Sarepta Therapeutics (SRPT) Company Report

Sarepta Therapeutics has made a $200 million milestone payment to Arrowhead Pharmaceuticals.
This payment is for the advancement of the Phase 1/2 clinical trial of ARO-DM1 (SRP-1003), an RNA interference treatment for type 1 myotonic dystrophy.
The trial has progressed, with dose escalation approved and patient enrollment targets met, and plans to initiate cohort 5 at a 12 mg/kg dose in early 2026.

Nov 24, 2025, 12:40 PM

Morningstar

Sarepta Therapeutics Faces Investigation Following Gene Therapy Trial Failure

SRPT

Legal Proceedings

New Projects/Investments

Pomerantz LLP is investigating Sarepta Therapeutics, Inc. for potential securities fraud or other unlawful business practices.
This investigation follows Sarepta's disclosure on November 3, 2025, that its late-stage ESSENCE trial for two gene therapies, AMONDYS 45 and VYONDYS 5, did not meet statistical significance on its primary endpoint.
These gene therapies are aimed at treating Duchenne muscular dystrophy.
Following this news, Sarepta's stock price fell $8.25 per share, or 33.74%, to close at $16.20 per share on November 4, 2025.

Nov 20, 2025, 3:00 PM

Press Release

Sarepta's Elevidys Receives Boxed Warning and Restricted Use by FDA

SRPT

The FDA has mandated significant labeling changes for Sarepta Therapeutics' gene therapy Elevidys, including a Boxed Warning, due to fatal cases of acute liver failure in non-ambulatory pediatric patients with Duchenne muscular dystrophy (DMD).
Elevidys' approved use is now restricted to ambulatory patients aged four and older with a confirmed DMD gene mutation, and it is contraindicated in patients with deletions involving DMD exons 8 and/or 9.
Sarepta is required to conduct a postmarketing observational study monitoring liver function in approximately 200 DMD patients over at least 12 months.

Nov 14, 2025, 7:06 PM

Bloomberg

Sarepta Therapeutics Reports Mixed Q3 2025 Results and Strategic Financial Actions

SRPT

Earnings

Debt Issuance

New Projects/Investments

Sarepta Therapeutics reported mixed third-quarter 2025 financial results, with revenues of approximately $399 million beating analyst expectations, despite a year-over-year decline, and a non-GAAP EPS loss of $0.13 which exceeded estimates. The company is strengthening its financial foundation by refinancing $700 million in convertible notes, extending debt maturities to 2030, and achieving expense savings.
The ESSENCE Phase 3 trial for its PMO therapies showed positive trends in slowing disease progression, including a 30% reduction when excluding COVID-19 impact, and Sarepta plans to seek FDA discussions for traditional approval. Discussions are also ongoing with the FDA regarding safety labeling for Elevidys, potentially including a box warning.
Sarepta is preparing to join the S&P SmallCap 600 index. Its share price has rebounded nearly 46% over the past 90 days, though the 1-year total shareholder return remains at -80%.

Nov 3, 2025, 10:17 PM

Morningstar

Sarepta Therapeutics Reports Q3 2025 Financial Results and Provides Updates on ESSENCE Trial and Elevidys Label

SRPT

Earnings

Guidance Update

New Projects/Investments

Sarepta Therapeutics reported Q3 2025 total revenues of $399 million, including $370 million in net product revenues from Elevidys and PMOs.
The ESSENCE trial for Vyondys and Amondys did not meet its primary endpoint for statistical significance but demonstrated a 30% to 35% reduction in disease progression in post-hoc and prognostic score analyses, with plans to discuss traditional approval with the FDA.
For Elevidys, the company agreed to a black box warning for ALI and ALF and the removal of non-ambulatory patients from the indication; however, they reiterated a $500 million annual revenue opportunity floor for the ambulant population.
Sarepta took proactive steps to strengthen its financial position, including a debt exchange reducing 2027 maturities to $450 million and incurring $41 million in restructuring costs in Q3, while increasing cash and investments to $865 million.

Nov 3, 2025, 9:30 PM

Transcript

Sarepta Therapeutics Announces Q3 2025 Financial and Clinical Updates

SRPT

Earnings

Guidance Update

New Projects/Investments

Sarepta Therapeutics reported Q3 2025 ELEVIDYS revenue of $131 million and PMO product revenue of $239 million, with ELEVIDYS demonstrating resilience despite disruptions and PMOs delivering strong performance.
The company completed the ESSENCE confirmatory trial for AMONDYS and VYONDYS, which missed its primary endpoint but showed clinically favorable trends, and plans to meet with the FDA to discuss a path to traditional review.
For ELEVIDYS, the FDA agreed to a black box warning and the removal of the non-ambulatory population from the Indication and Usage section of the Prescribing Information.
Sarepta executed a financial strategy in Q3 2025, including a convertible debt exchange on August 28, 2025, extending maturity to 2030, and would have reported an operating profit excluding certain charges.
Upcoming R&D milestones include an FDA meeting for SRP-9003 in Q4 2025 and preliminary data for DM1 and FSHD studies in early 2026.

Nov 3, 2025, 9:30 PM

Presentation

Sarepta Therapeutics Announces Q3 2025 Financial Results and ESSENCE Study Completion

SRPT

Earnings

Layoffs

Debt Issuance

Sarepta Therapeutics reported net product revenues of $370.0 million for the third quarter of 2025, comprising $238.5 million from PMO and $131.5 million from ELEVIDYS. Total revenues for the quarter were $399.4 million, a decrease from Q3 2024, primarily due to $49.5 million less in net product revenue of ELEVIDYS following a decision to suspend shipments to non-ambulatory patients in June 2025.
The company completed its confirmatory ESSENCE study for AMONDYS 45 and VYONDYS 53, which, while not achieving statistical significance on its primary endpoint, indicated positive and encouraging trends and supported a favorable safety profile. Sarepta intends to schedule a meeting with the FDA to discuss a path to traditional approval based on these results and real-world evidence.
For Q3 2025, Sarepta reported a GAAP net loss of $179.9 million and a non-GAAP net loss of $12.9 million, with diluted GAAP loss per share of $1.80 and non-GAAP loss per share of $0.13.
The company strengthened its financial position through the refinancing of a majority portion of its 2027 Notes and cost restructuring initiatives, which included $40.5 million in restructuring charges and resulted in a $138.6 million loss on debt extinguishment in Q3 2025.

Nov 3, 2025, 9:18 PM

8-K

Sarepta Therapeutics Completes Convertible Note Exchange and Private Placement

SRPT

Debt Issuance

Sarepta Therapeutics, Inc. entered into agreements on August 20, 2025, to exchange $700.0 million in aggregate principal amount of its 1.25% Convertible Senior Notes due 2027.
The consideration for this exchange included $602.0 million in aggregate principal amount of new 4.875% Convertible Senior Notes due 2030, 5,851,693 shares of common stock, and approximately $123.3 million in cash.
The new 4.875% Convertible Senior Notes due 2030 were issued on August 28, 2025, mature on September 1, 2030, and have an initial conversion price of approximately $60.00 per share, representing a 191.5% conversion premium based on the August 20, 2025, common stock price of $20.58.
Concurrently, the company completed a private placement of 1,106,806 shares of common stock at a purchase price of $18.07 per share.

Aug 29, 2025, 8:18 PM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for Sarepta Therapeutics.

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