Unusual Number of 52-Week Highs in BioHealth Stocks (BCRX, CRIS, NKTR, OGXI, SCLN, SVA, SPPI, TRGT, VICL)
As you will see, there are many new 52-week highs out there in some drug and biotech names…. Some of this is on swine flu news despite a big drop in the stock market today, but here goes:
- BioCryst Pharmaceuticals Inc. (BCRX) hit $13.24 today…. 52-week low is $0.85.
- Curis Inc. (NASDAQ: CRIS) hit $2.25 today, the drug discovery company has a small cap at $140 million; 52-week low is $0.68.
- Nektar Therapeutics (NASDAQ: NKTR) hit 8.29 but on very low volume, 52-week low is $8.29.
- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) hit a high of $42.99, also on fairly thin trading volume…. The 52-week low is all the way down at $2.00 on this cancer company. In 2007, this was over a $100 stock…
- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) is up big on heavy block trading as it hit $4.90 vs. a 52-week low of $0.63.
- Sinovac Biotech Ltd. (AMEX: SVA) is what led the flu names today after securing Chinese approval for its swine flu vaccine. Shares are up over 40% at $8.90… but it hit $9,44 today versus a 52-week low of $0.75.
- Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) is up over 7% and hit $8.32 on strong volume… 52-week low is $0.55.
- Targacept, Inc. (NASDAQ: TRGT) hit $14.69 today, but on thin trading volume, compared to a 52-week low of $1.40.
- Vical Inc. (NASDAQ: VICL) hit a high of $4.93 versus a low of $1.04. This is on strong volume and is after a rise of flu awareness stocks in China.
JON C. OGG
August 31, 2009
Europe steps up timetable on swine flu vaccines (VICL, NVAX, BCRX)
Shares of vaccine makers including Vical Inc. ((Nasdaq: VICL), Novavax Inc. (Nasdaq: NVAX) and BioCryst Pharmaceuticals Inc. (Nasdaq: BCRX) all are up strongly Monday after Europe’s version of the FDA decided to fast-track swine flu vaccine testing.
According to the Associated Press, The European Medicines Agency is greenlighting swine flu vaccine approvals; Britain, Greece, France and Sweden say they’ll start using the vaccines possibly within weeks.
Amid criticism from some doctors who warn about the potential for unkown side effects, the agency has decided that flu vaccines have been around for four decades, and the type of extensive testing reserved for most new drugs is not needed for swine flu vaccines. It would be using well-tested technology.
Speeding the vaccines to market in Europe may be a numbers game. The World Health Organisation has provided a guesstimate that only 900 million doses of swine flu vaccine may be able to be produced annually on a worldwide basis, for a world population of more than 6.5 million. In a pandemic scenario, that may pit rich countries versus poorer ones for vaccine access. Rich countries appear to want a jump-start.
That already appears to be happening. President Obama earlier this year set aside about $1 billion to buy needed vaccines.
But Europe is moving more aggressively. The U.K., for example, hopes to protect at least half its population from swine flu with vaccines by the start of next year.
For companies like Vical Inc., the news may create a revenue opportunity for the company’s experimental H1N1 swine flu vaccine much quicker than expected. The company late last month showed strong efficacy data for its vaccine in animal models. The company said that at least 75% of vaccinated animals achieved or exceeded the protection threshold after a single dose of vaccine. The company said it is ready to advance directly to large-scale manufacturing for human clinical trials, subject to external funding.
Novavax, Inc. is another big play. The company last month signed a deal with Spain’s health ministry and ROVI Pharma, a specialty drug maker in Spain, to license its genetically engineered technology to produce pandemic and seasonal flu vaccines and build that country’s first vaccine-making plant.
BioCryst is not a vaccine play. But the company made strides with its anti-flu program earlier this month. A study sponsored by BioCryst partner Shionogi & Co Ltd. in Japan showed that its Peramavir candidate was not inferior in terms of efficacy and safety to the anti-flu standard, Roche’s Tamiflu. The study involved a total of 1,099 patients at 146 centers. BioCryst now says it is planning late-stage studies of Peramivir, in hopes of winning an FDA approval.
Analysts covering all three companies are not expecting much, if anything in terms of swine flu-related revenue this year. But that could soon change.
It’s appears to be a race to get ready for the winter flu season. The Centers for Disease Control and Prevention (CDC) today said parents should have their children ages 6 months to 18 months vaccinated for flu this fall as soon as the flu vaccine becomes available. And the FDA wants to test swine flu vaccines among several thousand volunteers in August, in preparation for some vaccinations being available in October.
Europe, meanwhile, is not willing to wait that long. — Mike Tarsala
Vical takes strides with its herpes vaccine, may eventually gain a partner (VICL)
Vical Inc. (Nasdaq: VICL) on Wednesday announced a positive four-month interim analysis for what is arguably its second-largest market opportunity, taking potentially another small step toward the goal of attracting a partner for its herpes vaccine program.
The results jump the gun a bit, as detailed endpoints were not provided. Vical expects the trial to be completed in the fourth quarter of 2009, and to have final data available in the first half of 2010.
But the company said its TransVax cytomegalovirus herpes vaccine provided promising results compared with placebo across a broad range of clinical efficacy endpoints. Vical said the vaccine demonstrated a clear viral reduction compared with placebo in the percentage of recipients experiencing herpes virus reactivation. The vaccine also showed a decrease in peak and cumulative viral loads. TransVax also provided an overall increase in cellular immune responses compared with placebo.
The TransVax vaccine appears to be Vical’s No. 2 market opportunity in its pipeline. The No. 1 appears to be Allovectin-7, which is in a Phase III trial to treat metastatic melanoma.
The cytomegalovirus infects more than half of all adults in the U.S. by age 40, and is even more widespread in developing countries. A healthy immune system can fight off the irus, but it can severely affect those with a weak immune system, including transplant patients, pregnant mothers and newborns. — Mike Tarsala
Two More Promising Attacks on Flu and Swine Flu (VICL, NVAX)
Vical Inc. (NASDAQ: VICL) showed promising swine flu test data in its animal model today and was one of the top rising stocks. A pact from Novavax, Inc. (NASDAQ: NVAX) with the government of Spain and ROVI Pharmaceuticals sent its shares even higher on a percentage basis.
Vical Incorporated (NASDAQ: VICL) said tests in its vaccine against A/H1N1 pandemic influenza, the swine flu, produced robust immune responses that were “well above the accepted protection threshold in 100% of vaccinated mice and rabbits” after a standard two-dose vaccine regimen. The company said that at least 75% of vaccinated animals achieved or exceeded the protection threshold after a single dose of vaccine. Vical went so far as saying that it is ready to advance directly to large-scale cGMP manufacturing of the vaccine for human clinical trials, subject to securing external funding for this program.
Novavax, Inc. (NASDAQ: NVAX) signed a deal with Spain’s health ministry and ROVI Pharma, a specialty drug maker in Spain, to license its genetically engineered technology to produce pandemic and seasonal flu vaccines and build that country’s first vaccine-making plant.
While exact terms are outstanding, this could easily bring in tens of millions of dollars in future royalty and milestone payments if and after the vaccines are approved and marketed. The target here is to get both pandemic flu vaccines and seasonal flu vaccines by 2012.
ROVI has committed to make a $3 million equity investment in Novavax at $2.74, a 10% premium to yesterday’s close. The Spanish government is forming a foundation and will invest in a 60 million facility and a non-profit foundation will be formed will be formed and initially funded with a 25 million euro credit line from the Spanish government.
This was a huge boom for both companies today. Vical Inc. (NASDAQ: VICL) rose over 22% to $2.70, on over 8 million shares. Novavax, Inc. (NASDAQ: NVAX) shares closed up 31% at $3.28, on over 32 million shares. As far as how high that volume is, that is about 14-times average on Vical and nearly 8-times average volume on Novavax.
Jon C. Ogg
BioHealth & Healthcare Score Major Win in Russell Index Rebalance (AVII, CTIC, CEGE, IPXL, STEM, SUPG, VICL, XOMA)
This year’s Russell 3000 Index rebalancing and reconstitution may end up being the mother of all index rebalances. Because of the billions managed by Russell and because of the billions of outside funds that benchmark to the various Russell indexes, this year has many changes. All in all, there are over 400 additions and deletions to the Russell 3000 alone. The count was overwhelmingly “good” for healthcare. We screened out a few stocks under the Russell “Health Care” sector as they were not classic companies in the “BioHealth” space. But even after we screened those out, the ratio was huge by our own individual count:
- Healthcare additions were 57 and deletions were only 12… Yep a ratio of almost 5:1 for Health Care in the Russell 3000 alone.
Many of these additions or deletions were very surprising and based mostly on recent share price changes. Some of those standouts are are AVI Biopharma, Inc. (NASDAQ: AVII), Cell Therapeutics, Inc. (CTIC), Cell Genesys, Inc. (CEGE), Impax Laboratories Inc. (IPXL), StemCells Inc. (STEM), SuperGen Inc. (SUPG), Vical Inc. (VICL), and XOMA Ltd. (XOMA). We have broken out the fullist of additions and deletions below, and we started with the additions first as they may see more benefit between now and next Friday’s adjustments.
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Vical milestone may eventually lead to more government funding (VICL)
Vical (VICL) announced this morning that has achieved second-year milestones under a 3-year, $6 million grant from the National Institutes of Health — a small step, but one that’s a potential gateway to Vical getting more government funding.
The company also said it’s still advancing with development of its RapidResponse system that it hopes will eventually be able to produce several million doses of vaccines quickly in the event of a pandemic.
While the continued NIH grant is a small dollar amount, it validates RapidResponse as a potential delivery system for vaccines that might protect against infectious diseases such as swine flu, bird flu, ebola, West Nile, SARS, or another yet-to-be-discovered pandemic threat.
Vical already has a partnership with the U.S. Navy to make a prototype DNA vaccine targeting swine flu; it would benefit strongly from additional government dollars that would help speed clinical development and boost potential vaccine production.
As advertised, the company’s delivery system’s major potential advantage is speed. The traditional method of making vaccines is to build a gigantic facility that grows viruses in chicken eggs or cell cultures for use in drugs. The Vical RapidResponse DNA vaccine process is cell-free, and in theory could help make hundreds of millions of vaccine doses in the early stages of a disease outbreak. There are also potential safety benefits, as the system doesn’t require injection of a live or partially-killed virus.
The delivery system has yet-to-be-tested in humans. But companies such as Novartis’ (NVS) Aqua Health have used Vical’s technology in farm-raised salmon, and Wyeth’s (WYE) Fort Dodge Animal Health Group have used a DNA-based vaccine technology in horses.
Vical Moving From Speculative H1N1/Swine Flu Stock To Real Vaccine Company (VICL)
Vical Incorporated (NASDAQ: VICL) has made an announcement updating what has happened in the two weeks since launching its program to develop a vaccine against H1N1 influenza, or swine flu. The company has completed the development of a prototype H1 vaccine, produced an initial supply of research-grade material, and initiated immunogenicity testing in animals.
Last Gains Seen on Speculative Swine Flu Stocks? (NVAX, GNBT, BCRX, PURE, VICL, VIVO, AVII)
As you will see, the life has been taken out of many of the very speculative swine flu stocks from last week’s highs.
NovaVax, Inc. (NVAX) gained almost 15% to $1.93 today, but this is down about half from last week’s highs of $3.88; shares were at $0.81 before the swine flu scare came out.
Generex Biotechnology Corp. (NASDAQ: GNBT) was up 18% today at $0.438; shares peaked at $0.70 last week and were at $0.27 before the swine flu scare came out.
BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) rose 14% to $3.24; shares peaked at $4.89 last week and were at $1.75 before the swine flu scare came out.
Pure Bioscience (NASDAQ: PURE) was down 1.2% at $2,40; shares peaked at $3.19 last week and were at $1.75 before the swine flu scare came out.
Vical Inc (NASDAQ: VICL) fell by 7% to $2.09; shares peaked at $3.30 last week and were at $2.40 before the swine flu scare came out.
Meridian Bioscience Inc. (NASDAQ: VIVO) were up barely above flat at $17.69; shares peaked at $18.30 last week and were at $16.13 before the swine flu scare came out.
AVI BioPharma Inc. (NASDAQ: AVII) was flat at $0.76; shares peaked at $1.29 last week and were at $0.74 before the swine flu scare came out.
Jon C. Ogg
Speculative Flu Stocks Started Giving Gains Back (NVAX, GNBT, BCRX, PURE, VICL, VIVO, AVII)
This week there have been many crazy stock gains among the speculative biotech sector, and these were tied directly to the ’speculative stocks’ that could have any ties in reality, fiction, and even imagination to a cure or hope in the fight against Swine Flu.
As you will see below, Novavax, Inc. (NASDAQ: NVAX), Generex Biotechnology Corp. (NASDAQ: GNBT), BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX), Pure Bioscience (NASDAQ: PURE), Vical Inc (NASDAQ: VICL), Meridian Bioscience Inc. (NASDAQ: VIVO), and AVI BioPharma Inc. (NASDAQ: AVII) have all begun their overbought roll-over.
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Swine Flu Speculation Stocks (GILD, BCRX, NVAX, GNBT, VICL, AVII, CRXL, RHHBY, GSK)
Monday is looking like a SWINE FLU speculative flu stock stock bonanza. The two approved drug treatments, not vaccines, which are being released are Tamiflu made by Roche (OTC: RHHBY) and Relenza made by GlaxoSmithkline (NYSE: GSK). Gilead Sciences, Inc. (GILD) gets royalties from Roche for Tamiflu, and its shares are indicated north of $48.00 after a $45.80 close on Friday.
There is a second-tier level of stocks here: BioCryst Pharmaceuticals Inc. (BCRX) was up big Friday as it is a maker of drugs that block key enzymes in viral diseases like the flu, shares are indicated over $3.00 after a $2.21 close on Friday. Novavax, Inc. (NVAX) is another clinical stage company using its virus-like particle platform technology for flu treatments; stock is indicated north of $2.50 after closing up some 75% at $1.42 Friday.
And here is the third-tier of these stocks: Generex Biotechnology Corp. (GNBT) is being passed around as a penny stock flu player with shares indicated around $0.40 after closing up 25% at almost $0.34 Friday. Vical Inc. (VICL) closed up 3% Friday at $2.53 and shares are indicated up around $3.00. AVI Biopharma, Inc. (AVII) rose over 20% to $0.89 Friday and shares are indicated up marginally as a result. Crucell NV (CRXL) has a faster way of making flu vaccines. This closed up 1% on Friday and is hardly moving.
As a reminder, these huge gap ups generally have a one day to multi-day move with each move usually being less than the first. As with issues such as SARS and bird flu, the world did not end and it was only the SARS scare which actually caused real damage. You can probably bet that you will be hearing “squeal like a pig!” jokes.
JON C. OGG
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