iRobot Corp. (IRBT: Quote) rose more than 9% to close Thursday's trading at $23.06, following its RP-VITA Remote Presence Robot getting FDA clearance for use in hospitals. RP-VITA, which enables doctors to provide patient care from anywhere in the world via a telemedicine solution, becomes the first autonomous navigation remote presence robot to receive the regulatory agency's nod.
Solazyme Inc. (SZYM: Quote) has closed its offering of 6% Convertible Senior Subordinated Notes due 2018, resulting in net proceeds of $119.4 million. The company intends to use the net proceeds of the offering to fund project related costs and capital expenditures and for general corporate purposes. The stock closed Thursday's trading at $7.45, down 2.49%.
Anthera Pharmaceuticals Inc. (ANTH: Quote) dropped over 12% in extended trading on Thursday to $0.63 after its proposed public offering of common stock. The actual size or terms of the offering are yet to be revealed.
Exelixis Inc.'s (EXEL: Quote) metastatic medullary thyroid cancer drug COMETRIQ, which was approved last November, is now commercially available in the U.S. The drug is being distributed exclusively through Diplomat Specialty Pharmacy in the U.S.
Endologix Inc. (ELGX: Quote) Thursday received CE Mark for its Nellix EndoVascular Aneurysm Sealing System for the treatment of patients with abdominal aortic aneurysms. The company expects to begin a limited market introduction of the Nellix System in Europe during the second quarter 2013. The Nellix System is not approved in the United States for either investigational use or commercial sale.
ARIAD Pharmaceuticals Inc. (ARIA: Quote) Thursday priced an underwritten public offering of 15,307,000 shares of its common stock at $19.60 each. The offering is expected to close on or about January 29, 2013, subject to customary closing conditions. The underwriters have a 30-day option to purchase up to 2,296,050 additional shares of common stock to cover over-allotments, if any.
Watson Pharmaceuticals Inc. Thursday changed its name to Actavis Inc. and began trading under a new symbol - ACT, (ACT) on the New York Stock Exchange. Last year, the company acquired Actavis Group, creating the world's third largest generic pharmaceutical company, with anticipated pro forma combined 2012 revenues in excess of $8 billion.
In what would provide for an entry into the North African market, Therapeutic Solutions International Inc. (TSOI: Quote) on Thursday signed an agreement with Smile Cosmetic SARL for the distribution of Therapeutic Solutions International's AMPSA products in Morocco. The stock closed the day's trading 4.17% higher at $0.02.
Seattle Genetics Inc. (SGEN: Quote) announced the initiation of a global phase III clinical trial, dubbed ECHELON-2, evaluating ADCETRIS in combination with chemotherapy for the treatment of newly diagnosed CD30-positive mature T-cell lymphoma patients, including patients with systemic anaplastic large cell lymphoma and other types of peripheral T-cell lymphomas.
ADCETRIS is already approved by the FDA to treat relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma. The drug is jointly developed by Seattle Genetics and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd.
Gilead Sciences Inc. (GILD: Quote) has initiated the first of two phase III clinical trials, dubbed Study 104, evaluating a single tablet regimen containing tenofovir alafenamide for the treatment of HIV-1 infection in treatment-naïve adults. The second Phase 3 study, known as Study 111, will be initiated later this quarter. GILD touched a new high of $78.75 on Thursday before closing at $78.40.
Pernix Therapeutics Holdings Inc. (PTX: Quote) has reduced the number of sales representatives to approximately 125 from 187 as part of the integration of its Pernix and Hawthorn sales forces. Last November, Pernix acquired Cypress Pharmaceuticals Inc., a privately-owned generic pharmaceutical company, and Hawthorn Pharmaceuticals Inc., a privately-owned branded pharmaceutical company.
The company is also in search of a replacement for CFO David Becker as he will be resigning his position, due to personal reasons, effective March 31, 2013.
Varian Medical Systems' (VAR: Quote) Vitesse Brachytherapy Treatment Planning Software was given FDA clearance Thursday. This tool enables clinicians to plan and perform high-dose-rate brachytherapy treatments for prostate cancer using real-time ultrasound guidance.
Novavax Inc. (NVAX: Quote) on Thursday announced that the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority, or BARDA, has decided continue the contract for both the seasonal and pandemic influenza programs of the company. The decision was taken following the completion of an In-Process Review.
Amarin Corp. plc's (AMRN: Quote) Vascepa, a therapy for patients in the United States to treat severe hypertriglyceridemia commonly known as very high triglycerides, or VHTG, is now available by way of physician prescription, and will be supported with a national commercial launch on January 28, 2013. Vascepa is the first and only FDA approved pure-EPA Omega-3 prescription therapy now available.
Biogen Idec's (BIIB: Quote) investigational drug peginterferon beta-1a has demonstrated significant reductions in annualized relapse rate at both the two-week and four-week dose regimens in a phase 3 pivotal clinical trial, dubbed ADVANCE. The company will be making regulatory submissions for peginterferon beta-1a in the United States and European Union this year based on top-line data from the ADVANCE clinical trial. The stock closed Thursday's trading 1.99% higher at $146.41.
Acorda Therapeutics Inc. (ACOR: Quote) set a new high of $29.51 on Thursday before closing at $29.46 after securing a $2.67 million research contract from the U.S. Army Medical Research and Material Command. The contract will help support a phase II clinical trial designed primarily to assess the safety and tolerability of AC105 in people with acute spinal cord injury. The company plans to open enrollment for this study in the first half of 2013.
Cellceutix Corp. (CTIX) announced Thursday that in in vivo studies, tumor shrinkage was noted in renal cancer with its investigational anti-cancer drug Kevetrin, in combination with Sunitinib. The company has an agreement in place with BIDMC, a teaching hospital of Harvard Medical School, on an innovative research project with Kevetrin. The stock closed the day's trading at $2.02, up 3.59%.
AVEO Pharmaceuticals Inc. (AVEO: Quote) has sold a total of 7,667,050 shares at a price of $7.50 per share in the recently announced public offering. The aggregate net proceeds from the offering were approximately $53.8 million. The stock closed Thursday's trading at $7.72, down 1.40%.
Biodel Inc. (BIOD: Quote) reported positive top-line results from a phase 1 clinical trial of two ultra-rapid-acting insulin analog-based formulations, BIOD-238 and BIOD-250, conducted to evaluate the pharmacokinetic and injection site toleration profiles relative to Humalog, a rapid-acting insulin analog.
BIOD-238 and BIOD-250 are combinations of Biodel's proprietary excipients with the marketed formulation of Humalog.
Ipsen S.A. (IPSEY: Quote) set a new high of $8.75 on Thursday before closing at $8.65. The company along with Inspiration Biopharmaceuticals Inc. has entered into an Asset Purchase Agreement with Baxter International. According to the agreement, Baxter has agreed to acquire the worldwide rights to OBI-1, a recombinant porcine factor VIII in development for congenital hemophilia A with inhibitors and acquired hemophilia A, and Ipsen's industrial facility in Milford.
by RTT Staff Writer
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