The US FDA has granted approval for Sarepta Therapeutics' gene therapy, Elevidys, for Duchenne muscular dystrophy in patients aged four and above. This decision has led to a surge in Sarepta Therapeutics' stock by 38-40%, indicating a significant market impact. The approval comes after a controversial decision by a top FDA official to expand the therapy's use, overriding agency staff recommendations.
FDA has a different Peter principle problem: poorly articulated, idiosyncratic decision-making. In a @BioCentury Editor's Comment, @SteveUsdin1 argues that @US_FDA approval of @Sarepta's gene therapy exposed management failures. https://t.co/7mQLzPIN6y
Expanded US FDA approval of @Sarepta's Elevidys in DMD https://t.co/fFH0lXwUmv https://t.co/MEW2OkaxM9
Sarepta Wins Key Label Expansion for DMD Gene Therapy, in Wake of Pfizer Failure. Learn more: https://t.co/yiNwbCuwc3 https://t.co/BkoF2b4IJy
just wow, really wow. FDA's Peter Marks single-handedly approved Sarepta’s gene therapy — what does that mean for everyone else? - https://t.co/n4HXJGAmQy
wow. FDA widens Sarepta’s Duchenne gene therapy label to older boys in significant expansion of use - https://t.co/qMQy43WuJ9
Top FDA official overrules staff to approve gene therapy that failed trial Peter Marks overruled three teams and two top directors. The Food and Drug Administration (FDA) on Thursday announced expanded approval for a gene therapy to treat Duchenne muscular dystrophy… https://t.co/QItCFjFUSO
Sarepta Therapeutics’ stock soars 38% after FDA expands use of its Duchenne muscular-dystrophy drug https://t.co/Xzkc8gQY6F
$SRPT Sarepta CEO on what's next after expanded muscular dystrophy drug approval. #DMD https://t.co/UAqZGDUvhn
$SRPT soaring on expanded FDA approval for its Duchenne Muscular Dystrophy drug Elevidys @Sarepta CEO Douglas Ingram talks about what it means for the company and patients: https://t.co/e7vZ0pNDxQ
FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff https://t.co/5wJ8DYwf1M
Sarepta Therapeutics shares surged as much as 40% to a more than three-year high on Friday as an expanded use approval cemented its dominant position in the gene therapy market for Duchenne muscular dystrophy (DMD). https://t.co/Oz78Unmqr1 https://t.co/Oz78Unmqr1
The FDA approved Elevidys, Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, for nearly all patients with the disease. https://t.co/lL2t1DRgmH
Duchenne approval exposes FDA rift over Sarepta gene therapy https://t.co/1qUpCjN2cd $SRPT by @BentheFidler
The FDA has expanded approval for Sarepta's Elevidys gene therapy for Duchenne muscular dystrophy in patients at least 4 years old. Analysts predict rapid uptake and revenue growth. $SRPT
There is much to unpack from the decision by the FDA to expand the use of Sarepta’s Elevidys to nearly all Duchenne patients. https://t.co/cqzr3EJR3Y
US regulators give go-ahead for muscle wasting treatment costing $3mn: “US FDA gave Sarepta Therapeutics the green light to roll out Elevidys, its gene therapy for Duchenne muscular dystrophy to all patients aged four and over.” https://t.co/lM8cPTfXpz