SRPT Q3 Earnings Miss Estimates, Stock Down as Elevidys Sales Decline - Yahoo Finance
Yahoo Finance · Nov 6, 2:21 PM
Sarepta Therapeutics Announces Third Quarter 2026 Financial Results and Recent Corporate Developments - BioSpace
BioSpace · Nov 6, 2:12 PM
Sarepta quits enrolling for confirmatory Phase 3 trial of Elevidys - Endpoints News
Endpoints News · Nov 6, 2:10 PM
Sarepta Therapeutics sells four approved drugs for Duchenne muscular dystrophy, a genetic muscle-wasting disease; two hold accelerated approvals that FDA is reviewing for conversion to full approval.
Sarepta sold $328.7 million of Duchenne drugs in the second quarter: $230.6 million of exon-skipping PMOs and $98.1 million of ELEVIDYS, and guides to $1.2 to $1.3 billion for 2026. FDA expects to decide in early 2027 whether AMONDYS 45 and VYONDYS 53 convert to full approval, although the ESSENCE confirmatory trial missed its primary endpoint. ELEVIDYS lost its non-ambulatory indication in November 2025. Sarepta now needs its siRNA programs, with DM1 and FSHD data due in the second half of 2026.
Thesis checklist
1 risk needs attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: AMONDYS 45 and VYONDYS 53 keep their approvals
Does FDA grant traditional approval to AMONDYS 45 and VYONDYS 53?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
FDA decides in early 2027 whether two Sarepta exon-skipping drugs keep their approvals
Profitable DMD franchise seeks permanent approval status; whether ESSENCE data converts two accelerated approvals determines the durability of a $1.4B revenue base
ESSENCE trial missed primary endpoint
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Neuromuscular diseases, Neurology and pain
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
10 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.