Market Shrugs Off Big Allos Therapeutics (ALTH) News
Shares of Allos Therapeutics (ALTH) are going nowhere fast on eight million shares traded.
The company said the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). FOLOTYN is the first and only drug approved by the FDA for this indication and represents a new treatment option for patients with relapsed or refractory PTCL. This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. Allos expects to make FOLOTYN available to patients in the U.S. in October.
The stock is up only 2.8% to $8.37.
Douglas A. McIntyre
Allos Therapeutics (ALTH) Gets No Follow-Through On FDA News
Allos Therapeutics (ALTH) is another one of the biotech industry’s one-day wonders.
ALTH announced that that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10-4 that the response rate and duration of response observed with FOLOTYNTM (pralatrexate) are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL comprises a biologically diverse group of aggressive blood cancers that has a worse prognosis than most other types of lymphoma, including B-cell lymphoma. If approved, FOLOTYN would be the first drug approved by the FDA for the treatment of relapsed or refractory PTCL.
Shares rose from $7.35 to over $8 on the news. Today, the shares are trading heavily at over three million shares at 9.35, but the stock cannot get the interest to rally any further. In other words, a lot of investors are taking profits.
Douglas A. McIntyre
Allos Therapeutics (ALTH) Dips Ahead Of FDA Decision
Allos Therapeutics (ALTH) is down almost 10% to $7 ahead of a September 2 announcement from a regulatory panel which is reviewing its cancer drug candidate pralatrexate.
There is no other news that might move the stock
Douglas A. McIntyre
Full 2009 ASCO Cancer & Oncology Primer (ABII, AEZS, ALTH, AMGN, APPA, ARQL, BMY, CLDX, CELG, CTIC, CGRB, LLY, EXEL, GHDX, GSK, IMGN, MEDX, MDVN, MITI, OGXI, OSIP, PPHM, PFE, ROSG, SNTA, TRBN, ZIOP, ZGEN)
We have already seen a massive round of abstracts ahead of the huge American Society of Clinical Oncology, or ASCO meeting for 2009, which is scheduled to start this weekend. ASCO is usually thought of as the Holy Grail of cancer conferences and these abstracts and presentations are viewed by investors, analysts, clinicians, doctors, and by cancer patients.
We compiled a brief synopsis for the following drug and biotech companies: Abraxis BioScience, Inc. (NASDAQ:ABII), AEterna Zentaris Inc. (NASDAQ: AEZS), Allos Therapeutics, Inc. (NASDAQ: ALTH), Amgen Inc. (NASDAQ: AMGN), A.P. Pharma, Inc. (Nasdaq: APPA), Arqule Inc. (NASDAQ: ARQL), Bristol-Myers Squibb (NYSE: BMY), Celldex Therapeutics (NASDAQ: CLDX), Celgene Corporation (NASDAQ: CELG), Cell Therapeutics (NASDAQ: CTIC), Cougar Biotechnology, Inc. (NASDAQ: CGRB), Eli Lilly and Company (NYSE: LLY), Exelixis (NASDAQ: EXEL), Genomic Health, Inc. (NASDAQ: GHDX), GlaxoSmithKline (NYSE: GSK) , Immunogen (NASDAQ: IMGN), Medarex (NASDAQ: MEDX), Medivation, Inc. (NASDAQ: MDVN), Micromet, Inc. (NASDAQ: MITI), OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), OSI Pharmaceuticals (NASDAQ: OSIP), Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), Pfizer Inc. (NYSE: PFE), Rosetta Genomics (NASDAQ:ROSG), Synta Pharmaceuticals (NASDAQ: SNTA), Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN), ZIOPHARM Oncology (NASDAQ: ZIOP), and ZymoGenetics, Inc. (NASDAQ: ZGEN).
Be advised that some of the data may have been changed since the first abstracts came out, but this is an expansive list of companies with data.
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Bill Gates, Small Biotech's New Biggest Investor (ALTH, AMAG, RDEA, ARYX, AUXL, BMRN, ETRM, INCY, ITMN, MAPP, OREX, VRUS, REGN, SGEN, VRTX, XNPT)
Late yesterday came the 13-F quarterly filing from the Bill & Melinda Gates Foundation Trust. Bill and Melinda have invested in drugs and research before, as well as dug companies, but there was a slew of biotech stocks in their quarterly holdings. Some of these are cancer winners, while others may seem random. Below we have broken these out by company and size of the position in dollars (M for million; K for thousand) as well as the number of shares.
ALLOS THERAPEUTICS INC. (NASDAQ: ALTH) $3.090M; 500,000 shares
AMAG PHARMACEUTICALS INC. (NASDAQ: AMAG) $1.839M; 50,000 shares
ARDEA BIOSCIENCES INC. (NASDAQ: RDEA) $2.165M; 210,386 shares
ARYX THERAPEUTICS INC. (NASDAQ: ARYX) $1.635M; 480,799 shares
AUXILIUM PHARMACEUTICALS INC. (NASDAQ: AUXL) $2.062M; 74,400 shares
BIOMARIN PHARMACEUTICAL INC. (NASDAQ: BMRN) $1.295M; 104,856 shares
ENTEROMEDICS INC. (NASDAQ: ETRM) $81K; 59,700 shares
INCYTE CORP. (NASDAQ: INCY) $1.02M; 435,700 shares
INTERMUNE INC. (NASDAQ: ITMN) $1.807M; 109,900 shares
MAP PHARMACEUTICALS INC. (NASDAQ: MAPP) $98K; 46,524 shares
OREXIGEN THERAPEUTICS INC. (NASDAQ: OREX) $36K; 13,900 shares
PHARMASSET INC. (NASDAQ: VRUS) $821K; 83,641 shares
REGENERON PHARMACEUTICALS (NASDAQ: REGN) $492K; 35,500 shares
SEATTLE GENETICS INC. (NASDAQ: SGEN) $34.718M; 3,521,088 shares
VERTEX PHARMACEUTICALS INC. (NASDAQ: VRTX) $2.729M; 95,000 shares
XENOPORT INC. (NASDAQ: XNPT) $2.517M; 130,000 shares
ASCO's Pre-Abstract Previews (ABII, ALTH, ARQL, CLDX, CTIC, CGRB, LLY, EXEL, GHDX, GSK, IMGN, MEDX, MDVN, OGXI, OSIP, PPHM, PFE, SNTA, ZIOP)
The first massive round of abstracts ahead of the huge American Society of Clinical Oncology, or ASCO meeting for 2009, is due out 6:00PM EST. This is thought of as the Holy Grail of cancer conferences and these abstracts are being picked apart all night by hundreds of investors, analysts, clinicians, doctors, and even by cancer patients. We have brief data here for the following biotech and drug companies, and you can bet there will be more than this: Abraxis BioScience, Inc. (NASDAQ:ABII), Allos Therapeutics, Inc. (NASDAQ: ALTH), Arqule Inc. (NASDAQ: ARQL), Celldex Therapeutics (NASDAQ: CLDX), Cell Therapeutics (NASDAQ: CTIC), Cougar Biotechnology, Inc. (NASDAQ: CGRB), Eli Lilly and Company (NYSE: LLY), Exelixis (NASDAQ: EXEL), Genomic Health, Inc. (NASDAQ: GHDX), GlaxoSmithKline (NYSE: GSK) , Immunogen (NASDAQ: IMGN), Medarex (NASDAQ: MEDX), Medivation, Inc. (NASDAQ: MDVN), OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), OSI Pharmaceuticals (NASDAQ: OSIP), Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), Pfizer Inc. (NYSE: PFE), Synta Pharmaceuticals (NASDAQ: SNTA), and ZIOPHARM Oncology (NASDAQ: ZIOP).
Be advised that there may be new data from many of these companies between now and the May 29 to June 2, 2009 meeting in Orlando, Florida. We have already compiled a pre-ASCO cheat sheet to get in ahead of some of these abstracts, and the brief notes are as follows:
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Weekend of Cancer and Ocology Data at AACR; semi-preview for ASCO (ALTH, AMGN, ARIA, ARRY, AZN, BIIB, CELG, CRIS, IMMU, IMGN, INFI, MEDX, MNTA, ONCY, PFE, PCYC, SUPG, TELK, THLD)
This weekend will kick off a rather important oncology meeting, and it has a chance of setting the expectations for the highly anticipated ACSO (American Society of Clinical Oncology) annual meeting next month. The American Association for Cancer Research Meeting will take place in Denver, CO. and many of the smaller and larger cancer and disease biotech and drug companies will be presenting data. Amazingly enough, this will be the 100th annual meeting.
Allos Therapeutics, Inc. (NASDAQ: ALTH) will present data from an in vitro study examining the potency of pralatrexate in colon, breast, ovarian, lung, prostate, and head and neck cancer cell lines.
Amgen (NASDAQ: AMGN) had industry news earlier this week about its experimental drug called AMG 479 shows promise against pancreatic cancer. Amgen will also be presenting lung cancer data.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) will offer new preclinical data on deforolimus, its investigational mTOR inhibitor, AP24534, its investigational multi-targeted kinase inhibitor, and its investigational anaplastic lymphoma kinase (ALK) inhibitor.
Array BioPharma, Inc. (ARRY) has eighteen abstracts being presented at the meeting and will disclose findings in 7 new anti-cancer programs. Lung and colon cancer data are in these presentations.
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Warburg Pincus Hikes Stake in Allos Therapeutics (ALTH)
Allos Therapeutics, Inc. (NASDAQ: ALTH) had already announced that its 10.8 million shares had priced at $5.64. That was old news.
But what isn’t old news is that in a Form 4 filing after today’s close, WARBURG PINCUS PRIVATE EQUITY VIII L.P. disclosed that took down 3,500,000 additional shares at $5.64 on May 29. This now gives the private equity fund a stake of some 26,124,430 shares. Our last data showed 78.88 million shares outstanding, but that may not reflect the new share issuance.
This last equity sale is a good indication that the market is willing to finance this molecular therapeutic company for cancer treatment further, particularly for a pre-clinical and pre-revenue biotech operation.
Allos said in its original filing that it plans to use the financing primarily for clinical and pre-clinical research and development of its candidates, manufacture of clinical trial material and pre-commercial scale-up activities for PDX, working capital and general corporate purposes.
Allos closed flat today, but shares are at $6.34. Its 52-week trading range is $3.91 to $7.70.
Jon C. Ogg
May 30, 2008
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