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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Earnings data Q1 2024

Earnings data Q2 2024

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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 (SRPT) is seeking accelerated approval for exon 45 amenable DMD candidate, casimersen. Amondys 45 is likely to be the brand name for the candidate.

Sarepta's Casimersen NDA Gets Priority Review From FDA

Sarepta Therapeutics on Tuesday announced that the FDA agreed to an accelerated approval process for its treatment for certain patients with Duchenne muscular dystrophy, lifting SRPT stock.
The post Sarepta Therapeutics Gets Fast-Track FDA Review For Muscular Dystrophy Drug appeared first on Investor's Business Daily.

Sarepta Therapeutics Gets Fast-Track FDA Review For Muscular Dystrophy Drug

-- FDA grants Priority Review Status and sets regulatory action date for February 25, 2021 --  -- FDA has indicated it does not currently plan to hold an advisory committee meeting to discuss the application --  -- Received FDA's conditional approval of AMONDYS 45™ as brand name for casimersen --  -- Casimersen has been studied for the treatment of exon 45 amenable patients, approximately eight percent of patients with Duchenne --  CAMBRIDGE, Mass., Aug.  25, 2020  (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) seeking accelerated approval for casimersen (SRP-4045) and provided a regulatory action date of February 25, 2021. The FDA has indicated it does not currently plan to hold an advisory committee to discuss the application. In addition, the Company has received conditional approval of AMONDYS 45 as the brand name for casimersen. Casimersen, a phosphorodiamidate morpholino oligomer (PMO), is engineered to treat patients with Duchenne muscular dystrophy (DMD) who have genetic mutations that are amenable to skipping exon 45 of the dystrophin gene.

Sarepta Therapeutics Announces FDA Acceptance of Casimersen (SRP-4045) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45

CAMBRIDGE, Mass. and GAINESVILLE, Fla., Aug.  11, 2020  (GLOBE NEWSWIRE) -- Sarepta Therapeutics Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, and the University of Florida today announced a strategic collaboration to enable cutting-edge research for novel genetic medicines. Through the agreement, Sarepta will fund multiple research programs at the University, and will have an exclusive option to further develop any new therapeutic compounds that result from the funded research programs.

Sarepta Therapeutics and University of Florida Announce Collaboration to Accelerate the Discovery and Development of Therapies for Rare Genetic Diseases

Sarepta (SRPT) Q2 revenues increase year over year.

Sarepta (SRPT) Q2 Loss Widens Y/Y, Revenues Beat Estimates

Sarepta Therapeutics' (SRPT) CEO Doug Ingram on Q2 2020 Results - Earnings Call Transcript

– Net product sales of $111.3 million, an 18% increase over same quarter of prior year  –

Sarepta Therapeutics Announces Second Quarter 2020 Financial Results and Recent Corporate Developments

Sarepta Therapeutics (SRPT) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Will Sarepta Therapeutics (SRPT) Report Negative Q2 Earnings? What You Should Know

CAMBRIDGE, Mass., July  29, 2020  (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report second quarter 2020 financial results after the Nasdaq Global Market closes on Wednesday, August 5, 2020. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its second quarter 2020 financial results and to provide a corporate update.

Sarepta Therapeutics to Announce Second Quarter 2020 Financial Results and Recent Corporate Developments on August 5, 2020

CAMBRIDGE, Mass., July  24, 2020  (GLOBE NEWSWIRE) -- 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) has granted Fast Track designation to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin). SRP-9001 is an investigational gene transfer therapy intended to deliver its micro-dystrophin-encoding gene to muscle tissue for the targeted production of the micro-dystrophin protein.  Safety and tolerability data at one year from four clinical trial participants who received SRP-9001 in Study 101 were recently published in JAMA Neurology, and Study 102, a randomized, double-blind, placebo-controlled study of SRP-9001, is ongoing with results expected in early 2021. 

Sarepta Therapeutics Receives Fast Track Designation for SRP-9001 Micro-Dystrophin Gene Therapy for the Treatment of Duchenne Muscular Dystrophy

CAMBRIDGE, Mass., July  15, 2020  (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the launch of Rare Lessons, a Sarepta-led lesson planning competition intended to promote the development and implementation of educational materials to increase rare disease awareness in the K-12 classroom setting. The competition is open to educators in grades K-12, based in the United States and actively teaching in an accredited educational institution. A blinded selection committee will review and select up to four winning lesson plans. Sarepta will grant up to four monetary awards of $2,500 to the authors of the lesson plans and $2,500 to the educational institution with which the authors are affiliated.

Sarepta Therapeutics Launches “Rare Lessons” Program to Promote Greater Diversity and Inclusion in the Classroom and Support Awareness of Rare Diseases

-- Exclusive worldwide license enables Sarepta to develop and promote imlifidase as a pre-treatment for gene therapy in Duchenne and Limb-girdle muscular dystrophy patients who have pre-existing antibodies to AAV --  CAMBRIDGE, Mass., July  02, 2020  (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced an agreement with Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare Immunoglobulin G (IgG) mediated diseases, for imlifidase. Under the terms of the agreement, Sarepta obtains an exclusive, worldwide license to develop and promote imlifidase as a pre-treatment to enable Sarepta gene therapy administration in Duchenne muscular dystrophy (DMD) and Limb-girdle muscular dystrophy (LGMD), for patients who may otherwise not be eligible for treatment.

Sarepta Therapeutics Signs Agreement with Hansa Biopharma for Imlifidase

CAMBRIDGE, Mass., June  30, 2020  (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the retirement of Sandy Mahatme, Sarepta’s executive vice president, chief financial officer and chief business officer, from the company effective July 10, 2020. The company has commenced a search process to identify the future chief financial officer. During the interim period, the finance and accounting functions will report directly to Sarepta’s Chief Executive Officer, Doug Ingram, and other departments reporting to Mr. Mahatme will be overseen by members of Sarepta’s executive committee.

Sarepta Therapeutics Announces Retirement of Sandy Mahatme, Chief Financial Officer and Chief Business Officer

Sarepta (SRPT) is seeking accelerated approval for its third exon-skipping therapy, casimersen, for DMD patients.

Sarepta Completes Rolling NDA Submission for New DMD Therapy

-- Casimersen is designed for the treatment of exon 45 amenable patients, approximately eight percent of patients with Duchenne --   -- Casimersen is the third exon-skipping medicine using the Company’s proprietary PMO RNA-based platform -- 

Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Casimersen (SRP-4045) for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45

Bank of America

Sarepta Therapeutics, Inc. (SRPT) CEO Doug Ingram Presents at Bank of America Napa Healthcare Conference (Transcript)

On the heels of research deals with two small biotechs, shares of Sarepta Therapeutics Inc.

Sarepta Addressing Gene Therapy Issue With Two Acquisitions

Sarepta (SRPT) and Codiak BioSciences sign agreement to develop potential gene therapies targeting neuromuscular indications using Codiak's engineered exosomes.

Sarepta Inks Agreement With Codiak to Develop Gene Therapies

- Alliance to explore the utility of engineered exosomes developed with Codiak’s engEx™ Platform to deliver gene therapy, gene editing and RNA technologies -

Sarepta Therapeutics and Codiak BioSciences Collaborate to Research and Develop Exosome-Based Therapeutics for Rare Diseases

Aptose Biosciences

Can the run for Sarepta Therapeutics, Viela Bio, and Aptose Biosciences continue?

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Selecta Biosciences

Selecta Biosciences Inc. (NASDAQ: SELB) and Sarepta Therapeutics Inc. (NASDAQ: SRPT) have announced that they had entered into a research license and option agreement.

How Sarepta and Selecta Bio Are Taking the Fight to DMD

Sarepta Therapeutics (SRPT) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Sarepta Therapeutics (SRPT) Upgraded to Buy: What Does It Mean for the Stock?

Is  (SRPT) Outperforming Other Medical Stocks This Year?

Is Sarepta Therapeutics (SRPT) Stock Outpacing Its Medical Peers This Year?

Early safety data for the potential one-shot cure for the lethal muscle wasting disorder looks encouraging.

Sarepta's Gene Therapy for Duchenne Muscular Dystrophy Clears a Major Safety Hurdle

-- Results at one year demonstrate continued safety and tolerability of SRP-9001 micro-dystrophin gene therapy in four patients with Duchenne muscular dystrophy --  -- Confirmed vector transduction and functional improvements maintained through one year --

News for Sarepta Therapeutics Stock (SRPT)