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#SS31 #Elamipretide #CellularEnergy #Mitochondria

#NORDSummit: Shelley Bowen, director of family services and advocacy for the Barth Syndrome Foundation, which successfully lobbied for FDA approval of #Elamipretide for an X-linked disease that affects only 500 boys worldwide. @nordrare.bsky.social

#RareDisease #BarthSyndrome #MedSky

News and Press Releases : News & Events : Barth Syndrome Foundation

An update: the FDA granted approval yesterday! Truly, truly grateful 💙🌀🥺. #happytears #barthsyndrome #elamipretide #mitochondrialdisease #raredisease

www.barthsyndrome.org/newsevents/n...

News and Press Releases : News & Events : Barth Syndrome Foundation

Historic. I can’t help but think of my brothers and wish they were here to benefit from this. Mostly, I’m just so proud of my mom and everyone who worked so hard to make this happen. www.barthsyndrome.org/newsevents/n...

#BarthProgress #elamipretide #mitochondrialdisease #raredisease #barthsyndrome

Navigating heart failure and mitochondrial disease. Help save #elamipretide for patients with #mitochondrialdisease and #heartfailure Dr. Gatcombe shares her son's story and her journey. Listen allaccessdna.podbean.com or wherever you get podcasts! #GeneChat #genetictesting

youtu.be/V8ROTIEzr98

Stealth BioTherapeutics Receives FDA Acceptance for Elamipretide NDA Resubmission for Barth Syndrome Stealth BioTherapeutics announces the FDA's acceptance of their NDA resubmission for elamipretide, targeting Barth syndrome and offering hope for treatment.

Stealth BioTherapeutics Receives FDA Acceptance for Elamipretide NDA Resubmission for Barth Syndrome #United_States #Needham #Stealth_BioTherapeutics #Barth_Syndrome #Elamipretide

Time is running out for kids with a rare disease, parents say, unless the FDA acts After a more than decadelong process to bring the experimental drug elamipretide to market, the treatment’s approval has repeatedly hit roadblocks.

“Our kids are dying. We have seen that this drug works,” said Kate McCurdy, a co-founder of the Barth Syndrome Foundation. “This drug totally saves the lives of babies.”

#elamipretide #ApproveElamipretide #FDAActNow #BarthProgress #BarthSyndrome #RareDisease #MitochondrialDisease

Stealth BioTherapeutics Resubmits New Drug Application for Elamipretide to Treat Barth Syndrome Stealth BioTherapeutics has resubmitted a New Drug Application for elamipretide to the FDA for the treatment of Barth syndrome, a rare genetic disorder.

Stealth BioTherapeutics Resubmits New Drug Application for Elamipretide to Treat Barth Syndrome #United_States #Needham #Stealth_BioTherapeutics #Barth_Syndrome #Elamipretide

@fda.gov Please reconsider your decision re #elamipretide and approve it for the small population currently benefiting from it

Please take a moment to read this 🧵 by @annabower.bsky.social.

I lost two brothers to Barth Syndrome, an ultra-rare, genetic, mitochondrial disorder. For nearly a decade, Stealth BioTherapeutics has been working to develop and get approval for #elamipretide.

#MedSky #FDA #elamipretide #RareDiseases #CRDAC

Approve #Elamipretide! @fda.gov people's lives hang in the balance!!

@vanhollen.senate.gov @alsobrooks.senate.gov @ivey.house.gov Please use your leadership to encourage @fda.gov to reconsider and approve #elamipretide to give Hope and others who can benefit a chance.

@kirstengillibrand.bsky.social @schumer.senate.gov @meng.house.gov
🙏🏽 Please pressure the FDA to greenlight general use of ELAMIPRETIDE asap‼️ The thread 🧵 above details why #ELAMIPRETIDE is necessary.

@fda.gov Please reconsider your decision and approve ELAMIPRETIDE ~ be a hero 🙏🏽
#Hope #TeamHope

Stealth BioTherapeutics Charts New Path Forward After Delay in Barth Syndrome Treatment Approval Stealth BioTherapeutics is adjusting its strategy for elamipretide after FDA's delayed drug approval for Barth syndrome, offering new hope.

Stealth BioTherapeutics Charts New Path Forward After Delay in Barth Syndrome Treatment Approval #United_States #Needham #Stealth_BioTherapeutics #Barth_Syndrome #Elamipretide

Stealth BioTherapeutics' Elamipretide Receives PDUFA Action Date Extension for Barth Syndrome Treatment Stealth BioTherapeutics announced that the FDA extended the PDUFA action date for elamipretide for Barth syndrome treatment to April 2025.

Stealth BioTherapeutics' Elamipretide Receives PDUFA Action Date Extension for Barth Syndrome Treatment #USA #Needham #Stealth_BioTherapeutics #Barth_Syndrome #Elamipretide