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. The company's lead product candidate is Eteplirsen, an antisense phosphorodiamidate morpholino oligomer therapeutic, which is in Phase III clinical development for the treatment of individuals with Duchenne muscular dystrophy (DMD), a genetic muscle-wasting disease caused by the absence of dystrophin. It is also developing exon-skipping drugs for the treatment of DMD; and therapeutic candidates for the treatment of infectious diseases, such as influenza, Marburg, and Ebola. The company has a strategic alliance with Charley's Fund, Inc. to support the development of product candidates using its proprietary exon-skipping technologies; and a license agreement with the University of Western Australia for the use of antisense sequences in the treatment of DMD. Sarepta Therapeutics, Inc. was founded in 1980 and is headquartered in Cambridge, Massachusetts.
Word on the streets is don't be surprised it gets FDA approval. 6 to 7. Very curious to how this opens. Still nothing is set in stone
In a statement, the company said an FDA advisory committee did not recommend the approval of its drug eteplirsen, developed for a disease called Duchenne muscular dystrophy, or DMD .just posted it on the daily trading thread ... in pre losing 50%
Its been a rough ride ever since the first sell off last Wednesday, it looks like the open will be around $8
I think the best way to play this stock is simply buy both calls and puts 3 months out. The way this thing bounces around like crazy will ensure one of them pays off!
Sarepta Therapeutics Announces FDA Request For Dystrophin Data Prior To Making A Decision on Eteplirsen NDA Sarepta Therapeutics, Inc. (SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has requested that Sarepta provide dystrophin data, as measured by western blot, from biopsies already obtained from the ongoing confirmatory study of eteplirsen (PROMOVI), as part of its ongoing evaluation of the eteplirsen New Drug Application (NDA). The Company plans to submit data from thirteen patient biopsy samples, at baseline and Week 48, to the FDA over the coming weeks to facilitate a prompt decision on the NDA by the Agency. Read full article here: http://finance.yahoo.com/news/sarepta-therapeutics-announces-fda-request-214000495.html
http://finance.yahoo.com/news/sarepta-therapeutics-announces-proposed-offering-201900782.html So about 2M shares will be offered. I guess they need the money now that they have a drug to market. This can give an opportunity to get in.
Talk about over reaction. Sarepta Therapeutics shares jump on news of critic’s departure from FDA By Emma Court Published: Sept 14, 2016 10:58 a.m. ET Dr. Ron Farkas had led a critical review of Sarepta’s eteplirsen drug The FDA voted against approval of Sarepta’s treatment for Duchenne muscular dystrophy Sarepta Therapeutics Inc. shares rose 26% Wednesday after reports that a prominent critic of the company’s Duchenne muscular dystrophy drug has left the Food and Drug Administration for another job. Sarepta SRPT, +24.18% shares have fluctuated significantly over the course of the approval process for the drug, eteplirsen, which would be the only treatment for the genetic disease and has been the focus of significant activism by the patient community. News of the departure of Dr. Ronald Farkas, who had led a critical FDA review on eteplirsen, was first reported byBenzinga late Tuesday. Benzinga’s report noted Farkas was hardly the only member of the advisory committee with concerns about the drug. See: More bad news for those that have this disease with no treatment Farkas’ role in the drawn-out saga of eteplirsen has been attacked, notably by The Wall Street Journal, which said in an August editorial that Farkas and another FDA employee “have lost the public’s confidence that they can conduct a fair review, and no bureaucratic proceeding should stop the FDA from reviewing their fitness for service.”
