|Macrogenics Initiates Phase 1 Study Of MGD010; Boston Scientific Surges Following Watchman Approval|
|By Marilyn Mullen|
|Monday, 16 March 2015 19:06|
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 17, 2015.
MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and
developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune
disorders and infectious diseases, today announced the initiation of a Phase 1 study with MGD010, its first
Dual-Affinity Re-Targeting (DART®) molecule being developed for patients with autoimmune disorders. MGD010 is a
bi-specific molecule that simultaneously targets CD32B and CD79B, two B-cell surface proteins, for the treatment of
autoimmune disorders. MGD010 is designed to inhibit B-cell activation by exploiting the inhibitory function of
CD32B, a checkpoint molecule expressed by B cells. As a result of the study initiation, MacroGenics will receive a $3
million milestone payment from its partner, Takeda Pharmaceutical Company Limited.
"The initiation of this Phase 1 study marks the advancement of our third DART program into clinical development,"
said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "MGD010 has been shown to inhibit B-cell
activation by a novel dual-targeting mechanism without depleting B cells in pre-clinical models. We believe this
molecule has the potential to address features that limit currently approved B-cell-targeted therapies, including
delayed onset of action and prolonged depletion of antibody-producing B cells and thus, potentially treat a broader
population of patients with autoimmune disorders."
The recently-initiated Phase 1 clinical trial is a first-in-human, double-blind, placebo-controlled, single ascending
dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of
MGD010 in healthy subjects.
Shares of Boston Scientific Corporation (NYSE: BSX) surged more than 3 percent Monday's following news that the
company's Watchman device was approved by the U.S. FDA.
According to RBC Capital Markets analysts Glenn Novarro, Watchman is a "novel left atrial appendage closure device
for the treatment of atrial fibrillation" that has already been implanted in more than 10,000 patients in 75 countries.
The approval came slightly ahead of schedule, according to Deutsche Bank analyst Kristen Stewart, who viewed it as
a positive and maintained a Hold rating on the stock. The device was expected to generate $500 million in sales over
the next five years, according to Wedbush analyst Tao Levy.
Credit Suisse also viewed the news as a positive. Analyst Bruce Nudell revised 2015/2020 EPS estimates of $0.90/
$1.44 from $0.90/$1.41 and increased the DCF-based price target from $18 to $19. Nudell maintained an Outperform
rating. Boston Scientific recently traded at $17.16, up 3.3 percent.
Accelerate Diagnostics, Inc. (Nasdaq:AXDX), an in vitro diagnostics company dedicated to providing solutions for the global challenge of antibiotic resistant organisms, announced today that it received ISO 13485:2003 certification for its quality management system and began manufacturing and installing GMP compliant systems at select study sites.
Achaogen, Inc. (Nasdaq:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, today reported financial results for the quarter and year ended December 31, 2014.
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage cancer immunotherapy company, presented preliminary data from the Phase 1/2 clinical study of its lead immunotherapy product candidate, ADXS-HPV (ADXS11-001), in 10 patients with HPV-associated locally advanced anal cancer indicating that all patients who have completed treatment in the study have had a complete response with no evidence of recurrence to date (follow-up ranging from 0.5 – 24 months).
Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced today that it will host a conference call and live webcast to present the 12-month CASCADE clinical results, a blinded, randomized clinical trial that compared outcomes of spinal fusion surgery between its composite silicon nitride fusion devices manufactured with a central core of cancellous structured ceramic (CsC), to the industry gold standard, i.e., PEEK (polyether ether ketone plastic) spacers filled with bone autograft.
Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its Arcelis® technology platform, today announced that the Company's fourth quarter and year-end 2014 financial results will be released after market close on Monday, March 30, 2015.
Aquinox Pharmaceuticals, Inc. (Nasdaq:AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, today provided a corporate update and reported financial results for the year ending December 31, 2014.
Auris Medical Holding AG (Nasdaq:EARS) today announced that it will release its financial results for the fourth quarter and full year 2014, on Thursday, March 19, 2015.
Bacterin International Holdings, Inc. (NYSE MKT:BONE), a leader in the development of bone graft material, today announced that it has extended its contract with Novation for an additional year.
Bellerophon Therapeutics, LLC. (Nasdaq:BLPH) a clinical stage biotherapeutics company, today announced that it will preside over the ceremonial NASDAQ Stock Market Closing Bell on Tuesday, March 17, 2015, at 4:00 p.m. ET at the NASDAQ MarketSite in New York City.
Coherus BioSciences, Inc. (Nasdaq:CHRS), a late-stage clinical biologics platform company focused on the global biosimilar market, today announced that it has scheduled a conference call for Monday, March 23, 2015 at 1:30 p.m. PT / 4:30 p.m. ET to discuss its fourth quarter and year end 2014 financial results and product updates.
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today announced that veteran healthcare executive Lâle White has been appointed to the CombiMatrix Board of Directors, effective March 12, 2015.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today that it will host a conference call and webcast to report its year-end 2014 financial results on Monday, March 23, 2015, at 4:30 p.m. ET.
Forward Pharma A/S (Nasdaq:FWP), a biopharmaceutical company working to advance a proprietary formulation of dimethyl fumarate for the treatment of multiple sclerosis and other immune disorders such as psoriasis, today announced that Joel Sendek, Forward Pharma's Chief Financial Officer, will present at the following conference:
FutureWorld Corp. (OTC: FWDG), a leading provider of advanced technologies and solutions to the global cannabis industry, announced that CB Scientific, a subsidiary of FutureWorld Corp., has reached a definitive distribution agreement with ÜTest. The agreement makes CB Scientific's "Product of the Year", PersonalAnalytics THC & CBD Home Test Kits available through ÜTest. ÜTest has served the diagnostic needs of North America since 1996.
Heat Biologics, Inc. (Nasdaq:HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced the closing of a previously announced underwritten public offering of 1,886,000 shares of common stock at a public offering price of $6.50 per share, which includes 246,000 shares of common stock to cover over-allotments.
Inovio Pharmaceuticals, Inc. (Nasdaq:INO) announced today that the company and its academic collaborators, including the University of Pennsylvania (UPenn), were awarded a new five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine Development Program grant from the National Institute of Allergy and Infectious Diseases (NIAID).
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today announced the closing of its underwritten public offering of 2,994,793 shares of its common stock at a price to the public of $48.00 per share for gross proceeds of approximately $143.8 million, which includes the exercise in full by the underwriters of their option to purchase up to 390,625 shares of common stock.
NTT Medical Center Tokyo and UBIC, Inc. (Nasdaq:UBIC) (TSE:2158), a leading provider of international litigation support and big-data analysis services, announced today that they have conducted a joint research program concerning a system designed to mitigate patients' risk of falling in a broader effort to prevent unexpected adverse events in the field of healthcare.
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today provided shareholders with an update on developments on progress in its cancer and diabetes programs and at the corporate level.
Relypsa Inc. (Nasdaq:RLYP), a biopharmaceutical company, today highlighted multiple data presentations of Patiromer for Oral Suspension (FOS) at the 2015 World Congress of Nephrology.
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced financial results for the fourth quarter and year ended December 31, 2014.
StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics for diseases of the central nervous system, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2014.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has commenced sales of the PolarCath peripheral dilatation system in the United States in collaboration with NuCryo Vascular LLC, the manufacturer of the product.