On Wednesday, Shares of Sarepta Therapeutics Inc (NASDAQ:SRPT), lost -11.78% to $29.06.
Sarepta Therapeutics, declared the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is tentatively planned to review Sarepta’s New Drug Application (NDA) for eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping, on January 22, 2016. There has been no formal communication to the company or Federal Register notice of a confirmed advisory committee meeting date.
It is estimated that DMD affects about one in every 3,500 boys born worldwide, with 13% of people with the disease having mutations addressable by eteplirsen/exon 51 skipping.
“We have been verbally informed by the FDA that we have a tentative date of January 22, 2016 for our advisory committee review of eteplirsen and our PDUFA date of February 26, 2016, remains unchanged.” said Edward Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. “We look forward to discussing the efficacy and safety data comprised in our NDA submission for eteplirsen with the committee, with the ultimate aim of bringing treatment to more patients with Duchenne.”
Sarepta Therapeutics, Inc., a biopharmaceutical company, focuses on the discovery and development of RNA-based therapeutics for the treatment of rare, infectious, and other diseases. Its lead product candidate is Eteplirsen, an antisense phosphorodiamidate morpholino oligomer therapeutic, which is in Phase III clinical development stage for the treatment of individuals with Duchenne muscular dystrophy (DMD), a rare genetic muscle-wasting disease caused by the absence of dystrophin.
Shares of Bank of New York Mellon Corp (NYSE:BK), declined -1.46% to $39.26, during its last trading session.
BNY Mellon, has launched a new US government securities clearance platform that provides clients with industry leading processing speed, custom reporting and analytics, and a dashboard that serves as a central hub for monitoring and managing transactions and positions on a real-time basis. The new platform provides seamless access to the Federal Reserve Banks book-entry system with millisecond response time for clients clearing and settlement activities.
Weve made note worthy investments in our technology platform to provide our clients with what they need – instantaneous response time, an aggregated dashboard displaying all activity with innovative drill down capabilities, and data and analytics that provide insights for improved decision-making, said Brian Ruane, CEO of Broker-Dealer and Tri-Party Services. With large trading volumes and volatility, efficient securities clearance and servicing requires a commitment like ours to the latest technology and infrastructure.
The new platform leverages architectural tools and metrics to assist clients manage and monitor their programs across various user-defined levels. In addition, BNY Mellon has significantly improved the overall user experience while preserving the core capabilities to which clients have become accustomed.
The Bank of New York Mellon Corporation, an investment company, provides financial products and services to institutions, corporations, and high net worth individuals in the United States and internationally. It operates through two segments, Investment Administration and Investment Services.
Finally, Shares of ArcelorMittal SA (ADR) (NYSE:MT), ended its last trade with 2.36% gain, and closed at $6.51.
ArcelorMittal and IMETAL, an Algerian state-owned company, have reached an outline agreement for the restructuring of the shareholding of the companies ArcelorMittal Algeria, ArcelorMittal Pipes and Tubes Algeria and ArcelorMittal Tébessa.
The restructuring follows the strategy of the Algerian Government to ensure the promotion and development of the national steel industry and to promote self-sufficiency in steel. The restructuring is aligned with ArcelorMittal`s strategy of asset portfolio optimization.
The restructuring plan will see ArcelorMittal transfer its minority shareholding in both ArcelorMittal Algeria and ArcelorMittal Tebessa in addition to its majority participation in ArcelorMittal Pipes & Tubes Algeria, with the state of Algeria controlling the full shareholding of these entities. Furthermore, ArcelorMittal will continue its technical support for the successful implementation of El Hadjar Complex development plan.
ArcelorMittal, together with its auxiliaries, operates as an integrated steel and mining company worldwide. The company operates through five segments: NAFTA; Europe; Brazil and Neighboring Countries (Brazil); Africa & Commonwealth of Independent States (ACIS); and Mining.
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