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Sarepta Therapeutics Receives Complete Response Letter From The U.S. Food And Drug Administration For Golodirsen New Drug Application
Sarepta Therapeutics Comments On Erroneous Submission To Us FDA Adverse Event Reporting System
Sarepta Therapeutics Q2 Non-GAAP Loss Per Share $0.83
Sarepta Therapeutics, Inc. is a biopharmaceutical company. The Company focuses on the discovery and development of ribose nucleic acid (RNA)-targeted therapeutics for the treatment of rare neuromuscular diseases. It operates through discovering, developing, manufacturing and delivering therapies to patients with Duchenne muscular dystrophy (DMD). It is focused on the development of its disease-modifying DMD drug candidates. It has received accelerated approval for its product, EXONDYS 51, indicated for the treatment of DMD in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. EXONDYS 51 is studied in clinical trials under the name of eteplirsen. Its next generation phosphorodiamidate morpholino oligomer (PMO)-based compounds are synthetic compounds that bind to complementary sequences of RNA by standard Watson-Crick nucleobase pairing. Its PMO-based chemistries are peptide conjugated PMO (PPMO), PMO-X and PMOplus.
Biotechnology & Drugs
215 1st St Ste 415
M. Kathleen Behrens
Independent Chairwoman of the Board
Douglas S. Ingram
President, Chief Executive Officer, Director
Executive Vice President, Chief Financial Officer and Chief Business Officer
David Tyronne Howton
Executive Vice President, General Counsel, Secretary
Executive Vice President and Chief Commercial Officer
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Shares of Sarepta Therapeutics Inc plunged 14% on Tuesday after the U.S. health regulator, in an unexpected move, declined to approve the drugmaker's newest treatment for a muscle-wasting disorder that mainly affects young boys.
Shares of Sarepta Therapeutics Inc plummeted 17% on Tuesday after the U.S. health regulator, in a surprise move, declined to approve the drugmaker's newest treatment for a muscle-wasting disorder that mainly affects young boys.
Sarepta Therapeutics Inc said on Monday the U.S. Food and Drug Administration declined to approve its newest treatment for Duchenne muscular dystrophy (DMD), citing safety concerns including the risk of infection and kidney toxicity.
The U.S. Food and Drug Administration declined to approve Sarepta Therapeutics Inc's newest treatment for Duchenne muscular dystrophy (DMD), a rare muscle-wasting disorder that mainly affects boys, the company said on Monday.
Sarepta Therapeutics Inc <SRPT.O> said on Thursday it was informed that an adverse event report was erroneously submitted to the U.S. health regulator regarding an ongoing study of the company's gene therapy for Duchenne muscular dystrophy (DMD).
Shares of Sarepta Therapeutics Inc plunged 12% after a notice from the U.S. health agency showed a patient in an ongoing study of the company's gene therapy for Duchenne muscular dystrophy was reported to have developed a serious illness.
Shares of Sarepta Therapeutics Inc <SRPT.O> surged 15% on Friday after some safety concerns were raised in a small, early-stage study of a competing gene therapy for a rare muscle-wasting disorder from Pfizer Inc <PFE.N>.
Sarepta Therapeutics Inc beefed up its gene therapies portfolio through the purchase of its partner Myonexus Therapeutics Inc and reported positive data for a genetic disorder therapy from the privately held company, sending its shares up 9 percent on Wednesday.
Sarepta Therapeutics Inc said on Wednesday it exercised its option to buy privately held gene therapy maker Myonexus Therapeutics Inc for $165 million.
Sarepta Therapeutics' shares jumped 60 percent on Tuesday after promising results from a gene therapy study positioned the specialty drugmaker as a potential leader in the market for Duchenne muscular dystrophy (DMD) treatments.
* SAREPTA AND INVITAE EXPAND PARTNERSHIP TO ADVANCE CLINICAL RESEARCH IN DUCHENNE MUSCULAR DYSTROPHY Source text for Eikon: Further company coverage:
* SAREPTA THERAPEUTICS ANNOUNCES FIRST QUARTER 2018 FINANCIAL RESULTS AND RECENT CORPORATE DEVELOPMENTS
* SAREPTA THERAPEUTICS ANNOUNCES PARTNERSHIP WITH MYONEXUS THERAPEUTICS FOR THE ADVANCEMENT OF MULTIPLE GENE THERAPY PROGRAMS AIMED AT TREATING DISTINCT FORMS OF LIMB-GIRDLE MUSCULAR DYSTROPHIES
* SAREPTA THERAPEUTICS INC SAYS CEO DOUGLAS INGRAM'S 2017 TOTAL COMPENSATION WAS $56.9 MILLION – SEC FILING Source text for Eikon: (http://bit.ly/2I3lSGe) Further company coverage:
A federal appeals court has upheld the dismissal of a lawsuit accusing Sarepta Therapeutics Inc of misleading shareholders by suggesting it had gathered enough data to seek U.S. Food and Drug Administration approval in 2014 to market a treatment for a rare muscle disorder.
* SAREPTA THERAPEUTICS ANNOUNCES PLAN TO SUBMIT A NEW DRUG APPLICATION (NDA) FOR ACCELERATED APPROVAL OF GOLODIRSEN (SRP-4053) IN PATIENTS WITH DUCHENNE MUSCULAR DYSTROPHY (DMD) AMENABLE TO SKIPPING EXON 53
* SAREPTA THERAPEUTICS ANNOUNCES FOURTH QUARTER 2017 AND FULL-YEAR 2017 FINANCIAL RESULTS AND RECENT CORPORATE DEVELOPMENTS
* CAPITAL VENTURES INTERNATIONAL REPORTS A 5.4 PERCENT PASSIVE STAKE IN SAREPTA THERAPEUTICS INC AS OF DECEMBER 11, 2017 - SEC FILING Source text: (http://bit.ly/2kzjwV3) Further company coverage:
A lawyer for Sarepta Therapeutics Inc shareholders urged a federal appeals court on Monday to revive a lawsuit claiming the company misled investors about whether it had gathered enough data to seek Food and Drug Administration approval for a treatment for a rare muscle...
Health insurer Anthem Inc has eased access to Sarepta Therapeutics' treatment for Duchenne muscular dystrophy, and on Thursday changed its reimbursement policy on its website to "medically necessary."
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