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 is down big this week on news that the Food and Drug Administration raised concerns about its New Drug Application.

We See Opportunity In Sarepta

Here's what bargain biotech shoppers need to know about Sarepta's future.

Is Sarepta Therapeutics a Bad News Buy?

Sarepta receives complete response letter for golodirsen in DMD, but safety issues cited should be corrected within the next few years.

Sarepta May Have Lost The Battle For Latest FDA Approval Of DMD Drug, But It Will Win The War

Sarepta Therapeutics stock continued a three-day tumble Thursday after the Food and Drug Administration rejected its newest Duchenne muscular dystrophy treatment, dubbed golodirsen.
The post Why Analysts Are Upbeat On Sarepta Despite A Notable FDA Rejection appeared first on Investor's Business Daily.

Why Analysts Are Upbeat On Sarepta Despite A Notable FDA Rejection

Investors need to pay close attention to Sarepta Therapeutics (SRPT) stock based on the movements in the options market lately.

Is the Options Market Predicting a Spike in Sarepta Therapeutics (SRPT) Stock?

Sarepta Therapeutics (NASDAQ:SRPT) was just hit with a hefty dose of regulatory reality.

FDA Rejection of Sarepta's Golodirsen Should Have Been Expected

The biotech is reeling following the thumbs-down for its experimental DMD drug golodirsen.

What's Next for Sarepta Therapeutics After Its Surprising FDA Rejection

Madison Square Garden

Hain Celestial Group

These stocks led the broader market lower.

Why Madison Square Garden, Hain Celestial Group, and Sarepta Therapeutics Slumped Today

Sarepta Therapeutics Inc (NASDAQ: SRPT)'s new drug application for its second Duchenne muscular dystrophy drug received a a complete response letter from the FDA on Monday.

Analysts Unfazed By FDA Snub Of Sarepta's DMD Drug, Pin Hopes On Gene Therapy

Sarepta Therapeutics stock crashed Tuesday after the Food and Drug Administration left the biotech company twisting "in the wind" over its newest Duchenne muscular dystrophy treatment.
The post Why The FDA Left Sarepta To 'Twist In The Wind' Over Its Newest Drug appeared first on Investor's Business Daily.

Why The FDA Left Sarepta To 'Twist In The Wind' Over Its Newest Drug

The CRL to golodirsen NDA comes as a surprise for Sarepta (SRPT) and investors as no issues were raised by the FDA during the review period that could have lead to non-approval of the candidate.

Sarepta Stock Falls as FDA Denies Approval to Golodirsen

Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) are tanking Tuesday morning as a binary event turned up a negative outcome for the company.

Sarepta Plunges After FDA Spurns Its Second Duchenne Muscular Dystrophy Drug

Sarepta Therapeutics stock toppled late Monday after the Food and Drug Administration rejected of the biotech company's latest Duchenne muscular dystrophy drug, dubbed golodirsen.
The post Sarepta Dives After FDA Rejects Its Newest Muscular Dystrophy Drug appeared first on Investor's Business Daily.

Sarepta Dives After FDA Rejects Its Newest Muscular Dystrophy Drug

Sarepta Therapeutics Inc. SRPT, -3.71% shares fell in the extended session Monday after the drug maker said the Food and Drug Administration raised concerns about its muscular dystrophy treatment.

Sarepta stock falls on FDA concerns about drug

CAMBRIDGE, Mass., Aug.  19, 2019  (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.

Sarepta Therapeutics Receives Complete Response Letter from the US Food and Drug Administration for Golodirsen New Drug Application

AxoGen

Capri Holdings Ltd

General Electric

Ryman Hospitality Properties

Insiders invest in Capri Holdings, General Electric, Sarepta Therapeutics, Ryman Hospitality Properties and Axogen.

Weekly CEO Buys Highlight

The market has not reacted well to Sarepta's plan to expand the company's Micro-Dystrophin program.

Sarepta Therapeutics - Buy The Latest 'Bad News'

President & CEO of Sarepta Therapeutics Inc (30-Year Financial, Insider Trades) Douglas S Ingram (insider trades) bought 16,252 shares of SRPT on 08/12/2019 at an average price of $123.07 a share.

Sarepta Therapeutics Inc (SRPT) President & CEO Douglas S Ingram Bought $2 million of Shares

Its high-profile DMD gene-therapy candidate hit an unexpected stumbling block.

Why Sarepta Therapeutics Stock Tanked on Thursday

Sarepta Therapeutics has been struggling lately, but the selling pressure may be coming to an end soon.

Sarepta Therapeutics Sees Hammer Chart Pattern: Time to Buy?

Sarepta Therapeutics Inc said on Thursday it was informed that an adverse event report was erroneously submitted to the U.S. health regulator regarding an ongoing study of the company's gene therapy for Duchenne muscular dystrophy (DMD).

Sarepta says adverse event report for DMD gene therapy erroneously submitted

CenturyLink

Zillow

Earnings and other bad news hit these stocks hard.

Why Zillow Group, Sarepta Therapeutics, and CenturyLink Slumped Today

Sarepta Therapeutics Inc. SRPT, -7.99% shares fell Thursday after the gene therapy company said an adverse event report was sent to the Food and Drug Administration in error over a muscular dystrophy treatment.

Sarepta stock drops on erroneous adverse event report to FDA

Shares of Sarepta Therapeutics Inc plunged 12% after a notice from the U.S. health agency showed a patient in an ongoing study of the company's gene therapy for Duchenne muscular dystrophy was reported to have developed a serious illness.

Patient in Sarepta gene therapy trial develops serious illness; shares plunge

Investors punished biotech companies Sarepta Therapeutics and Arena Pharmaceuticals on growing losses in the second quarter, and lauded Aerie Pharmaceuticals for its guidance cut.

News for Sarepta Therapeutics Stock (SRPT)