|Salix's Relistor Could Provide FDA Panel 'Another Meaningful Catalyst'; Biota Initiates Phase 2 Trial of Laninamivir Octanoate|
|By Staff and Wire Reports|
|Tuesday, 11 June 2013 19:47|
With Salix Pharmaceutical's (NASDAQ: SLXP) Relistor scheduled for an FDA panel within the next three to four months, Cantor Fitzgerald's Irina Rivkind sees “another meaningful catalyst” for investors in Salix. The analyst especially liked the prospect for the panel meeting ahead of expected retreatment due from Xifaxan IBS-D near the end of 2013.
Rivkind believes the hurdle for approval of Relistor may now be “more manageable” than previously expected, even as the analyst still sees further clinical data from Salix in order to address FDA concerns related to potential heart risks.
Rivkind assured Cantor analysts she sees “no downside from current expectations.” Cantor Fitzgerald reiterated a Buy rating and $72 price target on shares of Salix. With Salix shares up 5 percent
SLXP shares are currently up 4.3 percent to $64.95 at last check, Rivkind's price target implies potential upside of about 11 percent.
Biota Pharmaceuticals (Nasdaq: BOTA) today announced that it has commenced dosing in a multi-national, randomized, double blind, placebo controlled, parallel arm Phase 2 clinical trial of laninamivir octanoate, a long-acting neuraminidase inhibitor. The trial, referred to as "IGLOO", will compare the safety and efficacy of 40 mg and 80 mg of laninamivir octanoate with placebo, all delivered by a TwinCaps® inhaler in adults with symptomatic influenza A or B infection. The trial is designed to enroll 636 subjects, randomized equally across the three treatment arms, with the primary end point being the time to alleviation of influenza symptoms. Secondary end points include whether the use of laninamivir octanoate reduces the incidence of secondary bacterial infections compared to placebo. The Company's goal is to have top-line data from this trial available in mid-2014.
IGLOO is being conducted under the Company's contract with the U.S. Office of Biomedical Advanced Research and Development Authority ("BARDA"). Further details regarding the design of IGLOO are available at www.clinicaltrials.gov.
"The initiation of this robust, multi-center Phase 2 trial for the treatment of influenza is an important milestone in the clinical development of laninamivir octanoate," stated Dr. John Lambert, the Company's Vice President of Product Development. "We believe that the potential for once-only inhaled dosing of laninamivir octanoate could represent a significant advantage over the five-day, twice-daily dosing associated with the currently marketed neuraminidase inhibitors to treat influenza."
Abbott (NYSE: ABT) today announced that it has initiated the ABSORB Japan randomized controlled clinical trial to evaluate the Absorb™ Bioresorbable Vascular Scaffold (BVS) in patients with coronary artery disease (CAD), the most common form of heart disease.1
Advaxis, Inc., (OTCQB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has submitted an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus (HPV)-associated head and neck cancer.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the initiation of the Phase 2 trial of Iclusig® (ponatinib) in adult patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST).
ALR Technologies Inc. (OTCBB: ALRT) will exhibit at AHIP's Institute 2013 in Las Vegas on June 12th - 13th. AHIP's Institute attracts thousands of healthcare stakeholders and representatives from hundreds of the most important health plans in the United States, a key target market for ALRT.
Cerus Corporation (NASDAQ: CERS) announced today that it has initiated patient enrollment in two European Phase III clinical trials for the INTERCEPT System for red blood cells (RBCs).
China Cord Blood Corporation (NYSE: CO) today announced its plan to release financial results for the fourth quarter and full fiscal year ended March 31, 2013 on Tuesday, June 18, 2013, after market close in the U.S.
Elan Corporation, plc (NYSE:ELN) today issued a letter urging shareholders to protect the value of their investment in Elan by rejecting Royalty Pharma’s grossly inadequate offer to acquire Elan and by voting FOR all four resolutions in connection with Elan’s fast approaching Extraordinary General Meeting (EGM).
Enzo Biochem, Inc. (NYSE:ENZ) announced today that it has arranged an $8 million senior secured revolving line of credit that may be increased to $12 million with Healthcare Finance Group, LLC (HFG), of New York, New York, that may be utilized for working capital and growth purposes.
International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com), a California-based biotechnology company developing novel stem cell-based therapies, biomedical and skin care products, announced today that Lifeline Skin Care, its operating subsidiary, has signed distribution agreements to sell its breakthrough stem cell skin care products in both Thailand and Viet Nam.
Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced it has received clearance by Health Canada to initiate its Phase II dose-sparing clinical trial for an H5N1 Avian Influenza VLP vaccine candidate ("H5N1 vaccine").
Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for the life sciences industry, announced that Chief Financial Officer Cory Douglas was named the 2013 CFO Hero by NetSuite Inc. (NYSE: N), the industry’s leading provider of cloud-based financials/ERP software suites.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced positive results from a meta-analysis study of Lymphoseek® (technetium Tc 99m tilmanocept) Injection that compared the performance of Lymphoseek, a novel, receptor-targeted radiopharmaceutical recently approved by the U.S. Food and Drug Administration, against a commonly used agent, vital blue dye (VBD), in identifying lymph nodes likely to harbor cancer cells over a period of time after injection.
PDL BioPharma, Inc. (NASDAQ: PDLI) today announced that on June 7, 2013, the Company filed a Notice of Arbitration against Genentech with the American Arbitration Association in Voorhees, New Jersey, alleging, inter alia, that Genentech underpaid royalties going back to at least 2007 and impeded PDL's attempts to have Genentech's books and records inspected to determine whether Genentech's past payments to PDL were accurately calculated.
PDL BioPharma, Inc. (NASDAQ: PDLI) today announced royalty revenue guidance for the second quarter ending June 30, 2013, of approximately $143 million, as compared with actual royalty revenue of $126 million for the second quarter of 2012, an approximate 14 percent increase.
Rite Aid Corporation (NYSE: RAD) said today that it will release financial results for its Fiscal 2014 First Quarter, which ended June 1, 2013, on Thursday, June 20, 2013. The company will hold an analyst call at 8:30 a.m. Eastern Daylight Time (5:30 a.m. Pacific Time) with remarks by Rite Aid's management team.
SAP AG (NYSE: SAP) and Technical University Munich (TUM) today announced ProteomicsDB, a new offering based on the SAP HANA® platform that stores protein and peptide identifications from mass spectrometry-based experiments.
SOHM, Inc. (PINKSHEETS: SHMN), a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories, today announced financial results for the Company's fiscal first quarter 2013, ended March 31, 2013.
SpectraScience, Inc. (OTCQB: SCIE) announced today that results from a critical study conducted by Dr. Helmut Neumann, of the University of Elrangen - Nuremberg in Erlangen, Germany were released recently.
Thermo Fisher Scientific Inc. (NYSE:TMO) today announced that the underwriters of its previously announced public offering of common stock have exercised their option to purchase an additional 3,859,649 shares of its common stock at $85.50 per share.
Therapeutic Solutions International, Inc. (OTCQB: TSOI) announced today the creation of a Scientific Advisory Board with Dr. Barry Glassman appointed as Chairman.