Sarepta Therapeutics

Sarepta Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which is engaged in the discovery and development of therapeutics for the treatment of rare diseases. The company was founded on July 22, 1980, and is headquartered in Cambridge, MA.

Earnings data Q1 2021

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Earnings data Q4 2024

Sarepta reports robust earnings, poised for gene therapy milestone

Sarepta Therapeutics delivered strong financial performance in Q4 2022, driven by revenue growth and positive market reception of its RNA-based PMO therapies.
While facing challenges in managing expenses and navigating regulatory uncertainties, the company is strategically positioned to capitalize on growth opportunities in gene therapy and market expansion.
By focusing on innovation, operational readiness, and market access, Sarepta aims to secure a leading position in Duchenne muscular dystrophy treatment and drive sustainable revenue growth.

Sarepta Therapeutics exceeds Q1 revenue expectations, poised for growth

Sarepta Therapeutics delivered strong financial results in Q1 2023, exceeding expectations and showcasing market confidence in their growth trajectory.
The company's proactive approach to patient access, payer engagement, and therapy development highlights their commitment to addressing unmet medical needs and advancing innovative treatments.
While facing pricing challenges and regulatory decisions, Sarepta's focus on research, partnerships, and therapy expansion presents opportunities for sustained growth and impact.
With a robust pipeline, positive payer discussions, and ongoing studies, Sarepta is poised to make a significant difference in treating rare diseases and improving patient outcomes.

Sarepta Therapeutics excels in Q2 with ELEVIDYS approval and patient-focused strategies

Sarepta Therapeutics demonstrated strong performance in Q2 2023 with positive revenue growth and progress in clinical studies and commercial activities.
Despite challenges in administrative processes and label expansion, the company's focus on patient care and operational efficiency remains a key strength.
Opportunities lie in broadening therapy access, addressing limitations, and streamlining patient access post label expansion for enhanced market reach and treatment efficiency.

Sarepta Therapeutics excels in Q3 earnings, eyes label expansion

Sarepta Therapeutics delivered robust financial performance in Q3 2023, driven by the success of ELEVIDYS and PMOs. Despite challenges in regulatory processes and market competition, the company's strategic focus on label expansion and patient access presents significant growth opportunities.

Sarepta Therapeutics reports robust Q4 earnings and targets pipeline expansion

Sarepta Therapeutics delivered strong financial results in Q4 2023, showcasing revenue growth and profitability. Despite facing challenges such as potential margin declines and clarity issues, the company is well-positioned to capitalize on opportunities for pipeline advancement and expansion.

Sarepta Therapeutics excels in Q1 earnings, eyes label expansions

Sarepta Therapeutics delivered strong financial performance in Q1 2024, driven by robust revenue growth and steady demand for key products like ELEVIDYS.
The company's strategic focus on label expansions and innovative R&D efforts positions it well for future success in addressing unmet medical needs and driving market expansion.
While facing challenges in patient demographics and operational readiness, Sarepta remains well-capitalized and poised to capitalize on upcoming opportunities for growth and market leadership.

Sarepta Therapeutics reports robust Q2 revenue and eyes therapy expansion

Sarepta Therapeutics is experiencing strong revenue growth driven by ELEVIDYS, with a focus on patient outcomes and manufacturing capacity. Challenges include addressing bottlenecks and patient prioritization, while opportunities exist in therapy development and market expansion.

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Sarepta (SRPT) sells its priority review voucher that was awarded following the FDA's approval to Elevidys gene therapy for treating DMD. The company will invest these proceeds into R&D.

Sarepta (SRPT) Sells Priority Review Voucher for $102M

Sarepta Therapeutics Inc. SRPT, -0.90% said Wednesday it has completed the sale of its Rare Pediatric Disease Priority Review Voucher for $102 million and will use the proceeds for R&D. Sarepta was awarded the voucher by the Food and Drug Administration after the agency granted accelerated approval of Elevidys for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

Sarepta Therapeutics completes sale of priority review voucher for $102 million

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced it had completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV). Sarepta received a payment of $102 million upon completion of the sale. Sarepta was awarded the PRV following U.S. Food and Drug Administration (FDA) accelerated approval of ELEVIDYS (delandistrogene moxeparvovec-rokl) for the treatment of ambulatory pediatri.

Sarepta Therapeutics Announces Sale of Priority Review Voucher for $102 million

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will participate in a fireside chat at Cowen's 2nd Annual RNA Therapeutics Summit on Monday, July 10, 2023 at 11:00 a.m. E.T. The fireside chat will be held virtually. The presentation will be webcast live under the Events & Presentations section of the investor relations section of Sarepta's website at https://invest.

Sarepta Therapeutics to Present at Cowen's 2nd Annual RNA Therapeutics Summit

Sarepta recently secured conditional approval for its gene-editing therapy. But the therapy's high price tag might slow down its uptake among patients.

Sarepta Therapeutics' Stock Is Down 14% in 1 Month, So Why Does Wall Street Expect It to Rise 65%?

On May 15, Sarepta Therapeutics Inc. NASDAQ: SRPT learned that its treatment for Duchenne muscular dystrophy (DMD) was recommended for approval by the Food and Drug Administration (FDA) advisors. Naturally, the stock jumped more than 30% to a two-year high.

Sarepta Therapeutics Gets FDA Nod, Drops Warning (or Opportunity?)

Following FDA???s approval, Sarepta's (SRPT) Elevidys becomes the first gene therapy for treating DMD.

Sarepta (SRPT) Gets FDA's Accelerated Nod for DMD Gene Therapy

Sarepta Therapeutics shares slumped 11% on Friday as some analysts voiced concerns that upcoming confirmatory trial data for its gene therapy to treat Duchenne muscular dystrophy (DMD) may not be enough to secure approval for expanded use.

Sarepta slumps as concerns emerge around upcoming gene therapy data

The $3.2 million one-time treatment is the first gene therapy approved to treat DMD, a progressive and fatal condition that manifests in early childhood.

Sarepta's Gene Therapy Approval Lands With a Thud

Sarepta Therapeutics Inc. SRPT, -2.33%, which yesterday scored a win with U.S. Food and Drug Administration approval of the first gene therapy for children with Duchenne muscular dystrophy, was downgraded Friday by analysts who are skeptical that Sarepta can expand the treatment's narrow label. The treatment, Elevidys, was approved under the FDA's accelerated approval pathway, which gives patients access to promising new treatments while the company conducts trials to confirm the expected clinical benefit.

Sarepta Therapeutics downgraded at Evercore ISI after FDA approval of gene therapy

Sarepta Therapeutics Inc (NASDAQ:SRPT) said the US Food and Drug Administration (FDA) has accelerated approval for ELEVIDYS, its first-of-a-kind gene therapy for Duchenne muscular dystrophy (DMD). DMD is an inherited progressive muscle-wasting disorder that generally affects young boys.

Sarepta Therapeutics announces FDA approval of first gene therapy to treat Duchenne muscular dystrophy

WASHINGTON — The first gene therapy for a deadly form of muscular dystrophy received preliminary U.S. approval on Thursday despite concerns from some government scientists about the treatment's ability to help boys with the inherited disease.

First gene therapy for deadly form of muscular dystrophy gets FDA approval for young kids

The drug, from Sarepta Therapeutics, promises to repair the defective gene at the root of the fatal disorder, but is expected to cost millions of dollars.

The Price of First Gene Therapy for Muscular Dystrophy: $3.2 Million

The decision marks the first approval of a gene therapy to treat DMD, a fatal and progressive disease that manifests in young children.

FDA Approves Sarepta's Gene Therapy for Duchenne Muscular Dystrophy

Sarepta won approval Thursday for its highly anticipated Duchenne muscular dystrophy gene therapy. SRPT stock yo-yoed in response.

Sarepta Stock Yo-Yoes After Winning Highly Anticipated Gene Therapy Nod

Sarepta Therapeutics Inc. SRPT, +0.60% said Thursday that the Food and Drug Administration approved its Elevidys gene therapy to treat the rare genetic disorder Duchenne muscular dystrophy, or DMD. Sarepta shares rose 2% in recent activity, following a brief halt, while the S&P 500 index SPX, +0.17% was up 0.2%.

Sarepta gets FDA approval for rare genetic disorder treatment

The U.S. drug regulator on Thursday granted accelerated approval to Sarepta Therapeutics' first-of-its-kind gene therapy for Duchenne muscular dystrophy (DMD), an inherited progressive muscle wasting disorder that almost always affects young boys.

US FDA approves Sarepta's gene therapy for rare muscular dystrophy in some kids

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics announces the FDA approval of ELEVIDYS, the first gene therapy approved to treat Duchenne muscular dystrophy.

Sarepta Therapeutics Announces FDA Approval of ELEVIDYS, the First Gene Therapy to Treat Duchenne Muscular Dystrophy

Sarepta Therapeutics should earn ~$1bn from its Duchenne Muscular Dystrophy franchise in 2023 - although the company has made eye-watering losses in recent years. Sarepta ought to hear any day whether the FDA has granted accelerated approval for its gene therapy DMD candidate SRP-9001. This catalyst will likely significantly move the share price needle. SRP-9001 could become a new standard of care in DMD. Mgmt. has suggested the peak revenue opportunity could exceed $4bn.

Sarepta Therapeutics: Value Proposition Ahead Of DMD Gene Therapy Decision

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Sarepta Therapeutics (SRPT) reported earnings 30 days ago. What's next for the stock?

Why Is Sarepta Therapeutics (SRPT) Down 1.5% Since Last Earnings Report?

The FDA has delayed its decision on Sarepta's gene therapy, SRP-9001, and investors are concerned. An approval could still be coming, but it may be narrower in scope.

Is Sarepta Therapeutics' Gene Therapy in Danger of Not Obtaining FDA Approval?

The FDA extends the review period for Sarepta's (SRPT) BLA for DMD gene therapy by almost four weeks to Jun 22. The agency may limit the use of the therapy in children aged between four and five.

Sarepta (SRPT) Down 11% on FDA Extending DMD Gene Therapy Review

Sarepta focuses on gene therapies to treat rare diseases. SRP-9001 is designed to correct the genetic mutation that can cause Duchenne muscular dystrophy.

News for Sarepta Therapeutics Stock (SRPT)