|Positive FDA meet boosts Bionovo shares. Cerus drops on offering. Sunesis rises on updated trial data. After the bell: SurModics falls|
|By Mary Davila|
|Wednesday, 10 November 2010 20:00|
After the bell shares of SurModics, Inc. (Nasdaq:SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, fell sharply after the company reported financial results for the fourth quarter and fiscal year ended September 30, 2010. The company reported a drop inQ4 results that was a surprsie to analyst. SurModics attributed the loss to weak econmic conditions. The company also revised downward its full year 2011 forecast. In the after hours session, shares of SurModics dropped nearly 24% or $3.10 to $10.01.
SuperGen, Inc. (NASDAQ:SUPG) after the bell today announced that it has discontinued clinical development of its phase 1 PIM kinase drug candidate, SGI-1776, while continuing development of the PIM inhibitor program.
On heavy volume, shares of Bionovo, Inc. (Nasdaq:BNVI) surged nearly 29% of the company today announced that the U.S. Food and Drug Administration (FDA) has approved the company's total clinical development plan for Menerba, the company's drug candidate for menopausal hot flashes.
"We had a very positive meeting with the FDA on our clinical program for Menerba. As anticipated, they agreed with our overall clinical development plan which included the number of clinical trials, number of subjects and length of exposure as well as non-clinical studies necessary for New Drug Application (NDA) submission for a non-estrogen drug such as Menerba. They also provided useful suggestions for improving the clinical trial protocols," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "While we are awaiting the formal minutes from the FDA meeting, we are moving forward to implement the agency's suggestions and have forwarded the approved clinical trial design to our investigators and their investigational review boards, or IRBs."
"Menerba is a first-in-class, unique drug candidate that is intended for a large medical need, for the safe and effective treatment of menopausal symptoms," said Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "We want to do everything necessary to bring Menerba to market for the treatment of hot flashes, while we also investigate its potential use in the treatment of breast cancer prevention. Now that we have agreements with the FDA and the EMA (the European Medicines Agency) on the overall development of Menerba, we have accelerated discussions with potential partners to successfully bringing Menerba to market."
Shares closed the day at $1.30, up 29 cents driven by volume of more than 3 million shares.
Shares of Cerus Corporation (NASDAQ:CERS) fell more tan 20% today after the company announced the pricing of an underwritten public offering of 7,368,422 units, with each unit consisting of one share of its common stock and a warrant to purchase 0.5 of a share of its common stock, at a price to the public of $2.85 per unit. The aggregate public offering price of this offering is approximately $21.0 million, and the net proceeds to the Company, after deducting underwriting discounts and commissions, but before legal and other estimated offering expenses, are expected to be approximately $19.7 million.
Shares of Cerus closed the day at $2.50, down 66 cents.
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced updated data from Phase 2 clinical trials of the Company's lead drug candidate, vosaroxin, in combination with cytarabine, a widely used chemotherapy, in relapsed/refractory acute myeloid leukemia (AML) and as a single agent in frontline elderly AML. Consistent with results presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, vosaroxin achieved clinically meaningful complete remission rates balanced with low all-cause early mortality. Preliminary leukemia free survival, measured as time from complete remission to relapse or death, is now 14.4 months (440 days). Median overall survival was 7.1 months, with 14 patients continuing in survival follow up well beyond this median.
On heavy volume, shares of Sunesis advanced 7%, closing the day at 33 cents.
Amarin Corporation plc (Nasdaq:AMRN), saw its shares rally 9% on heavy volume today after the clinical-stage biopharmaceutical company focused on cardiovascular disease, reported its financial and operational results for the three-month period ended September 30, 2010. In addition, the Company provided an update regarding its MARINE and ANCHOR trials, the two on-going Phase 3 clinical trials of its lead product candidate AMR101 for treating elevated triglyceride levels, including a positive update regarding the timing of key future milestones for these trials.
Cortex Pharmaceuticals, Inc. (OTCBB:CORX.ob) announced that it had been notified by Les Laboratoires Servier, France’s largest privately held pharmaceutical company, of their intent to move forward into Phase I clinical studies with the jointly-discovered High Impact AMPAKINE compound S47445 (CX1632).
"We are very pleased with the progress Servier has made with moving S47445 through pre-clinical efficacy, safety and toxicology studies, and into man in the near future," said Mark Varney, Ph.D., Cortex’s President and Chief Executive Officer. "The High Impact AMPAKINE technology represents a potential disease-modifying approach to treat Alzheimer’s disease and other memory and cognitive impairments associated with a range of neurodegenerative diseases because of the ability of the compounds to stimulate growth factors within the brain."
CytRx Corporation (Nasdaq:CYTR) a biopharmaceutical company specializing in oncology, today announced initiation of a pharmacokinetic clinical trial with its oncology drug candidate bafetinib in patients with recurrent brain tumors. Results from this trial are expected in the second quarter of 2011 and will be used in evaluating potential further clinical development of bafetinib in patients with brain cancer.
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced additional positive results from an open-label pilot study of XOMA 052 in patients with uveitis of Behcet's disease who were suffering from vision-threatening exacerbations despite maximal doses of immunosuppressive medicines. XOMA 052, a therapeutic antibody designed to inhibit the inflammatory cytokine interleukin-1 beta (IL-1 beta) is designated as an orphan drug for the treatment of Behcet's disease by the U.S. Food and Drug Administration and the European Medicines Agency. The new data presented at the 2010 American College of Rheumatology Scientific meeting include effects of XOMA 052 retreatment on uveitis exacerbations and analysis of serum cytokine levels.
Also Wednesday:Amgen Inc. (Nasdaq:AMGN) today announced the publication of results from the first open-label study to compare Nplate® (romiplostim) treatment to standard of care therapies (SOC) in non-splenectomized adult patients with chronic immune thrombocytopenia (ITP).
Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS) announced today that it will present at the Lazard 7th Annual Healthcare Conference on Wednesday, November 17, 2010 at 11:30 a.m. EST (8:30 a.m. PST). The conference is being held at the St. Regis New York. Steve Worland, Ph.D., President and Chief Executive Officer of Anadys, will provide an overview of Anadys and its clinical development programs.
Astro-Med, Inc. (NASDAQ: ALOT), a manufacturer of high tech specialty printers, test and measurement systems, and electronic medical instrumentation, will announce its financial results for the Third Quarter ended October 20, 2010 on November 16, 2010.
Boston Scientific Corporation (NYSE:BSX) today announced that it will be hosting an Investor Day meeting, which will be simultaneously webcast on Friday, November 19, 2010.
CDEX Inc. (OTCBB: CEXI) a leading developer of chemical detection products, using patented technologies, for use in healthcare and security markets, announced today the launch of its new Pocket ID2 Scanner.
Celsion Corporation (Nasdaq:CLSN), a late stage biotechnology drug development company that is leveraging its heat sensitive liposomal platform to encapsulate and deliver high concentrations of proven chemotherapeutics, today announced that it has changed the date and time to discuss third quarter 2010 results due to the Veteran's Day Holiday on November 11, 2010.
Celsius Holdings, Inc., (NASDAQ: CELH) the creator and marketer of Celsius®, Your Ultimate Fitness Partner™, today reported results of operations for the third quarter ended September 30, 2010.
China PharmaHub Corp. (OTC Bulletin Board:CPHB) ("PharmaHub") announced it has signed an agreement to be a distributor for Integrated Biometrics ("IB"), a provider of high performance fingerprint biometric identity solutions.
Corcept Therapeutics Incorporated (NASDAQ:CORT), a pharmaceutical company engaged in the discovery and development of drugs for the treatment of severe metabolic and psychiatric disorders, reported financial results today for the third quarter ended September 30, 2010, and updated its corporate progress.
Dendreon Corporation (Nasdaq:DNDN) today announced that it has completed the submission of the post-approval supplement to the PROVENGE® (sipuleucel-T) Biologics License Application for the Morris Plains, New Jersey manufacturing facility. Dendreon is requesting licensure for an additional 36 workstations to manufacture PROVENGE.
eResearchTechnology, Inc. (ERT), (Nasdaq:ERES), a global provider of technology and services to the pharmaceutical, biotechnology, and medical device industries, today announced it has filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission (the "SEC").
Generex Biotechnology Corporation (www.generex.com) (OTC Bulletin Board:GNBT) announced today that its wholly-owned immunotherapeutics subsidiary, Antigen Express, Inc., has been awarded two Therapeutic Discovery Project grants, totaling $488,958.50, by the United States Internal Revenue Service (IRS) and the Department of Health and Human Services (HHS) pursuant to the Patient Protection and Affordable Care Act of 2010.
Genesis Biopharma, Inc. (OTC Bulletin Board:GNBP), a biotechnology company developing targeted cancer therapies, has formed Genesis Advanced Development Programs (Genesis ADP) to initiate and promote drug development collaborations with leading academic researchers.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that its investigational flexible catheter vascular robotic system, including an overview of its preclinical evaluation and the recently completed First in Man study, will be presented at the upcoming 37th annual VEITHsymposium™ November 17-21 at the Hilton New York in New York City.
InfuSystem Holdings, Inc. (OTCBB:INHI) (OTCBB: INHIW) (OTCBB: INHIU), the leading provider of infusion pumps and associated clinical services, announced today that its Board of Directors has authorized a share repurchase program of up to $2 million of the Company's outstanding common shares
Insulet Corporation (NASDAQ: PODD), the leader in tubing-free insulin pump technology with its OmniPod® Insulin Management System, today announced the Company will participate in the Lazard 7th Annual Healthcare Conference at the St. Regis Hotel in New York City.
IntelGenx Technologies Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) today announced its financial results for the three and nine month period ended September 30, 2010 and presented highlights of recent business developments. All figures are in U.S. dollars, unless otherwise stated.
Luminex Corporation (Nasdaq:LMNX) today announced that management will present at the Stephens Fall Investment Conference to be held November 16-17, 2010, in New York.
NeoStem, Inc. (NYSE Amex:NBS), an international biopharmaceutical company with operations in the U.S. and China, announced today that Chief Executive Officer Robin Smith, M.D., MBA, will present on some of the latest developments at the Company at the LifeTech Capital Miami Medical Investors Conference to be held at the JW Marriott Marquis Miami on November 12, 2010.
Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) today announced its financial results and operational highlights for the quarter ended September 30, 2010.
ONE Bio, Corp. (OTCBB: ONBI), an innovative company utilizing green process manufacturing to produce raw chemicals and herbal extracts, natural and health supplements and organic products, announces unaudited results for the third quarter and year-to-date (YTD) ended September 30, 2010.
Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today announced that it will present at the Lazard Capital Markets 7th Annual Healthcare Conference on Wednesday, November 17, 2010 at 10:30 a.m. Eastern Time (7:30 a.m. Pacific Time).
PDL BioPharma, Inc. (PDL) (Nasdaq:PDLI) today reported financial results for the third quarter and nine months ended September 30, 2010.
ProPhase Labs, Inc. (NASDAQ:PRPH) today reported net sales of $5.20 million for the three months ended September 30, 2010, compared to net sales of $4.98 million for the three months ended September 30, 2009.
Regenicin, Inc. (OTC Bulletin Board: WDST), a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs, today announced the change of its ticker symbol on the OTC Bulletin Board from "WDST" to "RGIN.OB" effective at the opening of the market on Wednesday, November 10, 2010.
Spencer Pharmaceutical (PINKSHEETS: SPPH) holds the patents on a new drug delivery system that controls the release of drugs to the bloodstream, which in turn can curb side effects, such as nausea and vomiting.
STAAR Surgical Company (Nasdaq:STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that it will participate in the Stephens Fall Investment Conference at The New York Palace Hotel on Wednesday, November 17, 2010 at 11:00 a.m. Eastern Time.