BioCryst Pharmaceuticals (BCRX) leads the list of top losers so far today and is now at $9.72, down $0.68 (-6.54%) on volume of 4,947,233 shares traded. Last night BCRX priced an offe...(Click the story link or go to http://www.marketintelligencecenter.com for the full story)
eFuture Information Technology Inc. (NASDAQ: EFUT) moved down 28% to $7.20 in the morning trading hours after EFUT announced its financial results for the second quarter ended June 30, 2009. The 52 week trading range for EFUT is $2.51 - $13.84.
HF Financial Corp. (NASDAQ: HFFC) is currently trading at $8.20, declined by $1.55 or 15.90% on 35K shares in the morning trading hours after HF Financial announced the pricing of its public offering Of 2.5 million common shares at $8.00 per share.
DryShips Inc. (NASDAQ: DRYS) declined 3.37% to $6.31 on 7.28 million shares. So far this year, DRYS is down over 40%. The 52 week trading range for DRYS is $2.72 - $17.35. Yesterday, DryShips Inc. announced the pricing of its $400 million convertible senior notes offering.
Dell Inc. (NASDAQ: DELL) plummeted 8.19% to $14.55 on 2.28 million shares. Yesterday, Dell reported net income of $337 million or $0.17 a share as compared to $727 million or $0.37 a share, a year ago quarter. In the last six months, DELL gained over 26%.
Vodafone Group Plc (ADR) (NASDAQ: VOD) tumbled 1.77% to $22.15 on 834K shares after The 52 week trading range for VOD is $15.46 - $23.85. Vodafone Spain has appointed Cristina Rivas Saiz as its marketing director for the enterprise business unit in Spain. In the last six months, VOD gained over 18%.
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) plunged 6.54% to $9.72 on 1.09 million shares. Yesterday, BioCryst Pharmaceuticals announced pricing of a public offering of 5,000,000 shares of its common stock at $9.75 per share. So far in 2009, BCRX gained over 609%.
ADC Telecommunications (NASDAQ: ADCT) declined 14% to $5.69 on 1.38 million shares. Yesterday, ADC Telecommunications reported that it lost $19.2 million in the fourth quarter. So far this year, ADCT is up only 4%.
Golden Green Enterprises Ltd (NASDAQ: CHOP) is another stock down 5.51% and now trades at $5.15, on 136K shares. In the last six months, CHOP gained only around 2%.
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BloggingStocks: Today was a very unusual day. There was no real economic data to absorb. And the markets did see some unusual options trading ahead of expiration date at 4:00 PM today. Disappointing earnings kept a negative bias in the air despite a brief recovery ... Read more
In mid September, on the same day that CEL-SCI Corporation (AMEX:CVM) announced that the U.S. Food and Drug Administration (FDA) had indicated that the company could proceed with its first clinical trial to evaluate the effect of its investigational LEAPS-H1N1 treatment on the white blood cells of hospitalized H1N1 patients. CEL-SCI Corporation also announced plans to raise $20 Million in Registered Direct Offering. Shares showed some resiliency after investors were told that the net proceeds from the offering would be used to commence a pivotal Phase III clinical trial with its cancer drug Multikine and that the company would rapidly take its new LEAPS - H1N1 compound into human studies for the treatment of hospitalized H1N1 patients.
{tiny;CVM;0}After the market closed on Tuesday, investors learned that the company had filed an "amended" Form S-3 with the SEC. The form appears to be part of a $30 million bump to a previously filed "shelf offering" that had just been filed with the SEC two weeks ago, on October 30th.
In that original filing, the company had disclosed that they were looking to raise only $10 million. The total now is $40 million. Was there a miscalculation? Did something unforeseen develop at the recent vaccine conference in D.C.?While the filing has impacted the shares negatively over the last couple of days, the company may not even be planning to take advantage of the new shelf immediately.These types of filings, while not usually publicized, give informed investors significant information regarding the securities offered, and are basically designed to help alert investors ahead of any sudden moves.Still, one is left to wonder. Is this a "tell?" Especially given the odd timing of the filing.One day prior to the amendment, the company had reported from the big conference in Washington that their L.E.A.P.S. platform had shown the ability to modify immune response. Those findings based on studies conducted by Dr. Kenneth S. Rosenthal, Professor of Immunology and Microbiology of Northeastern Ohio Universities College of Medicine and Pharmacy, in collaboration with scientists at the Cleveland Clinic were supportive of the role that the technology might play in the treatment of H1N1 hospitalized patients. That news, coupled with a release two days earlier that an Institutional Review Board of The Johns Hopkins University School of Medicine (Johns Hopkins) had given clearance for the company's H1N1 clinical study to proceed. The news boosted credibility among investors and basically let them know that CEL-SCI had indeed been working diligently with their CRO and Johns Hopkins to actively prepare submissions to the FDA. The aim, as explained by company officials in a pre-released statement, is to move ahead "in the fastest and most effective way" towards clinical trials going forward for this unique investigational treatment. That sent shares up 50% during back-to-back sessions on Friday and Monday.Then came the new amended filing.Here is what we do know:Some time in the next two years (as allowed by the SEC), Cel-Sci can offer and sell up to $40 million of the securities described in the registration statement. The terms of any future offering would be established at the time of the offering and would be subject to market conditions and approval by the company’s board of directors.So while the Company doesn't appear to have any immediate plans to use the shelf registration statement, this filing may allow CEL-SCI to offer and sell securities on an expedited basis if market opportunities present themselves and that prospect has left investors wondering if some kind of news, event or even partnership is in the works.We know that the company has several pending news items including, but not limited to:1- The validation of its newly completed state-of-the-art facility in Maryland which it expects to utilize to launch aseptic filling for stem cell produced therapies and other biological products. In addition to serving as the "home base" for manufacturing Multikine® going forward, the facility could also bring substantial revenue to the company if they decide to lease it to other companies on a per-hour or per-day basis.2- The official announcement that the long awaited global Phase III trials for Multikine®- which is being readied as a cancer vaccine in advanced primary head and neck cancer- have begun.3- An announcement- or series of announcements- regarding CEL-SCI's prevention and treatment for H1N1 swine flu using their L.E.A.P.S. technology platform. Those announcements could include the results of clinical human blood tests, FDA designation or status changes for the H1N1 treatment. Another expedited trial announcement or change of clinical process itself . After this past weekend's hearing in front of congress, where the nation's top health officials were criticized for not investing more into U.S. based flu prevention platforms and being "ill-prepared" to deal with the pandemic flu- as evidenced by the late delivery of vaccines, it's not even far fetched to think that some kind of federal funding for the L.E.A.P.S. H1N1 program (similar to the funding seen for BioCryst's (NASDAQ:BCRX) Peramavir) could come into play.Take a look at that company's stock performance during the last two months. Impressive. Especially given the criticism that Peramavir has gotten in the press.
Like Tamiflu and Relenza, Peramavir is a neuraminidase inhibitor and the problem with neuraminidase blocking is that there are human genes that utilize neuraminidase for normal and healthy cell function (NEU1, NEU2, NEU3, NEU4). Critics of the drug argue that any neuraminidase blocking drug runs the risk of interfering with general communication needed for healthy cell function. The L.E.A.P.S. platform works completely differently and is intended to enable stimulation of the specifically-needed immune responses, while avoiding the administration of regions of H1N1, and other viruses, which may exacerbate the problem of cytokine storm, which scientists believe may be involved in the death of these H1N1 patients."What's promising is LEAPS immunogen's ability to activate the desired immune response without generating pro-inflammatory responses, which should make for inherently safe vaccines," According to Melly Alazraki of AOL's Daily Finance which published a story about researchers who are rushing to build better defenses against H1N1 on Wednesday.
Speculation. All of it. Yet it fuels the market and particularly stocks like CVM, who have so much ammo in their trunk.On the other side of the coin, critics pounce on CEl-SCI's possible motives and cry "Dilution!""We just hope the company gives some of it's investors a chance to actually make money on good news, instead of simply raising money and keeping that entirely for themselves," says one long time investor in the company. "I'm not happy about the latest filing and it makes me wonder why they're going to go after more money. After all, didn't the company just announce that they had enough money to finally start Phase III trials for Multikine and to provide funding for their H1N1 program the last time they raised money?"
As explained so clearly in Investopedia, "sometimes current market conditions are not favorable for a specific firm to issue a public offering. For example, suppose the housing market is heading toward a dramatic decline. In this case, it may not be a good time for a home builder to come out with its second offering, as many investors will be pessimistic about companies working in that sector. By using shelf registration, the firm can fulfill all registration-related procedures beforehand and go to market quickly when conditions become more favorable."
After cruisin' the message boards, one reader sent me this comment by a poster who goes by the name xji590. Apparently, his take has attaracted quite a bit of attention from the longs.
"The shelf is an opportunistic move," he writes. "It is there in case someone comes along willing to buy a major block of shares at a price that the company thinks is reasonable. But clearly he needs to wait to utilize the shares made available through this shelf until he can minimize dilution. They are well capitalize right now, however, the H1N1 opportunity has thrust upon the company cash flow requirements, I'm sure, that were not anticipated a year ago, or even six months ago. Geert (Kersten, the CEO) knows that his cash flow model has changed, and needs to put the company in a position, through the shelf, to raise additional working capital should the company need to do that... I love seeing the company going out with a bold statement like this shelf offering... They have confidence. So what are they confident in? That's the $60 thousand dollar question... If they just need cash, Geert would go out with a shelf grabbing $2M, $5M maybe even $10M... But $40M??? That's a big shelf for CVM. That conveys management confidence."
Shares closed down only slightly for the second day in a row.
I'd venture to say that given all the drama and attention, what comes next will definitely be interesting.
"Progress in public health depends on innovation. Some of the greatest strides forward for health have followed the development and introduction of new medicines and vaccines," said WHO Director-General Margaret Chan said.
Veronica Garcia, New Mexico's Secretary of Education, talks about a seminar she and other officials attended on H1N1, the swine flu.
Companies with Certified Existing Treatments for Swine Flu
Gilead Sciences, Inc. (NASDAQ:GILD) /Roche Holding Ltd. (OTC:RHHBY) Product: Tamiflu (oseltamivir)GlaxoSmithKline plc (NYSE:GSK) /Biota Holdings Ltd.(ASX:BTA)Product: Relenza (zanamivir)Baxter International Inc. (NYSE: BAX) Product: A(H1N1) vaccine using its Vero cell culture technologyNovartis AG (NYSE:NVS)Product: Influenza A(H1N1) vaccine using Cell-based manufacturing technology
Companies with Potential Vaccines and Treatments for Swine Flu
MedImmune / AstraZeneca PLC (NYSE:AZN) Product: needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology
Sanofi-Aventis SA (NYSE:SNY) Product: Swine Flu Vaccine
Companies with Adjuvantsfor Swine Flu VaccinesHemispherx Biopharma (AMEX:HEB)Product: AmpligenAntigenics, Inc. (NASDAQ:AGEN) Product: QS-21 StimulonOther Technologies Which Combat H1N1Oculus Innovative Sciences, Inc. (NASDAQ:OCLS)Microcyn® Technology platform
Chan, who last month declared a full pandemic underway from the H1N1 virus, said that patents can help ensure that companies develop medicines to "stay ahead of the development of drug resistance" in diseases like malaria and tuberculosis.
The discovery of isolated H1N1 infections that resist the anti-viral Tamiflu, made by Roche and Gilead, and the global scramble to secure flu vaccines have shown the importance of robust research and development, Chan said.
"Innovation is needed to keep pace with the emergence of new diseases, including pandemic influenza caused by the new H1N1 virus," she told a meeting on intellectual property and health, a contentious issue that has divided rich and poor nations.
In the speech, Chan said most drug access problems faced by developing countries could be remedied by tinkering with the existing patent system, which "operates as a stimulus for research and development for new products."
In May, at the WHO's annual assembly, rich and poor nations failed to reach consensus on how they should share virus samples of H1N1 and other flu strains with companies that use the biological material to make vaccines.
Indonesia has been especially vocal against this, arguing that developing countries would not be able to afford patented jabs made from their specimens.
PROBLEMS WITH PATENTS
Chan said those talks on "one of the most difficult, and divisive, issues ever negotiated by WHO" had identified problems with patents but said that the existing intellectual property regime did not need to be fully dismantled in pursuit of equity.
"R&D can indeed be needs-driven as well as profit driven," the former Hong Kong health director said. "International agreements that govern the global trading system can indeed be shaped in ways that favor health needs of the poor."
Chan described the global vaccine making capacity as "finite and woefully inadequate for a world of 6.8 billion people, nearly all of whom are susceptible to infection by this entirely new and highly contagious virus."
While acknowledging that "the lion's share of these limited vaccines will go to wealthy countries," she said the shortfall was "the result of limited global manufacturing capacity. It is not, in essence, a result of intellectual property issues."
The WHO has recommended that health workers, pregnant women and children should get priority access to H1N1 vaccines, and noted that every country worldwide will need them.
Chan said the ideal H1N1 shot would protect against seasonal strains as well as a range of candidate pandemic viruses.
"This innovation has not come about yet," she said. "This would be the best and most rational insurance policy for increasing supplies and encouraging more equitable access."
Top flu vaccine makers include Sanofi-Aventis, Novartis, Baxter, Schering Plough's Nobilon, GlaxoSmithKline, Solvay and AstraZeneca's MedImmune.
, the world leader in flu shots, will commence within days, company officials said on Tuesday.
Companies with Certified Existing Treatments for Swine Flu
Gilead Sciences, Inc. (NASDAQ:GILD) Roche Holding Ltd. (OTC:RHHBY) Product: Tamiflu (oseltamivir)GlaxoSmithKline plc (NYSE:GSK) /Biota Holdings Ltd.(ASX:BTA)Product: Relenza (zanamivir)Baxter International Inc. (NYSE: BAX) Product: A(H1N1) vaccine using its Vero cell culture technologyNovartis AG (NYSE:NVS)Product: Influenza A(H1N1) vaccine using Cell-based manufacturing technology
Companies with Potential Vaccines and Treatments for Swine Flu
MedImmune / AstraZeneca PLC (NYSE:AZN) Product: needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology
Sanofi-Aventis SA (NYSE:SNY) Product: Swine Flu Vaccine
Companies with Adjuvantsfor Swine Flu VaccinesHemispherx Biopharma (AMEX:HEB)Product: AmpligenAntigenics, Inc. (NASDAQ:AGEN) Product: QS-21 StimulonOther Technologies Which Combat H1N1Oculus Innovative Sciences, Inc. (NASDAQ:OCLS)Microcyn® Technology platform
The launch of clinical trials is a key part of a widening programme of work being undertaken by big pharmaceutical companies as they prepare for mass vaccination from next month.
GlaxoSmithKline , the other "big three" flu vaccine supplier, said it would initiate clinical studies later this month.
H1N1 swine flu, which first surfaced in Mexico in April and was declared a pandemic by the World Health Organisation (WHO) in June, has infected millions and killed an unknown number.
The WHO stopped counting at 800 confirmed deaths, since not every patient can possibly be tested.
Healthcare officials are relying on a vaccine to contain the spread of disease, providing a potential sales windfall for those companies that are able to deliver quickly and in large volume.
Australia's CSL has so far been the fastest commercial operator, after starting its first clinical trials in Australia two weeks ago. Now others are catching up.
"We started a little over a week ago," Novartis spokesman Eric Althoff said by telephone from Basel.
Benoit Rungeard, product communications director for Sanofi Pasteur, the vaccines division of the French drugmaker, told Reuters his company would start "in the coming days or next week".
Althoff said Swiss-based Novartis was conducting its clinical trials in a number of countries, including the United States, Britain and Germany, and was testing both single and booster, or repeat, doses of vaccines.
Novartis, in common with other manufacturers, will also compare vaccines with and without adjuvants -- ingredients that boost the immune system response.
AstraZeneca, whose MedImmune unit makes smaller amounts of a flu vaccine that is sprayed into the nose rather than injected, said it would start clinical trials in the United States around Aug. 17.
As well as racing against the clock, vaccine companies are also working flat out to maximise their production capacity.
Initially, all the manufacturers except MedImmune -- which uses a different process -- struggled with low yields when making swine flu vaccine, with most companies only getting about 30 percent of the usual yield of seasonal flu strains.
But that is starting to improve.
"We are higher than that (30 percent)," Sanofi's Rungeard said.
"During the production campaign the yield increases because we learn how to better use it -- at the beginning it is not same as at the end," he added. Regulators in Europe and the United States plan to fast-track approval of swine flu vaccines to ensure they are available for the start of the northern hemisphere winter.
At the moment swine flu is rated only a "moderate" pandemic by WHO standards but it could worsen as temperatures cool, making conditions better for the virus. (Editing by Greg Mahlich)
This was a company struggling to keep their doors open before a recent influx of millions in bullish investment capital and recent debt pay-offs.
One can see trading volume increasing as speculators have begun to move in now that the most recent filings with the SEC have confirmed that CEL-SCI has also been quietly positioning itself as a player in the H1N1 space with solutions that will get the attention of parties at the CDC, FDA and beyond (if they haven't already). This possibility now ringing more true than ever given the warning bells sounded by the Obama administration's advisory group on Science and Technology, who said in a report released yesterday afternoon that the H1N1 flu virus could cause as many as 30,000 and 90,000 deaths in the United States and that it "poses a serious health threat" to young people and children- unlike past strains of the virus.
The widely published report predicts that at least 1.8 million people will be hospitalized during the epidemic, with up to 300,000 patients requiring intensive care units. These patients could occupy 50-100 percent of all ICU beds in affected regions at the peak of the epidemic and would place "enormous stress" on ICU units.
Keep in mind that these are U.S. numbers alone and that this is one of the few countries with the financial resources to begin "hording" vaccine suuplies. Imagine what the impact might be in coutries with far, far fewer resources.
From a trading standpoint, one need only look at the recent run ups by "small" companies like Novavax, Inc. (NasdaqGM:NVAX), BioCryst Pharmaceuticals Inc. (Nasdaq:BCRX), and Generex Biotechnology (Nasdaq:GNBT) to realize that speculative buyers have not only been turning the increasingly bad news into a Swine Flu Bonanza. Look at what those stocks were trading at back in March and realize that it only gets more interesting from here.
And so, day after day, we see press releases from companies attempting to position themselves as players in this space. Still, few have offered solutions that prove substantive after a close look under the microscope, both figuratively and literally.By contrast, CEL-SCI has become tantalizingly alluring because they have kept their head down, busily preparing both in the lab and via back channels in Washington- at least according to some sources at our nations capital, interestingly, not far from where CEL-SCI is headquartered.
When I first approached them for comments after stumbling across them while doing research for my investigative article about H1N1 they said only enough as was required. Now, more details have emerged about the rumored flu vaccine and treatment I first told our subscribers about over the weekend. Although the details were very sketchy when we interviewed the company CEO, Geert Kersten on Friday, we have now pieced together more information about their innovative, dare I say revolutionary, approach to dealing with the growing flu problem.The latest filing with the SEC confirms, that CEL-SCI has created one (and perhaps even several) potential peptide vaccine/treatments against H1N1 swine flu using their L.E.A.P.S.™ technology- a patented, T-cell modulation, peptide epitope delivery technology. The platform has enabled CEL-SCI to begin pre-clinical formulation, evaluation and testing of a new application of its H1N1 vaccine, which will allow the targeting of "mutated" versions of H1N1 swine and other influenza viruses. World health officials believe that the influenza virus may mutate and evolve between now and the winter flu season. According to the filing:"In conjunction with the testing, CEL-SCI has produced several L.E.A.P.S. flu vaccines that focus on the conserved, non changing epitopes of the different strains of Type A Influenza viruses (H1N1,H5N1, H3N1, etc.), including "swine", "avian or bird", and "Spanish Influenza", in order to minimize the change of viral "escape by mutations" from immune recognition. CEL-SCI's L.E.A.P.S. flu vaccine contains epitopes known to be associated with immune protection against influenza in animal models."This is a developing story. As we mentioned earlier we have scheduled an interview with the company CEO, who was not available for immediate comment.It is known, however that administered like vaccines, LEAPS combines T-cell binding ligands with small, disease associated, peptide antigens and may provide a new method to treat and prevent certain diseases (the company has disclosed that they are also working on a potential rheumatoid arthritis vaccine)."The ability to generate a specific immune response is important because many diseases are often not combated effectively due to the body's selection of the 'inappropriate' immune response. The capability to specifically reprogram an immune response may offer a more effective approach than existing vaccines anddrugs in attacking an underlying disease."Also according to the filing, CEL-SCI also discovered a second peptide named CEL-2000."The data from animal studies of rheumatoid arthritis using the CEL-2000 treatment vaccine demonstrated that CEL-2000 is an effective treatment against arthritis with fewer administrations than those required by other anti-rheumatoid arthritis treatments, including Enbrel(R). CEL-2000 is also potentially a more disease type specific therapy, is calculated to be significantly less expensive and may be useful in patients unable to tolerate or who may not be responsive to existing anti-arthritis therapies."
New details have begun to emerge about Cel-Sci Corporation's (Amex:CVM) new new, state-of-the-art "Cold-Fill" manufacturing facility which will not only be used to manufacture Multikine® the world's first immunotherapeutic agent (which is being developed as a first-line standard of care treatment for cancer) for both the Phase III trials and commercial sales, but CEL-SCI plans to offer the use of the facility as a service to pharmaceutical companies and others, particularly those that need to "fill and finish" their drugs in a cold environment (4 degrees Celsius, or approximately 39 degrees Fahrenheit).
This is a key process of filling injectable drugs in a sterile manner and is an important part of the manufacturing process for many medicines.
This lab, which many now consider a cornerstone to the future financial success of the company is located near Baltimore, MD. According to newly released documents filed with the SEC, it was designed over several years, and was built out to CEL-SCI's specifications during the past 18 months. One insider calls it "absolutely state-of-the art" and "extremely impressive down to the smallest screw."
An interview between CEL-SCI's CEO, Geert Kersten, has been scheduled and more details will follow in this space as soon as I can provide them, but CEL-SCI believes it will be able to charge approximately $150,000 for an eight hour fill and finish "run" at this extremely unique facility whose aseptic filling suites are maintained at FDA and EU ISO classifications of 5/6. CEL-SCI also has the capability to formulate,inspect, label and package biologic products at cold temperatures. Furthermore, the company discloses that they do not know of any other facility in the United States which is able to provide cold 4 degrees Celsius finish and fill services on a contract basis.
What this will mean for the financial security and future of the company is significant, particularly given the fact that the fastest area of growth in the biopharmaceutical and pharmaceutical markets is biologics, and most recently stem cell products. These compounds andtherapies are derived from or mimic human cells or proteins and other molecules. Nearly all of the major drugs developed for unmet medical needs (e.g., Avastin(R), Erbitux(R), Rituxan(R), Herceptin(R), Copaxon(R), etc.) are biologics. Biologics are usually very sensitive to such things as heat and humidty and are known to quickly lose their biological activity if exposed to room or elevated temperatures (which may also affect the shelf-life of a biologic- with the result being that the product cannot be stored for as long as desired). These products do not generally lose activity when kept at 4 degrees Celsius.
This story continues to develop and we will keep you posted.
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