Dashboard/SRPT/ELEVIDYS/event

PDUFAPDUFA Decision

ELEVIDYS sBLA PDUFA Decision

SRPT·ELEVIDYS·Duchenne Muscular Dystrophy·

Approved

current best date

JUL 30

2026

EXACT3 months

Takeaway

FDA decision deadline on extending ELEVIDYS to ambulatory DMD patients aged ≥4. Three possible outcomes: approval, Complete Response Letter (CRL), or PDUFA extension. ELEVIDYS is currently Sarepta’s primary commercial product.

What’s at stake

market · comparables · base rate · prior moves

Market opportunity

—

company filings

Peer comparables

1 readout

ClinicalTrials.gov

Stage base rate

~100%

BIO Industry Analysis 2023 (2011–2020)

Avg prior-readout move

—

historical price reactions

Drug

gene therapy

ELEVIDYS

delandistrogene moxeparvovec · INN

MoAAAVrh74-microdystrophin transfer

ELEVIDYS (delandistrogene moxeparvovec) is a one-time gene therapy for Duchenne muscular dystrophy — a fatal progressive muscle-wasting disease caused by dystrophin gene mutations — developed by Sarepta Therapeutics. The therapy uses a hollow AAVrh74 virus to deliver a shortened but functional microdystrophin gene into muscle cells throughout the body, enabling patients to produce a form of the missing structural protein. ELEVIDYS received accelerated FDA approval in 2023 as the first gene therapy for DMD; Sarepta is pursuing a label expansion to ambulatory patients aged 4 and older.

Indication

Rare Disease

Duchenne Muscular Dystrophy

MeSH · D020388

X-linked genetic disease causing progressive muscle weakness in boys. Median survival in late 20s with current care; gene therapy (ELEVIDYS) is the lead curative approach.

Source signal

This event was extracted from a primary disclosure. The full chain of citations is in the disclosure trail below.

Glossary · what this readout is measuring

3 terms detected in the takeaway

PDUFAregulatory
Prescription Drug User Fee Act
The FDA's self-imposed review deadline for an NDA/BLA. Standard reviews are ~10 months from filing; priority reviews are ~6 months.
DMDdisease
Duchenne Muscular Dystrophy
X-linked genetic disease causing progressive muscle weakness in boys. Median survival in late 20s with current care; gene therapy (ELEVIDYS) is the lead curative approach.
CRLregulatory
Complete Response Letter
FDA letter rejecting an NDA/BLA and listing what must be fixed. Re-submission resets the clock to 2 or 6 months depending on what changed.

Competitive landscape

3 peers in Rare Disease · ranked by indication + modality match

Drug	Company	Modality	Mechanism	Next catalyst
KRESLADImarnetegragene autotemcel	RCKT	gene therapy	lentiviral ITGB2 transfer (LAD-I)	PDUFA · Oct 26
VOXZOGOvosoritide	BMRN	peptide	CNP analog (FGFR3 antagonism)	PDUFA · Nov 26
GALAFOLDmigalastat	FOLD	small molecule	pharmacological chaperone of α-galactosidase A	PDUFA · Nov 26

Prior SRPT reactions to PDUFA events

3 historical events · base rate, not prediction

Median 1W move

-27.5%

Median 1M move

-22.9%

Positive outcomes

1/ 3

33%

Negative outcomes

1/ 3

33%

Date	Headline	Outcome	1W	1M	6M
Dec 2025	ELEVIDYS — PDUFA — CRL Issued	negative	-27.5%	-38.9%	-34.2%
Nov 2025	ELEVIDYS — PDUFA — Approved	positive	+44.8%	+22.7%	+20.5%
Jul 2025	ELEVIDYS — PDUFA — CRL Issued	mixed	-38.9%	-22.9%	+45.1%

Historical SRPT stock reaction to past PDUFA catalysts. Past performance is not a forecast — base rates anchor expectations, not outcomes. Positive rate 33%.

Disclosure trail

1 observation · sorted by confidence

Jan 22, 2026·3mo agopinned · highest confidence
HIGH confPR
top claim
JUL 302026
EXACT
“The FDA has set a PDUFA action date of July 30, 2026 for the supplemental Biologics License Application for ELEVIDYS expanding to ambulatory patients ≥4 years.”
contextSarepta press release announcing FDA acceptance of sBLA.
conf 96%via llm

MethodologyEvery catalyst date is anchored to a primary source. Disclosures with confidence ≥ 0.85 auto-publish; the rest are reviewed by a human within 24 hours. We never interpret data — we organize public information.