corporation (NASDAQ: CELG), Delcath Systems, Inc. (NASDAQ: DCTH), Javelin Pharmaceuticals, Inc. (AMEX: JAV), Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX), Pharmacyclics Inc. (NASDAQ: PCYC), Talecris Biotherapeutics Holdings Corp. (NASDAQ: TLCR), and VIVUS, Inc. (NASDAQ: VVUS).  We have provided data on the news, trading moves and relative data and color on each where applicable.

ArQule Inc. (NASDAQ: ARQL) is trading up along with many other cancer-related stocks due to ASCO.  The company says its drug could help lung cancer patients after the presentation of final Phase 2 results for ARQ 197 c-Met inhibitor in Non-Small cell lung cancer at ASCO.  Shares were up at first but are now down by 13.7% at $4.84 on 1.3 million shares; 52-week range is $2.97 to $7.49.

AspenBio Pharma Inc. (NASDAQ: APPY) appears to be the worst performer of all stocks today.  This one has been halved after news that the submission of its marketing approval application for AppyScore with the FDA will not occur as previously anticipated by late June 2010.  Additional data analysis is needed and there was unexplained variability in site-to-site results in the initial draft of the statistical analysis report.  Shares are trading down a whopping 54% at $1.55 on more than 5 million shares.  The average volume is only 600K per day and the 52-week range is $1.30 to $4.98.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) is trading up after it announced the receipt of a FDA Orphan Drug Designation for GVAX as a chronic myeloid leukemia cancer vaccine.  Shares were up over 9% early in pre-market trading at $2.12, but now the stock is down 90.5% at $1.93.

Bristol-Myers Squibb Company (NYSE: BMY) is soaring for a company of this size on positive melanoma drug news out of ASCO and after Goldman Sachs raised the rating to Buy.  Shares are up over 8% at $24.27 versus a 52-week range of $19.12 to $27.07.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) is lower on what sounded to be good news on the surface.  The company showed “promising clinical data” on CDX-011 in metastatic melanoma. The phase 2 study met its primary endpoint and the results support additional studies in this indication for the treatment of melanoma and advanced breast cancer.  It also presented the study design for its recently initiated Phase II trial of CDX-1307 in bladder cancer, an antibody-based cancer vaccine candidate that is being evaluated as a treatment for bladder cancer.  Shares are trading lower by 14.6% at $5.60 on 1.8 million shares; average volume is 822K and the 52-week range is $4.16 to $11.82.

Celgene Corporation (NASDAQ: CELG) is up after data presented at ASCO this weekend AND on an analyst upgrade.  Jefferies upgraded the stock to “Buy” this morning.  Shares are up 5% at $54.10 on 5.2 million shares; 52-week range is $42.00 to $65.79.

Delcath Systems, Inc. (NASDAQ: DCTH) released data at ASCO this weekend which appeared to be positive, but shares are lower.  It highlighted the Phase III trial data presented on June 5 at ASO comparing percutaneous hepatic perfusion with melphalan to the best alternative care for patients with hepatic metastases from ocular or cutaneous melanoma.  Shares are trading down 23% at $11.27 on over 7 million shares; average volume is 2.05 million shares and the 52-week range is listed as $2.71 to $16.45.  Ouch.

Javelin Pharmaceuticals, Inc. (AMEX: JAV) announced that on June 4 it received notice from Hospira that the company will fund a $2 million loan to Javelin on June 10, 2010 under the existing loan agreement between the two.  Shares are up almost 7% at $1.41 on 1.5 million shares; 52-week range is $1.08 to $2.28.

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is not feeling any love…. The company announced Phase I data of its Perifosine in the treatment of recurrent pediatric solid tumors, with data including patients with advanced brain tumors and neuroblastoma.    Shares are down 7.7% at $4.43 on 2.45 million shares.  Average volume is 3.9 million shares and the 52-week range is $0.69 to $6.67.

Pharmacyclics Inc. (NASDAQ: PCYC) was up at first this morning as it announced a presentation of results from a Phase I trial of its first-in-Human BTK Inhibitor called PCI-32765.  The pop has faded, and now shares are down by 10% at $5.90 on almost 700,000 shares.  The 52-week range is $1.10 to $8.60.

Talecris Biotherapeutics Holdings Corp. (NASDAQ: TLCR) is a strange performer despite the notion that it is being acquired for $3.4 billion in a friendly merger deal from Spanish firm Grifols.  The cash and stock deal came to roughly $26.19 before the effects of any share price changes, but the share performance today was grossly different from perhaps what the two companies anticipated.  Shares were up 0ver 50% in pre-market trading above $24.00… Currently, shares are up by just under 25% at $19.89 on 15 million shares.  Shares did not even put in a 52-week high today.  This came public in late-2009 and had slid lower.

VIVUS, Inc. (NASDAQ: VVUS) announced positive results from the phase 3 REVIVE-Diabetes study of avanafil.  This is for the treatment of erectile dysfunction in men with type 1 and type 2 diabetes. The REVIVE-Diabetes study did meet all three of its primary endpoints across the two doses studied by demonstrating statistically significant improvement in erectile function and improvements in the International Index of Erectile Function score.  There were also not instances with certain foods and alcohol.  Shares opened up as high as $12.77 and traded as high as $12.80, but now the stock is in negative territory by 0.5% at $12.28 on only 1.8 million shares.  Investors have seen, heard, or anticipated most of these results.  The 52-week range is $5.24 to $13.68.

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JON C. OGG