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SRPT

Sarepta

$131.10

-0.3 (-0.23%)

16:43
07/25/18
07/25
16:43
07/25/18
16:43

Sarepta: Phase 1/2a DMD Micro-Dystrophin Gene Therapy trial placed on hold

Sarepta Therapeutics has been notified by the Research Institute at Nationwide Children's Hospital that they have received a letter from the Food and Drug Administration on July 24, 24 stating that their Phase 1/2a Duchenne Muscular Dystrophy Micro-Dystrophin Gene Therapy Trial has been placed on clinical hold due to the presence of a trace amount of DNA fragment in research-grade third-party supplied plasmid. Preliminary in-vivo testing performed by the Research Institute indicates that the trace fragment does not result in protein expression and is quickly cleared.The Research Institute, working with Sarepta, has developed their action plan with immediate plans to submit for review by the FDA, which will include the use of GMP-s plasmid for the program. Subject to the FDA's acceptance of the action plan, Sarepta does not anticipate any material delay in dosing patients as originally planned by year-end 2018."Patient safety is our top priority at Sarepta as we know it is for Nationwide Children's Research Institute," stated Doug Ingram, Sarepta's president and chief executive officer. "We intend to rapidly respond to the FDA's clinical hold letter, including a commitment to the Agency to only use GMP-s plasmid. Independently, we will also request a meeting with the Agency to discuss the micro-dystrophin program with the goal of commencing a pivotal trial by year-end 2018."

SRPT Sarepta
$131.10

-0.3 (-0.23%)

06/25/18
NOMU
06/25/18
NO CHANGE
Target $57
NOMU
Buy
Solid Biosciences price target raised to $57 from $37 at Nomura Instinet
Nomura Instinet analyst Christopher Marai raised his price target on Solid Biosciences (SLDB) to $57 from $37 after Sarepta (SRPT) presented key biopsy data showing biochemical success of the AAV/microdystrophin approach, which Solid is also investigating. Marai maintains his Buy rating on Solid Biosciences shares.
06/25/18
JMPS
06/25/18
NO CHANGE
Target $275
JMPS
Outperform
Sarepta price target raised to $275 after 'landmark' data at JMP Securities
JMP Securities analyst Liisa A. Bayko raised her price target on Sarepta Therapeutics to $275 after hosting a dinner with Sarepta management on the heels of the R&D day at which the company revealed its "landmark" gene therapy data, noting that the dinner meeting provided her with more color on the micro-dystrophin gene therapy development strategy and commercial plans for the DMD franchise. She keeps an Outperform rating on Sarepta and continues to recommend the shares as she sees potential for significant upside as the program becomes further derisked with additional data, such as at the World Muscle Society meeting in early October.
06/22/18
RHCO
06/22/18
NO CHANGE
Target $176
RHCO
Buy
Sarepta price target raised to $176 from $100 at SunTrust
SunTrust analyst Edward Nash raised his price target on Sarepta to $176 and kept his Buy rating after the company's R&D day where it presented preliminary results from the Phase I/IIa micro-dystrophin gene therapy program. Nash said the 3-month data "showed robust micro-dystrophin expression in muscle using Western blot and immunohistochemistry". The analyst states that he views the gene therapy program as "extremely promising", while also noting the company's other therapeutic modalities for DMD and LGMD.
06/21/18
BARD
06/21/18
NO CHANGE
Target $202
BARD
Outperform
Sarepta price target raised to $202 from $120 at Baird
Baird analyst Brian Skorney raised his price target on Sarepta to $202 from $120 to reflect his confidence in the company's gene therapy platform, which he believes can go beyond DMD expression. Skorney reiterated his Outperform rating on Sarepta shares.

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$19.83

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NFLX

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IBM

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