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On 7/22/09, Schering-Plough (NYSE:SGP) announced that a New Drug Application (NDA) for a fixed-dose combination of mometasone furoate and formoterol fumarate was filed and accepted for review by the FDA. The NDA is seeking marketing approval from the FDA for the maintenance treatment of asthma in patients 12 years of age and older. This new product combines the active ingredients of already-approved and marketed single-agent products which include an inhaled corticosteroid (Asmanex -mometasone furoate inhalation powder) and a long-acting beta2-agonist (Foradil - formoterol fumarate inhalation powder), administered via a single metered-dose inhaler. SGP has exclusive worldwide rights for the development and commercialization of the mometasone furoate and formoterol furmarate fixed-dose combination and is in the process of being acquired by Merck (NYSE:MRK).
On 7/22/09, Hemispherx Biopharma (AMEX:HEB) provided guidance that it does not expect a FDA decision on its Ampligen New Drug Application (NDA) until fall 2009. President/CEO Dr. William Carter said staffing problems at the FDA this year have resulted in the agency missing deadlines for final decisions on nearly two-thirds of NDAs under review. During a 7/22 conference call, Dr. Carter said HEB has been in contact with the FDA since May, has been regularly providing reports to different reviewers, and does not believe any additional documentation will be required by the Agency. Ampligen (Poly I: Poly C12U) is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) with Orphan Drug Status.
On 7/22/09, Human Genome Sciences (NASDAQ:HGSI) reported its quarterly results and stated that the Company and Novartis (NYSE:NVS) have completed pre-submission meetings with the FDA and EMEA regarding Zalbin (albinterferon-alfa 2b, formerly Albuferon) with planned submissions for global regulatory marketing approvals on track for fall 2009 seeking treatment of hepatitis C (HCV) types 2 or 3 viral infection. In April 2009, positive Phase 3 results for Zalbin in patients with chronic hepatitis C were presented at a medical conference and data from two pivotal Phase 3 trials, ACHIEVE 1 and ACHIEVE 2/3, showed that Zalbin met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a). With half the injections, Zalbin achieved a rate of sustained virologic response comparable to Pegasys in these studies and comparable safety results.
On 7/22/09, Bovie Medical (AMEX:BVX) announced a 510(k) submission to the FDA seeking pre-market clearance for the Company's Polarian Seal-N-Cut vessel sealing line of hybrid monopolar and bipolar forceps. The new Seal-N-Cut line of instruments provides for monopolar and bipolar energy combined with intelligent feedback from Bovie's Hybrid VS electrosurgical generator. The Seal-N-Cut devices also accommodate a wide array of possible applications in either monopolar or bipolar surgeries thereby serving endoscopic needs in multiple endoscopic fields including Endo GYN, General Surgery, Pediatric surgery, Thoracic Endoscopy and Urology. Bipolar vessel sealing and coagulation is one of the fastest growing markets in Endoscopy, estimated to exceed $1 billion in revenues worldwide.
On 7/22/09, Bayer (BAYRY.PK) and Onyx Pharma (NASDAQ:ONXX) announced that their first cooperative group-sponsored randomized Phase 2 trial in advanced metastatic breast cancer met its primary endpoint of progression-free survival. The study evaluated Nexavar (sorafenib) tablets in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer. Study findings demonstrated that the median progression-free survival was extended in patients treated with Nexavar and capecitabine compared to patients receiving capecitabine and placebo. These results were statistically significant (p = .0006). In this trial, the safety and tolerability of the combination was as expected and did not show any new or unexpected toxicities. A complete data analysis from this study is expected to be presented at an upcoming scientific meeting. Onyx and Bayer are currently evaluating various strategies for Nexavar in breast cancer.
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 [...]
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 63% and 21.3%, respectively.
R&D expenses increased due to developmental programs of Nexavar for additional indications including thyroid, colorectal and adjuvant liver cancer and costs related to further development of another candidate, ONX 0801. Earlier, in September, Onyx began enrolling patients in a phase I study of ONX 0801 as a potential treatment for advanced solid tumors. This triggered a milestone payment of $7 million to BTG International Limited, which licensed the drug to Onyx.
At the end of the reported quarter, cash, cash equivalents, and marketable securities were $843.1 million, up from $458 million at the end of December 2008. The 84% increase in cash balance was primarily due to net proceeds of debt and equity financings in August 2009.
During the quarter, Onyx acquired 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 candidate for the treatment of multiple myeloma. We believe that the acquisition of Proteolix results in a significant addition to Onyx’s cancer pipeline. Read the full analyst report on "ONXX" Read the full analyst report on "BAYRY.PK" Zacks Investment Research
That's what happens when you say a you are 'not yet able to project 2008 financial results due to uncertain trends'. Onyx Pharmaceuticals, Inc. (Public, NASDAQ:ONXX) was a stockmaster pick back in 2006 when it traded below $12 a share. It's gone on an incredible ride since that time, but today, shares are just $10 away from a new 52-week low.
Ten dollars may sound like a ton of room to breathe, but considering shares were almost $60 last month, it's a huge drop.
So what went wrong?
Today Onyx reported a fourth-quarter net loss of $11.7 million, or 21 cents a share, including an employee stock-based compensation expense of $3.9 million, or 7 cents a share.
In the year-earlier quarter, Onyx posted a net loss of $20.7 million, or 47 cents a share.
The mean estimate of analysts polled by Thomson Financial was for earnings of 7 cents a share.
Slight miss.
Sales of the company's anti-cancer therapy drug, Nexavar, were $124.9 million for the quarter ended Dec. 31, representing a 96% increase from the $63.7 million in the same period of 2006.
Their drug Nexavar is a potential gold mine, which is why the Masters took interest in the 1st place. In collaboration with Bayer HealthCare Pharmaceuticals, Inc., Onyx is developing and marketing Nexavar(R) (sorafenib) tablets, a small molecule drug.
Nexavar is currently approved for the treatment of advanced kidney cancer and for the treatment of liver cancer. Additionally, Nexavar is being investigated in several ongoing trials in non-small cell lung cancer, melanoma, breast cancer and other tumor types.
Nexavar is approved in more than 60 countries for the treatment of patients with advanced kidney cancer. They were recently granted approval in a second indication, liver cancer, in the U.S. and E.U. As part of a broad development program. Nexavar is also currently being evaluated in pivotal trials in metastatic melanoma but the hope to treast lung cancer just hit a snag.
Onyx announced today that the late-stage study of Nexavar in lung cancer patients after an independent monitoring board concluded that the study had no chance to succeed.
Boom, 20% drop in shares, the end.
Onyx and Bayer are running additional lung cancer trials with Nexavar, including a second phase III study that combines the drug with a chemotherapy regimen commonly used in Europe. Monday's negative results, however, raise doubts about their outcomes.
The setback disappointed investors who've been hoping for a more positive outcome from the lung cancer study to further fuel Nexavar sales growth and push Onyx's stock price much higher.
Fellow Masters, let's watch the downgrades come in, let the stock fall lower, then think about making a position.
By Todd Sullivan from ValuePlays - Anytime the largest shareholder of a company goes on a buying spree like Barnes and Noble's (NYSE:BKS) Leonard Riggio did recently, I have to look closer.
Riggio, who bought 100,000 shares both in August and September, bought an additional $11.3 (approximately 420,000 shares) million dollars worth in October. This bring his total stake in the company to 24%. Much like Sear Holding's (SHLD) Eddie Lampert's buying spree this summer, when people intimately involved in the company cannot seem to buy enough shares, you have to be interested.
If you recall Barnes and Noble in August predicted a more optimistic outlook than was previously thought and about this time Riggio began his buying spree. On has to infer from this that the future for BKS may be even rosier that predicted in August. For those hoping for a Barnes and Noble and Borders (BGP) merger, this news ought to put a damper on those expectations. Were a merger or other collaboration to be announced anytime in the near future, Riggio's purchases was be reduced to simple insider trading ahead of the announcement. That does not mean it will not happen, just that it will not happen anytime soon.
I am going to look closer here over the weekend and get back next week..... I am very intrigued though..
Todd Sullivan, Contributor to theStockMasters.com and ValuePlays Founder
The Stockmasters Master Picks newsletter has been kicking ass and taking names for the past year. The StockMasters Master Picks Newsletter has a 17.5% Positive return since our inception in October 2006. The Average duration for our stock picks is 3.61 months, and we have the track record to prove it (click here to view Master Picks track record).Our new publication just came out on Monday (10/15) and our newsletter produced over a 132% gain with Onyx Pharmaceuticals (ONXX) and a 53% gain with Savient Pharmaceuticals (SVNT) within 2 months.
We've had impressive returns, great feedback, and in turn have already created a unique following of thousands of Stockmasters, on sale at WallStNewsletters.com. for only $45 a year. That's cheaper than a round of beers and an order of hot wings for your crew. Why not have more money in your pocket for beers and wings?
Bank of America Corporation (Public, NYSE:BAC) shares are down 8% in the past 5 days. They are the Juggernaut of the Banking Industry and if you think they won't come back, they'll just smash down your wall and put up a BofA ATM in your house.
The StockMasters are all gitty about this dip in BAC, so what if they Q3 profit fell 32%? Get over it, they are not a worthless Washington Mutual (NYSE:MU) per say, they are America's bank and one of the world's largest financial institutions with a $215 Billion market cap.
The Peridot Capitalist, Mr. Chad Brand (Fellow WallStNewsletters.com and Full Monte Contributor) thought Bank of America (BAC) stock at $47 was attractive with a 5.4% dividend yield. The shares moved above $52 since his post, but today are falling back sharply, to $48 each, after the company posted poor third quarter results, just like every other bank has thus far. The dividend now stands at 5.3%, and Chad thinks it is very safe.
If you want to generate even more income on this trade, you could buy the stock to collect the dividend and any capital appreciation, while simultaneously selling out of the money call options on the shares to collect more cash. For example, the May 2008 52.5 calls are selling for about $1.75 each right now. Buying the stock and selling those calls would result in a breakeven point of ~$45 per share over the next 7 months or so. Conversely, your upside would be up to $52.50 on BAC stock, plus dividends and option premiums of around $3 per share (up to 15% in total gains).
Folks, now that BofA has been hit by Wall Street and is $2 below their 52-week low, it's the perfect entry point and in a few weeks it could get even lower. But there isn't a analyst alive that doesn't think Bank of America will return to greatness, its just a matter of time. There isn't a mutual fund or low risk stock out there that will give you a better return in 12 months than damaged shares of BAC.
Bank of America's profit fell short of Wall Street expectations and the CEO isn't trying to fool anyone. "While the significant dislocations in the capital markets have hurt most participants, we are still very disappointed in our third quarter performance," Bank of America chairman and chief executive officer Kenneth Lewis said
The bank unveiled earnings per share of 82 cents. Wall Street had anticipated earnings per share of 1.05 dollars. Revenues moderated 12 percent to 16.3 billion dollars during the July-September period from the third quarter of 2006.
Fellow Masters, wait for a new 52-week low if you aren't convinced, but BofA will comeback.
Article by Ted Gottsegen
Contributor at TheStockMasters.com
Disclaimer: The Author does not hold any positions or shares in the securities mentioned in this publication nor does he stuff his shorts.
The Stockmasters Master Picks newsletter has been kicking ass and taking names for the past year. Our new publication just came out on Monday (10/15) and our newsletter produced over a 100% gain with Onyx Pharmaceuticals (ONXX) and a 50% gain with Savient Pharmaceuticals (SVNT) within 3 months. In October 07's newsletter we cashed out: Activision, Inc. (ATVI) up almost 20% since we told you to buy in April 2007. Service Corp. International (SCI) up 43% since our 1st newsletter back in October 2006.
In March 2007 we said buy Halliburton Company (HAL), it's up more than 25% since we told you to buy. Blockbuster Inc. (BBI) ran up 36% since told Masters to buy back in June 2007.
We recommend stocks that don't take years to see a return, we look for returns within 2 to 5 months, this isn't grandpa's buy and hold strategy.
The Masters don't play when it comes to their money our your's for that matter. Our Original newsletter that has enlightened our our subscribers for over a year. It contains What to Buy, What to Sell, and Market Commentary. We've had impressive returns, great feedback, and in turn have already created a unique following of thousands of Stockmasters, on sale at WallStNewsletters.com. for only $45 a year. That's cheaper than a round of beers and an order of hot wings for your crew. Why not have more money in your pocket for beers and wings?
I subscribe to Maxim because it happens to be the most entertaining magazine I've ever read that makes me laugh and keeps my attention this side of Mad or Cracked Magazine. But now the one and only Jim Cramer has been popping up in the last few issues of Maxim, which just seems a bit odd.
Cramer has a one page deal where he gives some general advice and of course it always plugs him at the end with 'Jim Cramer is Co-Founder of theStreet.com'. The question I want to know is how much are they paying him?
Love him, hate him, you can't deny the Cramer Effect, and sooner or later he'll turn up on our cereal boxes, Sears catalogs and eventually church flyers. I found one 'article' that Cramer did for Maxim on their online site (click here to view), which I might add isn't 'work safe'. Maxim is a great magazine, no question, but now that it's a stomping ground for Cramer, I'm just taken back a step. I love this photo they used of him which has some great airbrushing to give him back 10 years, yea, Jim is sexier then ever and get your Bud Light on while you're at it.
You just can't get around Cramer's impact, at least not for a few years. It works out great when you own a stock before he mentions it but once that happens even Alfred E. Newman buy shares after-hours or the next day. Don't get me wrong, Cramer isn't all bad, he is to the stock market as Flavor Flav was to hip-hop in the 90's -- a great hype man. He's entertainment, which is why he's showing up in Maxim, and if someone paid you or me the money he's getting to say a few words, we'd be all over it. His track record has been called into question, he's CNBC's poster boy, and above all, the dude is a TV personality, take it for what it is -- Television. You don't believe everything you watch or you read, so when taking investment advice from the guy, myself, or anybody, just remember Alfred's catch phrase and ask yourself should you worry?
So what's next for Cramer? Playgirl? That could get him some great press and attention. Boo-Yah indeed.
Article by Frank Lara Jr.
Contributor at TheStockMasters.com
Disclaimer: The Author does not hold any positions or shares in the securities mentioned in this publication nor does he stuff his shorts.
The Stockmasters Master Picks newsletter has been kicking ass and taking names for the past year. Our new publication just came out on Monday (10/15) and our newsletter produced over a 100% gain with Onyx Pharmaceuticals (ONXX) and a 50% gain with Savient Pharmaceuticals (SVNT) within 3 months. In October 07's newsletter we cashed out: Activision, Inc. (ATVI) up almost 20% since we told you to buy in April 2007. Service Corp. International (SCI) up 43% since our 1st newsletter back in October 2006.
In March 2007 we said buy Halliburton Company (HAL), it's up more than 25% since we told you to buy. Blockbuster Inc. (BBI) ran up 36% since told Masters to buy back in June 2007.
We recommend stocks that don't take years to see a return, we look for returns within 2 to 5 months, this isn't grandpa's buy and hold strategy.
The Masters don't play when it comes to their money our your's for that matter. Our Original newsletter that has enlightened our our subscribers for over a year. It contains What to Buy, What to Sell, and Market Commentary. We've had impressive returns, great feedback, and in turn have already created a unique following of thousands of Stockmasters, on sale at WallStNewsletters.com. for only $45 a year. That's cheaper than a round of beers and an order of hot wings for your crew. Why not have more money in your pocket for beers and wings?
Nexavar is currently approved for the treatment of advanced kidney cancer and for the treatment of liver cancer. Additionally, Nexavar is being investigated in several ongoing trials in non-small cell lung cancer, melanoma, breast cancer and other tumor types.
f you recall Barnes and Noble in August predicted a more optimistic outlook than was previously thought and about this time Riggio began his buying spree. On has to infer from this that the future for BKS may be even rosier that predicted in August. For those hoping for a Barnes and Noble and Borders (BGP) merger, this news ought to put a damper on those expectations. Were a merger or other collaboration to be announced anytime in the near future, Riggio's purchases was be reduced to simple insider trading ahead of the announcement. That does not mean it will not happen, just that it will not happen anytime soon.
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