|Celsion to continue Phase III trial. Rexahn initiates Phase IIb ED trial. Radient soars on positive analyst comments. After the bell, BioSphere acquired by Merit Medical|
|By BioMedReports.com Staff|
|Thursday, 13 May 2010 19:25|
Below is a list of the companies that made news in the healthcare sector on Thursday, May 13, 2010.
BioSphere Medical, Inc. (NASDAQ: BSMD) soared after the market closed after the company reported that it has agreed to be acquired by Merit Medical Systems, Inc. (NASDAQ: MMSI) in a cash transaction valued at approximately $96 million.
BioSphere shareholders will receive about $4.38 per share for each outstanding share of BioSphere common stock, a 54 percent premium over the May 12th closing price.
BioSphere Medical is a pioneer in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy. Merit Medical said it anticipates cuts in expenses and achievement of sales synergies with the addition of BioSphere products to its global sales channels.
In the after hours session, shares of BioSphere hit $4.19, a gain of $1.19 or 40% over Thursday's closing price.
Anika Therapeutics, Inc. (Nasdaq: ANIK) announced that the U.S. Food and Drug Administration has accepted the corrective actions put forth by Anika to address the issues raised in the 2008 Warning Letter received by the company, and therefore has removed any restrictions placed upon Anika as a result of that letter.
Anika’s CEO, Charles H. Sherwood, Ph.D. commented, "We have worked very hard in tandem with the FDA to develop and implement a plan that will keep Anika at an exemplary level with respect to compliance. We appreciate all of the cooperation that we received from the Agency to aid in our progress."
News from earlier in the day:
Celsion Corporation (Nasdaq:CLSN) surged nearly 10% today after the company announced that after reviewing data from 294 patients including data from 12 Japanese patients enrolled in the pivotal Phase III ThermoDox clinical study (HEAT Study) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial. Celsion's global Phase III ThermoDox study for primary liver cancer plans to enroll 600 patients and is being conducted under a FDA Special Protocol Assessment (SPA). The study is designed to evaluate the efficacy of ThermoDox in combination with radiofrequency ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival. Shares jumped 41 cents to $4.59.
Rexahn Pharmaceuticals, Inc. (NYSE Amex:RNN), edged higher today after the company announced that it will initiate a Phase IIb clinical trial for Zoraxel in the treatment of erectile dysfunction (ED).
The Phase IIb study is designed to assess Zoraxel’s efficacy in approximately 225 male subjects, ages 18 to 65, with ED. The double blind, randomized, placebo-controlled, 12-week study will include the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) survey, and quality of life study endpoints. The Phase IIb study is expected to begin in the second half of 2010 and the preliminary data is expected to be available in 2011. The study will be conducted at multiple sites in the U.S.
Rexahn’s decision to move forward with the Phase IIb trial is supported by data from a Phase IIa proof of concept study of 39 ED patients treated with Zoraxel. The Phase IIa study was completed in May 2009 and demonstrated that Zoraxel consistently improved IIEF scores of treated subjects. Furthermore, the study found that treated subjects demonstrated a dose dependent treatment effect with improved erectile function and quality of life measures. Zoraxel was also found to be safe and well tolerated, with no serious adverse events reported.
Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) surged 67% today after a positive research report was issued by Goldman Research. Said analyst Rob Goldman, "We view Radient as a stock that offers great value and potential for its existing operations, hidden but soon-to-be monetized value in its non-core assets, and home run potential with its next-gen product, should it be awarded FDA approval. A steady stream of news and events prior to FDA submission should serve as catalysts for the stock." Goldman rated Radient a speculative buy with a $4.00 price target.
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) today reported financial and operating results as at and for the three months ended March 31, 2010.
Juergen Engel, Ph.D., Aeterna Zentaris' President and Chief Executive Officer commented, "This has been a very exciting quarter as we made great strides in the development of our lead oncology compound, perifosine, now in Phase 3 registration trials for multiple myeloma and refractory advanced colorectal cancer. Furthermore, the different designations recently granted by the FDA in both indications and the EMA's positive Scientific Advice for multiple myeloma, will accelerate as well as facilitate the future review and marketing authorization processes in North America and Europe."
Dennis Turpin, Senior Vice President and Chief Financial Officer of Aeterna Zentaris added, "With more than $40 million in cash, including proceeds from our recent $15 million registered direct offering and no debt, combined with our expected significantly reduced burn rate, we are in a solid financial position to execute our focused drug development and business strategy."
Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported selected financial results for the fiscal quarter ended March 31, 2010 and provided a progress update of the Company's ANCHOR and MARINE trials, the two pivotal Phase 3 clinical trials of its lead product candidate AMR101 for treating elevated triglyceride levels.
ARCA biopharma, Inc. (NASDAQ: ABIO) today announced that it received notification from the NASDAQ Stock Market that the Company has demonstrated compliance with the minimum stockholders’ equity requirement for the NASDAQ Global Market set forth in Listing Rule 5450(b)(1)(A) and that ARCA is in compliance with all applicable requirements for continued listing on the NASDAQ Global Market.
ARYx Therapeutics, Inc. (NASDAQ:ARYX) today reported results of operations and provided an update on its business activities for the first quarter ended March 31, 2010.
"ARYx made substantial progress on two fronts in this quarter towards optimizing the value of our assets for our stockholders. First, we held an End of Phase 2 meeting with the Food and Drug Administration regarding our gastrointestinal therapy, ATI-7505, and are very pleased with the outcome. The FDA has given us clear guidance on the path forward into Phase 3 and ultimately to the filing of a New Drug Application. Second, we have submitted to the FDA the Phase 3 protocol for the real-world trial of our anticoagulant therapy, tecarfarin, under the Special Protocol Assessment procedure," said Dr. Paul Goddard, chairman and chief executive officer of ARYx. "Both of these achievements further clarify the road to the potential approval and commercialization of these two assets and enhance our work with Cowen and Company, the investment bank retained just over two months ago to advise ARYx on our best strategic alternatives," added Dr. Goddard.
Cell Therapeutics, Inc.(Nasdaq and MTA: CTIC) today announced an agreement with the North Central Cancer Treatment Group (NCCTG) to conduct a phase II study of pixantrone in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens. The trial will be conducted through the NCCTG, a national network of cancer specialists at community clinics, hospitals, and medical centers in the United States and Canada. The research base for NCCTG is located at Mayo Clinic in Rochester, MN.
GenVec, Inc. (Nasdaq:GNVC) reported today that the company received a notice from The NASDAQ Stock Market stating that the minimum bid price of the Company's common stock was below $1.00 per share for 30 consecutive business days and that the Company was therefore not in compliance with the minimum bid price requirement for continued listing set forth in Marketplace Rule 5450. The notification letter has no effect at this time on the listing of the Company's common stock on The NASDAQ Global Market. GenVec's common stock will continue to trade on The NASDAQ Global Market under the symbol GNVC. The notification letter states that GenVec will be afforded 180 calendar days, or until November 8, 2010, to regain compliance with the minimum closing bid price requirement of at least $1.00 for ten consecutive trading days.
Geron Corporation (Nasdaq:GERN) today reported positive preclinical study data showing that GRNCM1, Geron’s cardiomyocyte product derived from human embryonic stem cells (hESCs), does not cause cardiac arrhythmias after transplantation into a model of chronic heart damage designed to test this potential safety concern. GRNCM1 is being developed for the treatment of heart failure.
Immunomedics, Inc. (Nasdaq:IMMU), jumped 8% today after announcing that clinical trial results on epratuzumab, the anti-CD22 humanized monoclonal antibody licensed to UCB SA, Brussels, for autoimmune disease indications, from the Phase IIb study in patients with lupus, will be presented in four posters sessions and one published abstract. These presentations will occur at the 2010 annual Congress of the European League Against Rheumatism (EULAR), June 16 -- 19, 2010, in Rome, Italy. In the second half of 2010, UCB will initiate two Phase III studies of epratuzumab for the treatment of patients with moderate and severe lupus.
Inhibitex, Inc. (NASDAQ:INHX) today announced its financial results for the first quarter ended March 31, 2010. The Company also announced that it has initiated a Phase I single ascending dose trial of INX-189, its lead HCV nucleotide polymerase inhibitor, in healthy volunteers under an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA).
"We are pleased with the progress made with both of our internally-driven antiviral development programs over the past quarter," stated Russell H. Plumb, President and CEO of Inhibitex, Inc. "Our IND for INX-189 is now in effect and we have initiated a first-in-man study to evaluate its safety and pharmacokinetics. We have also completed two-thirds of the planned enrollment in our ongoing Phase II trial of FV-100, and continue to anticipate that top-line data from the completed trial will be available in the fourth quarter of 2010."
Medical Nutrition USA, Inc. (NASDAQ:MDNU) edged higher today after announcing the results of a clinical study showing that 91% of women with recurrent urinary tract infections remained symptom-free while taking the company's UTI-Stat (ProAntinox) supplement. The study, which was published by Urology, the official journal of the International Society of Urology, also found that UTI-Stat significantly improved quality of life as measured by the American Urologic Association Symptom Index. "This new study by Dr. Katz shows that UTI-Stat is equally as effective for younger women with recurrent UTI as it has previously been shown to be for older, nursing home residents," said Arnold Gans, Chief Scientific Officer of Medical Nutrition USA. "The absence of symptoms and the improved quality of life shown in these studies are of huge benefit to those who are susceptible to urinary tract infections."
Novavax, Inc. (Nasdaq:NVAX) announces the first report of a vaccine protecting ferrets against the 2009 pandemic H1N1 virus has been published in the journal Vaccine May 12, 2010 online issue. Scientists from Novavax and the Centers for Disease Control and Prevention (CDC) based in Atlanta, GA, under a collaborative agreement, co-authored the scientific report.
Omeros Corporation (Nasdaq:OMER) today announced that, based on successful preclinical studies, the Company has selected a clinical candidate for its MASP-2 antibody program and has initiated the cGMP manufacturing development process in preparation for clinical trials. Preclinical studies have shown that Omeros' proprietary, fully human, monoclonal MASP-2 antibodies shut down the lectin pathway of the complement system, which is part of the immune system. The lectin pathway is involved in multiple inflammatory disorders and, in independent studies, patients who are genetically deficient in the pathway have been shown to have better clinical outcomes. MASP-2 inhibition has also demonstrated efficacy across a wide range of preclinical disease models.
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) announced today that it has been awarded a $3 million grant from the National Institutes of Health’s National Heart, Lung and Blood Institute to support and accelerate the clinical development of its novel product candidate RGN-352, an injectable formulation of the novel therapeutic peptide Thymosin beta 4 for patients who have suffered an acute myocardial infarction, or AMI, commonly known as a heart attack. The award is being issued under the American Reinvestment and Recovery Act of 2009. The Company is planning to initiate a Phase 2 clinical trial with RGN-352 later this year. This highly competitive grant award will allow the Company to conduct a number of key scientific activities in parallel that should facilitate the commercial development of RGN-352.
Repligen Corporation (Nasdaq:RGEN) announced today that it has filed an Investigational New Drug Application (IND) with the Food and Drug Administration for a Phase 1 study of RG2833, a selective histone deacetylase 3 (HDAC-3) inhibitor. This is a double-blind, single ascending dose, Phase 1 study in healthy volunteers to evaluate the pharmacokinetic and safety profile of RG2833 in up to 40 subjects. This study will also evaluate the pharmacodynamic response of various biomarkers in peripheral blood to RG2833. Pending FDA approval, this study will be the first step in the clinical development of RG2833 as a potential treatment for Friedreich's ataxia.
St. Jude Medical, Inc. (NYSE:STJ) and iRhythm Technologies, Inc., a privately-held company, announced today they have entered into partnership with a focus on iRhythm's Zio Patch. iRhythm also announced closure of a $10 million private equity round of financing, which was led by St. Jude Medical and included existing investors Mohr Davidow Ventures and Synergy Life Science Partners. Proceeds will be used to support the commercial launch of the Zio Patch. The announcement was made concurrent with Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions, in Denver.
VirtualScopics, Inc. (Nasdaq:VSCP), a leading provider of quantitative imaging for clinical trials, today reported revenues of $3,071,007 for the first quarter of 2010 compared to revenues of $2,134,370 in the first quarter of 2009, a 44% increase. Excluding work performed in 2009 for the Department of Defense under projects that ended mid-2009, the company posted a 60% increase in first quarter 2010 revenues as compared to the first quarter of 2009.
YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), today reported operational and financial results for the third quarter of fiscal 2010, ended March 31, 2010. "During the third quarter, we completed the merging into YM of Cytopia Limited, now YM BioSciences Australia, expanding our pipeline through the addition of two promising new drug candidates in drug classes that have been established as being of high interest and value to the pharmaceutical industry," said David Allan, Chairman and CEO of YM BioSciences. "With a strengthened balance sheet from our recent financing and a portfolio of four late-stage products, the quality and prospects for our drug portfolio are unmatched in YM's history as a company. This quarter we gathered momentum in for our clinical programs with an expansion of our Phase I/II clinical trial for CYT387 as well as the acceptance and presentation of our data at several international forums. We look forward to numerous clinical and corporate events during the balance of 2010."
Alkermes, Inc. (NASDAQ: ALKS) today reported financial results for its fiscal year ended March 31, 2010, and provided financial expectations for fiscal 2011.
Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial and operating results for the first quarter ended March 31, 2010.
Ardea Biosciences, Inc. (Nasdaq: RDEA) today announced that it will present additional data from its completed Phase 2a and Phase 2b monotherapy studies of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Rome, Italy on June 18th and 19th.
BioNeutral Group, Inc. (OTCBB:BONU), a specialty chemical technology-based life science company, reports that it has completed the required Independent Good Laboratory Practice (GLP) toxicity, chemistry and efficacy testing required for submission of its Ygiene Hospital Disinfectant to the U.S. Environmental Protection Agency (EPA).
China Sky One Medical, Inc. (Nasdaq: CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China, today announced that Mr. Stanley Hao, the Company's Chief Financial Officer, will participate in the following investor conferences in May 2010.
CVS Caremark Corporation (NYSE:CVS) today announced that members of its senior management team will be speaking to investors at the Citi Investment Research 2010 Food & Drug Retail Conference on May 25, 2010.
Derma Sciences, Inc. (Nasdaq: DSCI), a specialty medical device/pharmaceutical company focused on advanced wound care, reported financial and operating results today for the three months ended March 31, 2010.
DUSA Pharmaceuticals, Inc.® (Nasdaq: DUSA), a dermatology company that is developing and marketing Levulan® Photodynamic Therapy (PDT) and other products focused on patients with common skin conditions, today announced that its Annual Meeting of Shareholders will be held on Thursday, July 29, 2010 at 11:00 AM at the Company's offices at 25 Upton Drive, Wilmington, MA.
EpiCept Corporation (Nasdaq: EPCT) today announced that Jack Talley, President and CEO, will be presenting at the Rodman & Renshaw Annual Global Investment Conference on May 18, 2010 at 9:50 am local time at the Grosvenor House Hotel in London, England. Mr. Talley will present a company overview.
Genta Incorporated (OTCBB: GETA) today announced financial results for the quarter ended March 31, 2010.
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical technology solutions that enhance the efficiency of customers' clinical development, today announced its financial results for the first quarter 2010 and provided financial guidance for the second quarter and full year 2010.
NanoViricides, Inc. (OTC BB: NNVC.OB), reports that it has signed a research and development agreement with Dr. Ken S. Rosenthal's laboratory at Northeastern Ohio Universities Colleges of Medicine and Pharmacy.
Omnicare, Inc. (NYSE: OCR) today announced that it has priced its public offering of $400 million aggregate principal amount of 7.75% senior subordinated notes due 2020.
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today reported financial result for the quarter ended March 31, 2010 and provided an update on its corporate developments.
Pernix Therapeutics Holdings, Inc. (NYSE/AMEX: PTX), a specialty pharmaceutical company primarily focused on serving the needs of the pediatric marketplace, today announced it would report its financial results for the first quarter of 2010 on Monday, May 17th, 2010.
Renhuang Pharmaceuticals, Inc. (Pink Sheets: RHGP) a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines, today announced that the Company successfully exhibited its products at the 63rd PHARMACHINA fair held in Xiamen, China.
Tengion, Inc. (Nasdaq: TNGN), a regenerative medicine company focused on discovering, developing, manufacturing and commercializing neo-organs and neo-tissues, today announced it will release its first quarter 2010 financial report before market open on Tuesday, May 18, 2010.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that Marc N. Casper, president and chief executive officer, will present at the Baird 2010 Growth Stock Conference being held at the Four Seasons Hotel Chicago, in Chicago, Ill.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results of the voting at its 2010 Annual Meeting of Shareholders.
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