Sarepta Therapeutics, Inc. (SRPT): PESTLE Analysis [Nov-2025 Updated]

You need a clear, actionable breakdown of Sarepta Therapeutics, Inc.'s (SRPT) operating environment, especially after the turbulence of 2025. The core takeaway is that while the company's financial foundation remains strong, driven by ELEVIDYS, the regulatory and legal risks surrounding its core AAVrh74 gene therapy platform are now the single biggest near-term variable.

Political Headwinds: Regulatory Scrutiny and Pricing

The political environment for Sarepta Therapeutics, Inc. is dominated by the US Food and Drug Administration (FDA). Following the July 2025 clinical hold on AAVrh74-vector gene therapy trials, regulatory uncertainty has spiked. Honestly, the temporary revocation of the AAVrh74 vector's 'platform technology' designation is a major setback; it means future pipeline assets face a much higher regulatory burden. Still, the company's orphan drug status offers some insulation from the Inflation Reduction Act (IRA) drug price negotiation, but political pressure on high drug prices remains a constant threat.

Global market access is defintely a watchpoint, as international bodies like the European Medicines Agency will likely follow the FDA's lead on ELEVIDYS's safety profile. The FDA is the ultimate gatekeeper here.

Economic Reality: Strong Revenue, High Cost-Cutting

Sarepta Therapeutics, Inc. is navigating a sharp financial pivot. The good news is the full-year 2025 total product revenue guidance was revised to between $2.3 billion and $2.6 billion, which is a significant year-over-year increase. But, Q1 2025 non-GAAP Research & Development (R&D) expenses surged to $749 million, largely due to a massive upfront payment for the Arrowhead collaboration. Here's the quick math: to offset these costs and the regulatory uncertainty, the strategic restructuring in July 2025 aims to cut expenses by about $400 million annually starting in 2026, including a painful 36% workforce reduction. The market is also concerned about the company's ability to service its 2027 convertible notes debt if ELEVIDYS sales suffer a severe impact from safety issues. Cash flow is king, and cost control is now paramount.

Sociological Impact: Trust, Ethics, and $3.2 Million Price Tags

Patient trust is a critical factor after the tragic 2025 patient deaths linked to the AAVrh74 vector. This scrutiny affects the entire gene therapy sector, not just SRPT. Plus, high-cost, single-dose therapies like ELEVIDYS, priced around $3.2 million, face increasing ethical and payer scrutiny over value and access. It's hard to justify that cost to payers without rock-solid long-term data. To be fair, the company has a strong patient-centric mission focused on rare diseases like Duchenne muscular dystrophy (DMD), which provides a crucial social license to operate. Their corporate responsibility efforts also focus on Inclusion, Belonging, and Connection for employees, which helps with internal morale during tough times.

Technological Shift: The Pivot Away from AAVrh74

The core technology, the AAVrh74 gene therapy vector, is now under intense scrutiny, forcing a pipeline pivot. The company is strategically shifting to prioritize the small interfering RNA (siRNA) platform, acquired via the Arrowhead collaboration, for new indications like Myotonic Dystrophy Type 1. This is a smart move. The continued commercial success of the Phosphorodiamidate Morpholino Oligomer (PMO) exon-skipping franchise provides a stable, proven RNA technology base. Still, advancing gene editing capabilities is key to long-term competitive positioning against other biotech leaders, specifically Vertex Pharmaceuticals. They can't afford to be a one-trick pony.

Legal Risks: Black Boxes and Confirmatory Trials

The legal landscape is tightening. The FDA requested a black box warning be added to the ELEVIDYS label in July 2025 concerning the risk of acute liver injury and failure. This is a significant legal liability signal. The company must also complete the confirmatory ENVISION trial for non-ambulatory DMD patients to maintain accelerated approval for that population-a major regulatory hurdle. The complexity of compliance with a fragmented global regulatory environment is increasing after the FDA's high-profile actions in 2025. What this estimate hides is the potential legal risk of product liability claims stemming from the 2025 patient fatalities, which remains a factor that could impact future earnings.

Environmental Footprint: Necessary Compliance

Like any biotech, Sarepta Therapeutics, Inc.'s operations-R&D and manufacturing-contribute to negative impacts in GHG emissions and waste creation. They have an Environmental, Health, and Safety (EHS) policy and sponsor green initiatives like sustainable commuter benefits and 'green lab initiatives.' Environmental stewardship is a stated commitment in their corporate responsibility reporting, but honestly, this factor is not a material driver of the stock price or the near-term investment thesis. It's a box they need to check for compliance and stakeholder reporting.

Next Action:

Investment Team: Model the downside scenario for ELEVIDYS sales based on a 20% reduction due to the black box warning and the potential delay of the ENVISION trial data by the end of the week.

Sarepta Therapeutics, Inc. (SRPT) - PESTLE Analysis: Political factors

US Food and Drug Administration (FDA) regulatory uncertainty following the July 2025 clinical hold on AAVrh74-vector gene therapy trials.

The political environment for Sarepta Therapeutics, Inc. is dominated by the regulatory actions of the US Food and Drug Administration (FDA), particularly concerning the safety profile of its flagship gene therapy, ELEVIDYS (delandistrogene moxeparvovec-rokl). Following reports of fatal acute liver failure in non-ambulatory pediatric males, the FDA issued a CBER Safety Communication in June 2025, which led to the company voluntarily pausing shipments for this patient group. The uncertainty was partially resolved in November 2025 when the FDA approved an updated label that included a Boxed Warning for the risk of acute serious liver injury and acute liver failure.

This regulatory scrutiny resulted in a significant narrowing of the approved indication, which is now limited to ambulatory patients four years of age and older with Duchenne muscular dystrophy (DMD). This restriction immediately impacted revenue; ELEVIDYS net product revenue dropped from $375.0 million in Q1 2025 to $131.5 million in Q3 2025, a decrease largely attributed to the lower volume following the shipment suspension for non-ambulatory patients. This is a clear example of political/regulatory decisions directly translating into financial risk. Honestly, a single safety signal can derail a multi-billion dollar product overnight.

FDA's temporary revocation of the AAVrh74 vector's 'platform technology' designation increases future regulatory burden for pipeline assets.

The regulatory fallout extended beyond ELEVIDYS itself, impacting Sarepta's entire AAVrh74-vector platform. In July 2025, the FDA revoked the Platform Technology Designation for the AAVrh74 vector. This designation, which was intended to streamline the review process for multiple products using the same vector, was granted earlier in 2025. Its revocation increases the regulatory burden and uncertainty for Sarepta's pipeline assets, such as the investigational gene therapy for limb-girdle muscular dystrophy (LGMD), which was already placed on a clinical hold in June 2025.

The loss of this designation means that future gene therapies using the AAVrh74 vector will likely face more rigorous, individualized reviews, slowing down the time-to-market and increasing R&D costs. The political signal is that the FDA is prioritizing safety over accelerated review mechanisms in the gene therapy space, even if it means a slower path for rare disease treatments.

Political pressure on drug pricing remains high, though Sarepta's orphan drug status offers some insulation from the Inflation Reduction Act (IRA) price negotiation.

While Sarepta's regulatory challenges are severe, the political landscape for drug pricing provided a notable opportunity in 2025. The company's products, including ELEVIDYS, which has a list price of $3.2 million per dose, are insulated from the most immediate effects of the Inflation Reduction Act (IRA) price negotiation due to their Orphan Drug Designation (ODD) for a single indication (DMD).

Crucially, the political risk of losing this exemption was significantly mitigated in July 2025. On July 4, 2025, the Orphan Drug and Biologic Breakthrough Act (OBBB) was signed into law, which expands the IRA's exemption from Medicare price negotiation. This change ensures that orphan drugs designated for one or more rare diseases will be excluded from negotiation (starting in Initial Price Applicability Year (IPAY) 2028), provided they have no non-orphan indications. This legislative action removes a major near-term political risk for Sarepta, allowing it to pursue additional rare disease indications for its portfolio without triggering price controls on its high-value assets.

Global market access hinges on international regulatory bodies (like the European Medicines Agency) following the FDA's lead on ELEVIDYS's safety profile.

Sarepta's global political and market access strategy suffered a major setback in Europe. In July 2025, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the conditional marketing authorization (CMA) for ELEVIDYS. This decision was primarily based on the pivotal Phase 3 EMBARK study, which failed to show a statistically significant difference in the primary endpoint (North Star Ambulatory Assessment (NSAA) score) at 52 weeks.

The negative EMA opinion, coupled with the FDA's safety-driven label narrowing, creates significant political pressure in other international markets. The EMA's focus on the lack of statistically significant efficacy, even as the FDA tightened safety warnings, demonstrates a lack of regulatory alignment between the two major bodies, complicating global expansion. Sarepta's partner, Roche, must now work with the EMA to explore a path forward, but the negative ruling puts the hundreds of millions of dollars in expected ex-US revenue at risk.

• Negative EMA opinion issued in July 2025.
• Opinion based on EMBARK study not meeting its primary endpoint.
• FDA's safety actions and EMA's efficacy concerns create a global market disconnect.

Sarepta Therapeutics, Inc. (SRPT) - PESTLE Analysis: Economic factors

The economic outlook for Sarepta Therapeutics is defined by a sharp, proactive pivot in 2025, following a significant revenue guidance cut and massive one-time research and development (R&D) expenses. The company's financial health is now a balancing act between the growth of its core Duchenne Muscular Dystrophy (DMD) franchise and the management of substantial debt obligations.

You need to focus on two things: the immediate cash drain from strategic investments and the long-term debt restructuring that bought the company time. Honestly, the restructuring was a necessary move to stabilize the balance sheet after the ELEVIDYS safety concerns hit the market.

Full-year 2025 total product revenue guidance was revised to $2.3 billion to $2.6 billion, still representing a significant year-over-year increase.

Sarepta revised its full-year 2025 total net product revenue guidance downward in May 2025, moving the range from the previous forecast of $2.9 billion to $3.1 billion to a new range of $2.3 billion to $2.6 billion. This reduction was a direct result of an updated outlook for ELEVIDYS, their flagship gene therapy for DMD, following initial commercial headwinds and patient safety concerns.

Despite the cut, the revised midpoint still represents approximately 37% year-over-year growth, indicating that their core RNA-based PMO franchise (like EXONDYS 51, VYONDYS 53, and AMONDYS 45) and the initial uptake of ELEVIDYS continue to drive substantial sales. For example, Q1 2025 net product revenue was $611.5 million, a 70% increase year-over-year, with ELEVIDYS contributing $375.0 million of that. However, preliminary Q2 2025 ELEVIDYS net product revenue dropped sequentially to $282 million, underscoring the immediate economic sensitivity to regulatory and safety developments.

Q1 2025 non-GAAP R&D expenses surged to $749 million, largely due to a major upfront payment for the Arrowhead collaboration.

The first quarter of 2025 saw a massive spike in non-GAAP research and development (R&D) expenses, totaling $749.2 million, compared to just $178.1 million in the same period of 2024. This surge was not due to operational burn but a strategic, one-time investment. The bulk of this increase-specifically $584 million-was attributed to the upfront and milestone expenses associated with the global licensing and collaboration agreement with Arrowhead Pharmaceuticals.

This transaction, while strategically sound for diversifying the pipeline into small interfering RNA (siRNA) therapies, caused a significant non-GAAP net loss of $332.5 million for the quarter. Here's the quick math on the expense shift:

• Q1 2025 Non-GAAP R&D: $749.2 million
• Q1 2025 Arrowhead Transaction Cost: $584 million
• Q1 2025 Operating R&D (Excluding Arrowhead): ~$165.2 million

Strategic restructuring in July 2025 aims to cut expenses by about $400 million annually starting in 2026, including a 36% workforce reduction.

In July 2025, Sarepta announced a major strategic restructuring to enhance operational efficiency and bolster its financial foundation following the ELEVIDYS challenges. This decisive action is projected to deliver approximately $400 million in annual cost savings starting in 2026.

The restructuring includes a significant workforce reduction of 36%, impacting approximately 500 employees, which is expected to save about $120 million in annual cash costs in 2026. The rest of the savings, about $300 million annually, will come from pipeline reprioritization, shifting focus from a broad gene therapy portfolio to the high-impact siRNA platform acquired through the Arrowhead deal. This is defintely a move to ensure long-term, sustainable profitability.

Analyst concern over the company's ability to service its 2027 convertible notes debt if ELEVIDYS sales are severely impacted by safety issues.

A critical economic risk has been the company's substantial debt load, particularly the convertible senior notes due in September 2027, which had an aggregate principal value of $1.15 billion. The uncertainty surrounding ELEVIDYS sales-especially after the FDA requested a black box warning and temporarily paused shipments for non-ambulatory patients-raised serious concerns about Sarepta's ability to generate sufficient cash flow to meet this obligation.

To address this, Sarepta executed a crucial debt refinancing in August 2025. They exchanged approximately $700 million of the original 1.25% notes due 2027 for $602 million in new 4.875% convertible notes due 2030, plus $123.3 million in cash and stock. This move successfully pushed the maturity date for the majority of the debt back by three years, significantly easing the near-term liquidity pressure. As a result, approximately $450 million of the original 2027 notes remain outstanding.

The table below summarizes the key financial shifts in 2025:

Sarepta Therapeutics, Inc. (SRPT) - PESTLE Analysis: Social factors

Significant public and patient advocacy scrutiny due to the tragic 2025 patient deaths linked to the AAVrh74 vector, affecting trust in gene therapy

The core social challenge for Sarepta Therapeutics in 2025 is the profound loss of public and patient trust following several fatal adverse events. In July 2025, the FDA confirmed it had received three reports of fatal acute liver failure linked to the company's AAVrh74 adeno-associated virus vector-based gene therapies. Two of these deaths were in non-ambulatory pediatric Duchenne muscular dystrophy (DMD) patients treated with ELEVIDYS (delandistrogene moxeparvovec-rokl), and a third was in an adult patient in a clinical trial for Limb-Girdle Muscular Dystrophy (LGMD). This is a massive blow to the social license to operate, especially in the rare disease space where patient advocacy groups are highly influential.

Honestly, the immediate fallout was a public health crisis and a regulatory one. The FDA requested a suspension of ELEVIDYS distribution and placed clinical trials using the AAVrh74 vector on hold. Sarepta Therapeutics later agreed to pause U.S. shipments of ELEVIDYS. The resulting safety concerns prompted some families to delay treatment, which the company cited as a factor in revising its 2025 annual revenue guidance. This is a clear example of how a safety signal in a rare disease therapy can immediately impact both patient behavior and financial performance.

The patient deaths led to a major change in the drug's official prescribing information, which now includes a Boxed Warning (often called a black box warning) for acute liver injury and acute liver failure. This is a defintely serious signal for any drug, but especially for a single-dose gene therapy.

High-cost, single-dose gene therapies like ELEVIDYS (priced around $3.2 million) face increasing ethical and payer scrutiny over value and access

The price of ELEVIDYS, a one-time, single-dose intravenous infusion, remains a significant social and ethical flashpoint. The drug is priced at $3.2 million, placing it among the most expensive medicines globally. This staggering cost immediately raises questions about equitable access, particularly for a rare disease that primarily affects children.

To be fair, the company has defended the price, citing a company-sponsored study that suggested the therapy would be cost-effective at prices between $5 million and $13 million, meaning the actual price is 'conservative.' Still, for payers (insurance companies and government programs) and the public, a $3.2 million price tag for a single treatment invites intense scrutiny on the long-term value proposition, especially with the added safety concerns in 2025. Sarepta Therapeutics has to constantly collaborate with health networks and payers to 'rethink pricing models' for these revolutionary treatments, which is a massive administrative and social burden. The sheer cost means access is heavily mediated by the patient's insurance coverage, which introduces a layer of social inequality.

Strong patient-centric mission focused on rare diseases like Duchenne muscular dystrophy (DMD) provides a social license to operate and robust patient support programs

Despite the safety setbacks, Sarepta Therapeutics maintains a strong social license to operate, largely due to its unwavering and long-standing focus on ultra-rare diseases like DMD. The company's mission is deeply patient-centric, which is a powerful social asset in the biotechnology sector.

This commitment translates into tangible support programs that help mitigate the social and logistical stress on patient families. The SareptAssist program, for instance, provides dedicated case managers to help U.S. patients and families navigate complex issues like insurance benefits, financial assistance options, and treatment logistics. The company's Patient Affairs team is also highly engaged, issuing multiple 'Community Letters' in 2025 to directly communicate safety updates and label changes, demonstrating an effort to maintain transparency with the Duchenne muscular dystrophy community.

The company also provides significant financial support to the community:

• Provides grants, donations, and sponsorships to patient advocacy groups.
• Prioritizes funding for organizations focused on Duchenne muscular dystrophy and Limb-Girdle Muscular Dystrophy.
• The Patient Affairs team ensures the patient voice is integrated from the earliest stages of drug development through to access.

The company's corporate responsibility efforts include a focus on Inclusion, Belonging, and Connection for its employees

Sarepta Therapeutics's internal social environment and corporate responsibility efforts are focused on fostering a culture of Inclusion, Belonging, and Connection (IBC). This focus is a key part of their broader Environmental, Social, and Governance (ESG) commitment, which helps attract and retain talent in a highly competitive industry.

The company strives to deliver a 'belonging-focused employee experience' across well-being and professional development. They use Employee Resource Groups (ERGs) to support this goal. For example, the ERG named DisCO is specifically dedicated to amplifying a culture of belonging for the disability community and their allies. This is a smart move, connecting their internal culture directly to their external mission of serving patients with disabilities. The company's focus on meritocracy and diverse perspectives is crucial for driving the innovative science that underpins their entire business model.

Sarepta Therapeutics, Inc. (SRPT) - PESTLE Analysis: Technological factors

Core technology, the AAVrh74 gene therapy vector, is under intense scrutiny, forcing a pivot to other platforms.

The technological foundation of Sarepta Therapeutics, Inc. is undergoing a forced, high-stakes re-evaluation in 2025. The core adeno-associated virus (AAV) vector, specifically AAVrh74, used in the gene therapy Elevidys (delandistrogene moxeparvovec-rokl), has faced intense regulatory scrutiny following adverse events. This scrutiny peaked in July 2025 when the FDA revoked the AAVrh74 platform technology designation, a status initially granted to accelerate future vector-based programs.

This revocation, which followed three confirmed patient fatalities from acute liver failure (ALF) linked to AAVrh74-based therapies, has necessitated a sharp pivot. The agency's subsequent action in November 2025 was to update the Elevidys label, explicitly removing the indication for non-ambulatory Duchenne muscular dystrophy (DMD) patients due to a heightened risk profile. The company has responded by announcing a strategic restructuring in July 2025, which includes a 36% workforce reduction (approximately 500 employees) and a plan to generate $400 million in annual cost savings starting in 2026. That's a decisive move to de-risk the portfolio.

Strategic pipeline shift prioritizes the small interfering RNA (siRNA) platform, acquired via the Arrowhead collaboration, for new indications like Myotonic Dystrophy Type 1.

The strategic pivot is clearly directing resources toward the small interfering RNA (siRNA) platform, a technology that modulates gene expression by silencing specific messenger RNA (mRNA). This platform, largely secured through a multi-billion-dollar licensing deal with Arrowhead Pharmaceuticals, now represents the company's most promising near-term growth driver outside of the DMD market.

The lead asset in this new focus is SRP-1003 for Myotonic Dystrophy Type 1 (DM1). The program is advancing quickly, demonstrating the company's commitment to the new platform. In November 2025, the progress of the Phase 1/2 study for SRP-1003 triggered a second, significant milestone payment of $200 million to Arrowhead Pharmaceuticals. This is real capital being deployed to validate a new technological path.

The siRNA pipeline is broad, targeting multiple rare diseases:

• SRP-1003 for Myotonic Dystrophy Type 1 (DM1)
• SRP-1001 for Facioscapulohumeral muscular dystrophy (FSHD)
• SRP-1004 for Spinocerebellar ataxia type 2 (SCA2)
• SRP-1002 for Idiopathic pulmonary fibrosis (IPF)

Continued commercial success of the Phosphorodiamidate Morpholino Oligomer (PMO) exon-skipping franchise provides a stable, proven RNA technology base.

While the gene therapy platform faces headwinds, the Phosphorodiamidate Morpholino Oligomer (PMO) exon-skipping franchise remains a stable, revenue-generating technological anchor. This technology, which includes on-market therapies like Exondys 51 (eteplirsen), Vyondys 53 (golodirsen), and Amondys 45 (casimersen), provides a continuous, reliable revenue stream that funds the riskier, next-generation pipeline.

The PMO franchise's continued commercial success provides essential financial stability. For the second quarter of 2025, the Duchenne muscular dystrophy franchise (PMOs plus Elevidys) generated a total net product revenue of $513 million. Of this, the RNA-based PMO products contributed approximately $231 million. The company's full-year 2025 total net product revenue guidance remains strong, projected to be between $2.9 billion and $3.1 billion.

Here's the quick math on the core technology platforms' recent performance:

Advancing gene editing capabilities is key to long-term competitive positioning against other biotech leaders like Vertex Pharmaceuticals.

To secure its long-term competitive position, especially against well-capitalized biotech leaders, Sarepta must move beyond its current RNA and AAV technologies into gene editing (a permanent modification of the disease-causing gene). Vertex Pharmaceuticals, for example, has already established a dominant position in the gene editing space through its collaboration with CRISPR Therapeutics, which led to the FDA-approved Casgevy (Exa-cel) for severe blood disorders. That's the bar for true technological leadership.

Sarepta's advancement in this area is still in the preclinical phase, focusing on next-generation delivery. The company has a collaboration with GenEdit, announced in 2022, to use GenEdit's non-viral NanoGalaxy polymer nanoparticle platform to deliver Sarepta's proprietary gene editing technology specifically to muscle tissue. This non-viral delivery method is an attempt to sidestep the systemic toxicity issues that have plagued the AAV vector platform. The goal is to identify development candidates for up to four neuromuscular indications, but the lack of a clinical-stage gene editing program means Sarepta is defintely playing catch-up in this transformative technology.

Sarepta Therapeutics, Inc. (SRPT) - PESTLE Analysis: Legal factors

FDA Black Box Warning and Acute Liver Injury Risk

You're watching Sarepta Therapeutics navigate the toughest regulatory environment for gene therapy since the sector's inception, and the near-term legal risks are centered squarely on ELEVIDYS (delandistrogene moxeparvovec-rokl). The Food and Drug Administration (FDA) formally requested a Boxed Warning-the most serious level-for ELEVIDYS in July 2025, which was finalized in November 2025. This warning alerts physicians to the risk of acute serious liver injury and acute liver failure, including fatal outcomes.

This action was a direct response to safety concerns that escalated in June 2025 after two non-ambulatory pediatric patients died from acute liver failure following treatment. The new labeling significantly restricts the market, limiting the approved use to only ambulatory patients aged four years and older. The non-ambulatory indication has been removed. That's a massive legal and commercial headwind.

The revised labeling also mandates a stricter monitoring protocol to mitigate risk:

• Weekly liver function testing for at least three months post-infusion.
• Patients are advised to remain near a medical facility for at least two months post-treatment.
• The drug is contraindicated for patients with pre-existing liver impairment or recent infection.

Confirmatory Trial Status and Accelerated Approval

The accelerated approval pathway for gene therapies requires a successful confirmatory trial to prove clinical benefit, and for Sarepta, this was the ENVISION trial (Study SRP-9001-303) for non-ambulatory Duchenne Muscular Dystrophy (DMD) patients. Following the fatalities, Sarepta voluntarily paused dosing in the ENVISION study in June 2025, with the FDA concurring. Since the non-ambulatory indication is now being formally removed from the commercial label, the legal requirement to complete ENVISION for that population is effectively mooted for the time being.

Here's the quick math on the regulatory pivot: Sarepta is now working with the FDA on a new registrational study, likely Cohort 8 of the Endeavor trial, to test an enhanced immunosuppressive regimen. The goal is to gather data that could eventually support re-adding the non-ambulatory patient group to the label. The initial approval was contingent; the new path is a fresh, high-stakes regulatory submission. The company defintely needs this new data.

Fragmented Global Regulatory Environment

Compliance is a fragmented global challenge, and 2025 highlighted this complexity. The high-profile FDA scrutiny was mirrored by a major setback in Europe. The European Medicines Agency (EMA) formally rejected ELEVIDYS on July 24, 2025, concluding the data did not demonstrate clear benefits for DMD patients. Sarepta's ex-U.S. partner, Roche, immediately paused all dosing in non-ambulatory individuals globally in June 2025, showing the immediate, worldwide impact of the U.S. safety events. The lack of a unified global regulatory view on ELEVIDYS's risk/benefit profile adds significant legal and commercial uncertainty for international expansion.

Product Liability Claims and Financial Impact

The legal risk of product liability claims is substantial and ongoing. In 2025, the FDA received reports of three fatal acute liver failure cases linked to Sarepta's AAVrh74 gene therapy platform: two in non-ambulatory DMD patients receiving ELEVIDYS and one in an adult LGMD patient in a clinical trial of SRP-9004. These fatalities are the foundation for a securities class action lawsuit, Dolgicer v. Sarepta Therapeutics, Inc., alleging the company misled investors about the safety and approval prospects of ELEVIDYS.

The market reaction illustrates the financial severity of the legal and safety disclosures:

Beyond the market cap loss, Sarepta announced in July 2025 a layoff of 500 employees, representing 36% of its staff, directly tied to the regulatory and safety headwinds. This is a clear, material financial consequence of the legal and safety issues.

Sarepta Therapeutics, Inc. (SRPT) - PESTLE Analysis: Environmental factors

The environmental factors for Sarepta Therapeutics, Inc. are primarily driven by the resource-intensive nature of biotechnology research and manufacturing, specifically in gene therapy production. While the company is actively establishing a formal Environmental, Health, and Safety (EHS) framework, the core challenge is mitigating the environmental footprint that naturally scales with business growth, especially as product revenue guidance for 2025 is projected between $2.3 billion and $2.6 billion, indicating significant operational activity.

The company has an Environmental, Health, and Safety policy and sponsors green initiatives like sustainable commuter benefits.

Sarepta has a published Environmental, Health, and Safety (EHS) policy, which establishes a formal commitment to regulatory compliance and risk mitigation. This policy is communicated to all employees and contractors from their start date. The company is actively sponsoring green initiatives to reduce its Scope 3 (indirect) emissions, mainly from employee travel. These programs are a concrete step toward environmental stewardship (the responsible use and protection of the natural environment through conservation and sustainable practices).

• Offer fully subsidized public transportation for commuters.
• Provide access to electric vehicle (EV) charging stations at key locations (Andover, MA; Burlington, MA; and Cambridge, MA).
• Offer discounts for bike-sharing programs to encourage low-carbon commuting.
• Implement flexible work arrangements, like remote and hybrid options, to reduce daily travel impact.

Operations, typical for R&D and manufacturing, contribute to negative impacts in GHG emissions and creating all types of waste.

As a growing leader in precision genetic medicine, Sarepta's operations-especially the research and development (R&D) and manufacturing of its gene therapies like ELEVIDYS-generate significant environmental impacts, particularly in energy use, greenhouse gas (GHG) emissions, and material waste. The company has identified energy, water, material and hazardous waste, and transportation as the largest contributors to its environmental footprint. Here's the quick math on the most recent reported baseline data from the 2023 Sustainability Report, which informs the 2025 strategy:

The overall reduction in Scope 1 and 2 GHG emissions, totaling a 37% drop to 6,129 metric tons of $\text{CO}_2$e in 2023, is a strong positive trend. But, the massive increase in hazardous waste to 135 metric tons in 2023 is a clear near-term risk that demands focused action and investment in specialized waste management, especially as manufacturing scales up in 2025.

Focus on 'green lab initiatives' and recycling programs aims to mitigate the environmental footprint of research and production facilities.

To directly address the high-impact areas of R&D and manufacturing, Sarepta has implemented 'green lab initiatives' and recycling programs. These are essential for mitigating the high energy and waste intensity of laboratory work, where constant ventilation, cooling, and specialized equipment are necessary. You have to be defintely aggressive on lab efficiency to move the needle in biotech.

Concrete actions taken to reduce the environmental footprint of facilities include:

• Implementing nighttime and weekend setback programs for lighting and heating at most sites, including all laboratories.
• Undertaking a companywide re-lamping initiative to replace older compact fluorescent and metal halide bulbs with energy-efficient Light Emitting Diode (LED) technology in offices and the Andover, MA, site parking lot.
• Maintaining recycling programs for non-hazardous materials across facilities.

Environmental stewardship is a stated commitment in their corporate responsibility reporting.

Environmental stewardship is a stated core pillar in Sarepta Therapeutics' corporate responsibility reporting, a clear signal to investors and regulators that ESG (Environmental, Social, and Governance) factors are being formally integrated into their strategy. They recognize the vital connections between planetary health and human health, which is a strong narrative for a company focused on life-altering medicines. This commitment is supported by the formal tracking and measurement tools they've established to collect data on energy consumption, water use, material and hazardous waste, and GHG emissions, using 2022 as a baseline year. They are also evaluating their performance based on guidance from the Task Force on Climate-related Financial Disclosures (TCFD).

- Environmental stewardship is a stated commitment in their corporate responsibility reporting.

The company's commitment to environmental stewardship is a strategic move to manage long-term risk and align with investor expectations. Sarepta's overall net impact ratio, a measure of holistic value creation, is reported at a positive 62.3%, but this positive impact is achieved while causing negative impacts in categories like GHG emissions, highlighting the ongoing tension between their mission and their operational footprint. The next step for the company is to set concrete, time-bound reduction targets for waste and emissions that go beyond the 2023 baseline, particularly in the hazardous waste category.