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 Q3 2023

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

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 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.

Gene-Therapy Investors Have a Powerful Ally: Patients

Sarepta Therapeutics Inc. NASDAQ: SRPT jumped nearly 31% on May 15, after a Food and Drug Administration committee gave a thumbs up to the company's experimental gene therapy to treat Duchenne muscular dystrophy.

Sarepta Soars 31% As FDA Panel Backs Muscular Dystrophy Therapy

The FDA's CTGTAC narrowly recommends granting accelerated approval to Sarepta's (SRPT) DMD gene therapy. A final decision from the agency is expected by the end of this month.

Sarepta's (SRPT) DMD Gene Therapy Gets Endorsed by FDA Panel

Sarepta (NASDAQ: SRPT ) stock is on the move Monday as investors react to news of FDA advisors voting on its gene therapy for Duchenne muscular dystrophy. The big news here is the FDA advisors voting in favor of the agency supporting the gene therapy treatment.

Why Is Sarepta (SRPT) Stock Up 29% Today?

Sarepta Therapeutics shares added almost 25% on Monday morning after the US Food and Drug Administration (FDA) Cellular, Tissue and Gene Therapies Advisory Committee voted eight to six in favor of the accelerated approval of the company's therapeutic SRP-9001 for Duchenne muscular dystrophy (DMD).  The company said the vote, while not binding, would be considered by the FDA when considering the potential accelerated approval of SRP-9001.

Sarepta Therapeutics shares soar on FDA panel's support for muscular dystrophy therapeutic

An FDA advisory committee voted 8-6 in favor of accelerated approval for SRP-9001. The FDA doesn't have to go along with the advisory committee's recommendation, but usually does.

Why Sarepta Therapeutics Stock Is Skyrocketing Today

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U.S. Food and Drug Administration advisers voted 8-6 Friday to recommend the agency grant accelerated approval to Sarepta Therapeutics Inc.'s gene therapy for Duchenne muscular dystrophy despite questions about its clinical benefit and safety.

FDA advisers narrowly back accelerated approval of Sarepta gene therapy

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in support of accelerated approval of SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene. “Today's advisory commit.

Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy to Treat Duchenne Muscular Dystrophy

FDA advisors will vote Friday on the approvability of Sarepta's highly anticipated gene therapy. SRPT stock was halted ahead of the meeting.

Sarepta Halted As FDA Mulls Its Highly Anticipated Gene Therapy

Sarepta Therapeutics Inc. stock SRPT, -0.88% was halted premarket Friday, ahead of a meeting of a Food and Drug Administration advisory panel to discuss the company's SRP-9001 gene therapy for the rare genetic disorder Duchenne muscular dystrophy, or DMD. DMD typically affects boys.

Sarepta Therapeutics stock halted premarket ahead of FDA panel meeting on new Duchenne muscular dystrophy treatment

Sarepta Therapeutics is heading into an important expert panel review this Friday for its Duchenne muscular dystrophy gene therapy candidate. The FDA's briefing documents ahead of this meeting raised concerns about the therapy's efficacy and safety.

Why Sarepta Therapeutics Stock Faded This Week

Sarepta Therapeutics, Inc. (NASDAQ:SRPT ) Q1 2023 Earnings Conference Call May 2, 2023 4:30 PM ET Company Participants Mary Jenkins – Associate Director-Investor Relations Doug Ingram – President and Chief Executive Officer Louise Rodino-Klapac – Executive Vice President, Head-R&D and Chief Scientific Officer Dallan Murray – Executive Vice President and Chief Customer Officer Ian Estepan – Executive Vice President and Chief Financial Officer Conference Call Participants Colin Bristow – UBS Gena Wang – Barclays Brian Abrahams – RBC Capital Markets Judah Frommer – Credit Suisse Salveen Richter – Goldman Sachs Gil Blum – Needham and Company Tazeen Ahmad – Bank of America Danielle Brill – Raymond James Mike Ulz – Morgan Stanley Neena Bitritto-Garg – Citi Tim Lugo – William Blair Kristen Kluska – Cantor Fitzgerald Hartaj Singh – Oppenheimer and Company Debjit Chattopadhyay – Guggenheim Joseph Schwartz – SVB Securities Zhiqiang Shu – Berenberg Gavin Clark-Gartner – Evercore ISI Brian Skorney – Baird Anupam Rama – JPMorgan Operator Good afternoon and welcome to the Sarepta Therapeutics First Quarter 2023 Earnings Call. At this time all participants are in a listen-only mode.

Sarepta Therapeutics, Inc. (SRPT) Q1 2023 Earnings Call Transcript

Sarepta Therapeutics (SRPT) came out with a quarterly loss of $0.97 per share versus the Zacks Consensus Estimate of a loss of $1.46. This compares to loss of $1.20 per share a year ago.

Sarepta Therapeutics (SRPT) Reports Q1 Loss, Tops Revenue Estimates

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the first quarter 2023. “We are pleased to report another strong quarter of performance serving the Duchenne community. With EXONDYS 51, VYONDYS 53, and AMONDYS 45, we once again exceeded analyst estimates, with total revenue for the quarter reaching $253.5 million and net product revenue standing at $231.5 million and grow.

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