SRPT stock, which traded below $117 per share early on June 20, was trading at nearly $160 in pre-market trading this morning. This brought the market capitalization from $11.7 billion to nearly $16 billion. Elevidys, Sarepta's gene therapy, is a single-dose infusion usually given to children in the early stages of the disease. The agency gave traditional approval for these patients and accelerated approval for older ones. Sarepta CEO Doug Ingram called approval "a defining moment for the Duchenne community ...

Loading... Confirming the functional benefits, the FDA granted traditional approval for ambulatory patients (patients who can walk) and accelerated approval for non-ambulatory patients (patients who cannot walk). Continued approval for non-ambulatory Duchenne patients may be contingent upon verification of clinical benefit in a confirmatory trial. ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. Consistent with the accelerated approval pathway, Sarepta will ...

Kagenmi/iStock via Getty Images Sarepta Therapeutics, Inc. (NASDAQ:SRPT), submitted a request to the FDA aiming to erase the ambulation and age restrictions for Elevidys, as well as a switch in the designation from accelerated to standard approval. The company reported, in its Q1 2024 conference call, that the FDA will be issuing a response by June 21st or earlier. SRPT's management seems very certain about their chances to obtain the label expansion. However, I believe the FDA has enough grounds to support ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Q1 2024 Earnings Conference Call May 1, 2024 4:30 PM ET Company Participants Mary Jenkins - Associate Director, Investor Relations & Corporate Communications Douglas Ingram - President & Chief Executive Officer Dallan Murray - Executive Vice President & Chief Customer Officer Louise Rodino-Klapac - Executive Vice President, Chief Scientific Officer & Head of Research & Development Ian Estepan - Executive Vice President and Chief Financial Officer Conference Call Part ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-14895 SAREPTA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpor ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Q4 2023 Earnings Conference Call February 28, 2024 4:30 PM ET Company Participants Francesca Nolan - Executive Director of Investor Relations and Corporate Communications Douglas Ingram - President and Chief Executive Officer Louise Rodino-Klapac - Executive Vice President, Chief Scientific Officer and Head of Research & Development Dallan Murray - Executive Vice President and Chief Customer Officer Ian Estepan - Executive Vice President and Chief Financial Officer C ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number : 001-14895 Sarepta Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 93-0797222 (State or other jurisdi ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Q3 2023 Earnings Conference Call November 1, 2023 4:30 PM ET Company Participants Francesca Nolan - IR Director Douglas Ingram - President and CEO Louise Rodino-Klapac - EEVP, Chief Scientific Officer and Head of Research & Development Dallan Murray - EVP & Chief Customer Officer Ian Estepan - EVP & CFO Conference Call Participants Anupam Rama - JPMorgan Tazeen Ahmad - Bank of America Securities Gena Wang - Barclays Colin Bristow - UBS Brian Skorney - Baird Salveen R ...

BENJAMIN Living with Duchenne muscular dystrophy Other timed secondary endpoints: • Stride velocity 95th centile (SV95C) • 100-meter walk/run (100MWR) • Ascend 4 steps ©SAREPTA THERAPEUTICS, INC. 2023. ALL RIGHTS RESERVED. 5 ©SAREPTA THERAPEUTICS, INC. 2023. ALL RIGHTS RESERVED. 8 NSAA -3.29 (-8.28, 1.70) 0.1942 Overall Treatment Group ELEVIDYS t == Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-14895 SAREPTA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 93-0797222 (State or other ...