|United Therapeutic Shares Rocketing Higher Following FDA Approval of Orenitram; CorMedix Receives Minutes from Neutrolin Pre-IND FDA Meeting|
|By Staff and Wire Reports|
|Monday, 23 December 2013 20:53|
Shares of United Therapeutic (NASDAQ: UTHR) are up more than 23 percent just after Monday morning's opening bell, breaking to a new high over $108.
United Therapeutic announced on Friday that the United States FDA approved Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity. United Therapeutics' President and Chief Operating Officer commented that this approval supports the company's mission to provide a "wider choice of PAH therapies for physicians and patients."
Monday morning JP Morgan analyst Geoffrey Meacham upgraded the stock form Underweight to Neutral and raised the price target from $62.00 to $90.00.
Despite the optimism in share price, Meacham noted that approval isn't enough to warrant a move to Overweight. The analyst cited the Sandoz litigation on Remodulin, a potential competition in PAH from Actelion's selexipag. In addition, JP Morgan commented that the Orenitram label appears "very restrictive."
United Therapeutic closed at a record high on December 2, at $94.95. Shares closed at $87.84 on Friday. Shares of United Therapeutic are currently up 23.06% at $108.10.
CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardio-renal and infectious disease, announced receipt of the official minutes from the Nov. 14, 2013 Pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA). The minutes confirmed the guidance received from the FDA concerning the development of Neutrolin. CorMedix intends to work with the FDA to finalize a clinical protocol and file an IND to support activities required to commercialize Neutrolin in the U.S.
"Commercializing Neutrolin in the U.S. is an important long-term goal for CorMedix, and is one that we plan to pursue in tandem with several, more immediate, key objectives," said Randy Milby, CorMedix Chief Executive Officer. "We recently began shipping Neutrolin to our first hemodialysis customers in Germany. As we enter 2014, we will be keenly focused on expansion into other targeted EU countries as well as non-European markets that recognize the CE Mark."
CDW Corporation (Nasdaq:CDW), a leading provider of technology solutions to business, government, education and healthcare, today announced that its wholly owned subsidiaries, CDW LLC and CDW Finance Corporation, have delivered a Notice of Partial Redemption to holders of their outstanding 12.535% Senior Subordinated Exchange Notes due 2017.
Cerner Corporation (Nasdaq:CERN) announced today that Mitch Daniels has been appointed to the company's Board of Directors, effective immediately. Daniels, 64, is president of Purdue University, a role he assumed in January 2013 after serving as Governor of Indiana since 2004.
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that it has entered into a contractual agreement for coverage of its diagnostic laboratory services with FedMed, a national provider network and healthcare financial services organization.
Gevo, Inc. (Nasdaq:GEVO), the world's only commercial producer of bio-based isobutanol, today confirmed that Underwriter Laboratories (UL) has approved the generic use of up to 16% isobutanol in UL 87A pumps by any manufacturer meeting ASTM specifications, providing all of the service stations across the country with the assurance that isobutanol blended gasoline will work in their current gasoline pumps without the need to purchase new equipment.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today that it has completed patient enrollment in a multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Integra® Dermal Regeneration Template to the standard of care for the treatment of diabetic foot ulcers.
Liberator Medical Holdings, Inc. (NYSE MKT: LBMH) today announced the financial results for its fiscal year ended September 30, 2013.
NanoViricides, Inc. (NYSE MKT: NNVC) is a development stage company that is creating special purpose nanomaterials to destroy viruses in and on the body.
PPJ Enterprise (OTC Pink: PPJE), a proprietary automated health care software company, is pleased to share current update with the company followers regarding the current issues.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late stage, proprietary formulations and combinations of existing drugs, today reported positive results from a pharmacokinetic (PK) study with RHB-105, a proprietary combination therapy, oral capsule formulation, for eradication of Helicobacter pylori (H. pylori) infection, a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma.
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced top-line results for two Phase 3 trials of rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV).
ThermoGenesis Corp. (Nasdaq:KOOL), a leading supplier of enabling technologies for the processing and storage of stem cells and other biological tissues, today announced it has entered into a long term agreement to provide its AXP® AutoXpress® System (AXP) to Bebevida, a leading cord blood stem cell bank in Portugal.
Ultralife Corporation (Nasdaq:ULBI) announced today it has received final IEC certification for its newly developed medical cart battery and intelligent power supply system and will commence initial shipments this month under an expanded strategic supplier agreement with Scott-Clark Medical, a leading provider of medical carts.