|Nevro Receives Approvable Letter From FDA for Senza; KYTHERA Announces Date of FDA Advisory Committee Review of ATX-101|
|By Marilyn Mullen|
|Friday, 23 January 2015 20:44|
Nevro Corp (NYSE: NVRO) was trading 25 percent higher Friday on the news that the company received an Approvable Letter from the FDA for the Senza spinal cord stimulation system.
Senza is used to treat chronic back pain. Traditional therapies use low-frequency spinal cord stimulation, but Nevro has developed Senza to deliver up to 10,000 Hz of high-frequency stimulation.
The letter stated that Senza is approvable by the strength of the clinical data, but still will need to meet compliance with the FDA's Quality System Regulation, which evaluates the manufacturing facilities and process.
Nevro and the FDA also need to finalize the products labeling, but the company expects the system to be commercially available in the U.S. by mid-2015. The data evaluated by the FDA was from the SENZA-RCT study.
The SENZA-RCT study evaluated the safety and effectiveness of the Senza system. The following was also evaluated in the trial: Change in back pain VAS; Change in disability as measured by Oswestry Disability Index; Number of subjects with adverse events.
The trial results were presented at the Groundbreaking Clinical Trial Results plenary session at the 2014 North American Neuromodulation Society Meeting in December.
Currently, the Senza system is available in Europe and Australia. Shares traded recently at $47.69, up 26.3 percent.
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) announced the Dermatology and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review KYTHERA's New Drug Application (NDA) for ATX-101 (deoxycholic acid) for improvement in the appearance of moderate to severe submental fullness in a half-day meeting on the morning of March 9, 2015.
The date and details of the meeting are subject to confirmation by the FDA in a Federal Register notice. KYTHERA submitted the ATX-101 NDA to the FDA on May 12, 2014. The NDA will be subject to a standard review and has a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
American CareSource Holdings, Inc. (Nasdaq:ANCI), operator of urgent care centers and a national network of ancillary health care providers, announced today the hiring of a new Chief Financial Officer, Anthony Levinson.
Argos Therapeutics Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on the Arcelis® technology platform, today announced that Dr. Fred Miesowicz, the company's chief operating officer and vice president of manufacturing, will speak at the Phacilitate Cell & Gene Therapy Forum 2015 to be held January 26-28th at the Grand Hyatt in Washington, D.C.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, and Florida Cancer Specialists & Research Institute (FCS), the largest independent privately-held medical oncology/hematology practice in the United States, today announced that FCS has selected athenaCollector® revenue cycle and practice management services as part of a pilot program which will be implemented in phases to support its team of 300 health care providers.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the underwriters for its recently announced public offering of 8,500,000 shares of its common stock (the "Firm Shares") exercised in full their option to purchase an additional 1,275,000 shares (the "Additional Shares" and, together with the Firm Shares, the "Shares").
Heat Biologics, Inc. (Nasdaq:HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that Taylor Schreiber, MD, PhD, Vice President of Research and Development, and Eckhard Podack, MD, PhD, Scientific Founder, will be speaking at the 7th Annual Phacilitate Immunotherapy Forum 2015, being held at the Grand Hyatt Hotel in Washington, D.C. from January 26-28, 2015.
Northwest Biotherapeutics, Inc. (NASDAQ: NWBO), a U.S. biotechnology company developing DCVax® personalized immune therapies for operable and inoperable solid tumor cancers, announced today that CEO Linda Powers will present at the 7th Annual Phacilitate Immunotherapy Forum in Washington D.C.
RestorGenex Corporation (OTCQB:RESX), a specialty biopharmaceutical company focused on developing products for oncology, ophthalmology and dermatology, announced that it presented scientific data on RES-529 for the treatment of glioblastoma multiforme (GBM) at the Keystone Symposia Series on PI 3-Kinase (PI3K) Signaling Pathways.
Vitae Pharmaceuticals, Inc. (Nasdaq:VTAE), a clinical stage biotechnology company, today announced the pricing of its follow-on public offering of 3,000,000 shares of its common stock at $11.90 per share.