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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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.

Sarepta Therapeutics Announces First Quarter 2023 Financial Results and Recent Corporate Developments

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report first quarter 2023 financial results after the Nasdaq Global Market closes on Tuesday, May 2, 2023. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its first quarter 2023 financial results. The event will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarept.

Sarepta Therapeutics to Announce First Quarter 2023 Financial Results

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Per a Stat News article, the FDA initially considered rejecting Sarepta's (SRPT) regulatory filing seeking FDA's accelerated approval for DMD gene therapy.

Sarepta Down on Reports of FDA Almost Rejecting DMD Gene Therapy

WHY: Rosen Law Firm, a global investor rights law firm, continues investigating potential securities claims on behalf of shareholders of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) resulting from allegations that Sarepta may have issued materially misleading business information to the investing public.

ROSEN, A LEADING LAW FIRM, Encourages Sarepta Therapeutics, Inc. Investors to Inquire About Securities Class Action Investigation - SRPT

A report raised questions about the chances for approval of the company's gene therapy to treat Duchenne muscular dystrophy.

Sarepta Therapeutics Tumbles on Gene Therapy Drama

Sarepta Therapeutics Inc (NASDAQ:SRPT) shares took a beating Thursday as Stat News reported that reviewers at the US Food and Drug Administration (FDA) were leaning toward rejecting a closely watched gene therapy for Duchenne muscular dystrophy made by the company. The “non-binding conclusion" prompted FDA official Peter Marks to intervene earlier this year and schedule an advisory meeting on May 12, Stat said citing three people with direct knowledge of the agency deliberations.

Sarepta Therapeutics shares fall as report says FDA almost rejected its gene therapy

Several FDA staffers were leaning toward rejecting a highly watched gene therapy from Sareptas, according to a report Thursday that sent SRPT stock into a dive. The post Sarepta Tumbles As Report Of Internal FDA Strife Scorches Its Gene Therapy appeared first on Investor's Business Daily.

Sarepta Tumbles As Report Of Internal FDA Strife Scorches Its Gene Therapy

Sarepta Therapeutics (NASDAQ: SRPT ) stock is taking a beating on Thursday following reports that the FDA was considering rejecting one of its drugs. According to these reports, regulators at the FDA were originally planning to reject the company's request for approval of SRP-9001.

Why Is Sarepta Therapeutics (SRPT) Stock Down 12% Today?

Sarepta Therapeutics Inc. stock SRPT, -1.02% slid 11% in premarket trade Thursday, after a report said the U.S. Food and Drug Administration was leaning toward rejecting the company's experimental gene therapy for Duchenne muscular dystrophy.

Sarepta stock slides 11% premarket on report FDA was leaning toward rejecting its gene therapy for Duchenne muscular dystrophy

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the date of the U.S. Food and Drug Administration's Cellular, Tissue and Gene Therapies Advisory Committee meeting for the SRP-9001 (delandistrogene moxeparvovec) biologics license application (BLA) is May 12, 2023. The advisory committee meeting will be hosted as a virtual meeting.

Sarepta Therapeutics Announces that the Date of the Advisory Committee Meeting for SRP-9001 will be May 12, 2023

NEW YORK , April 6, 2023 /PRNewswire/ -- WHY: Rosen Law Firm, a global investor rights law firm, continues investigating potential securities claims on behalf of shareholders of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) resulting from allegations that Sarepta may have issued materially misleading business information to the investing public. SO WHAT: If you purchased Sarepta securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

SRPT LOSS ALERT: ROSEN, A GLOBALLY RECOGNIZED LAW FIRM, Encourages Sarepta Therapeutics, Inc. Investors to Inquire About Securities Class Action Investigation - SRPT

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