BioSante (BPAX) Soars On Drug Safety News
BioSante Pharmaceuticals (BPAX) is up 33% to $2.39 on news that itssFemale sexual dysfunction drug has proven safe in a late-stage study.
BioSante reported that with over 1,250 women enrolled and almost 825 women-years of exposure in its LibiGel Phase III clinical development program, there have been no deaths and only five cardiovascular events.
The Phase III Cardiovascular and Breast Cancer Safety Study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study that will enroll between 2,400 and 3,100 women, exposed to LibiGel or placebo for 12 months. An NDA can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. That is encouraging news but not definative.
In late June BioSante said it will pay 0.1615 of its own common shares for each share of Cell Genesys (CEGE) a total purchase price of $38 million.
After announcing the purchase BioSante incurred a net loss of approximately $4.6 million or ($0.17) per share for the quarter ended June 30, 2009, compared to a net loss of $6.0 million or ($0.22) per share for the same period in 2008.
BioSante may be in some trought becaseu cash and cash equivalents as of June 30, 2009 were approximately $6.0 million, as compared to cash, cash equivalents and short-term investments of approximately $14.8 million on December 31, 2008.
Douglas A. McIntyre
The Rise of Biotechs May Be Attracting The Shorts (PFE, MRK, BAX, BDSI, SPPI, GNBT, AVII, CEGE, BBH, GILD)
Biotechnology stocks have risen faster than any sector in the past 30 days, although the new short-interest data suggest traders are now increasing their directional bets against the group.
Large biotechs including Pfizer Inc. (NYSE: PFE) and Merck & Co. (NYSE: MRK) are in the top 10 of all large-cap stocks with the greatest increase in the number of shares shorted. And biotechs including Baxter (BAX) are among the stocks seeing a greater than 50 percent increase in short interest from mid-June until the end of that month, the most recent short interest data available.
Perhaps one reason biotechs are an increasing near-term target of the shorts is that the group’s price movement has been counter to the overall market. The price of all biotech stocks with a market cap of $1 billion or more is up 3.6 percent in the past 30 days, vs. a drop of 6.2 percent for the S&P 500. Biotech is the only group to advance more than 3 percent over that time period, other than health care services, up 3.2 percent.
Pfizer is not a stock most traders bet against, with only 3.5 percent of its float sold short. But the short interest of Pfizer rose 16.2 percent to more than 235 million shares by the end of June. Merck shares, with a heftier 6.9 percent sold short, saw its short interest rise 9.1 percent over the same time period.
Some smaller biotech names have seen a very large short interest increase, including BioDelivery Sciences International (Nasdaq: BDSI), up 93 percent. Spectrum Pharmaceuticals Inc. (Nasdaq: SPPI) short interest is up 54 percent. Biotech stocks with at least a 40 percent rise in short interest include Generex Biotechnology Corp. (Nasdaq: GNBT), AVI BioPharma Inc. (Nasdaq: AVII) and Cell Genesis Inc. (Nasdaq: CEGE).
One of the biotech ETFs that is watched most closely by traders is the Biotech HOLDRs (BBH). One of its top holdings is Gilead Sciences Inc. (Nasdaq: GILD), which makes up roughly a third of the index. Its stock saw a 17 percent increase in its short interest to more than 20 million shares.
The biotech Holdrs in early July rose to levels not seen since September 2008, although the index has fallen early this month after creating a bearish candlestick pattern. The fall occurred not not long after MACD, an oscillator watched by technical traders, turned negative — Mike Tarsala
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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Record Number of Biotechs Under Strategic Review (BPAX, CEGE, EPIX, IDMI, NRGN, TPTX, LJPC, NFLD)
It is hard to know if this is a record of the number of biotech stocks which are under strategic review, but the number is above and beyond normal. Biosante Pharmaceuticals, Inc. (NASDAQ: BPAX), Cell Genesys, Inc. (NASDAQ: CEGE), EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX), IDM Pharma, Inc. (NASDAQ: IDMI), Neurogen Corporation (NASDAQ: NRGN), and TorreyPines Therapeutics, Inc. (NASDAQ: TPTX) are all under strategic reviews and many of their futures are probably questionable at best. Even La Jolla Pharmaceutical Co. (NASDAQ: LJPC) is in this group; and Northfield Laboratories Inc. (NASDAQ: NFLD) fits loosely into this category while not being a classic biotech.
Biosante Pharmaceuticals, Inc. (NASDAQ: BPAX) has Deutsche as its advisor in its exploration of strategic alternatives. This stock is at $2.06 and its 52-week range is $0.81 to $5.85. This used to be a $10 stock and it has been public since 2001. Back in December, Kingsbridge committed to provide up to $25 million of capital for a period of two years. This one was set up to explore treatments for female sexual health, menopause, contraception, and male hypogonadism.
Cell Genesys, Inc. (NASDAQ: CEGE) retained Lazard last month to help it explore strategic alternatives now that most of its operations have been wound down. Some were once hoping it would have the same sort of hope that Dendreon had for prostate cancer, but that is history now. Amazingly enough, this one has been public since the early 1990’s and shares used to be massively higher than now.
EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) has JPMorgan to help it explore strategic alternatives. This one is at $0.30 and the 52-week range is $0.21 to $2.50. EPIX has been public since 1997 and was usually above $10.00 until late in 2005. It never saw that again. This is set up to treat diseases of the central nervous system and lung conditions.
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Cell Genesys Positive Prostate Cancer Study Data (CEGE, DNDN)
Cell Genesys, Inc. (NASDAQ: CEGE) has announced that the final data from the second of two Phase II clinical trials (G-0010) of GVAX immunotherapy for prostate cancer has been published in the online issue of Cancer. This is the publication of the American Cancer Society.
As a reminder, this company is somewhat after the same goal as Dendreon (NASDAQ: DNDN) in the fight to treat prostate cancer.
The results from this Cell Genesys multi-center trial showed an overall median survival of 35.0 months in the subset of patients who received a dose of GVAX immunotherapy for prostate cancer comparable to that currently being evaluated in the ongoing Phase 3 program. It also noted that these results were consistent with those observed in the first multi-center Phase II trial which indicated an overall median survival of 34.9 months in those patients who received a dose comparable to that being evaluated in the Phase III program.
The survival results from both Phase II clinical trials compare favorably to the previously published median survival for metastatic hormone-refractory prostate cancer patients treated with Taxotere® chemotherapy plus prednisone, the current standard of care for this patient population.
A copy of this article titled “Phase 1/2 Dose-Escalation Study of a GM-CSF-Secreting, Allogeneic Cellular Immunotherapy for Metastatic Hormone-Refractory Prostate Cancer” can be seen at the following URL:
http://www3.interscience.wiley.com/journal/120840830/abstract
As a result, the company notes that it is on track to complete enrollment of the second of the two ongoing Phase III trials, in the first half of 2009 and its expects to reach the number of events needed to trigger final analysis of the first of the two Phase III trials in the second half of 2009.
Much of this data seems to be reaffirming what has already been observed. But this stock has a huge short interest of more than 18.4 million shares and this has shares indicated about 5% higher in the immediate pre-market reaction.
Jon Ogg
July 22, 2008
Speculative Prostate Cancer Stocks On Ropes (DNDN, CEGE)
Investors have been warmed up to biotech stocks in recent weeks, but a trend is starting to emerge where investors want companies that are either very close to commercialization of a key product or one where there is a diversified portfolio of molecules and drug candidates with various indications. Cell Genesys, Inc. (NASDAQ: CEGE) and Dendreon Corp. (NASDAQ: DNDN) are two companies who had promising prostate cancer hopes in 2007, but they have gone to the wayside and today is not looking any better for the companies.
Cell Genesys Inc. (NASDAQ: CEGE) is seeing a very poor showing today. Its shares are down 12% to $2.63 and it hasn’t even traded its average daily volume of a normal trading day right after 2:30 PM EST. This is a low not seen since the end of March.
Last week we saw a shelf filing from Dendreon Corp. (NYSE: DNDN) allowing the company to raise up to $300 million for marketing and development of PROVENGE for prostate cancer (if and when it is approved). The stock has been holding up right under the $5.00 mark, but today the stock is now at a 5-day low at $4.85 and a low not seen since the end of March. There is likely a fear that a deal is coming much sooner rather than later as we have seen four-times normal volume.
The culprit here could be a published story in Proceedings of the National Academy of Sciences about lifestyle change studies of 30 men with “low risk prostate cancer” and the study found that many disease-promoting genes (including those associated with cancer, heart disease, and inflammation) were “downregulated” or “turned off” and the protective and disease-preventing genes were “upregulated” or “turned on.” For whatever it is worth, the study/article concludes “we’ve raised more questions than we’ve answered, and we need larger, longer-term studies.”
It is hard to imagine that a small university study would unseat these companies further, but we are talking about small cap questionable stocks.
Jon Ogg
June 18, 2008
Short Sellers Lighten Up on Major Biotechs in May
We ran the short selling report that just came out on major NASDAQ biotech stocks to see what the change in short selling was. Interestingly enough, in almost all of the major and large US biotechs traded on NASDAQ.
STOCK (Ticker) MAY 30 MAY 15 CHANGE
Amgen Inc. (AMGN) 22,678,517 24,778,770 -8.48%
Biogen Idec Inc. (BIIB) 6,346,464 6,788,432 -6.51%
Celgene Corporation (CELG) 13,775,373 16,336,232 -15.68%
Genzyme Corporation (GENZ) 5,684,945 5,621,969 +1.12%
Gilead Sciences, Inc. (GILD) 32,478,444 32,690,603 -0.65
ImClone Systems Inc. (IMCL) 7,149,395 7,664,009 -6.71%
And below you can see the short selling changes on some of the smaller biotechs that are still rather active in daily trading volume. The results below are more mixed than they are in the major biotechs.
STOCK (Ticker) MAY 30 MAY 15 CHANGE
Amylin Pharmaceuticals, Inc. (AMLN) 23,855,471 23,642,854 +0.90%
Cell Genesys, Inc. (CEGE) 16,931,592 17,222,281 -1.69%
Dendreon Corporation (DNDN) 31,117,812 30,728,499 +1.27%
Illumina, Inc. (ILMN) 12,239,553 11,902,877 +2.83
Invitrogen Corporation (IVGN) 9,125,954 9,340,210 -2.29%
Medarex, Inc. (MEDX) 21,837,573 19,682,828 +10.95%
Jon C. Ogg
June 11, 2008
