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Technical Breakout Alert Issued For CytRx (NASDAQ:CYTR)

Mon, 23 Nov 2009 13:57:08 GMT

Miv Investments Inc. has initiated an independent bullish technical trading alert for 11/23/09 on CytRx Corporation (NASDAQ:CYTR). Shares of the company finished trading during 11/20/09 at $1.35 per share, up 20.18% from the opening bell on heavy buying pressure. As of 11/18/09, the biopharmaceutical company announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.[More...]

FDA Calendar Update: Acusphere (OTC:ACUS), Cephalon (NASDAQ:CEPH)

Mon, 25 May 2009 13:27:31 GMT

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, s (...)[More...]

Eyeing Opportunities In Micro-Cap Bio-Pharma Index

Tue, 02 Dec 2008 13:49:00 GMT

The accompanying table profiles the 13 companies mentioned in this article and statistics for all 113 companies (click here for a link to the entire index) with market caps between $25M-$150M, which are included in the new ETF Innovators (ETFI) Micro-Cap Bio-Pharma Index as a complement to the ETFI Emerging Bio-Pharma Index of companies with market caps between $150M-$1.5B.[More...]

Noteworthy Developments in Biotech - Zacks Analyst Interviews

Mon, 03 Nov 2008 17:00:00 GMT

Though we're anywhere but in a high growth market presently, there are groups that may provide big upsides based on growth potential, especially in light of major recent pull-backs. One industry that interests us is biotech, so Zacks senior analyst Jason Napodano, CFA helped us with some notable suggestions in the space. What's new in the world of biopharmaceuticals these days? Arena Pharmaceuticals (ARNA) reported financial results for the third quarter 2008. Although results were largely in-line with expectations, investors are starting to take notice of Arena's cash position. Despite the $212.1 million still on the books at the end of September 2008, management has reduced its year-end[More...]

Acusphere Strikes a Partnership - Analyst Blog

Fri, 31 Oct 2008 18:39:00 GMT

On October 24, 2008, Acusphere (ACUS) and Cephalon (CEPH) signed a definitive agreement whereby Cephalon will provide $20 million in upfront financing to Acusphere in the form of $5M in cash and $15M in a senior secured convertible note. ? The deal is very positive for Acusphere shareholders, as the company exited the third quarter with only $4.1 million in cash on the books and was going to run out of operating funds by mid-November 2008.? The financing avoids any near-term bankruptcy risk or the need for a massive dilutive offering. ? We also note that should Cephalon decide to license Imagify, Acusphere was able to maintain a significant portion of the[More...]

Analyst Comments: Toyota, Best Buy, LDK Solar, Beacon Roofing, Acusphere, Gerdau, Deere, AXA Group

Wed, 13 Aug 2008 22:11:00 GMT

In 2009 first quarter, Toyota Motor Corp. (TM) reported diluted earnings per ADR of $2.14 compared to $2.94 in the corresponding quarter of the previous year. Net revenues decreased 4.7% year over year to $5.92 billion. The company attributes the decrease in revenues to soaring raw material prices and exchange rates fluctuations. Consolidated vehicle sales for the quarter amounted to 2.19 million units, an increase of 24,000 units compared with the same period of fiscal 2008. The company continues to expand its production capacity in a manner that increases efficiency and meets local demand and simultaneously powering it to emerge as the world?s financially strongest automaker. A strong presence in North America has been further consolidated by gaining market share from the leading U.S. automakers. Moreover, the company also has a strong cash flow and a[More...]

On Acusphere from the Analyst

Mon, 30 Jun 2008 19:44:43 GMT

On June 24, 2008, the FDA's Cardiovascular and Renal Drug Advisory Committee met to discuss ultrasound contrast agents. Specifically, the committee met to discuss safety considerations in the development of new agents for approval.[More...]

Analyst Comments: Votorantim Celulose, SCOR Group, Acusphere, Eagle Test Systems

Mon, 30 Jun 2008 16:58:54 GMT

We are keeping our Hold recommendation on Brazilian pulp-producer Votorantim Celulose e Papel S.A. (VCP). Demand for pulp and paper remains heated in Brazil and abroad, especially in Asia, which is keeping prices elevated. Guidance for the second quarter of 2008 was positive, and the short-term outlook for the pulp and paper market remains encouraging. However, sales have stagnated and the higher worldwide inflation and interest...[More...]

A Speech, A Mistake And A Bunch Of Stocks Breaking Out

Tue, 29 Apr 2008 16:10:41 GMT

Speech at U of M went well last night, 100 or so in attendance, pics and maybe even some video to come shortly—some Dealbreaker loser live blogged it in the comments section of THIS post (although misquoting / drawing the wrong conclusions aka guy has a b[More...]

Analyst Comments: Cell Therapeutics, CastlePoint Holdings, Churchill Downs, Acusphere, Goldman Sachs, Lehman Brothers

Tue, 18 Mar 2008 14:44:06 GMT

Cell Therapeutics, Inc. (LMT) develops, acquires, and commercializes novel treatments for cancer. The recent acquisition of Zevalin will generate revenue for the company and prepare the company for the future launch of other cancer products. Two pipeline[More...]

City Settles Lawsuit: Texas Firm Pays $650,000.

Wed, 22 Apr 2009 19:15:00 GMT

Apr. 22--Kokomo city officials won a victory of sorts in court last week, when a Texas-based engineering firm paid a $650,000 settlement to end a 2-year-old lawsuit.
The payment, from ACUS Corp., isn't an admission of guilt, but it will help the city cover attorney fees and repairs associated with a $2.1 million wastewater treatment plant project.
Chris Cooper, superintendent of the Kokomo Wastewater Treatment Plant, said the city's troubles began in 2002, when former Mayor Jim Trobaugh's administration contracted with Indiana-based Bowen Engineering for a new filtration system at the Markland Avenue plant.

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Acusphere, Inc. Announces Prepayment of Equipment Loans

Tue, 19 May 2009 20:02:00 GMT

Acusphere, Inc. (ACUS.PK) today announced that it has prepaid its equipment loans with Oxford Finance Corporation and Massachusetts Development Finance Agency. These transactions, in combination with the previously disclosed prepayment in full of General Electric Capital Corporation debt, represent total debt reduction of $3.8 million. After such prepayments, the Company has approximately $2.4 million in unaudited cash which is expected to fund operations to the end of the third quarter of 2009 based on the current operating plan.[More...]

Acusphere, Inc. Reports Q4 2008 Recent Business Highlights, Business Priorities and Financial Results

Tue, 31 Mar 2009 20:14:00 GMT

Acusphere, Inc. (ACUS:PK) today reported financial results for the fourth quarter and year ended December 31, 2008, and commented on its business and progress to date. The Company continues to discuss its New Drug Application (NDA) with the U.S. Food & Drug Administration (FDA) for its lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension following the receipt of FDA’s complete response letter in late February. Imagify is a Perfusion Stress Echo imaging agent targeted for use in detecting coronary artery disease.[More...]

Acusphere Announces Further Cost Reductions and Voluntary Filing of Form 15 to Suspend SEC Reporting Obligations

Tue, 03 Mar 2009 21:26:00 GMT

Acusphere Inc. (OTCBB: ACUS) announced today its plan to substantially reduce costs while it continues its discussions with the U.S. Food & Drug Administration (FDA) about the regulatory path forward for its lead product candidate, Imagify™ (Perflubutane Polymer Microspheres) for Injectable Suspension. These cost reductions include a reduction in force, the termination of its lease in Watertown and the consolidation of operations at its manufacturing facility in Tewksbury, as well as the filing of a Form 15 with the U.S. Securities and Exchange Commission (“SEC”) to suspend the company’s SEC reporting obligations. These cost reductions are in addition to cost reductions previously announced in February 2009, involving the renegotiation of certain intellectual property agreements to push certain future payments into 2013.[More...]

Acusphere Announces Change In Imagify Regulatory Strategy and Deferral of Near-Term Contractual Cash Payments

Tue, 17 Feb 2009 20:02:00 GMT

Acusphere Inc. (OTCBB: ACUS) announced today that it has submitted an amendment to its New Drug Application (NDA) for ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension. Imagify is designed for the detection of coronary artery disease, the leading cause of death in the United States. The NDA was submitted to the U.S. Food & Drug Administration (FDA) in April 2008 and filed in June 2008. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary artery disease. It is estimated that more than 10 million cardiac stress imaging procedures are done each year in the U.S. of which 6.5 million are conducted with exercise stress and 3.5 million are conducted with pharmacologic stress. If FDA accepts the submitted amendment, the Imagify indication will be limited to subsets of patients undergoing pharmacologic stress techniques. The amended indication is focused on patients where the risk-to-benefit ratio of Imagify is more compelling than the broader indication that was originally filed. Since this is a significant amendment to the NDA for Imagify, it is likely that the FDA will push back the Prescription Drug User Fee Act (PDUFA) target date for their complete response letter from February 28, 2009 to May 31, 2009.[More...]

Acusphere Announces Publication of Imagify™ Phase 3 Trials in the European Journal of Echocardiography

Wed, 21 Jan 2009 12:04:00 GMT

Acusphere, Inc. (OTCBB: ACUS) today announced that an original paper summarizing the Phase 3 clinical trial results for ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, has been published in the current issue of the European Journal of Echocardiography. The paper concludes that Imagify Perfusion Stress Echo is well-tolerated, and that its diagnostic performance in chest pain patients is comparable with single photo emission computed tomography, or SPECT, perfusion imaging. The paper, entitled “Detection of Coronary Artery Disease with Perfusion Stress Echocardiography Using a Novel Ultrasound Imaging Agent: Two Phase 3 International Trials in Comparison with Radionuclide Perfusion Imaging,” is authored by Dr. Roxy Senior, Consultant Cardiologist and Director of Cardiac Research, Department of Cardiovascular Medicine and Institute of Postgraduate Medical Education and Research at Northwick Park Hospital in the U.K., among others. Dr. Senior was the lead clinical investigator for Acusphere’s clinical trials for Imagify.[More...]

Acusphere, Inc. Announces Receipt of NASDAQ Panel Decision to Delist Common Stock

Wed, 07 Jan 2009 20:50:00 GMT

Acusphere, Inc. (NASDAQ:ACUS) announced today that it has received notification that the NASDAQ Listing Qualifications Panel has determined to delist the Company’s common stock from The NASDAQ Stock Market, effective with the open of business on Friday, January 9, 2009. The delisting is the result of the Company’s failure to meet the $2.5 million stockholders’ equity requirement for continued listing on The NASDAQ Capital Market or one of the alternative continued listing criteria.[More...]

Acusphere, Inc. Announces Resignation of Richard Walovitch

Wed, 07 Jan 2009 20:04:00 GMT

Acusphere, Inc. (NASDAQ: ACUS) today announced that Dr. Richard Walovitch, Senior Vice President of Clinical Research, has resigned to pursue another opportunity. His resignation, effective January 9, 2009, follows an 11 year career with Acusphere, in which he oversaw the Company’s clinical trials for its lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, a cardiovascular drug for the detection of coronary artery disease, which addresses a potential $2 billion U.S. marketplace.[More...]

Acusphere Announces Results of FDA Advisory Committee Meeting

Wed, 10 Dec 2008 23:56:00 GMT

Acusphere, Inc. (NASDAQ: ACUS) today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration advised that the diagnostic benefit of contrast enhancement using Acusphere’s ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension is not sufficient to justify the risks associated with the product. The vote was sixteen against, one in favor and one abstention. The Committee also discussed concerns that they would like addressed to support approval of the product for the detection of coronary artery disease.[More...]

Acusphere, Inc.’s Stock Trading Halted Today; FDA Advisory Committee Meets to Discuss Imagify™

Wed, 10 Dec 2008 11:15:00 GMT

Acusphere, Inc. (NASDAQ: ACUS) today announced that NASDAQ has halted trading in the Company’s common stock today. The Cardio Renal Advisory Committee to the U.S. Food & Drug Administration is meeting, in a public session, to review Acusphere’s lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States.[More...]

Acusphere, Inc. Announces Posting of Briefing Documents for FDA Cardio Renal Drugs Advisory Committee Meeting on Imagify™

Mon, 08 Dec 2008 14:02:00 GMT

Acusphere, Inc. (NASDAQ: ACUS) today announced that the U.S. Food & Drug Administration (FDA) has posted briefing documents on its website for the December 10th Cardio Renal Advisory Committee (CRAC) Meeting. The CRAC will be asked to review and discuss the New Drug Application (NDA) filed by Acusphere for ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States.[More...]