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tripleblack on RxNews Recap for Wednesday 11-25-09 Mr. Garza, you are a gentleman and a scholar, a...
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M. E. Garza on Key developments ahead for CytRx Corporation (NASDAQ:CYTR) Speculation huh?We'll see.
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RxNews Recap for Wednesday 11-25-09
Agilent Technologies Inc. (NYSE:A) today announced the following webcast for the investment community: Credit Suisse Annual Technology Conference ThePhoenician, Scottsdale, Ariz.Tuesday, Dec. 1, at 9:30 a.m. MSTRon Nersesian, president, Electronic Measurement Group.
Ardea Biosciences, Inc. (Nasdaq:RDEA) announced today that Barry D. Quart, Pharm.D., president and chief executive officer, will present at the Piper Jaffray 21st Annual Health Care Conference.
AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced that the Company will present at the 21st Annual Piper Jaffray Health Care Conference on Wednesday, December 2nd at 2:30 p.m. Eastern time (11:30 a.m. Pacific time) at the New York Palace Hotel in New York.
Biomagnetics Diagnostics Corp., (OTC:BMGP) a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis, and malaria detection, today announced the Company will hold an investor conference call to discuss upcoming business opportunities and its agreement with one of the world’s premiere research laboratories.
China Sky One Medical, Inc. (Nasdaq:CSKI), a leading fully integrated pharmaceutical company developing and producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that the Company recently passed the Chinese National Institute for the Control of Pharmaceutical and Biological Products ("ICPBP") examination for two of its new products: its Diagnostic Kit for Human Prostate Specific Antigen (Colloidal Gold) and its Determination Kit for Luteinizing Hormone (Colloidal Gold).
Covidien (NYSE:COV) will present at the 21st Annual Piper Jaffray Health Care Conference in New York on Wednesday, December 2, 2009. Charles J. Dockendorff, Executive Vice President and Chief Financial Officer, will represent the Company in a session scheduled at 8:30 a.m. ET.
Curis, Inc. (NASDAQ:CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the Company will be presenting at the Piper Jaffray 21st Annual Healthcare Conference at 11:00 a.m. EST on December 2, 2009, in New York City.
Enzo Biochem, Inc. (NYSE:ENZ) announced today that its Board of Directors approved the termination of Shahram K. Rabbani’s services as the Company’s Secretary and Treasurer, respectively, effective immediately.
Exact Sciences Corp. (Nasdaq:EXAS) today announced that it will present at the Piper Jaffray Health Care Conference, which is being held Dec. 1-2, at the New York Palace Hotel.GLG Life Tech Corporation (NASDAQ:GLGL), the vertically integrated leader in the agricultural and industrial development of high quality stevia extracts, announced today that it has completed its previously announced equity offering (the "Offering").
Human Genome Sciences, Inc. (Nasdaq:HGSI) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ZALBIN™ (albinterferon alfa-2b) for the treatment of chronic hepatitis C.
Idera Pharmaceuticals, Inc. (Nasdaq:IDRA), today announced that Novartis will terminate its research collaboration agreement with the Company, effective as of February 21, 2010.
Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH) announced today that Christy L. Shaffer, Ph.D., President and CEO, and Thomas R. Staab, II, CFO and Treasurer, will present at the 21st Annual Piper Jaffray Health Care Conference on Wednesday, December 2, 2009 at 10:00 am ET in New York City.
Illumina, Inc. (NASDAQ:ILMN) today announced that its Board of Directors has approved a new stock repurchase program, authorizing the company to repurchase in the aggregate up to $100 million of its outstanding common stock.
Incyte Corporation (NASDAQ:INCY) announced today that it has entered into a collaboration and license agreement with Novartis for two of its investigational hematology-oncology therapies: INCB18424, an oral JAK1/JAK2 inhibitor that is in Phase III development for myelofibrosis, a serious life-threatening neoplastic condition characterized by varying degrees of bone marrow failure, splenic enlargement and debilitating constitutional symptoms, and INCB28060, an oral cMET inhibitor that is about to enter Phase I development as a potential treatment for multiple cancers.
Medtronic, Inc. (NYSE:MDT), the world’s leading medical technology company, today announced it will participate in the 21st Annual Piper Jaffray Healthcare Conference on Tuesday, Dec. 1, 2009, in New York.
NuVasive, Inc. (Nasdaq:NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today that it will host a conference call on Monday, November 30, 2009, at 5:30 p.m. ET / 2:30 p.m. PT.
Osiris Therapeutics, Inc. (NASDAQ:OSIR), the leading stem cell therapeutic company focused on developing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas, announced today that C. Randal Mills, Ph.D., President and Chief Executive Officer, is scheduled to present at the 21st Annual Piper Jaffray Healthcare Conference on Wednesday, December 2, 2009 at 9:30 a.m. EST.
Par Pharmaceutical Companies, Inc. (NYSE:PRX) today announced the results of its "Modified Dutch Auction" tender offer, in which Par offered no purchase, for cash, up to $65,000,000 aggregate principal amount, or up to approximately 82.7%, of its outstanding 2.875% Senior Subordinated Convertible Notes due 2010.
Unilife Medical Solutions Limited (ASX:UNI) (OTC:UNIFF) today announced the filing of patent applications in the United States ("US") for a new ready-to-fill syringe product to be marketed as the Unifill™ Select.
Pending purchase from U.S. Govt. sends SIGA Technologies, Inc. (NASDAQ:SIGA) shares soaring
Our Subscribers were alerted Monday that a series of big government orders are anticipated to be announced "any day now," after sources confirmed to us that the official news and first purchase order could come within days.
SIGA Technologies, Inc. (NASDAQ:SIGA) has been trading up since late Thursday, when funds and others who were holding short positions started to cover in anticipation of this news.
The stock has a very, very low float and the price has been rising on just a little volume. It is not unrealistic to think that the stock could soar and see $15 -$20 range on the news (based on our own technical analysis).
In May, SIGA announced that it had submitted its response to the Biomedical Advance Research and Development Authority (BARDA) regarding the agency's outstanding RFP for the procurement of 1.7 million courses of a smallpox antiviral.
The U.S. government considers the inhaled smallpox virus the single biggest biological threat which could be used against Americans via a terrorist attack.
SIGA Technologies is applying viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense.
SIGA believes that it is a leader in the development of pharmaceutical agents and vaccines to fight potential biowarfare pathogens. In addition to smallpox, SIGA has antiviral programs targeting other Category A pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg).
Please learn more about the company here: www.siga.com/
Disclosure: No Positions
CytRx's launch of Phase 2 trial is only step one in the right direction
See this morning's Reuters Story here.
The company says it plans to initiate a multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a treatment for patients with advanced soft tissue sarcomas who have failed surgery and radiation.
For those of you who may not be familiar, soft tissue sarcomas are cancers that are formed in the muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body.
In the open-label Phase 2 clinical trial, 50 patients will receive INNO-206 once every three weeks for four consecutive cycles. The study will be conducted in approximately 25 study centers in the U.S., Europe and India. Following trial initiation, patient enrollment is expected to be completed in approximately 12 months. These patients will be evaluated on an ongoing basis for overall tumor response and progression-free survival.Please take not that this will be an opek-label study, which means the scientists and doctors who will be conducting the trials will be able to announce results to the investment and medical community along the way. Any positive news regarding this trial, could significantly impact share prices as those announcements are made.
In addition, BioMedReport readers are expecting the second (and perhaps more important) news item from the company to hit the wires in the coming days. As we reported on Monday, this news could be significant if it involves the lifting of the controversial clinical hold which the FDA placed on the company's Phase IIb clinical trial for Arimoclomol- a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).
When the hold was placed on those trials, the company's share price was affected significantly. The low price target from analysts now stands at $2 per share. The high target is $3 per share. See our chart and earlier story here.
Based on our interviews with the company CEO, CFO and others last Friday, we believe these price targets are realistic within the short term.
In the 12 to 15 month range, share price targets may continue to increase significanlty, especially since the cash equiped company seems determined to partner, acquire or develop more drugs for their oncology portfolio. Sources tell BioMedReports that some potential acquisition targets have drugs in both Phase 2 and 3 trails.
The right acquisition or partnership could significanlty add value to the company, so while the share price appears to be rebounding off lows, we believe those shares are still undervalued and will continue to rise in the days, months ahead.
Disclosure: Long CYTR
RxNews Recap for Tuesday 11-24-09
Advanced Cell Technology, Inc. (OTCBB:ACTC), a biotechnology company applying cellular technology in the field of regenerative medicine, announced today that it will present at the LD Micro Conference on Thursday December 3, 2009 at 4:30 p.m. (PST) at the Luxe Hotel in Los Angeles.
Affymax, Inc. (Nasdaq:AFFY) today announced the closing of its underwritten public offering of 4,726,027 shares of its common stock, which includes the full exercise of the underwriter’s overallotment option of 616,438 shares.
BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced that BioSpecifics' President, Tom Wegman, will present at the upcoming Piper Jaffray 21st Annual Health Care Conference on Tuesday, December 1, 2009, at 3:30pm ET at The New York Palace Hotel in New York, NY.
BioScrip, Inc. (Nasdaq: BIOS) today announced that the company will present at the 21st Annual Piper Jaffray Health Care Conference to be held December 1-2, 2009 t the New York Palace in New York City.
CardioGenics Holdings Inc. (OTC Bulletin Board: CGNH), a developer of technology and products targeting the immunoassay segment of the IVD testing market, reports that Merck Chimie S.A.S. ("Merck Chimie") is progressing to the next phase of the commercialization of CardioGenics' proprietary silver coated paramagnetic Beads ("Beads").
deCODE genetics, Inc. (Nasdaq:DCGN) today announced the approval of all of its "first day" motions by the U.S. Bankruptcy Court for the District of Delaware (the "Bankruptcy Court"). deCODE last week filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code with the Bankruptcy Court.
Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE), a company developing its needle-free Symphony(TM) tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and its Prelude(TM) SkinPrep System for transdermal drug delivery, announced today that Patrick T. Mooney, M.D., Chairman and Chief Executive Officer, will present at the 13th Annual Biotech and Specialty Pharmaceuticals Conference, sponsored by the New York Society of Securities Analysts, at 2:05 on December 1, 2009.
Global Pharmaceuticals, the generic products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced their cooperation in awarding a modest grant to Myasthenia Gravis Alliance, also known as Myasthenia Gravis Foundation of Greater New York, Inc., a 501(3)(c) non profit membership corporation, incorporated in the State of New York.
IPC The Hospitalist Company, Inc. (Nasdaq: IPCM), a leading national hospitalist physician group practice company, announced today that Philip Vaidyan, M.D., FACP, an IPC hospitalist, was named by ACP Hospitalist as one of the 2009 Top Ten Hospitalists in the nation. He was recognized in the November 2009 issue of the magazine.
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, announced today that presentations of clinical data for three product candidates employing its Targeted Antibody Payload (TAP) technology will be made at the 51st American Society of Hematology (ASH) Annual Meeting and Exposition to be held in New Orleans, LA, on December 5-8, 2009.
Lotus Pharmaceuticals, Inc. (OTC Bulletin Board: LTUS) a growing developer and producer of prescriptions drugs and license national seller of pharmaceutical products in the People's Republic China, today reported it will exhibit at the 62nd PHARMCHINA as a member of the Beijing pharmaceutical delegation.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the 21st Annual Piper Jaffray Health Care Conference in New York.
NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced the appointment of John A. Orwin to its Board of Directors, effective November 19, 2009.
OmniComm Systems, Inc. (OTCBB: OMCM), one of the fastest growing companies in the EDC marketplace, today announced that Beardsworth, a full service contract research organization (CRO) who specializes in difficult therapeutic areas, has selected OmniComm's TrialMaster EDC solution for conducting a Phase II vaccine study.
Radient Pharmaceuticals Corporation (NYSE Amex: RPC), a US-based pharmaceutical company that specializes in In Vitro Diagnostic (IVD) cancer tests and cell-renewing skin care products, announced today unaudited results and the filing of its Form 10-Q with the Securities and Exchange Commission ("SEC") for fiscal third quarter FY2009.
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) will webcast its presentation at the 21st Annual Piper Jaffray Healthcare Conference on Tuesday, December 1, 2009.
Synovis Life Technologies, Inc. (Nasdaq: SYNO), announced today that it has hired Patrick L. Horan to fill the key role of vice president of sales for the Surgical Group.
Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced that Gerald T. Proehl, president and chief executive officer, will make a presentation at the Piper Jaffray 21st Annual Health Care Conference on Wednesday, December 2, 2009, at 12:30 p.m. Eastern time (9:30 a.m. Pacific time) at The New York Palace Hotel in New York City.
ZymoGenetics, Inc. (NASDAQ: ZGEN) announced today that Douglas E. Williams, Ph.D., Chief Executive Officer of ZymoGenetics, will provide an update on company activities at the Piper Jaffray Healthcare Conference in New York City on Wednesday, December 2, 2009 at 8:30 a.m. Eastern Time.
RxNews Recap for Monday 11-25-09
Amarin Corporation plc (NASDAQ: AMRN) announced today that it has sent to its shareholders a Notice of the Annual General Meeting of the Company, which will be held on December 21, 2009 in Dublin, Ireland.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the Company and collaborating investigators from five major oncology research centers in the United States will present data from a Phase 1 clinical trial of ARIAD’s investigational, multi-targeted kinase inhibitor and pan-BCR-ABL inhibitor, AP24534, at the 51st Annual Meeting of the American Society of Hematology (ASH) being held in New Orleans, Louisiana, December 5-8, 2009.
Array BioPharma Inc. (Nasdaq: ARRY) today announced that its Chief Executive Officer, Robert E. Conway, will speak at the 21st Annual Piper Jaffray Healthcare Conference on December 1 in New York City.
Catalyst Rx, the pharmacy benefit management (PBM) subsidiary of Catalyst Health Solutions, Inc. (NASDAQ: CHSI), announced today that its member-focused Web site, CatalystRx.com, won a Platinum award in the Strategic Health Care Communications’ annual eHealthcare Leadership Awards for Best Interactive Site.
The clouds of darkness that have been hanging over over CytRx Corporation (NASDAQ:CYTR) may soon be cast aside.
CDEX Inc. (OTCBB:CEXI) (cdexinc.com) and All Business Machines, Inc. ("ABMI") (abmicorp.com) announce that the ValiMed™ MVS (Medication Validation System) and ID2 Meth Scanner™ product lines by CDEX have been placed on the ABMI GSA Contract Schedule.ValiMed MVS puts a technological safety net between the patient and errors made in the compounding of high risk medications and guards against narcotic diversion.
MedPro Safety Products, Inc. (OTCBB: MPSP), a pioneer in the development and marketing of passive needlestick injury prevention technology, today reported on the company’s recent progress.
NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company"), announced today that Dr. Eugene Seymour, MD MPH, CEO of the Company, presented lifetime data from the recent FluCide™ animal study on November 19th at the Influenza Congress USA 2009 in Washington, DC (terrapinn.com/usaflu).
Neogen Corporation (Nasdaq: NEOG) announced today that Richard T. Crowder, Ph.D., was elected to Neogen's Board of Directors at the company's recentannual meeting of shareholders.
Origin Agritech Limited (NASDAQ GS: SEED) (“Origin”), a leading technology-focused supplier of crop seeds and agri-biotech research in China, today announced it has received the Bio-safety Certificate from the Ministry of Agriculture as a final approval for commercial approval of the world’s first genetically modified phytase corn.
Oncolytics Biotech Inc., (TSX:ONC; NASDAQ:ONCY) announced today that it has closed its previously announced US$12,750,00 offering in which a syndicate of underwriters purchased 4,250,000 units of the Company, each unit comprised of one common share and 0.4 of a common share purchase warrant, at a price of US$3.00 per unit.
As part of its drug pipeline Ohr Pharmaceutical (OTCBB:OHRP) is developing a wet AMD (Macular Degeneration) therapy, based on technology acquired from Genaera Liquidating Trust.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP), a specialty pharmaceutical company, today announced it has closed its previously announced public offering of 5,500,000 shares of its common stock at a price of $21.00 per share.
TapImmune, Inc. (OTCBB:TPIV) announced that they have agreed with QualityStocks to be featured in The Small Cap QualityStocks Daily Newsletter, QualityStocks Daily Blogs and Message Boards. QualityStocks, based in Scottsdale, Arizona, is a free service that collects data from hundreds of Small-Cap and Micro-Cap online Investment Newsletters into one Free Daily Newsletter Report.
Walgreens (NYSE, NASDAQ: WAG), the nation’s largest drugstore chain and a leading destination for health and wellness services, today announced the re-launch of Walgreens.com (walgreens.com), offering users a variety of new healthy living and product resources, along with expanded yet simplified shopping tools and services.
Walgreens (NYSE:WAG)(NASDAQ:WAG) today announced the appointment of two new executives. Kathleen Wilson-Thompson has been named senior vice president and chief human resources officer, and Charles V. Greener has been named to the new position of vice president of corporate affairs and communications.
ZOLL Medical Corporation (NasdaqGS: ZOLL) announced today that the LifeVest® wearable defibrillator was discussed in three separate scientific presentations at the American Heart Association 2009 Science Session in Orlando, Florida last week.
Key developments ahead for CytRx Corporation (NASDAQ:CYTR)
On Friday morning, after seeing the stock gap up on heavy volume, we issued a trade alert to our subscribers rumors began to swirl throughout cyberspace and on message boards. "Someone knows something," claimed one investors who has been patiently following the stock since it was trading at close to $5 per share in late 2007.
Earlier in the week, shares of the company, whose drug development pipeline includes two product candidates in clinical development for cancer indications and treatments for neurodegenerative and other disorders based on its small-molecule molecular chaperone amplification technology, had barely registered a blip on the radar screen.
In fact the last significant spike (to $1.29) came in late July when CytRx announced that results demonstrating that their cancer drug candidate, INNO-206, had caused statistically significant tumor shrinkage in an animal model of ovarian cancer had been accepted for publication in the peer reviewed journal Investigational New Drugs.
By contrast, nearly 8 million shares traded and sent the stock up 25% to $1.14 from a previous close of $.91.
Could it be that investors are anticipating good news for the stock that fell out of grace on the day the FDA placed a clinical hold on their Phase IIb clinical trial for Arimoclomol- a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease)?
Perhaps news had leaked that the company was starting their Phase 2 clinical trial with INNO-206 as a second-line treatment in patients with advanced gastric cancer?
Others speculated that a partnership might soon be announced.
Perhaps all of the above?
Either way, the sudden injection of interest and excitement in the company has not been seen since early 2008, when the U.S. Food and Drug Administration surprised many in the biotech community by placing the company's promising Lou Gehrig's drug Arimoclomol on clinical hold.
Months earlier, the drug had been making headlines and offering tremendous hope to those suffering with the disease. In fact, prior to the surprise announcement, the company had been looking forward to showcasing the substantial potential for arimoclomol for ALS, stroke recovery and other neurodegenerative diseases.
Arimoclomol is one of CytRx's three orally-administered, small molecule compounds. This small molecule drug candidate is believed to function by stimulating a normal cellular protein repair pathway through the activation of "molecular chaperones." Since damaged proteins called aggregates are thought to play a role in many diseases, CytRx believes that activation of molecular chaperones could have therapeutic efficacy for a broad range of diseases.
"On that day, we put out the press release about that, the stock went down over a dollar and the share price began deteriorating day after day," explains Steven A. Kriegsman, President and CEO of CytRx.
Especially hard to swallow was the fact that the FDA's decision to place the Phase IIb program on clinical hold pertained to a previously completed toxicology study in rats and was not related to data generated from any human studies.
"I think our team's first reaction was, 'Wait! We're already past the animal studies. We're already at the human trials stage," explains Kriegsman.
At the end of the day, the company could have simply chosen to modify the protocol for the trial, but instead they chose to provide the FDA with all the materials and data they had aked for. Assuming that the company would get a promt response to all issues and that they would be able to resume the Phase IIb clinical trial, they- along with investors- were asked to wait and wait, then wait some more for that planned resumption. Many shareholders chose instead to move along and place their bets elsewhere.
"Many investors saw the hold as the end of the road for Arimoclomol," explains Kriegsman. "They misinterpreted the news, while others thought it meant that the drug and science behind it was not working."
It was an especially shocking blow to a drug candidate that had shown so much promise and hope for ALS. The company had been considering partnership opportunities with several pharmaceutical companies in hopes of advancing the development of the molecular chaperone asset. This is not surprising, given the tremendous promise of the technology.
While officials at the company would not confirm that the clinical hold on the trials might soon be finally lifted by the FDA, credible sources told BioMedReports that an announcement involving as many as two or three key positive developments might be only days away.
Asked to speculate about what this might mean for the share price of the company, one of several analysts who recently covered the stock said, "It means we'll have to raise our short term price target up, is what it means. I think that FDA hold really hurt the stock and if it does come off, it will definitely have an effect on the value of the company."
There is little doubt that the news would be welcome by investors, particularly those who have been holding long to the stock throughout the entire drama.
Asked specifically to comment about the rumors, Kriegsman refused to say anything other than he hopes any pending announcement will be embraced as good news for the company.
"We can't really comment on any pending news releases and I'm certainly not going to speculate on our share price or how the FDA might react since we don't control that, but we feel confident going forward and we've been working very hard to make sure that the company is on track to meet and announce some key milestones."
Developing...