Sarepta Therapeutics, Inc., a commercial-stage biopharmaceutical company, focuses on the discovery and development of RNA-targeted therapeutics, gene therapy, and other genetic therapeutic modalities for the treatment of rare diseases. The company offers EXONDYS 51 injection to treat duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping; and VYONDYS 53 for the treatment of DMD in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. It also developing AMONDYS 45, a product candidate that uses phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 45 of the dystrophin gene; SRP-5051, a peptide conjugated PMO that binds exon 51 of dystrophin pre-mRNA; SRP-9001, a DMD micro-dystrophin gene therapy program; and SRP-9003, a limb-girdle muscular dystrophies gene therapy program. The company has collaboration agreements with F. Hoffman-La Roche Ltd; Nationwide Children's Hospital; Lysogene; Duke University; Genethon; and StrideBio. It also has a research and option agreement with Codiak BioSciences, Inc. to design and develop engineered exosome therapeutics to deliver gene therapy, gene editing, and RNA technologies for neuromuscular diseases; and research collaboration with Genevant Sciences for lipid nanoparticle-based gene editing therapeutics. Sarepta Therapeutics, Inc. was incorporated in 1980 and is headquartered in Cambridge, Massachusetts.
IPO Year:
Exchange: NASDAQ
Website: sarepta.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 5/8/2025 | $50.00 | Outperform → In-line | Evercore ISI |
| 4/11/2025 | $115.00 | Overweight | Wells Fargo |
| 4/2/2025 | $75.00 | Sell → Neutral | H.C. Wainwright |
| 3/31/2025 | $161.00 → $87.00 | Outperform → Sector Perform | RBC Capital Mkts |
| 2/11/2025 | $136.00 | Hold | Deutsche Bank |
| 11/27/2024 | $205.00 → $202.00 | Buy | Needham |
| 11/25/2024 | $80.00 | Sell | H.C. Wainwright |
| 11/7/2024 | $152.00 → $167.00 | Neutral → Overweight | Cantor Fitzgerald |
| 10/21/2024 | $165.00 | Buy | Jefferies |
| 10/10/2024 | $150.00 | Outperform | Raymond James |
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
4 - Sarepta Therapeutics, Inc. (0000873303) (Issuer)
10-Q - Sarepta Therapeutics, Inc. (0000873303) (Filer)
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8-K - Sarepta Therapeutics, Inc. (0000873303) (Filer)
8-K - Sarepta Therapeutics, Inc. (0000873303) (Filer)
8-K - Sarepta Therapeutics, Inc. (0000873303) (Filer)
8-K - Sarepta Therapeutics, Inc. (0000873303) (Filer)
10-Q - Sarepta Therapeutics, Inc. (0000873303) (Filer)
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will participate in a fireside chat at the BofA Securities Health Care Conference at the Encore Hotel in Las Vegas, Nev. on Wednesday, May 14, 2025 at 8:40 a.m. P.T./11:40 a.m. E.T. The presentations will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-presentations and will be archived there following the presentation for 90 days. Please connect to Sarepta's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be
Net product revenues for the first quarter 2025 totaled $611.5 million, a 70% increase over the same quarter of the prior year ELEVIDYS net product revenue for the first quarter totaled $375.0 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $4.0 million Revised 2025 total net product revenues guidance to $2.3 to $2.6 billion Meaningfully advanced multiple clinical candidates in limb-girdle muscular dystrophy portfolio Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the first quarter 2025. "In the first quarter, we achieved net product revenue of $611.5 mi
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report first quarter 2025 financial results after the Nasdaq Global Market closes on Tuesday, May 6, 2025. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its first quarter 2025 financial results. The event will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-presentations and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone
– U.S. FDA has confirmed that screening and dosing may proceed in Study SRP-9005-101 for LGMD2C/R5 – Enrollment and dosing completed in Study SRP-9004-102 for LGMD2D/R3 – Data expected for SRP-9003 for LGMD2E/R4 by mid-2025 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today shared updates from its clinical programs focused on limb-girdle muscular dystrophy (LGMD) subtypes 2C/R5, 2D/R3, and 2E/R4. SRP-9005 for LGMD type 2C/R5: Following input from the U.S. Food and Drug Administration (FDA), Office of Therapeutic Products (OTP), Sarepta is cleared to proceed with dosing in Study SRP-9005-101 (COMPASS) in the U.S. CO
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, shared the following update related to ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with Duchenne muscular dystrophy. Following the safety update on acute liver failure that was issued on March 18, European Union (EU) reference member country authorities requested that the independent data monitoring committee (DMC) meet to review the adverse event. While the analysis is being finalized, recruitment and dosing in certain clinical studies of ELEVIDYS are temporarily halted. The independent DMC met on April 3 and concurred that based on the totali
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on March 31, 2025 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta's 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 39 individuals hired by Sarepta in the first quarter of 2025. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). The employees received, in the aggregate, options to purchase 31,344 shares of Sarepta's common stock, and in the aggregate 77,442 restricted stock units ("RSUs"). The options have an exercise price of $63.82 per share, wh
– Applications for the 2025-2026 academic year will be accepted until May 30, 2025 – Scholarships 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, 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 2025-2026 academic year. Academic scholarships of up to $5,000 will be awarded to as many as 20 individuals living with Duchenne muscular dystrophy and 5 siblings of individuals living with Duchenne. "In the past decade, there have been significant advancements
– Net product revenues for the fourth quarter 2024 totaled $638.2 million, a 75% increase over the same quarter of the prior year – ELEVIDYS net product revenue for the quarter totaled $384.2 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $4.9 million – Achieved GAAP and non-GAAP net income of $159.0 million and $206.0 million for the fourth quarter of 2024, respectively 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 2024. "2024 performance represented the fruition of our multi-year strategy to become a self-sustaining pro
– Provides non-dilutive financing flexibility and supplements strong balance sheet Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced today that it has closed on a $600 million senior secured revolving credit facility with a bank syndicate. "Sarepta's financial strength and the positive outlook for our business provide us with the flexibility to use non-dilutive financing by establishing a revolving credit facility. It supplements our strong balance sheet and allows for contingent liquidity as we execute our strategic plan to achieve our Sarepta 2030 objectives. Access to this instrument is a testament to our robust future cas
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report fourth quarter and full-year 2024 financial results after the Nasdaq Global Market closes on Wednesday, Feb. 26, 2025. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its fourth quarter and full-year 2024 financial results. The event will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-presentations and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After register
Evercore ISI downgraded Sarepta Therapeutics from Outperform to In-line and set a new price target of $50.00
Wells Fargo initiated coverage of Sarepta Therapeutics with a rating of Overweight and set a new price target of $115.00
H.C. Wainwright upgraded Sarepta Therapeutics from Sell to Neutral and set a new price target of $75.00
RBC Capital Mkts downgraded Sarepta Therapeutics from Outperform to Sector Perform and set a new price target of $87.00 from $161.00 previously
Deutsche Bank initiated coverage of Sarepta Therapeutics with a rating of Hold and set a new price target of $136.00
Needham reiterated coverage of Sarepta Therapeutics with a rating of Buy and set a new price target of $202.00 from $205.00 previously
H.C. Wainwright initiated coverage of Sarepta Therapeutics with a rating of Sell and set a new price target of $80.00
Cantor Fitzgerald upgraded Sarepta Therapeutics from Neutral to Overweight and set a new price target of $167.00 from $152.00 previously
Jefferies initiated coverage of Sarepta Therapeutics with a rating of Buy and set a new price target of $165.00
Raymond James resumed coverage of Sarepta Therapeutics with a rating of Outperform and set a new price target of $150.00
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Net product revenues for the first quarter 2025 totaled $611.5 million, a 70% increase over the same quarter of the prior year ELEVIDYS net product revenue for the first quarter totaled $375.0 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $4.0 million Revised 2025 total net product revenues guidance to $2.3 to $2.6 billion Meaningfully advanced multiple clinical candidates in limb-girdle muscular dystrophy portfolio Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the first quarter 2025. "In the first quarter, we achieved net product revenue of $611.5 mi
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report first quarter 2025 financial results after the Nasdaq Global Market closes on Tuesday, May 6, 2025. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its first quarter 2025 financial results. The event will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-presentations and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone
– Net product revenues for the fourth quarter 2024 totaled $638.2 million, a 75% increase over the same quarter of the prior year – ELEVIDYS net product revenue for the quarter totaled $384.2 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $4.9 million – Achieved GAAP and non-GAAP net income of $159.0 million and $206.0 million for the fourth quarter of 2024, respectively 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 2024. "2024 performance represented the fruition of our multi-year strategy to become a self-sustaining pro
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report fourth quarter and full-year 2024 financial results after the Nasdaq Global Market closes on Wednesday, Feb. 26, 2025. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its fourth quarter and full-year 2024 financial results. The event will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-presentations and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After register
– Treatment with ELEVIDYS corresponded with increases on the North Star Ambulatory Assessment (NSAA) at one year in crossover patients, while the study remained blinded – MRI results at two years in patients treated in Part 1 show minimal muscle pathology progression, aligning closely with observed functional benefits – Crossover-treated patients show statistically significant benefits of ELEVIDYS treatment on NSAA, Time to Rise (TTR), and 10-meter walk/run (10MWR), when compared to a pre-specified, well-matched external control (EC) – Part 1-treated patients show sustained expression at week 64, and functional improvements on NSAA, TTR and 10MWR were sustained two years after treatme
– Sarepta obtains exclusive worldwide licenses to four clinical-stage and three preclinical-stage programs in muscle, central nervous system, and rare pulmonary disorders, including potential best-in-class siRNA-based treatments for DM1 and FSHD – Additionally, Arrowhead and Sarepta have entered into a discovery partnership pursuant to which Sarepta will nominate, and Arrowhead will deliver, IND-ready constructs for six targets across skeletal muscle, cardiac, and CNS – Investigational treatments leverage Arrowhead's leading Targeted RNAi Molecule (TRiMTM) platform, capable of deep and durable target-gene knockdown – Upon closing, Arrowhead to receive $500 million in an upfront paymen
- Upon closing, Arrowhead will receive $825 million immediately, including an upfront payment and an equity investment at a 35% premium, and will receive an additional $250 million paid over five years - Arrowhead has potential to receive an additional $300 million in near-term clinical trial enrollment-related milestone payments and is eligible for future potential milestone payments up to $10 billion and royalties on sales - Sarepta to receive investigational treatments that leverage Arrowhead's leading Targeted RNAi Molecule platform - Arrowhead to discuss this agreement during the company's 2024 fiscal year end results conference call today, November 26, 2024, at 4:30 p.m. ET Ar
– Net product revenues for the third quarter 2024 totaled $429.8 million, a 39% increase over the same quarter of the prior year – ELEVIDYS net product revenue for the quarter totaled $181.0 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $9.5 million – Achieved GAAP and non-GAAP net income of $33.6 million and $67.0 million for the third quarter 2024, respectively Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the third quarter 2024. "I am pleased to report another strong quarter of performance, as we posted $429.8 million in net product revenue for the third
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report third quarter 2024 financial results after the Nasdaq Global Market closes on Wednesday, Nov. 6, 2024. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its third quarter 2024 financial results. The event will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-presentations and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all pho
Net product revenues for the second quarter 2024 totaled $360.5 million, a 51% increase over the same quarter of the prior year ELEVIDYS net product revenue for the quarter totaled $121.7 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $2.4 million Achieved GAAP net income of $6.5 million for the second quarter 2024 and non-GAAP net income of $46.7 million for the same period Sarepta provides net product revenues guidance of $2.9 billion to $3.1 billion for 2025 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the second quarter 2024. "The second quar
- Veteran biopharmaceutical executive from GSK and Eli Lilly brings more than 30 years of experience to Sarepta's Board Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the appointment of Deirdre P. Connelly to its Board of Directors. Ms. Connelly is a well-regarded executive with more than 30 years of experience in the pharmaceutical industry. Following Connelly's appointment, Sarepta's Board will comprise nine directors, eight of whom are independent. "Ms. Connelly is a seasoned board leader with extensive operating experience in biopharma and we're pleased to welcome her to the Sarepta Board of Directors as we work to
Rick Barry appointed Executive Chairman of the BoardRemi Barbier resigns as President and CEO and from the Board of DirectorsCassava initiates search for a new CEO AUSTIN, Texas, July 17, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ:SAVA) today announced that the Board of Directors has appointed Richard (Rick) Barry as Executive Chairman of the Board and as the Company's principal executive officer, effective immediately. The Company is undertaking a search for a new permanent CEO. Mr. Barry succeeds Remi Barbier, the Company's Chairman, President and CEO, who resigned from the Company and the Board. Mr. Barbier will remain employed by the Company until September 13, 2024 in a
NEW YORK, May 29, 2024 /PRNewswire/ -- Sarepta Therapeutics Inc. (NASD: SRPT) will replace Shockwave Medical Inc. (NASD: SWAV) in the S&P MidCap 400 effective prior to the opening of trading on Monday, June 3. S&P 500 constituent Johnson & Johnson (NYSE:JNJ) is acquiring Shockwave Medical in a deal expected to be completed soon pending final closing conditions. Following is a summary of the changes that will take place prior to the open of trading on the effective date: Effective Date Index Name Action Company Name Ticker GICS Sector June 3, 2024 S&P MidCap 400 Addition Sarepta Therapeutics SRPT Health Care June 3, 2024 S&P MidCap 400 Deletion Shockwave Medical SWAV Health Care For
CAMBRIDGE, Mass., June 02, 2022 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the appointments of Michael Chambers and Kathryn Boor, Ph.D., to its Board of Directors. Both Mr. Chambers and Dr. Boor bring distinct and invaluable experience to the Sarepta board that will help guide the company on its mission to change the course of life-threatening rare diseases. "We're pleased to welcome two new board members whose participation will contribute to the realization of Sarepta's strategic vision to create transformative therapies for patients with rare diseases," said M. Kathleen Behrens, Ph.D., Chai
Estepan brings to Cellarity's BOD deep experience and expertise in all aspects of finance, corporate strategy, investor relations, and business development, and a dedication to directly improving patient lives through innovation in medicine Cellarity, a life sciences company founded by Flagship Pioneering to transform the way medicines are discovered, announced today the appointment of Ian M. Estepan to its Board of Directors. Mr. Estepan currently serves as Executive Vice President and Chief Financial Officer (CFO) of Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases. At Sarepta and as a member of Sarepta's Executive Committee, he leads f
Gilmore O'Neill, M.B., M.M.Sc., will depart the Company and serve in a consulting capacity through March 31, 2022 CAMBRIDGE, Mass., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that, effective immediately, Louise Rodino-Klapac, Ph.D., executive vice president and chief scientific officer, has been named the Company's head of research and development (R&D) and will continue to serve in the role of chief scientific officer. Gilmore O'Neill, M.B., M.M.Sc., who has served as head of R&D since 2018, will leave the Company at the end of November and remain in a consulting capacity until
A renowned expert in protein engineering, Dr. Mayo brings extensive scientific expertise and strong business acumen to the Company's board CAMBRIDGE, Mass., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the appointment of Stephen L. Mayo, Ph.D., to its Board of Directors, effective immediately. Dr. Mayo is currently the Bren Professor of Biology and Chemistry at California Institute of Technology (Caltech), and serves on the board of directors for Merck and on the scientific advisory board of Rubryc Therapeutics. "We are delighted to welcome Dr. Mayo to the Sarepta Board of Directors
CAMBRIDGE, Mass.--(BUSINESS WIRE)--AavantiBio, a gene therapy company focused on transforming the lives of patients with rare genetic diseases, today announced the appointment of Ty Howton as Chief Operating Officer and General Counsel. A veteran life sciences executive, Mr. Howton brings to AavantiBio more than two decades of strategic, operational, and legal experience in the biopharmaceutical industry. In his most recent position, Mr. Howton served as Executive Vice President, General Counsel and Corporate Secretary of Sarepta Therapeutics (NASDAQ: SRPT), where he led Company’s global legal and compliance functions and oversaw quality assurance and information technology. Previo
CAMBRIDGE, Mass., Dec. 31, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on December 31, 2020 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 11 individuals hired by Sarepta in December 2020. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). The employees received, in the aggregate, options to purchase 4,525 shares of Sarepta's common stock, and in the aggregate, 1,720 restricted stock units (“RSUs”). The options hav
Submission status for SAREPTA THERAPS INC's drug AMONDYS 45 (SUPPL-8) with active ingredient CASIMERSEN has changed to 'Approval' on 07/11/2024. Application Category: NDA, Application Number: 213026, Application Classification: Labeling
For Immediate Release: June 20, 2024 Today, the U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ambulatory and non-ambulatory individuals 4 years of age and older with DMD with a confirmed mutation in the DMD gene. Elevidys was previously approved under accelerated approval for amb
Submission status for SAREPTA THERAPS INC's drug VYONDYS 53 (SUPPL-11) with active ingredient GOLODIRSEN has changed to 'Approval' on 06/04/2024. Application Category: NDA, Application Number: 211970, Application Classification: Labeling
Submission status for SAREPTA THERAPS INC's drug VYONDYS 53 (SUPPL-10) with active ingredient GOLODIRSEN has changed to 'Approval' on 06/04/2024. Application Category: NDA, Application Number: 211970, Application Classification: Labeling
For Immediate Release: June 22, 2023 Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a pre-existing medical reason preventing treatment with this therapy. “Today’s approval addresses an urgent unmet medical need
Submission status for SAREPTA THERAPS INC's drug AMONDYS 45 (SUPPL-5) with active ingredient CASIMERSEN has changed to 'Approval' on 03/23/2023. Application Category: NDA, Application Number: 213026, Application Classification: Labeling
Submission status for SAREPTA THERAPS INC's drug EXONDYS 51 (SUPPL-29) with active ingredient ETEPLIRSEN has changed to 'Approval' on 01/18/2022. Application Category: NDA, Application Number: 206488, Application Classification: Labeling
Submission status for SAREPTA THERAPS INC's drug EXONDYS 51 (SUPPL-28) with active ingredient ETEPLIRSEN has changed to 'Approval' on 01/18/2022. Application Category: NDA, Application Number: 206488, Application Classification: Labeling
Submission status for SAREPTA THERAPS INC's drug EXONDYS 51 (SUPPL-27) with active ingredient ETEPLIRSEN has changed to 'Approval' on 01/18/2022. Application Category: NDA, Application Number: 206488, Application Classification: Labeling
Submission status for SAREPTA THERAPS INC's drug AMONDYS 45 (ORIG-1) with active ingredient CASIMERSEN has changed to 'Approval' on 02/25/2021. Application Category: NDA, Application Number: 213026, Application Classification: Type 1 - New Molecular Entity