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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NEW YORK--(BUSINESS WIRE)---- $SRPT #SRPT--WHY: Rosen Law Firm, a global investor rights law firm, announces that it is 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.

EQUITY ALERT: ROSEN, A TOP RANKED LAW FIRM, Encourages Sarepta Therapeutics, Inc. Investors to Inquire About Securities Class Action Investigation – SRPT

Sarepta Therapeutics Inc. SRPT shares plummeted in the extended session Thursday after the Food and Drug Administration contradicted the biotech company and said it required an advisory committee meeting for its experimental Duchenne muscular dystrophy drug. Shares of Sarepta dropped as much as 20% after hours, following a 2.9% gain in the regular session to close at $149.67.

Sarepta Therapeutics plummets 20% after FDA contradicts company and requires advisory meeting

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that at its late cycle meeting for the SRP-9001 (delandistrogene moxeparvovec) biologics license application (BLA), the U.S. Food and Drug Administration's Office of Therapeutics (OTP) has determined that an advisory committee meeting will be held for SRP-9001 in advance of the May 29, 2023 regulatory action date.

Sarepta Therapeutics Announces Advisory Committee Meeting will be Held for SRP-9001

Sarepta Therapeutics recently reported their Q4 and full-year 2022 earnings with a minor miss on EPS and a solid beat on revenue. The market reacted positively moving SRPT up. The company continues to report solid growth trends for EXONDYS, VYONDYS, and AMONDYS. Notably, this growth is not coming from increases in prices.

Sarepta Therapeutics: Time To Change My Game Plan After Q4 Earnings

The company's latest Duchenne muscular dystrophy gene therapy may have an accelerated approval.

Why Sarepta Therapeutics' Shares Rose 23.4% This Week

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Shares of Sarepta Therapeutics Inc. SRPT were up 18.7% in trading on Wednesday afternoon, a day after the company told investors that the Food and Drug Administration does not plan to schedule an advisory committee meeting for its experimental Duchenne muscular dystrophy drug. Sarepta made the announcement as part of its fourth-quarter earnings.

Sarepta's stock still up after Tuesday's announcement that its Duchenne drug candidate won't require a FDA AdCom meeting

Sarepta (SRPT) delivers decent fourth-quarter 2022 results. Management confirms that the FDA does not plan to hold an advisory committee meeting for the DMD gene-therapy filing.

Sarepta (SRPT) Q4 Earnings & Sales Beat Estimates, Stock Up

Sarepta Therapeutics Inc (NASDAQ:SRPT) stock rocketed after the drug company posted fourth quarter financial results that topped Wall Street estimates and Morgan Stanley (NYSE:MS) said the stock could rally nearly 50%. For the period ended December 31, 2022, the Massachusetts-based company reported an adjusted earnings per share loss of $0.53, which beat analyst estimates for a loss of $0.83 per share.

Sarepta Therapeutics pops as results top estimates and Morgan Stanley raises share price to $187

Sarepta could snag an accelerated approval for its muscular dystrophy gene therapy, analysts suggested Wednesday as SRPT stock rocketed. The post Sarepta Rockets And Breaks Out As FDA Smooths The Path For Its Gene Therapy appeared first on Investor's Business Daily.

Sarepta Rockets And Breaks Out As FDA Smooths The Path For Its Gene Therapy

Sarepta Therapeutics (NASDAQ: SRPT ) stock is heading higher on Wednesday following the release of its latest earnings report. For the fourth quarter of 2022, Sarepta Therapeutics reported adjusted earnings per share of -53 cents.

Why Is Sarepta Therapeutics (SRPT) Stock Up 21% Today?

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Sarepta Therapeutics, Inc. (NASDAQ:SRPT ) Q4 2022 Earnings Conference Call February 28, 2023 4:30 PM ET Company Participants Mary Jenkins - Senior Manager of Investor Relations Doug Ingram - President & Chief Executive Officer Louise Rodino-Klapac - Executive Vice President, Head of R&D and Chief Scientific Officer Dallan Murray - Senior Vice President & Chief Customer Officer Ian Estepan - Executive Vice President & Chief Financial Officer Conference Call Participants Anupam Rama - JPMorgan Brian Abrahams - RBC Colin Bristow - UBS Matthew Harrison - Morgan Stanley Tazeen Ahmad - Bank of America Robert Fink - Guggenheim Gena Wang - Barclays Ritu Baral - Cowen Judah Frommer - Credit Suisse Gil Blum - Needham Danielle Brill - Raymond James Hartaj Singh - Oppenheimer Yun Zhong - BTIG Richard Miller - Cantor Gavin Clark-Gartner - Evercore Operator Good afternoon and welcome to the Sarepta Therapeutics Fourth Quarter and Full Year 2022 Earnings Call. [Operator Instructions] As a reminder, today's conference call is being recorded.

Sarepta Therapeutics, Inc. (SRPT) Q4 2022 Earnings Call Transcript

Sarepta Therapeutics (SRPT) delivered earnings and revenue surprises of 3.12% and 3.63%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

Sarepta Therapeutics (SRPT) Reports Q4 Loss, Tops Revenue Estimates

Sarepta Therapeutics Inc. SRPT shares rallied in the extended session Tuesday after the biotech drug maker topped Wall Street expectations, and said U.S. regulators granted a priority review status for its muscular dystrophy drug candidate SRP-9001. Sarepta shares rallied as much as 14% after hours, following a 3.3% rise in the regular session to close at $122.13.

Sarepta stock surges more than 10% as results top expectations, drug given priority review

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the fourth quarter and full-year 2022.

Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2022 Financial Results and Recent Corporate Developments

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the official opening of Route 79, The Duchenne Scholarship Program for the 2023-2024 academic year. Academic scholarships of up to $5,000 will be awarded to up to 20 individuals living with Duchenne muscular dystrophy and up to five siblings of individuals living with Duchenne.

Sarepta Therapeutics Announces Call for Applications for the 6th Annual Route 79, The Duchenne Scholarship Program

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report fourth quarter and full year 2022 financial results after the Nasdaq Global Market closes on Tuesday, February 28, 2023. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its fourth quarter and full-year 2022 financial results and to provide a corporate update.

Sarepta Therapeutics to Announce Fourth Quarter and Full-Year 2022 Financial Results

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the first patient has been dosed in Study SRP-9003-102. Also known as VOYAGENE, Study 9003-102 is a phase 1 study of SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy Type 2E/R4 (LGMD2E). VOYAGENE is a U.S.

Sarepta Therapeutics Announces Initiation of VOYAGENE, a Clinical Study of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E/R4

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Sarepta Therapeutics, Inc. net product revenues for Q4 2022 are expected to come in about 32% higher at $235.5 million; Financial results for Q4 2022 are expected late February 2023. BLA of SRP-9001 for the treatment of patients with Duchenne Muscular Dystrophy was accepted November 2022, Priority Review date established for May 29, 2023.

Sarepta: Raised Financial Guidance, Looming Catalyst Makes This Worth A Look

- The Company expects to exceed 2022 full-year guidance for net product revenues

Sarepta Therapeutics Reports Preliminary* Fourth Quarter and Full-Year 2022 Net Product Revenues

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SOMERSET, N.J. & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Catalent, Inc. (NYSE:CTLT), the leader in enabling the development and supply of better treatments for patients worldwide, and Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the signing of a commercial supply agreement for Catalent to manufacture delandistrogene moxeparvovec (SRP-9001), Sarepta's most advanced gene therapy candidate for the treatment of Duchenne muscular dystrophy (DMD). The agreement also structures how Catalent may support multiple gene therapy candidates in Sarepta's pipeline for limb-girdle muscular dystrophy (LGMD).

Sarepta and Catalent Expand Strategic Manufacturing Partnership With Commercial Supply Agreement for Duchenne Muscular Dystrophy Gene Therapy Candidate

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