BioCentury | Aug 28, 2020
Product Development

Aug. 27 Quick Takes: Priority Review for casimersen in DMD, tepotinib in NSCLC; plus asciminib meets in CML and a farewell to digital pioneer Proteus

...casimersenSarepta Therapeutics Inc. (NASDAQ:SRPT) said FDA granted Priority Review to its BLA for Amondys 45 casimersen...
...MET; HGFR) - c-Met receptor tyrosine kinase BC Staff benvitimod, tapinarof (DMVT-505, GSK2894512, WBI-1001) Tepmetko (tepotinib, MSC2156119J) asciminib (ABL001) casimersen (SRP-4045) Merck...
BioCentury | Dec 23, 2019
Company News

Roche’s ex-U.S. deal for Sarepta DMD programs could extend beyond micro-dystrophin gene therapy

...Sarepta's marketed DMD drugs Exondys 51 eteplirsen and Vyondys 53 golodirsen; and pipeline products including casimersen...
BioCentury | Nov 8, 2019
Clinical News

Roche’s RG6206 becomes second myostatin inhibitor to fail in DMD in past year

...for casimersen in the United States.” Sarepta had been planning to submit an NDA for casimersen...
...45, by mid-year. Targets - MSTN (GDF8) - Myostatin Stephen Hansen, Associate Editor VYONDYS 53, golodirsen (SRP-4053) casimersen (SRP-4045) Sarepta...
BioCentury | Aug 19, 2019
Company News

Sarepta sinks after FDA rejects DMD therapy

...Sarepta said its Phase III ESSENCE study of golodirsen and exon 45 skipping therapy casimersen...
...which began in 2016, is ongoing. The company had planned to submit an NDA for casimersen...
...Sarepta spokesperson told BioCentury that its meeting with FDA "will inform our plans for the casimersen...
BioCentury | Jun 29, 2019
Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

...NASDAQ:CELG) (A) Fedratinib Treat myelofibrosis PDUFA date; submit MAA 9/3/19; YE19 Sarepta Therapeutics Inc. (NASDAQ:SRPT) Casimersen...
BioCentury | Apr 5, 2019
Clinical News

Sarepta planning NDA for DMD candidate casimersen

...Sarepta said it plans to submit an NDA to FDA in mid-2019 for casimersen (SRP-4045) to...
...treat Duchenne muscular dystrophy amenable to exon 45 skipping. The company will seek approval for casimersen...
...All three compounds are phosphorodiamidate morpholino oligomers (PMOs) that target specific exons. Sandi Wong, Staff Writer casimersen (SRP-4045) Sarepta...
BioCentury | Feb 15, 2019
Clinical News

Sarepta's golodirsen under FDA Priority Review

...intensity levels. The company expects that the Phase III ESSENCE study of golodirsen and casimersen (SRP-4045...
...approval from FDA. All three compounds are phosphorodiamidate morpholino oligomers (PMOs) that target specific exons; casimersen...
BioCentury | Feb 14, 2019
Company News

Priority Review for Sarepta's golodirsen to treat DMD

...intensity levels. The company expects that the Phase III ESSENCE study of golodirsen and casimersen (SRP-4045...
...approval from FDA. All three compounds are phosphorodiamidate morpholino oligomers (PMOs) that target specific exons; casimersen...
BioCentury | Mar 16, 2018
Clinical News

Sarepta to submit NDA for DMD candidate by YE

...Western blot (p<0.001) (see BioCentury, Sept. 8, 2017 ). Sarepta is evaluating golodirsen and casimersen (SRP-4045...
...golodirsen if the candidate receives accelerated approval. Golodirsen is a PMO targeting exon 53 and casimersen...
...targeting exon 45. Sarepta Therapeutics Inc. (NASDAQ:SRPT), Cambridge, Mass. Product: Golodirsen (SRP-4053) Business: Musculoskeletal Allison Johnson casimersen (SRP-4045) Exondys...
BioCentury | Mar 14, 2018
Clinical News

Sarepta resumes dosing at U.K. sites after DMD trial halt

...dosing at U.K. sites in the Phase III ESSENCE trial evaluating golodirsen (SRP-4053) and casimersen (SRP-4045...
...for golodirsen, if it receives accelerated approval (see BioCentury Extra, March 12) . Golodirsen and casimersen...
...Sarepta gained $1.80 to $80.90 on Tuesday, and climbed another $1.37 to $82.27 on Wednesday. Paul Bonanos casimersen golodirsen SRP-4045 SRP-4053 Sarepta...
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