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.

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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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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.

Why Shares of Sarepta Therapeutics Are Dropping Wednesday

Sarepta Therapeutics shares fell by more than 12% on the news the US Food and Drug Administration (FDA) requires more time for its review of the company's Biologics License Application (BLA) of its investigational gene therapy SRP-9001 for Duchenne muscular dystrophy. The company said the FDA requires additional time to complete the review, including final label negotiations and postmarketing commitment discussions, and it expects to complete the review by June 22, 2023, almost a month later than its previous regulatory action date of May 29.

Sarepta Therapeutics shares fall as FDA delays decision on gene therapy

Sarepta Therapeutics Inc (NASDAQ:SRPT) is gaining some attention in the biotech realm today.

Biotech Stock Drops on FDA Update

Investors on Wednesday seemed to take the delay as a sign that opponents of approval within the agency were winning out.

Sarepta Stock Plunges. FDA Pushes Back Decision Date on Gene Therapy.

The FDA pushed back its review of a highly anticipated gene therapy from Sarepta Therapeutics on Wednesday, prompting SRPT stock to tumble. The post Sarepta Therapeutics Dives On An Unexpected Hold-Up For Its Gene Therapy appeared first on Investor's Business Daily.

Sarepta Therapeutics Dives On An Unexpected Hold-Up For Its Gene Therapy

The U.S. Food and Drug Administration has deferred its decision on an accelerated approval for Sarepta Therapeutics Inc's gene therapy for a muscle wasting disorder called Duchenne muscular dystrophy from May 29 to June 22, the company said on Wednesday.

FDA defers decision for Sarepta's gene therapy to June 22

Sarepta Therapeutics Inc. SRPT, -1.45% said Wednesday that the U.S. Food and Drug Administration has indicated after talks with the company that it's working toward granting accelerated approval of SRP-9001, its latest treatment for Duchenne muscular dystrophy, or DMD. The agency said that's subject to the completion of its Biologics License Application (BLA) review and that it would initially be for use in patients aged 4 to 5 years old.

Sarepta says FDA is working toward accelerated approval of its latest treatment for Duchenne muscular dystrophy

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today provided the following update on the Biologics License Application (BLA) for SRP-9001 (delandistrogene moxeparvovec), which is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD) who have a confirmed mutation of the DMD gene. Following discussions with FDA, the Agency has indicated that, subject to the.

Sarepta Therapeutics Announces Update on Regulatory Review of SRP-9001

SRP-9001's pivotal trial surrogate endpoint was highly statistically significant. The FDA's Advisory Committee voted 8-6 on May 12 in support of Accelerated Approval.

Buy Sarepta Therapeutics For A Likely Positive FDA Decision Date

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Last week, an FDA advisory committee voted in favor of approving Sarepta Therapeutics, Inc.'s SRP-9001 for treating DMD. Sarepta Therapeutics stock has good near-term momentum as the BLA is scheduled for May 29.

Sarepta Therapeutics: A Virtual Monopoly In Duchenne Muscular Dystrophy

Surging Sarepta can thank patients' families for an FDA victory.

News for Sarepta Therapeutics Stock (SRPT)