Onyx Pharmaceuticals (ONXX) reported third quarter earnings of 28 cents per share, well above the Zacks Consensus Estimate of 22 cents as well as 21 cents reported in the year-ago period. The company, along with Bayer AG (BAYRY.PK), developed Nexavar (sorafenib) tablets, an anticancer therapy currently approved and marketed for the treatment of liver cancer and advanced kidney cancer in the US, European Union, Japan and some other countries. Onyx’s earnings come in the form of royalty and collaboration income on Nexavar sales.  For the quarter, Onyx reported revenues of $69.1 million compared to $50.8 million for the same period in 2008 primarily due to an increase in Nexavar sales and royalty revenue and a decline in the drug’s commercial expenses. While revenues increased 36%, a 43.6% rise in operating expenses brought down Onyx’s operating margin by 450 basis points to 14.5%. R&D and SG&A expenses increased ...

Recently, Onyx Pharmaceuticals (ONXX) announced that it will purchase privately held cancer drugmaker Proteolix for an upfront cash payment of $276 million. This transaction gives Onyx access to Proteolix's lead compound, carfilzomib, a mid-stage multiple myeloma drug. Apart from the upfront cash payment, Onyx, which currently sells the liver and kidney cancer drug Nexavar along with Bayer AG, is also liable to pay $40 million in 2010 if carfilzomib achieves a development milestone and up to $535 million depending on the achievement of certain regulatory approvals for carfilzomib in the U.S. and Europe.  That is inclusive of a payment of $170 million if the Food and Drug Administration (FDA) decides to conduct a fast review of the drug. The all-cash transaction is expected to close in the fourth quarter of this year. As a reminder, carfilzomib is currently undergoing a phase II b trial (n=250) in ...

Provectus Pharmaceuticals Inc., a development-stage oncology and dermatology biopharmaceutical company, has initiated a Phase 1 study of their drug – PV-10 – for liver cancer. The study will enroll up to six subjects with cancer metastatic to the liver or with recurrent liver cancer. The same drug is currently undergoing Phase 2 study for metastatic melanoma.

The primary objective of the open-label study is to determine the safety and tolerability of a single intralesional injection of PV-10 in patients with liver cancer. Additional objectives are to assess the distribution and retention of PV-10 in the injected lesion, tumor response and viability, and plasma pharmacokinetics of the drug following intralesional injection.

The CEO of Provectus, Dr. Craig Dees, PhD, spoke about the Phase 1 trial, “We hope to demonstrate that PV-10, which has shown excellent selectivity for melanoma, will be a viable therapeutic for liver cancer and cancers metastatic to the liver.”

The

...

Earlier this month, Anadys Pharmaceuticals, Inc. (ANDS) announced the commencement of dosing in a 12- week phase II trial with ANA598 in hepatitis C patients. ANA 598 will be evaluated in combination with interferon-alpha and ribavirin (current standard of care) in the mid-stage study. The study is expected to provide important data at the end of this year and in the first two quarters of 2010. A total of 90 patients are planned to be enrolled in the study, with 30 patients receiving ANA598 and 15 receiving placebo at each dose level. The study would test 200 mg and 400 mg doses of the drug. In order to maximize early viral suppression, each patient would receive two 800 mg doses on the first day. The study would be conducted at various sites in the U.S. Chronic hepatitis C virus (HCV) affects approximately 3.2 million people ...

In a positive development, Bayer (BAYRY.PK) released encouraging results from a phase II trial of regorafenib in patients with metastatic renal cell carcinoma (RCC), a type of kidney cancer. The phase II trial was carried out on 49 previously untreated patients whose tumors could not be removed surgically or had started spreading. The trial met its primary endpoint, which was to evaluate response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST). It was observed that 31% of patients experienced a confirmed partial response (PR) whereas 50% of patients experienced stable disease (SD). In addition, the data showed an estimated median progression-free survival of 8.3 months. The data were presented in an oral session at the joint 15th Congress of the European CanCer Organisation and 34th Congress of the European Society for Medical Oncology (ECCO 15 - 34th ESMO) at ...

Provectus Pharmaceuticals, Inc.

(Public, OTC:PVCT)

StocksHaven Investments profiles one of the most exciting up-and-coming anti-cancer companies in the industry, Provectus Pharmaceuticals (OTC:PVCT). They have one of the deepest pipelines of any small cap biotech, focusing on treatments for: Melanoma, Psoriasis, Atopic Dermatitis, Breast Cancer, and Liver Metastasis. With three drugs nearly ready to enter Phase III, including one nearly entering Phase II for Breast Cancer, one of the largest target markets worldwide and seeking “compassionate use” in Australia and USA, look for Provectus to make a splash within the next couple of months.

They are developing and testing one of the most exciting anti- cancer compounds. It has been demonstrating significant effectiveness against Melanoma in Phase 2 clinical trials and it offers promising treatment for breast, liver and other solid tumor based metastatic cancers. The compound developed by Provectus, known as PV-10, is a

...

Yesterday, Anadys Pharmaceuticals Inc. (ANDS) started a 12-week phase II trial of its ANA598 for hepatitis C patients. ANA 598 will be evaluated in combination with interferon-alpha and ribavirin (current standard of care) in the mid-stage study. Data from the trial is expected to be released at the end of this year and in the first two quarters of 2010.

A total of 90 patients are planned to be enrolled in the study, with 30 patients receiving ANA598 and 15 receiving placebo at each dose level. The study would test 200 mg and 400 mg doses of the drug. In order to maximize early viral suppression, each patient would receive two 800 mg doses on the first day. The study would be conducted at various sites in the U.S.

Chronic hepatitis C virus (HCV) affects nearly 3.2 million people in the United States and about 170 million people

...

DrStockPick.com Stock Report!

Monday August 31, 2009

**************************************************************

Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced that the U.S. Food & Drug Administration granted Delcath’s request for orphan drug designation for doxorubicin for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer. Clinicians in the U.S. diagnose nearly 20,000 cases of HCC annually.

TAEJIN Technology, Co., Ltd., a supplier of linear and switching regulators to a wide variety of consumer and mobile applications, today announced it has selected Tower Semiconductor, Ltd. (NASDAQ: TSEM), a

...

BioSphere Medical (BSMD) reported a net loss of $0.04 per share for the second quarter of 2009, below the Zacks Consensus Estimate of $0.09 per share. It had posted a net loss of $0.07 a share in the same quarter a year ago. Revenues increased 6.6% to $8.1 million on higher sales of embolic and delivery systems in the U.S.

During the quarter, product revenues grew 5.7% to $7.9 million. U.S. product sales totaled $6.2 million, up 14.5% on the progress of market development initiatives. Product revenues in Europe, the Middle East and Africa (EMEA) amounted to $1.1 million, down 15.9% largely due to the negative impact of stronger U.S. dollar. Product sales from rest of the world rose to $0.64 million from $0.60 million. Revenues from gastric products, which were phased out last year, were negligible compared to $0.20 million, a year ago.

Licensing revenues increased to

...

For Immediate Release

Chicago, IL – July 27, 2009 – Zacks Equity Research highlights Onyx (ONXX) as the Bull of the Day and Starwood Hotels and Resorts Worldwide (HOT) the Bear of the Day. In addition, Zacks Equity Research provides analysis on D.R. Horton (DHI), Lennar (LEN) and Beazer (BZH).

Full analysis of all these stocks is available at http://at.zacks.com/?id=2676

Here is a synopsis of all five stocks:

Bull of the Day:

We maintain our Buy rating on Onyx (ONXX) shares with price target of $45.

Onyx delivered strong financial performance in 1Q09 and we expect the company will continue to deliver very good financials for 2009. Nexavar sales continued to grow in 1Q08, which was mainly attributed to the market penetration in liver cancer while market share has stabilized in kidney cancer market in spite of heavy competition. Total Nexavar

...