HEB

[setravis]

"HEB" Threads have been Merged.
Please use the search before starting new threads on a Stock Pick.
Chances are a thread already exist.
So why not post whatever you have to comment about on that pick to that thread.
"Simplicity" My fellow traders.                  
All history on a stock pick in 1 thread is awesome.                 
Just trying to get threads together,so we don't have a numerous amount floating around on the same stock.
Thank You....and good luck with all your trades....make some $$$        
   

Friday's closing chart.......

[Draak]

February 14, 2007 - 1:18 PM EST           

Hemispherx Avian Flu Prevention/Treatment Program Announces New Primate Results and Expands in both Europe and Southern Hemisphere
Experimental Treatment Designed to Prevent/Treat Multiple H5N1 Classes with Oral Non-Toxic Treatment

Hemispherx Biopharma, Inc. (AMEX:HEB) announced today initial results of a new primate treatment program with Viroclinics, based in the Netherlands, and directed by Professor Albert Osterhaus, a world authority in Avian influenza spread and prevention.

In the primate study, macaque monkeys were pre-treated orally (sublingually) with either Alferon-N (a proprietary formulation of 8 molecular types of human alpha interferon) or placebo. Thereafter, they were exposed to highly pathogenic avian influenza virus, strain H5N1, which has resulted to date in a > 60% death rate in humans. Control animals, as expected, shown massive pneumonia by both gross and microscopic examination which was greatly ameliorated by treatment with Alferon LDO (applied sublingually).

The Hemispherx Vaccine Enhancement™ Platform is the utilization of Alferon LDO (derived from an FDA licensed therapeutic for another virus, HPV) via the Viroclinics collaboration based on promising results in a human volunteer study recently conducted in Hong Kong.

Based on earlier primate studies reported by the independent Japanese Institute of Infectious Diseases (JIID), collaborating with Hemispherx, the addition of Hemispherx's second experimental therapeutic, Ampligen®, may also provide vaccine cross-protection against different H5N1 strains when co-administered with a influenza vaccine.

In the expanded Australian clinical trial, studies will determine whether seasonal vaccine co-administered with the experimental therapeutic Ampligen®, may provide long-lasting seroprotection against either/both of the emerging strains of H5N1. The level of measured immune response to provide adequate protection in humans is as yet unknown, however, primate and lower animal research conducted by the JIID suggest that broad based cross protection in man by a single therapeutic treatment (Ampligen®), acting as a "TLR3 agonist" (stimulator) may be sufficient.

The U.S. Department of Health and Human Services (HHS) has recently announced a new pre-pandemic vaccine procurement program out of concern that the existing vaccine "won't work well" against the newer pandemic strains now spreading thru birds in China, Indonesia (2004), the Middle East, Europe and Africa (2006) and Great Britain (2007).

Based on these overall positive results, the Company has initiated active discussions with the U.S. Department of Defense regarding its biopreparedness, biodefense initiatives and priorities.

[Buyhigh?]

Is HEB still on anyones radar screen?

[Draak]

Time to buy.

[Draak]

Time to buy! DD!

[ravenquork]

What makes you say that?
the chart looks terrible and the company has a solid history of disapointments.

[Draak]

Going Higher.

[Draak]

12th April 2007

Japanese Ministry Awards Grant to Advance Studies with Influenza Vaccines Co-Administered with Hemispherx's Ampligen(R)
Studies Indicate Ampligen's® Ability to Increase Efficacy of Influenza Vaccines across Various Strains

Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) issued authorization to its National Institute of Infectious Diseases (NIID) approving their budget to advance studies indicating that an H5N1 influenza vaccine co-administered intranasally with Hemispherx's experimental therapeutic double stranded RNA (dsRNA) Ampligen® (Poly I; Poly C12U) protected against mutated strains of the virus and, further that, the seasonal trivalent influenza vaccine co-administered intranasally with Ampligen® maintained efficacy even when challenged with the H5N1 influenza virus.

The studies are to be lead by Dr. Hideki Hasegawa of the National Institute of Infectious Diseases with whom Hemispherx has been collaborating on the earlier animal studies. Enlarged studies, scheduled over three years, will focus initially on efficacy and stability as it pertains to the formulation of the vaccine and adjuvant (Ampligen®). Subsequent studies will focus on GLP (Good Laboratory Practices) studies required for regulatory submission including pharmacology, safety, toxicology, reproduction and carcinogenicity, followed by clinical studies.

Dr. Hasegawa initially presented the results of his studies at the Second International Conference on Influenza Vaccines for the World in Vienna, Austria in October 2006. In this presentation, he examined the protective efficacy of intranasal co-administration of inactivated whole-virion H5N1 vaccine with Ampligen® in mice and non-human primates. Intranasal administration of a candidate influenza vaccine with Ampligen® resulted in dramatically increased secretion of IgA (also known as immunoglobulin A) which formed the basis of mucosal immunity. The induced mucosal immunity thereafter protected subjects when challenged with Vietnam, Hong Kong and Indonesian strains of the H5N1 viruses.

Dr. Hasegawa's presentation concluded: 1) that the intranasal administration of Ampligen® combined with H5N1 vaccine induced cross-protective mucosal immunity against heterologous H5N1 influenza virus infection in mice; 2) intranasal administration of Ampligen® combined with H5N1 vaccine provided protection in the macaque monkey, a non-human primate which has a complex immune system ,similar to that of humans, from H5N1 infection; and 3) Ampligen® is the only human-applicable dsRNA which has a well-documented safety profile in humans.

Dr. Hasegawa conveyed his desire to commence the studies as soon as possible.

[Draak]

April 23, 2007 - 8:53 AM EDT           


Hemispherx and Armada Health Care enter Agreement to Launch Alferon N Injection(R) via Specialty Pharmacy Network
Utilizing SP Capabilities to Facilitate Expanded Access to Biotech Drugs

Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that they have enter into an agreement with Armada Health Care to launch their natural interferon, Alferon N Injection® (Alferon®), FDA approved for HPV related genital warts, into Armada's Specialty Pharmacy infrastructure. Alferon® is the only naturally derived alpha interferon approved in the United States. Studies have indicated Alferon® produces fewer adverse reactions than recombinant alpha interferon, maintains efficacy when an individual's antibodies may render recombinant interferon ineffective and has higher levels of potency in certain tests. Twenty-two million Americans, according to NIH data, are afflicted by HPV (Human Papillomavirus), for which Alferon® may be indicate in the refractory cases.

This marks Hemispherx's first marketing/distribution collaboration and is the first initiative in their new strategy towards commercialization. Under the terms of the agreement, Hemispherx will utilize Armada's services including patient and physician clinical education, patient level pharmacy services, reimbursement and data reporting.

Specialty Pharmacy is characterized by intense therapeutic management and centrally managed distribution of medications treating chronic health conditions. Specialty Pharmacy serves unique patient populations that often utilize injectable, infusion and biotech drugs. Examples of some of the disease states treated by Specialty Pharmacy are: Cancer, HIV/AIDS, Crohn's Disease, Cystic Fibrosis, Diabetes, Hemophilia, Hepatitis, M.S., Pulmonary Hypertension, Renal Dialysis and others. Approximately 3% of the U.S. residents take Specialty Pharmaceuticals with a growth rate twice that of traditional pharmaceuticals (27% vs. 13%).

"We are pleased and optimistic to initiate our commercialization strategy by launching a drug with such potential into our collaboration with Armada", stated Mr. Anthony Bonelli, President and COO of Hemispherx. "The Specialty Pharmacy channel seems to be well suited for our core technologies and offers a promising template for further indications and future product launches".

"Armada is proud to have been selected by Hemispherx as a partner in helping launch this drug into the specialty market", stated Mr. Lawrence Irene, CEO of Armada Health Care. "The national network we have built is unique in every sense and includes some of the largest specialty pharmacies in the industry. Our group is a perfect platform to maximize the introduction of any drug into the specialty market and we are committed to helping make this program a huge success for Hemispherx".

[setravis]

Niche antiviral drugmakers rocket on flu news...


52wk Range: 0.25 - 1.20
Volume: 6,240,633
Avg Vol (3m): 238,271

Technicals
Most Actives
Percentage Gainer

Last Price Quote is:
64.17%above 13-day MA
74.85%above 50-day MA
RS Rating: 87 

Fundamentals
Key Data:
Market Cap (M): $72.69 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: Market Perform

[setravis]

11:19AM Hemispherx Biopharma announces Japanese Government accelerates hemispherx biopharma's ampligen research programs for influenza protection (HEB) 0.84 +0.26 : Co announces it had received notice of an Annual Report prepared by a Director of the National Institute of Infectious Diseases to the governing organization of the Japanese Ministry of Health reporting a series of successful preclinical studies in new pandemic vaccines which rely critically on Ampligen an experimental therapeutic for efficacy. The efficacy was demonstrated both within the airways themselves as well as systemically. As a result, the program is expected to be accelerated into human volunteers promptly under supervision of NIID staff. The project is officially titled: "Clinical Application of the Influenza Virus Vaccine in the Intranasal Dosage Form for Mucosal Administration."

[setravis]

Due to the explosive demand for BioPharma companies pending Food and Drug Approval on new and innovative drugs, I will begin focusing on companies which are a few weeks away from their reviews. Taking notice of the recent 1000% over night gains respectively of TTNP and VNDA, the risk versus rewards leans well towards the positive end on these choices.

Moreover, for those who are not high on risk tolerance, investing up to the FDA approval date may still be a very smart investment as these companies are poised to rise leading up to the decision.


Now let's move onto my first choice:


Hemispherx BioPharma, Inc

(Public, AMEX:HEB)

About: Hemispherx Biopharma, Inc. (Hemispherx) is a biopharmaceutical company engaged in the clinical development, manufacture, marketing and distribution of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. The Company's products include Ampligen and Alferon N and Injection. Ampligen includes application as a treatment for Chronic Fatigue Syndrome (CFS) and as a vaccine enhancer(adjuvant) for both therapeutic and preventative vaccine development. Alferon N is an indicator for refractory or recurring genital warts. Alferon LDO (Low Dose Oral) is an application under early stage development targeting influenza and viral diseases. Ampligen is an experimental drug undergoing clinical development for the treatment of CFS.

FDA News: Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of 5/25/09.

My suggestion for you is put a small amount you can afford to lose of your portfolio and  you could be either sitting on big gains, or loss. Either way, it is worth rolling the dice on these gems.


See this post...
12 Extreme FDA Trades on New Product Decisions
http://www.3stocksonfire.org/trading/index.php?topic=7100.msg119331#msg119331


Technicals
Record Price High
Most Actives
Record Price Break Out
Percentage Gainer

Last Price Quote is:
126.08%above 13-day MA
166.32%above 50-day MA
RS Rating: 98 

Fundamentals
Earnings Expected on May 11

Key Data:
Market Cap (M): $72.69 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: Market Perform

[setravis]

Swine Flu Index Jumps as Vaccine Stockpiling Continues...

Select stocks connected to H1N1 vaccine production and development were up big on Monday after reports of stockpiling.

Swine flu claimed its first New York victim yesterday, a 55-year-old school administrator who doctors said had no known preexisting medical conditions. A spokesperson for the state's Department of Health warned, "given the large number of cases, it's possible that we'll see more severe cases in the next few days, particularly among people with underlying illness." The virus is an international threat, with over 8,000 infections worldwide.

Meanwhile, Japan has emerged as a new area of focus, with 125 confirmed infections and officials moving to close schools in an effort to limit the spread of the disease. On Friday, the UK took steps towards reducing the threat of a pandemic, ordering 90 million doses of vaccine. France, Belgium, and Finland reportedly ordered a cumulative 67.9 million doses. The demand spike and the headlines are boosting swine flu stocks today, some by more than 10%.

As a whole, the Swine Flu and Bird Flu Stocks Index is up by 7.7%. It is now ahead of the S&P 500 by 36.7% over the last month.

Leading the index is Hemispherx Biopharma (AMEX: HEB), which is up by 30%. The company is trading at new 52-week high levels and has rebounded by nearly 600% since hitting its 52-week low of $0.25.

BioCryst Pharmaceuticals (NASDAQ: BCRX) and Novavax (NASDAQ: NVAX) are both up by more than 9% today. Rodman and Renshaw has an Outperform rating on Novavax and a $4 price target, and the analysts recently noted that the company's primary fundamental driver is its Phase II seasonal flu study. The company expects top-line data from the study to be available later this year.

Sinovac Biotech (AMEX: SVA), AVI BioPharma (NASDAQ: AVII), and Pure Bioscience (NASDAQ: PURE) are all up by more than 4%.

Generex Biotechnology (NADSAQ: GNBT) is off by -13% today. After the bell on Friday, the company announced the issue and sale of 15.2 million shares to selected accredited investors at 33 cents a share.

Gilead Sciences (NASDAQ: GILD) and GlaxoSmithKline (NYSE: GSK) are moving by -1.5% and 1.5% respectively.

As of this writing, the Swine Flu and Bird Flu Stocks Index is one of the top-three performing tickerspy Indexes over the last month, up by 40.4%.

Investors can follow the Swine Flu and Bird Flu Stocks Index and view related performance charts and metrics at tickerspy.com.

Fun and informative, tickerspy.com is a free investing website where you can track multiple stock portfolios and compare against 250 proprietary Indexes tracking themes from nanotech to agriculture to precious metals. Best of all, tickerspy.com lets you spy on the portfolios of nearly 3,000 Wall Street institutions and hedge funds and see graphs of their performance. Try tickerspy.com today and find out how you stack up against investing legends like Warren Buffett!

[setravis]

Updated chart look...

52wk Range: 0.25 - 2.03
Volume: 19,249,633
Avg Vol (3m): 1,688,480

Technicals
Record Price High
Most Actives
Percentage Gainer

Last Price Quote is:
82.53%above 13-day MA
177.31%above 50-day MA
RS Rating: 97 

Fundamentals
Key Data:
Market Cap (M): $72.69 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: Market Perform

[setravis]

Special Report: Hemispherx Biopharma and it's pending FDA decision 
Written by M.E. Garza and Michael Vlaicu     
Monday, 18 May 2009 13:34 

What is going on with Hemispherx Biopharma?  To casual observers, that is the big head scratcher.

Such a mystery, in fact, that the company was contacted by NYSE Amex officials and asked if Hemispherx might issue a public statement indicating as to whether there are any corporate developments which may explain the unusually high level of trading activity for the stock.

Many have wondered why in the past two trading sessions, the price per share for the company has doubled, without apparent "material events."

Those of you who have been keeping up with our coverage of this company on BiomedReports- and specifically those of you who invest using our FDA and Clinical Trials Calendars- know that the stock price continues to spike today following a 41% surge on Friday as traders anticipate the upcoming FDA decision on approval of the company's key drug candidate- Ampligen® (poly I:poly C12U)- a synthetic being developed for the potential treatment Ampligen includes application as a treatment for Chronic Fatigue Syndrome (CFS). The stock ended the day on Monday up another 48% and is currently trading at $2.10 per share after hours (as this story is posted).

To say that insiders at the company are excited about the drug's chances for approval three months after a PDUFA decision date was delayed is an understatement.  The journey has been long and difficult.


Earlier in the year, the original FDA decision date had been announced as 2/18/09, but then suddenly that was delayed because additional data was submitted by HEB within three months of original decision date.  When the delay was announced, there was a sell off  that took the stock price from about $0.80 per share down to nearly $0.40. Some investors wondered if the company was heading down the same rocky road they had been down before with Ampligen.

Ampligen was first synthesized in the 1970s and has been proposed and tested as a treatment for many illnesses, but primarily chronic fatigue syndrome and acquired immunodeficiency syndrome.

Ampligen was developed after Merck & Co. (NYSE: MRK), in the 1960s, synthesized a double-stranded RNA compound composed of inosinic and cytidylic acid residues inhibited tumor growth by inducing interferon production.  In the mid-1970s, Dr. William A. Carter, a post-doctoral researcher at Johns Hopkins University, modified the dsRNA molecule by adding uridylic acid molecules at specific interval along the RNA chain. The new compound, called Ampligen (for AMPLIfied GENetic activity) stimulated interferon production like poly I:C, but was less toxic.

Carter originally founded a company, HEM Research, Inc., based upon the compound and licensed it from Johns Hopkins. By the late 1980s, Carter and his company were pursuing other human therapeutic uses for Ampligen, as well as non-therapeutic uses, such as diagnostic testing for HIV and protecting plants from pathogens.

Ampligen was tested in clinical trials beginning in 1988, after DuPont invested $30 million in Hemispherx. Initial success in a small trial for AIDS treatment was followed by difficulties in persuading the FDA to permit large scale trials. By 1991, it was thought that the chance of approval for a large trial being conducted in the USA had gone. Hemispherx then began to move clinical trials to Canada and Belgium.

In Belgium, Ampligen has been available for use since the drug's trial beginning in May 1996. It has also been available under Canada's Emergency Drug Release Program for both Chronic Fatigue Syndrome (CFS) and HIV treatment since 1996, with marketing rights controlled by Biovail Corporation International.

Over its developmental history, Ampligen has received various designations, including "orphan drug product" and "emergency compassionate cost recovery sales authorization" both from the FDA and "promising" clinical outcome recognition based on the evaluation of certain summary clinical reports (AHRQ, Agency Health Research Quality).

On December 3, 2007, the FDA deemed the new drug application submitted by the company on October 10, 2007 to be incomplete. Specifically eleven deficiencies were noted in the Clinical Section and three in the Pre-Clinical Section.

Continuing down the rocky road, Hemispherx management had missed several target deadlines for new drug application (NDA) filing in the past, including the end of 2005, the third quarter of 2006, and the first quarter of the year 2007.

According to published sources, in October 2007, the US Food and Drug Administration (FDA) Ampligen NDA was filed, marketing for the treatment of CFS now hangs in the balance. This time around, the company was not going to take any chances. They have submitted plenty of positive data and spirits are high within the company that the approval will come. Some institutional investors like their chances as well. In the past few days, the company got an injection of capital from them for the continuing development of the drug. "We've signed to obtain an $18.3 million investment from some institutional shareholders," said Dr. Carter during an interview on Friday. "We also have a $28 million credit line with Fusion Capital."

Carter says the company is looking at a strong balance sheet which provides HEB with some level of guarantee towards multiple years of operation (at least 4 or 5 years according to Carter).

"Of course, we do have a commercial product that is already on the market (Alferon N Injection® ), we plan to expand its sales, so we see a very healthy future for the company and a healthy financial balance sheet- even in the event that the secondary approval is delayed, which by the way is not our expectation."

Dr. Carter, generally considered to be a pioneer in Interferons (IFNs are natural cell-signaling proteins produced by the cells of the immune system) and their Pharmaceutical uses. There are some 30 or so diseases in which Interferon therapy is now the treatment of choice and it captures about $7 billion a year.

"Our Ampligen product is pending FDA approval as a mono therapy for Chronic Fatigue Syndrome which affects 4 million Americans, potentially up to 6 million and there are no other drugs on the market for this disease."

In addition, Ampligen is of global importance given it's application for viral diseases and disorders of the immune system including HPV, HIV, Hepatitis and influenza. Hand in hand with the government of Japan, the company is conducting trials showing very positive results for the drug as a booster treatment for influenza in the vaccine space.

More recently, the FDA had requested additional information from the animal studies for Ampligen.

"We have completed the animal studies that were requested by the agency (FDA)," explains Dr. Carter. "And we have produced an initial report of the studies and are now in the process of submitting final reports, but we've already given the conclusions to the agency. "

Chronic Fatigue Syndrome, whose symptoms include widespread muscle and joint pain, cognitive difficulties, chronic, often severe mental and physical exhaustion and other characteristic symptoms in a previously healthy and active person, was largely considered psychosomatic until studies began to prove otherwise. Recently published papers indicate the problem may have it's origins at the genetic level.

"This is a disease that actually involves the genetic machinery, and specifically the machinery involved in mounting an immunological response  and also a gene that is involved in energy metabolism," explains Dr. Carter. "We now have a finger print test which can be applied (which didn't exist three or four years ago) and can identify patients at risk. So there has been a sea change in our understanding about the disease."

The Centers for Disease control recently asked Hemispherx to begin collaborating directly with them when it comes to CFS.

"We're very pleased that shortly we'll be working directly with the CDC to better understand the disease and of course specifically on how to take this experimental treatment and ultimately make it the first standard of care for these patients who are so sick." says Dr. Carter.

Ampligen is received intravenously.  It is generally administered twice weekly for periods of one year or greater. Two toxicology studies were recently completed that establish the safety of intranasal and intramucosal methods of Ampligen administration.

The drug has a PDUFA decision date of 5/25/09. (Note, the decison could come earlier or later than anticipated due to the fact that this date falls upon the Memorial Day holiday and the markets will be closed).