SenoRx, Inc. (NASDAQ: SENO) was the top percentage gainer on NASDAQ this morning. We figured it was traders trying to chase the next big winner on a drug study in the land of small-cap and low-priced stocks. As it turns out, this stock is up so much because of winning [...]
Facet Biotech Corporation (NASDAQ: FACT) is outright rejecting the buyout offer from Biogen Idec Inc. (NASDAQ: BIIB). The company issued a press release stating that the stockholders rejected Biogen Idec’s unsolicited tender offer for $17.50 per share. Furthermore, it noted that Biogen Idec has terminated its tender offer after the [...]
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc., a wholly owned member of the Roche Group (RHHBY), had a disappointment from the FDA. The FDA’s Oncologic Drugs Advisory Committee voted 12 to 1 recommending against the approval of the daily pill Tarceva® as a first-line maintenance use in people with [...]
Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) is yet another example of traders, investors, and speculators willingness to chase drug development study news. With the major gainers we have seen in 2009 and as we are entering year-end, this is actually of little surprise. Still, you have to wonder when you see [...]
Helicos Biosciences (NASDAQ:HLCS) is getting hammered this morning.
that it has priced a registered direct offering of 6.4 million units, at a price of $1.00 per unit, for gross proceeds of $6.4 million before deducting underwriting discounts and commissions and estimated offering expenses. Each unit consists of one share of [...]
Cyclacel Pharmaceuticals (NASDAQ:CYCC) is up after BeaconEquity.com announces a video investment report featuring the company. There is nothing new about CYCC and it would appear that the promotion is immaterial to the company’s future.
Douglas A. McIntyre
[...]Sunesis Pharmaceuticals (NASDAQ:SNSS) is up another 25% on news of positive comments from Skymark Research. Reuters reports that the shares are also being affected by rumors of a joint venture with a larger drug company.
Douglas A. McIntyre
[...]We have seen some developments over the last week on the companies that aim to fight lung cancer. OSI Pharmaceuticals Inc. (NASDAQ: OSIP) has an FDA review event coming up this week for Tarceva. We also wanted to review what occurred this week in Oncothyreon Inc. (NASDAQ: ONTY) and Eli [...]
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) has become the next small cap and low-prices biotech craze this week. We have seen this occur this year in other stocks, and now it seems that investors and traders are ready to jump into many of these small-cap biotech stocks with the hope of [...]
We have now seen the changes in short selling in biotech stocks via the late-November short interest report from NASDAQ. This marks the changes seen at the November 30, 2009 settlement date versus a November 13 settlement date. We have given short interest data on Amgen Inc. (NASDAQ: AMGN), Biogen [...]
Opexa Therapeutics (NASDAQ:OPXA) shares were battered as the company went to market to raise cash.
The firm said it entered into definitive agreements with institutional investors in a direct placement with gross proceeds of $5.1 million. The offering is made pursuant to the Form S-3 shelf registration statement that was filed by [...]
Oncothyreon (NASDAQ:ONTY) shares jumped as the firm announced that Merck KGaA has initiated a Phase 3 trial of Stimuvax (BLP25 liposome vaccine) in Asian patients with advanced non-small cell lung cancer (NSCLC). The trial, named INSPIRE (Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response), is anticipated to enroll approximately 420 [...]
Everyone wants to know which stocks in biotech and medical technology will be the next buyout target. It is rare that research reports or interviews from traditional brokerage firms point out an obvious takeover candidate, but that is exactly what came about in shares of Affymetrix Inc. (NASDAQ: AFFX) this [...]
Dendreon Corp. (NASDAQ: DNDN) has just filed an automatic shelf registration statement with the SEC. This will allow the company to raise capital, although no terms nor dollar amounts were listed initially (see below). As with most initial shelf registration of this sort, no underwriters were named as well (see [...]
PharmAthene (AMEX:PIP) shares were crushed down 50% to $1.62. The stock has a 52-week low of $1.12 and a high of $4.31. PIP’s market cap is down to $46 million.
that the Department of Health and Human Services Biomedical Research and Development Authority (BARDA) has canceled its request for proposal (RFP) for [...]
Somaxon Pharmaceuticals (SOMX) collapsed today, with shares down over two-thirds. It will be interesting to see if the company can recover from a major blow to its prospects.
The company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for [...]
ZIOPHARM Oncology (NASDAQ:ZIOP) dropped 16% at the open. The firm announced the pricing of its previously announced underwritten public offering of 15,484,000 shares of its common stock and warrants to purchase 7,742,000 shares of its common stock at a public offering price of $3.10 per unit. The warrants, which represent [...]
The National Institutes of Health has just today announced the approval of the first 13 human embryonic stem cell lines for use in NIH-funded research under the NIH Guidelines for Human Stem Cell Research adopted in July 2009. Children’s Hospital Boston developed 11 of the approved lines and Rockefeller University [...]
Keryx Biopharmaceuticals (NASDAQ: KERX – News) is up 12% on heavy volume to $3 after it announced that the U.S. Food and Drug Administration has granted Fast Track designation for KRX-0401 (perifosine), the Company’s novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory [...]
Novavax, Inc. (NASDAQ: NVAX) is trading up again on swine flu or H1N1 news. The company issued a press release showing positive clinical results from a pivotal study of H1N1 influenza vaccine in Mexico. It is up 7% to $3.43.
Douglas A. McIntyre
[...]Dyax Corp. (NASDAQ: DYAX) shares are rising 28% at $4.47 after the comapny won FDA approval to market its Kalbitor for the treatment of genetic hereditary angioedema in patients 16 years and up. This is a rare disorder caused by fluids building up outside of blood vessels and causes swelling in [...]
Genzyme Corporation (NASDAQ: GENZ) would normally be taken as though the company has some good news out after it announced that it has begun shipping vials of newly produced Cerezyme® from its Allston Landing plant. The problem is that Pfizer Inc (NYSE: PFE) is acquiring the worldwide marketing rights to [...]
Human Genome Sciences, Inc. (NASDAQ: HGSI) looks to be dwindling as a takeover candidate. There have been rumors surrounding the name for months and months, yet the shelf filing for it to raise capital dampened that hope for at least many investors. Today after the close came word that the [...]
StemCells Inc (NASD: STEM) has announced this morning that it and collaborator UCSF have initiated the enrollment of patients in the first ever clinical study of neural stem cells as a potential treatment in Pelizaeus-Merzbacher Disease (PMD), a neurological disorder that primarily afflicts children.
The company noted that the nature of [...]
Cephalon Inc. (NASDAQ: CEPH) is down sharply on news that it and privately-held Ception Therapeutics, Inc. did not meet some endpoints. Shares fell 8% to $54.76. Average volume is 1.9 million shares and the 52-week trading range is $52.55 to $81.35. This is the brief summary: The companies gave Phase [...]
This weekend we ran screens of several drug and biotech companies in our quest for ‘cheap stocks’ in the BioHealth sector. The intent is not solely for buyout targets because we prefer to look at value stocks rather than just picking buyout hopefuls. The obvious issue that makes most of [...]
Biogen Idec Inc. (NASDAQ: BIIB) is not exactly new to the world of activist investors as there have been problems inside the company for years. An SEC filing this morning was filed by a fund called HealthCor Management, L.P. located in New York. It turns out that the fund is [...]
Some secondary offerings are good for the existing holders and some are not. Adding cash to the coffers is good when a company can take advantage of a high share price when they need to raise long-term growth capital. But there is also the type of secondary offering that is [...]
VIVUS Inc. (NASDAQ: VVUS) may soon have a new erectile dysfunction drug on the market if the test results lead to an FDA approval. Shares are trading higher this morning after it announced positive results in a phase 3 pivotal study evaluating the safety and efficacy of avanafil for the [...]
Geron Corp. (NASDAQ: GERN) on Monday filed a registration statement for the resale of shares by existing holders. This is not a huge deal on the surface as it is ‘only’ 344,120 shares of common stock with a listed value of roughly $2 million. The following share counts are being [...]
Warren Buffett’s Berkshire Hathaway Inc. (NYSE: BRK-A) is still a holder of some drug companies and medical devices companies. Here are the Berkshire Hathaway biohealth positions as of September 30, 2009:
Becton Dickinson & Co. (NYSE: BDX) 1.2 million shares, same as last quarter. GlaxoSmithkline (NYSE: GSK) 1.51 million shares, same as [...]Carl Icahn, via his Icahn Capital LP and other entities owned the following drug and biotech or biohealth names. There may be some overlaps because of more than 1 filing, but here goes:
Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) 12,971,328 shares;
Biogen Idec Corp. (NASDAQ: BIIB) 3,215,051 shares, second filing showed 12,860,205 [...]
Poniard Pharmaceuticals, Inc. (NASDAQ: PARD) may be done, at least that is how the stock is acting this morning. The company announced that its pivotal Phase 3 SPEAR trial of picoplatin in the second-line treatment of small cell lung cancer failed to meet its primary endpoint of overall survival. The [...]
GlaxoSmithKline Biologicals (NYSE:GSK) and Nabi Biopharmaceuticals (NASDAQ:NABI)) today announced an exclusive worldwide option and licensing agreement for a nicotine conjugate candidate vaccine (NicVAX(), an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine.
Under [...]
Genzyme Corp. (Nasdaq: GENZ) issued a press release defending itself after such a large stock drop today due to the FDA notice on foreign particles being present in some drugs.
The company announced that it has issued letters to U.S. healthcare providers regarding its enzyme replacement products Cerezyme® (imiglucerase for injection), [...]
Lexicon Pharmaceuticals Inc. (NASDAQ: LXRX) is getting some very positive reaction after the closing bell today as investors love buying up low-priced and small cap biotechs in the current climate. The reason is that the company showed interim data on its LX1031. This is Lexicon’s investigational new drug that is [...]
Oncothyreon (NASDAQ:ONTY) reported a loss from operations of $2.8 million for the three months ended September 30, 2009, compared with a loss from operations of $3.6 million for the comparable period in 2008.
Oncothyreon reported a net loss of $5.9 million, or $0.24 per basic and diluted share, for the three [...]
MannKind Corp. (NASDAQ: MNKD) does not look like much is going on if you just look at the stock today. But there is a key trade around the January PDUFA review date for its Afresa. We were just given a key heads-up by OptionsHawk.com this morning:
Joe at OptionsHawk.com [...]
We have now been able to see the short interest changes that took place over the month of October-2009 in the world of biotech stocks. There were some key gains seen in a couple names, but the overall trend in biotech short selling seems to be down. We have given [...]
Metabolix (NASDAQ:MBLX) shares are under pressure.
The company announced that it has commenced a public offering of shares of its common stock pursuant to the Company’s effective shelf registration statement filed with the U.S. Securities and Exchange Commission (the “SEC”). Jefferies & Company and Thomas Weisel Partners LLC will serve as [...]
Sanofi-Aventis and Regeneron Pharmaceuticals (NASDAQ:REGN) said they expanded an existing development partnership to run through 2017. The previous arrangement ended in 2012.
Under the expanded deal, the companies plan on advancing up to five antibodies into clinical development each year, with Sanofi-Aventis funding up to $160 million annually for Regeneron research until [...]
Cadence Pharmaceuticals Inc. (NASDAQ: CADX) is about to have a monster event that will be one of those where the stock becomes a home run or a flop. The company has a November 13 PDUFA date for Acetavance, an intravenous version of acetaminophen, as a treatment for acute pain. The [...]
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHMD) has been in the news quite a bit of late, which is odd for a company its size. Recently it announced its second broad U.S. patent for anti-viral applications of phospholipid-targeting antibodies, and it also recently announced that had regained its listing requirements for NASDAQ-listing. [...]
Protalix Biotherapeutics (AMEX:PLX) has had a good run.
A little over a month ago, the ompany said preclinical data on pr-antiTNF, a biosimilar version of etanercept (Enbrel). Produced using the company’s proprietary ProCellEx technology, pr-antiTNF is a plant cell expressed recombinant fusion protein made from the soluble form of the human TNF [...]
Enzon Pharmaceuticals, Inc. (NASDAQ: ENZN) has entered into an agreement to sell its specialty pharmaceutical business to the Italian-owned company Sigma-Tau Group. The sale price is quoted as too many different numbers by too many different wire sources, and we wanted to clarify this. More importantly, this makes for a [...]
CEL-SCI Corporation (AMEX:CVM) will present at the 7th Annual Vaccines: All Things Considered Conference. The presenter is Dr.Daniel Zimmerman, Ph.D., Senior Vice President Research and Development
Novartis (NYSE:NVS), Sanofi Pasteur, and Merck (NYSE:MRK) are also expected to attend.
CEL-SCI is up 11% to $1.36 on heavy volume
Douglas A. McIntyre
[...]ZIOPHARM Oncology (NYSE:ZIOP)
presented today at the 15th Annual Connective Tissue Oncology Society (CTOS) Meeting, positive interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. As previously announced, having achieved the study-specified efficacy milestone following planned safety and [...]
The FDA recently issued its latest ”Development of Safe and Effective Tumor Vaccines and Gene Therapy Products” document.
Among the highlights:
*”Despite enormous efforts towards finding a cure and progress in some subsets, overall survival of cancer patients has not increased and new therapeutic approaches are warranted.”
*”Numerous investigational cancer gene therapies, tumor [...]
Bioanalytical Systems (NASDAQ:BASI) is up 63% on light volume and no news.
Watch for a sudden sell-off if profit takers look to make a killing
Douglas A. McIntyre
[...]Molecular Insight (NASDAQ:MIPI) is off about 10% today on no news.
The most recent announcement from the company was almost a week ago when it said it executed an exclusive 10-year agreement to supply the Onalta 90-Y edotreotide radiotherapeutic to BioMedica Life Sciences S.A., Athens, Greece.
In September, Molecular Insight entered into a [...]
