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Sarepta Announces Approval to Begin ENDEAVOR Cohort 8 to Evaluate Enhanced Immunosuppression Regimen as Part of ELEVIDYS Gene Therapy for Non-Ambulant Individuals with Duchenne

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA ...
Stocktwits on MSN

Sarepta Wins FDA Approval To Begin Study On Reducing Liver Injury Risk With Elevidys

Sarepta Therapeutics, Inc. (SRPT) on Tuesday said that the U.S. Food and Drug Administration (FDA) has approved dosing in a study cohort to evaluate the use of an immunosuppressive regimen as part of ...

FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury

The FDA is requiring the manufacturer to conduct a postmarketing observational study to further assess the risk of serious liver injury. The study will enroll approximately 200 patients with DMD and ...
Benzinga.com

Sarepta Secures FDA Nod For Elevidys Study To Reduce Liver Injury Risk

The U.S. Food and Drug Administration (FDA) on Tuesday approved dosing in Sarepta Therapeutics Inc.’s (NASDAQ: SRPT) Cohort 8 of ENDEAVOR (Study 9001-103). • SRPT shares are advancing steadily. Get ...
Seeking Alpha

Sarepta Announces FDA’s Approval of Updated ELEVIDYS Prescribing Information

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (SRPT), the leader in precision genetic medicine for rare diseases, today announced an update to the prescribing information for ELEVIDYS ...
WFMZ-TV

FDA Limits Duchenne Gene Therapy After Two Teens Die of Liver Failure

The FDA now limits Elevidys to walking boys ages 4 and up after two teens died from liver failure The therapy will now carry a boxed warning for serious liver injury, liver failure and death Doctors ...
FiercePharma

Sarepta gets FDA's go-ahead to study immunosuppressive Elevidys regimen in bid to reverse label restriction

When the FDA reworked the prescribing information for Sarepta Therapeutics' Duchenne muscular dystrophy (DMD) gene therapy Elevidys earlier this month, the company touted a plan to study a regimen ...
Seeking Alpha

Sarepta Therapeutics Provides Clarifying Statement on ELEVIDYS

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: Just before 6:00 p.m. ET today, ...
WAPT

FDA adds strongest warning to Sarepta gene therapy for Duchenne’s muscular dystrophy linked to 2 patient deaths

The Food and Drug Administration said Friday it will add a new warning and other limitations to a gene therapy for Duchenne’s muscular dystrophy that's been linked to two patient deaths.The infused ...

Sarepta a new outperform at Wedbush as selloff overdone

Wedbush has initiated Sarepta Therapeutics (SRPT) at outperform saying that a selloff that began earlier this year following ...
Morningstar

Sarepta Announces Approval to Begin ENDEAVOR Cohort 8 to Evaluate Enhanced Immunosuppression Regimen as Part of ELEVIDYS Gene Therapy for Non-Ambulant Individuals with Duchenne

Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to begin before the end of the year The enhanced ...