On Thursday, Amicus Therapeutics, Inc.(NASDAQ:FOLD)’s shares declined -3.79% to $11.94.
Amicus Therapeutics, Inc. (FOLD) declared that it has met very recently with regulatory authorities in Europe and the U.S. to talk about the approval pathways for the oral small molecule pharmacological chaperone migalastat HCl as a precision medicine monotherapy for Fabry patients who have amenable genetic mutations.
Meeting with European Rapporteurs
The Company held a meeting with the assigned European Rapporteurs to talk about the forthcoming marketing authorization application (MAA) for migalastat monotherapy. Amicus Chief Medical Officer Dr. Jay Barth led the Amicus delegation at the meeting in Europe last week. It was the first face-to-face meeting with the assigned Rapporteurs on the projected dossier for migalastat monotherapy. The European Medicines Agency (EMA) assigns Rapporteurs to review the data in the MAA in detail and to provide guidance to sponsors during the regulatory approval process.
Amicus Therapeutics, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of medicines for various rare and orphan diseases. Its product candidate is a small molecule that can be used as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease.
Cogent Communications Holdings Inc (NASDAQ:CCOI)’s shares dropped -3.81% to $34.55.
Cogent Communications Holdings Inc (CCOI) will host a conference call with financial analysts at 8:30 a.m. (EDT) on May 7, 2015 to talk about Cogent’s operating results for the first quarter of 2015. Cogent will issue a press release announcing the operating results at 7:00 a.m. (EDT) on May 7, 2015.
Cogent Communications Holdings, Inc., through its auxiliaries, provides high-speed Internet access and Internet protocol communications services primarily to small and medium-sized businesses, communications service providers, and other bandwidth-intensive organizations in North America, Europe, and Japan.
At the end of Thursday’s trade, Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA)‘s shares dipped -3.76% to $63.49.
Teva Pharmaceutical Industries Ltd (ADR) (TEVA) and Eagle Pharmaceuticals, Inc. (EGRX) recently declare that the New Drug Application (NDA) for a liquid bendamustine hydrochloride (HCl) rapid infusion product has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) aim date for a decision on this NDA by the FDA is December 2015.
This NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. This product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. The NDA is supported by data from a clinical trial accomplished in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low-volume, 50 mL admixture.
Teva Pharmaceutical Industries Limited develops, manufactures, markets, and distributes generic, specialty, and other pharmaceutical products worldwide. The company operates in two segments, Generic Medicines and Specialty Medicines.
Noble Corp plc (NYSE:NE), ended its Thursday’s trading session with -3.69% loss, and closed at $17.49.
Noble Corp plc (NE) declared it plans to report financial results for the first quarter 2015 on Wednesday, April 29, 2015, after the close of trading on the New York Stock Exchange. Copies of the Company’s press release will be accessible on the Noble Web site at www.noblecorp.com.
Noble also has planned a conference call and webcast related to its first quarter 2015 results on Thursday, April 30, 2015, at 8:00 a.m. U.S. Central Daylight Time.
Noble Corporation plc operates as an offshore drilling contractor for the oil and gas industry worldwide. It owns and operates a fleet of mobile offshore drilling units. As of December 31, 2014, the company operated a fleet of 15 jackups, 9 drillships, and 8 semisubmersibles, counting 1 high-specification, harsh environment jackup under construction. Noble Corporation plc was founded in 1921 and is headquartered in London, United Kingdom.
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