On Wednesday, Shares of Sarepta Therapeutics, Inc. (NASDAQ:SRPT), skyrocketed 60.20% to $26.24.
Sarepta Therapeutics, declared that the Company held a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD). Sarepta has agreed with the Agency to initiate a rolling NDA submission and will submit the non-clinical and CMC components of the NDA by the end of this week. As formerly declared, Sarepta plans to submit the final component of the NDA by mid-year 2015.
“We will initiate a rolling NDA submission to facilitate the regulatory review of the NDA,” said Edward Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. “The initiation of our NDA submission for eteplirsen marks a noteworthymilestone for the Duchenne community and we look forward to concluding the submission by the middle of the year and to ongoing to work with the Agency towards the aim of providing treatments to patients as quickly as possible.”
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 Bristol-Myers Squibb Company (NYSE:BMY), inclined 1.19% to $69.08, during its last trading session, hitting its highest level.
Bristol-Myers Squibb Company, declared that the U.S. Food and Drug Administration (FDA) has amended a formerly granted Breakthrough Therapy Designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients. The updated Designation reflects recently presented data on HCV genotype 1 patients with advanced cirrhosis (Child-Pugh Class B or C) and those who develop genotype 1 HCV recurrence post-liver transplant. Breakthrough Therapy Designation requires preliminary clinical evidence that demonstrates a drug may have substantial improvement on at least one clinically noteworthy endpoint over accessible therapy.
The designation is supported by data from ALLY-1, a Phase III clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with HCV with either advanced cirrhosis or post-liver transplant recurrence of HCV. Results from ALLY-1 were recently presented at The International Liver Congress™ 2015, this year’s annual meeting of the European Association for the Study of the Liver.
“Our daclatasvir clinical development program focuses on addressing high unmet medical needs still encountered in the treatment of hepatitis C despite the advent of new therapies,” said Douglas Manion, M.D., Head of Specialty Development, Bristol-Myers Squibb. “This Designation recognizes the importance of developing a new treatment option for post-liver transplant and cirrhotic patients, who are among the most challenging patient populations to treat with presently accessible regimens.”
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. It provides chemically-synthesized drugs or small molecules, and biologics in various therapeutic areas, counting virology comprising human immunodeficiency virus infection (HIV); oncology; neuroscience; immunoscience; and cardiovascular.
At the end of Wednesday’s trade, Shares of Kohl’s Corp. (NYSE:KSS), lost -0.99% to $65.84.
The Wisconsin State Fair, the Wisconsin State Fair Park Foundation and Kohl’s Department Stores (KSS) declared they will celebrate the fifth year of their partnership, offering local families access to the Fair at a fantastic value. The renewed partnership comprises the annual Kohl’s Family Value Day on Monday, August 10 from 8 a.m. until 6 p.m., where youth 11 and under will receive FREE admission (a $6 savings from the ticket price) and adults will receive admission for only $5 (a $7 savings from the ticket price). In addition, the partnership comprises the return of the popular Kohl’s Activity Zone and “Fair Day” at Children’s Hospital of Wisconsin.
“Kohl’s knows Wisconsin families look forward to attending the Fair on Kohl’s Family Value Day, and we are proud to provide fairgoers the opportunity to attend the Fair at a value they can feel good about,” said Bevin Bailis, Kohl’s senior vice president of communications and public relations. “We are also excited to again offer the Kohl’s Activity Zone, an area focused on inspiring young imaginations through educational and hands-on programs from some of the most premier organizations in Milwaukee.”
Kohl’s Corporation operates department stores in the United States. It offers private label, exclusive, and national brand apparel, footwear, accessories, beauty, and home products to children, men, and women customers.
Finally, Honeywell International Inc. (NYSE:HON), ended its last trade with 0.40% gain, and closed at $106.23.
Honeywell International, declared that Dave Cote, Chairman and CEO, will be presenting at the Bernstein Planned Decisions Conference in New York City on Wednesday, May 27, 2015 from 8:00 – 8:50 a.m. EDT.
Honeywell International Inc. operates as a diversified technology and manufacturing company worldwide. Its Aerospace segment provides aircraft engines, integrated avionics, systems and service solutions, and related products and services for aircraft manufacturers and operators, airlines, military services, and defense and space contractors; and spare parts, and repair and maintenance services for the aftermarket.
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