After the bell, shares of Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX) fell sharply after the company reported that the FDA has placed a clinical hold on GSK2248761, an experimental AIDS drug being developed in conjunction with ViiV Healthcare, an affiliate of GlaxoSmithKline (NYSE:GSK). The FDA action may affect as much as $390 million in royalty and milestone payments that the company could receive should the drug eventually gain regulatory approval.
Separately today, Idenix also announced that the FDA has lifted a full clinical hold on the company's Hep C drug, IDX184. The status was changed to a partial hold and the company plans to initiate a Phase IIb trial in the second half of 2011. The clinical hold for this study was blamed on toxicity of another company experimental drug, IDX320, which, as reported today, Idenix has decided to discontinue development.
After the bell, shares of Idenix lost 99 cents or 24.69% to $3.02.
Neuralstem, Inc. (NYSE Amex: CUR) announced today that the U.S. Food and Drug Administration has granted the company orphan drug designation for the treatment of Amyotrophic Lateral Sclerosis with its human spinal cord derived neural stem cells (NSI-566RSC). The drug is currently in a Phase I safety study to evaluate the safety of the product and the surgical route of administration in a wide range of ALS patients.
Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in a FDA-approved Phase I safety clinical trial for Amyotrophic Lateral Sclerosis, often referred to as ALS or Lou Gehrig's disease.
Shares of Neuralstem jumped 31 cents or 16% to $2.24. Nearly 2 million shares traded hands.
World Heart Corporation (WorldHeart) (Nasdaq:WHRT), fell more than 11% after the developer of mechanical circulatory systems, announced today that it has paused enrollment in its Levacor Ventricular Assist Device VAD Bridge-To-Transplant BTT Study pending U.S. Food and Drug Administration FDA approval for certain changes made to the device. The Levacor Ventricular Assist Device is a magnetically levitated centrifugal heart pump which provides unobstructed blood flow for adults who have suffered late-stage heart failure.
Specifically, the refinements pertain to the projection of the inflow cannula into the ventricle, the elimination of a false alarm that has led to controller exchanges and the optimization of surface finishing/coating manufacturing processes. The company expects the modifications to be ready in two to three months although the timeline is dependent on the FDA review process.
Shares of World Heart shed 21 cents to $1.65.
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) , a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, reported it has been receiving positive clinical feedback from doctors and nurse practitioners prescribing MuGard for patients undergoing radiation and chemotherapy for various cancers.
Allied Healthcare International Inc. (NASDAQ:AHCI), a leading provider of flexible healthcare staffing services in the United Kingdom, today issued financial results for its fiscal 2011 first quarter ended December 31, 2010.
Amicus Therapeutics (Nasdaq:FOLD) today announced the dosing of the first subject in a Phase 2 clinical trial designed to evaluate the co-administration of its investigational drug Amigal™ (migalastat hydrochloride) with enzyme replacement therapy (ERT) for Fabry disease.
Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) announced today that the company is scheduled to present at the 13th Annual BIO CEO & Investor Conference on Monday, February 14, 2011, at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) at the Waldorf=Astoria Hotel in New York City. Jack Lief, Arena's President and Chief Executive Officer, is scheduled to provide a corporate overview.
BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading Dental Laser company, announced today that it has raised approximately $4.65 million to-date through the sale of 1.5 million shares of its common stock (without warrants or options attached) under its Controlled Equity Offering Agreement to various institutions and retail investors in the open market at an average of $3.10 per share.BIOLASE has used a portion of these proceeds to pay off its remaining balance for the Loan and Security Agreement with MidCap Funding III, LLC and Silicon Valley Bank.
Cephalon, Inc. (Nasdaq:CEPH) and Alba Therapeutics Corporation, a privately held biopharmaceutical company, today announced that the companies have signed an agreement providing Cephalon with an option to purchase all of Alba's assets relating to larazotide acetate, a tight junction modulator, progressing toward a Phase IIb clinical trial for the treatment of celiac disease.
China-Biotics, Inc. (Nasdaq:CHBT), a leading developer, manufacturer and distributor of probiotics products in China, today reported its unaudited financial results for the third quarter and nine months of its 2011 fiscal year ended December 31, 2010.
D. Medical Industries Ltd. (NASDAQ:DMED) (TASE:DMDC), a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, today announced that the Company's Chief Operating Officer, Hezkiah Tsoory, has been chosen to present at the Fourth International Conference on Advanced Technologies and Treatments for Diabetes to take place at the Hilton London Metropole hotel in London, UK on February 16-19, 2011.
Elysium Internet, Inc. DBA (PINKSHEETS: EYSM), an emerging leader in the local business search and online marketing space, today announced that it has entered into an agreement to launch a new affiliate network promoting its local search network and Internet marketing products and services.
GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced today the opening of a second clinical trial site at the Alabama Vaccine Research Clinic (AVRC) of the University of Alabama at Birmingham (UAB) to expand the company's HIV therapeutic vaccine trial.
Hiru Corporation (PINK SHEETS:HIRU), is pleased to announce that researchers from its MindUp BioResearch, European subsidiaryhave presented their results at the fourth Conference of the TranslationalCancerMedicine 2010 (USA), held in San Francisco, California, July 11-14, 2010, under the auspices of American Association for Cancer Research (AACR).
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) today announced it will release fourth quarter and full-year 2010 financial results after the market closes on February 23, 2011. In conjunction, the Company will host a conference call at 4:30 p.m. Eastern Time.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the 13th Annual BIO CEO & Investor Conference, being held at the Waldorf=Astoria Hotel in New York City.
Mediware Information Systems, Inc. (NASDAQ: MEDW) announced that Carter BloodCare has licensed the KnowledgeTrak™ software which provides automated tools to oversee training requirements, electronically manage documents, and manage competency and compliance certifications across the organization.
mPhase Technologies, Inc. (OTCBB:XDSL) today announced that it has signed a 3 year CRADA (Cooperative Research and Development Agreement) with the U.S. Army Armament Research, Development, and Engineering Center (ARDEC) at Picatinny, New Jersey.
Orexigen® Therapeutics, Inc. (Nasdaq:OREX), today announced that it has implemented a corporate realignment of the Company's workforce, resulting in a reduction in staff of approximately 40%, or 23 employees.
Pegasystems Inc. (NASDAQ: PEGA), the leader in business process management (BPM) solutions, today announced its new Revenue Cycle Manager™ solution for the healthcare market.
PPJ Enterprise (PPJ) (PINKSHEETS:PPJE), a leader in proprietary automated health care reimbursement cycle (all specialties), online health information digital systems and practice information management digital system software for health care and general businesses worldwide, has announced that its subsidiary, Professional Billing Service's(PBS), revenue increased from $12,000 per month during the earlier months of 2010 to $80,000 to $100,000 per month, an increase of 700-800%, and continue to increase its monthly revenue to expected gross revenue of $1,500,000 or more in 2011.
Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) today announced that it will webcast an investor briefing on Sunday, February 13 from 9 a.m. to 10:30 a.m. Eastern Time.
Soligenix, Inc. (OTC Bulletin Board:SNGX) a late-stage biopharmaceutical company, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will give a corporate presentation at the 2011 BIO CEO & Investor Conference on Monday, February 14, at 9:00 AM Eastern Standard Time.