Sarepta Therapeutics
This article needs to be updated.(December 2016) |
Nasdaq: SRPT Russell 1000 Index component | |
Headquarters | |
Key people | Douglas S. Ingram (CEO & President) |
Revenue | $301 Million(2018) |
Website | www |
Sarepta Therapeutics, Inc. (Nasdaq: SRPT) is a medical research and drug development company with corporate offices and research facilities in Cambridge, Massachusetts, United States. Incorporated in 1980 as AntiVirals,[1] shortly before going public the company changed its name from AntiVirals to AVI BioPharma soon with stock symbol AVII and in July 2012 changed name from AVI BioPharma to Sarepta Therapeutics and SRPT respectively.[2] As of 2023, the company has four approved drugs (see the Products section below).
History
Sarepta started in Corvallis, Oregon on January 1, 1980 and was originally named Antivirals Inc.
In 2012, the company moved a second time, to Cambridge, Massachusetts. At the time, CEO Chris Garabedian indicated the move was motivated by the need to recruit expertise in rare diseases.[9] The Corvallis laboratory facility was closed in 2016. The company opened a new Genetic Therapies Center of Excellence in Columbus, Ohio in October, 2021 in order to dramatically advance research into therapeutics for several muscular dystrophies that had begun at Nationwide Children's Hospital several years earlier.[10]
In February 2019, Sarepta acquired five gene therapy candidates for $165 million after one of them, MYO-101, produced results with a new gene therapy candidate for patients with
As of 2022, there are three FDA-approved Duchenne muscular dystrophy drugs in Sarepta Therapeutics' portfolio.[12] In January 2023, Sarepta partnered with Catalent to manufacture delandistrogene moxeparvovec (SRP-9001).[13][14][15]
Products
Its primary products are based on
The Morpholino drug
In December 2019, golodirsen (Vyondys 53) received US FDA approval[20] for the treatment of cases that can benefit from skipping exon 53 of the dystrophin transcript. The other approved PMO developed by Sarepta is casimersen (AMONDYS45) which is indicated for the treatment of DMD in patients amendable by exon 45 skipping.[21]
In addition to development of Morpholinos as therapeutics, AVI has conducted six human trials for
In June 2023,
See also
References
- ^ Summerton, J (2005). "Morpholino Antisense Oligos: Applications in Biopharmaceutical Research". Innovations in Pharmaceutical Technology. No. Sept. Retrieved 29 Oct 2012. | archiveurl = http://www.gene-tools.com/sites/default/files/Summerton2005_IPT.pdf
- ^ "AVI BioPharma changes name, splits stock". Portland Business Journal. July 12, 2012. Retrieved 17 July 2012.
- ISBN 978-1-4939-6815-2.
- ^ a b Moody, Robin J. (November 5, 2003). "AVI BioPharma's losses shrinking". Portland Business Journal. Retrieved 2009-10-24.
- ^ Moody, Robin J. (June 12, 2003). "AVI BioPharma stock reaches new 52-week high". Portland Business Journal. Retrieved 2009-10-24.
- ^ a b c d DiMesio, Robbie (July 30, 2009). "AVI BioPharma moving HQ out of Oregon". The Oregonian. Retrieved 2009-10-24.
- ^ "AVI BioPharma loses $19.7M in Q2". Portland Business Journal. August 10, 2009. Retrieved 2009-10-24.
- ^ a b "AVI BioPharma gets $11.5M military contract". Portland Business Journal. October 5, 2009. Retrieved 2009-10-24.
- ^ Timmerman, Luke. Sarepta Moves From Seattle to Boston for the Talent. 7 September 2012.
- ^ Siefert, Kate (2023-05-09). "'It's transformational work,' Sarepta working on groundbreaking gene therapies in Columbus". WSYX. Retrieved 2023-10-05.
- ^ Renauer, Cory (2019-03-26). "Is Sarepta Therapeutics a Good Gene Therapy Stock to Buy Now? -". The Motley Fool. Retrieved 2019-05-21.
- ^ "Our Pipeline, Building an industry-leading genetic medicine pipeline". Sarepta Therapeutics.
- ^ "Sarepta and Catalent Expand Strategic Manufacturing Partnership With Commercial Supply Agreement for Duchenne Muscular Dystrophy Gene Therapy Candidate". www.businesswire.com. 2023-01-05. Retrieved 2023-01-24.
- ^ Tarun, Shafiul Islam. "Sarepta marches forward with its potential DMD gene therapy and an expanded Catalent manufacturing deal". Endpoints News (in English, Bengali, and Hindi). Retrieved 2023-01-24.
- ^ Keenan, Joseph (2023-01-05). "Catalent inks deal to manufacture Sarepta's DMD gene therapy". Fierce Pharma. Retrieved 2023-01-24.
- ^ "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of SRP-5051 in Patients With Duchenne Muscular Dystrophy (DMD) - Full Text View - ClinicalTrials.gov". clinicaltrials.gov.
- ^ Commissioner, Office of the (6 March 2019). "FDA grants accelerated approval to first drug for Duchenne muscular dystrophy". FDA.
- ^ Therapeutics, Sarepta. "Sarepta Therapeutics Announces FDA Approval of AMONDYS 45™ (casimersen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 45". Sarepta Therapeutics.
- ^ Sarepta's Marburg Drug Shows High Survival Rates After Intramuscular Delivery in Non-Human Primates. Marketwire, 4 March 2013.
- ^ U.S. Food and Drug Administration, Silver Springs, Maryland. News Release: FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation, December 12, 2019. Archived December 13, 2019, at the Wayback Machine
- ^ "A Biotech Growth Stock to Consider For Your Portfolio - Sarepta Therapeutics (NASDAQ: SRPT)". www.biocompounding.com. 2 October 2022.
- ^ Leo, Leroy; Samal, Aditya (22 June 2023). "US FDA approves Sarepta's gene therapy for rare muscular dystrophy in some kids". Reuters. Archived from the original on 29 June 2023. Retrieved 26 July 2023.
- ^ Stein, Rob (22 June 2023). "Muscular dystrophy patients get first gene therapy". NPR. Archived from the original on 25 July 2023. Retrieved 26 July 2023.
- ^ FDA. Archivedfrom the original on 26 June 2023. Retrieved 26 July 2023.
- ^ "The Accelerated Approval Pathway and Rare Diseases" (PDF). EveryLife Foundation for Rare Diseases. Archived (PDF) from the original on 25 February 2022. Retrieved 26 July 2023.
External links
- Official website
- AVI BioPharma drops two directors, shareholder group to dissolve – Portland Business Journal