|Vertex Pharma's Disappointing VX-661 Trial Results Isn't The End; Arch Therapeutics Announces Positive Safety Results for AC5 Surgical Hemostatic Device(TM)|
|By Marilyn Mullen|
|Monday, 23 March 2015 19:13|
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 23, 2015.
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) shares sank Monday on results from a trial of one of its cystic fibrosis treatments, but an analyst said further testing may still prove the drug's worth.
Deutsche Bank's Robyn Karnauskas maintained a Buy rating and a $155 price target, and said results of the Phase II study bolster the company's larger ongoing Phase III trial.
The study, of Vertex's VX-661 drug in combination with ivacaftor in 39 adults, met its primary safety end point. But lung function improvement of 4.4 percent after four weeks of treatment and 3 percent after 12 weeks was lower than some investors had reportedly hoped.
Karnauskas called the data important for the company but said Vertex may also benefit from future acquisitions to augment its portfolio of cystic fibrosis drugs.
Regulators are expected to rule by July on Vertex's application for its lumacaftor drug in combination with its ivacaftor treatment for cystic fibrosis. "The pricing of the combo remains the key event to watch for," Karnauskas said.
Arch Therapeutics, Inc. (OTCQB: ARTH), developer of the AC5 Surgical Hemostatic Device™ (AC5™) for use in controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, obtained additional favorable preclinical data from two (2) planned standardized medical device safety studies in which AC5 was assessed for toxicity to cells and for contamination from pyrogens (toxins that cause fever) produced by bacterial cells. The tests are major components of the panel of biocompatibility testing that medical devices must typically complete successfully prior to use in humans.
In the cytotoxicity test, which is an in vitro study that assesses AC5 for toxicity to cells using cell cultures, AC5 tested in clinically relevant amounts was found to be non-toxic to cells (non-cytotoxic).
In the pyrogenicity test, which is an in vitro study that assesses AC5 for the presence of pyrogens, AC5 tested in clinically relevant amounts was found to be non-pyrogenic, which is a desirable characteristic. Pyrogens, also known as bacterial endotoxins, are certain toxins made by bacteria. A product that were to contain sufficient amounts of pyrogen or other cell-toxins could trigger immune responses with the potential for tissue damage and significant harm to patients.
The tests were conducted under guidelines provided by the International Organization for Standardization (ISO), the United States Pharmacopeia (USP), the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI).
Arch Therapeutics President and CEO Terrence Norchi, MD, stated, "The favorable results demonstrated in these safety tests represent additional important milestones in the development of AC5 for planned use in humans. We continue to be pleased with the data generated, which continues to support a desirable safety profile for AC5."
3D Systems (NYSE:DDD) announced today the release of two new training modules for its SimbionixTM ARTHRO Mentor™ arthroscopic training simulator: the Hip Diagnostics module and the Advanced Knee module.
Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that it has received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for the Impella® 2.5 heart pump during elective and urgent high risk percutaneous coronary intervention (PCI) procedures.
Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, reports its financial results for the fiscal year ended December 31, 2014.
Amarantus BioSciences Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing diagnostics in neurology, and therapeutic products with the potential for orphan drug designation in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that Gerald E. Commissiong, President & CEO, will be presenting at the Neurotech Investing and Partnering Conference being held April 7-8, 2015 at the Hotel Nikko in San Francisco, CA.
Anavex Life Sciences Corp. (OTCQX:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer's and other central nervous system (CNS) diseases, pain and various types of cancer, has unveiled new promising preclinical data for both ANAVEX 2-73 and ANAVEX 3-71 (formerly AF710B) in two separate presentations at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders in Nice, France.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, today announced that 98.2 percent of participating health care providers who use athenaOne®, the company's fully integrated cloud-based services for EHR, practice management and patient engagement, successfully attested for Meaningful Use Stage 2 in 2014.
AtriCure, Inc. (Nasdaq:ATRC), a leading innovator in surgical treatments for atrial fibrillation and Left Atrial Appendage Management, will visit the Nasdaq MarketSite in Times Square.
Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR) is pleased to announce that it will be offering rights (the "Rights Offering") to holders of its common shares ("Common Shares") of record at the close of business on April 2, 2015 (the "Record Date").
Cancer Genetics, Inc. (Nasdaq:CGIX) announced today that it will present three posters at USCAP, the annual meeting of the United States and Canadian Academy of Pathology, March 23-24 at the Hynes Convention Center in Boston, MA.
Capricor Therapeutics, Inc. (Nasdaq:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, announced today that Linda Marbán, Ph.D., Chief Executive Officer, will present at the 3rd Annual Alliance for Regenerative Medicine (ARM) Investor Day to be held Wednesday, March 25, 2015 in New York City.
Coherus BioSciences, Inc. (Nasdaq:CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today reported financial results and reviewed corporate events for the quarter and fiscal year ended December 31, 2014.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) and its research collaborator BioReliance, Sigma-Aldrich Corporation's (Nasdaq:SIAL) biologics and early-development services business, are presenting a poster today at the 54th Annual Meeting of the Society of Toxicology (San Diego – March 22-26, 2015).
Dermira, Inc. (Nasdaq:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced the presentation of clinical data from its successful DRM01 Phase 2a trial in patients with facial acne vulgaris.
The Ensign Group, Inc. (Nasdaq:ENSG), the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health and hospice care, assisted living and urgent care companies, today announced that its Board of Directors has declared a quarterly cash dividend of $0.075 per share of Ensign common stock, payable on or before April 30, 2015 to shareholders of record as of March 31, 2015.
EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a Boston-based biopharmaceutical company focused on the global development of biosimilar monoclonal antibodies, today announced financial results for the fourth quarter and fiscal year ended December 31, 2014.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced financial results for the year-ended December 31, 2014.
Hemispherx Biopharma, Inc. (NYSE MKT:HEB) will present integrated findings of new studies of Ampligen® (rintatolimod), an experimental therapeutic, performed in various models of Ebola virus infection.
Hemp, Inc. (OTC:HEMP), a leader in the industrial hemp industry reports, today, on current material events in the industrial hemp industry.
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on cancer, today announced that it will report fourth quarter and year-end 2014 financial results at the closing of U.S. financial markets on Tuesday, March 31, 2015.
MediWound Ltd. (Nasdaq:MDWD), a fully integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, announces that Prof. Lior Rosenberg, M.D., the Company's Chief Medical Technology Officer, highlighted NexoBrid® in a presentation titled "A Novel Minimally Invasive Modality for Burn Care Based on Rapid Enzymatic Debridement" at the 2015 International Conference on Minimally Invasive Medicine (MIM 2015), held March 20-22 in Reston, Virginia.
MTBC (Nasdaq:MTBC), a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, today announced that its finance team received the 2015 Professional Excellence Award from the Institute of Chartered Accountants of Pakistan ("ICAP").
Novadaq Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, today announced that management will participate in two upcoming investor conferences.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB) and Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO), announce that on March 23, 2015 the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office (USPTO) issued a favourable decision, confirming the validity of certain claims in Neptune's '351 patent (U.S. Patent: 8,278,351) and triggering royalty payments to Neptune.
Pacific Biosciences of California, Inc., (Nasdaq:PACB) provider of the PacBio® RS II Sequencing System, today announced that the company has launched a Certified Service Provider (CSP) program and added new informatics partners to meet the increasing demand for Single Molecule, Real-Time (SMRT®) Sequencing and data analysis worldwide.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that Ira Kalfus, MD, RedHill's Medical Director, will present at the 3rd Annual Autoimmune & Inflammation Leaders' Forum 2015 on Wednesday, March 25, 2015, at 12:15 pm EDT, at the Hilton Boston Logan Airport Hotel, in Boston, MA.
Surgical Care Affiliates, Inc. (Nasdaq:SCAI) announced today the launch of an underwritten public offering of 7,000,000 shares of its common stock by certain existing stockholders of SCA (the "Selling Stockholders"), including certain affiliates of TPG Global, LLC and certain directors and officers of SCA.
Urologix, Inc. (OTCQB:ULGX), the leading provider of in-office procedures for the safe, durable and effective treatment of BPH, today announced the appointment of Scott M. Madson as its Chief Financial Officer effective April 1, 2015.
Vericel Corporation (Nasdaq:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today reported financial results for the fourth quarter and year ended December 31, 2014.
ZS Pharma, Inc. (Nasdaq:ZSPH), a biopharmaceutical company focused on the development and commercialization of highly selective, non-absorbed drugs to treat renal, cardiovascular, liver and metabolic disorders, today announced that it intends to offer and sell, subject to market and other conditions 3,300,000 shares of its common stock in an underwritten public offering.