BC Extra | Dec 23, 2019
Company News

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

After weathering one clinical failure in DMD this fall, Roche broadened its commitment to gene therapy by obtaining ex-U.S. rights to Sarepta’s micro-dystrophin-targeting program in a deal worth more than $1.1 billion up front. Roche...
BC Extra | Nov 8, 2019
Clinical News

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

The failure of Roche’s RG6206 marks another blow to the hypothesis that blocking myostatin can improve muscle growth and function in ambulatory boys with Duchenne muscular dystrophy. Roche (SIX:ROG; OTCQX:RHHBY) sent a letter Wednesday to...
BC Extra | Aug 19, 2019
Company News

Sarepta sinks after FDA rejects DMD therapy

Sarepta dropped $15.61 (13%) to $104.70 in after hours trading Monday, losing over $1.1 billion in market cap, after FDA issued a complete response letter for golodirsen, the biotech's second exon skipping therapy for Duchenne...
BioCentury | Jun 29, 2019
Finance

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

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
BC Week In Review | 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 based on a...
BC Week In Review | Feb 15, 2019
Clinical News

Sarepta's golodirsen under FDA Priority Review

Sarepta Therapeutics Inc. (NASDAQ:SRPT) said Feb. 14 that FDA accepted and granted Priority Review to its NDA for golodirsen (SRP-4053) to treat Duchenne muscular dystrophy amenable to skipping exon 53. its PDUFA date is Aug....
BC Extra | Feb 14, 2019
Company News

Priority Review for Sarepta's golodirsen to treat DMD

Sarepta Therapeutics Inc. (NASDAQ:SRPT) said FDA accepted and granted Priority Review to its NDA for golodirsen (SRP-4053) to treat Duchenne muscular dystrophy amenable to skipping exon 53. its PDUFA date is Aug. 19. Sarepta is...
BC Week In Review | Mar 16, 2018
Clinical News

Sarepta to submit NDA for DMD candidate by YE

Sarepta Therapeutics Inc. (NASDAQ:SRPT) said it plans to complete submission of a rolling NDA to FDA by year end for golodirsen (SRP-4053) to treat Duchenne muscular dystrophy amenable to exon 53 skipping. The company said...
BC Extra | Mar 14, 2018
Clinical News

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

Sarepta Therapeutics Inc. (NASDAQ:SRPT) President and CEO Doug Ingram said the company has resumed dosing at U.K. sites in the Phase III ESSENCE trial evaluating golodirsen (SRP-4053) and casimersen (SRP-4045) to treat Duchenne muscular dystrophy...
BC Extra | Mar 12, 2018
Company News

Sarepta to complete NDA submission for DMD candidate by YE18

Sarepta Therapeutics Inc. (NASDAQ:SRPT) said on Monday that it plans to complete submission of a rolling NDA to FDA by year end for golodirsen (SRP-4053) to treat Duchenne muscular dystrophy amenable to exon 53 skipping....
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