Sarepta Therapeutics (SRPT) Company Report

Sarepta Therapeutics announced positive 3-year topline functional results from Part 1 of the EMBARK (Study 9001-301) trial for ELEVIDYS (delandistrogene moxeparvovec-rokl) in boys with Duchenne Muscular Dystrophy (DMD) on January 26, 2026.
ELEVIDYS-treated patients remained above their baseline three years after treatment as measured by North Star Ambulatory Assessment (NSAA), with the functional gap compared to the external control group growing to a 4.39-point difference at Year 3.
The study demonstrated a statistically significant 73% slowing of disease progression as measured by Time to Rise (TTR) and a statistically significant 70% slowing of disease progression as measured by 10-meter walk run (10MWR).
The safety profile of ELEVIDYS remained consistent over three years, with no new safety signals observed.

Jan 26, 2026, 1:30 PM

Presentation

Sarepta reports significant three-year EMBARK data for ELEVIDYS

SRPT

Product Launch

New Projects/Investments

Sarepta announced positive three-year top-line results from the EMBARK Phase 3 pivotal trial for ELEVIDYS, demonstrating a dramatic shift in disease trajectory.
ELEVIDYS-treated patients, on average, remained above their baseline three years after treatment, as measured by the North Star Ambulatory Assessment (NSAA).
The therapy showed a 70% or greater reduction in disease progression relative to an external control group, based on time to rise and 10-meter walk/run assessments.
Key functional measures showed statistically significant differences at year 3, including a 4.39-point difference in NSAA (p=0.0002), a 6-second difference in time to rise (p<0.0001), and a 2.7-second difference in 10-meter walk/run (p=0.0039).
No new safety signals or treatment-related serious adverse events were observed in the third year, consistent with the known safety profile of ELEVIDYS.

Jan 26, 2026, 1:30 PM

Transcript

Sarepta Announces Three-Year Top-Line Results from ELEVIDYS EMBARK Trial

SRPT

Sarepta presented three-year top-line results from the EMBARK (ELEVIDYS Phase 3 pivotal trial), demonstrating a dramatic shift in disease trajectory for patients treated with ELEVIDYS.
ELEVIDYS-treated patients remained above baseline three years post-treatment, as measured by the North Star Ambulatory Assessment (NSAA), with a 4.39-point difference compared to the external control group (p-value = 0.0002).
The study showed a 70% or greater reduction in disease progression for ELEVIDYS-treated patients relative to the external control group, as measured by time to rise and 10-meter walk/run.
These statistically significant benefits persist and strengthen over time, creating a sustained and growing separation from the expected disease trajectory of Duchenne muscular dystrophy.
No new safety signals or treatment-related serious adverse events were observed in year three of the cohort.

Jan 26, 2026, 1:30 PM

Transcript

Sarepta Therapeutics Announces Positive Three-Year EMBARK Trial Results for ELEVIDYS

SRPT

Sarepta Therapeutics announced positive three-year top-line results from its EMBARK Phase 3 pivotal trial for ELEVIDYS, demonstrating a dramatic shift in disease trajectory for treated patients.
ELEVIDYS-treated patients remained above baseline on average in the North Star Ambulatory Assessment (NSAA) three years post-treatment, with a 4.39-point difference compared to the external control group (p=0.0002).
The trial demonstrated a 70% or greater reduction in disease progression for treated patients, measured by time to rise and 10-meter walk/run, with these benefits continuing to strengthen over time.
No new safety signals were observed in year three of the cohort, reinforcing the therapy's safety profile.

Jan 26, 2026, 1:30 PM

Transcript

Sarepta Announces Positive Three-Year EMBARK Results for ELEVIDYS

SRPT

Sarepta Therapeutics announced positive topline three-year functional results from the EMBARK (Study SRP-9001-301) Phase 3 study for ELEVIDYS (delandistrogene moxeparvovec-rokl) in ambulatory Duchenne muscular dystrophy patients.
At a mean age of 9 years, ELEVIDYS-treated patients achieved mean North Star Ambulatory Assessment (NSAA) scores above baseline three years after treatment.
ELEVIDYS gene therapy demonstrated a 70% or greater reduction in the rate of decline relative to the external control group, as measured by Time to Rise (TTR) and 10-meter walk/run (10MWR), with the treatment effect increasing over time.
No new treatment-related safety signals were observed, consistent with the manageable safety profile seen with ELEVIDYS in ambulatory patients to date.
ELEVIDYS is the only approved gene therapy for Duchenne and has been administered to over 1,200 patients globally.

Jan 26, 2026, 1:00 PM

Press Release

Sarepta to Report 3-Year Topline Data for ELEVIDYS Gene Therapy

SRPT

New Projects/Investments

Sarepta Therapeutics will host a webcast and conference call on Monday, January 26, 2026, at 8:30 am Eastern Time.
The event will present 3-year topline functional results from Part 1 of the EMBARK (Study 9001-301) Phase 3 study.
This study evaluates ELEVIDYS (delandistrogene moxeparvovec-rokl) in ambulatory individuals with Duchenne muscular dystrophy who were aged four to seven at the time of treatment.

Jan 23, 2026, 9:05 PM

Press Release

Sarepta Therapeutics Reports Preliminary Q4 and Full-Year 2025 Net Product Revenues

SRPT

Earnings

Guidance Update

Revenue Acceleration/Inflection

Sarepta Therapeutics, Inc. announced preliminary total net product revenue of $369.6 million for the fourth quarter of 2025 and $1.86 billion for the full-year 2025.
For full-year 2025, ELEVIDYS net product revenue reached $898.7 million, while PMO net product revenues totaled $965.6 million.
The company concluded 2025 with a preliminary cash, cash equivalents, restricted cash, and investments balance of approximately $953.8 million.
Sarepta reconfirmed a yearly sales floor for ELEVIDYS of $500.0 million for 2026, noting that Q4 2025 ELEVIDYS revenue was affected by the year-end flu season and rescheduled patient infusions.

Jan 12, 2026, 5:05 PM

8-K

Sarepta Therapeutics Reports 2025 Financial Results and Outlines 2026 Strategic Priorities

SRPT

Earnings

Guidance Update

New Projects/Investments

Sarepta Therapeutics reported full-year 2025 total net product revenue of $1.86 billion, with Elevidys at $899 million (9% growth) and PMOs at $966 million.
The company ended 2025 with $954 million in cash and cash equivalents and projects to be cash flow positive throughout the decade with no significant debt overhang.
Sarepta confirmed a $500 million yearly floor for Elevidys and plans to significantly grow this, focusing on communicating its efficacy and disease-slowing benefits.
Key 2026 pipeline milestones include Endeavor Cohort 8 trial results for non-ambulatory patients by year-end, and biomarker/safety data for FSHD (1001) and DM1 programs by the end of Q1.
The company will meet with the FDA by the end of Q1 2026 to discuss the pathway to traditional approval for its PMO therapies.

Jan 12, 2026, 5:00 PM

Transcript

Sarepta Therapeutics Provides 2025 Financial Results and 2026 Outlook at J.P. Morgan Healthcare Conference

SRPT

Guidance Update

New Projects/Investments

Sarepta Therapeutics reported full year 2025 total net product revenue of $1.86 billion, with Elevidys contributing $899 million (up 9% over the prior year) and PMOs $966 million. The company ended 2025 with $954 million in cash and cash equivalents.
For 2026, the company anticipates a non-GAAP profit of approximately $400 million (excluding Arrowhead transactions) and expects to be cash flow positive throughout the decade, growing its cash balance.
Sarepta is focused on expanding the reach of Elevidys, noting that 80% of the addressable ambulatory-only population remains untreated. Results from the Endeavor Cohort 8 trial for non-ambulatory patients are expected at the very back end of 2026.
The company will meet with the FDA by the end of Q1 2026 to discuss the pathway to traditional approval for its PMO therapies, Vyondys and Amondys.
Key milestones for the siRNA pipeline in 2026 include biomarker and safety data for FSHD (1001) and DM1 programs around the end of Q1 2026, and dosing patients in the Huntington's program in the first half of 2026.

Jan 12, 2026, 5:00 PM

Transcript

Sarepta Therapeutics Reports 2025 Financials and Outlines 2026 Strategic Priorities

SRPT

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

Sarepta Therapeutics reported $1.86 billion in total net product revenue for full year 2025, with Elevidys contributing $899 million and PMOs $966 million. The company ended 2025 with $954 million in cash and cash equivalents.
For 2026, Sarepta anticipates a non-GAAP profit of approximately $400 million and expects to add about $330 million in cash (both figures excluding Arrowhead transactions), projecting to be cash flow positive throughout the decade.
The company is focused on expanding Elevidys' reach, noting that 80% of the addressable ambulatory-only population remains untreated, and expects results from the Endeavor Cohort 8 trial for non-ambulatory patients by year-end 2026.
Sarepta plans to meet with the FDA by the end of Q1 2026 to discuss the pathway for traditional approval for its PMO therapies, which have demonstrated significant real-world evidence of slowing disease progression.
Key pipeline milestones for 2026 include biomarker and safety data for FSHD (1001) and DM1 programs by the end of Q1, and the initiation of patient dosing in the Huntington's program in the first half of the year.

Jan 12, 2026, 5:00 PM

Transcript

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