Sarepta Therapeutics Inc Stock Price, News & Analysis

Sarepta Therapeutics (NASDAQ:SRPT) announced significant progress in its limb-girdle muscular dystrophy (LGMD) pipeline programs. The FDA has cleared the company to proceed with dosing in Study SRP-9005-101 (COMPASS) for LGMD2C/R5, marking their fourth LGMD program to enter clinical trials.

The company has completed enrollment and dosing in Study SRP-9004-102 (DISCOVERY) for LGMD2D/R3. Additionally, enrollment and dosing are complete in the phase 3 EMERGENE trial of SRP-9003 for LGMD2E/R4, with data expected by mid-2025. The FDA has confirmed eligibility for accelerated approval, and Sarepta plans to submit a Biologics License Application in the second half of 2025.

These developments are significant as there are currently no disease-modifying treatments approved for any LGMD subtype. Sarepta's LGMD pipeline covers subtypes that represent over 70% of known LGMD cases.

Sarepta Therapeutics (NASDAQ:SRPT) announced a temporary halt in recruitment and dosing for certain clinical studies of ELEVIDYS, their approved gene therapy for Duchenne muscular dystrophy. This follows a safety update on acute liver failure from March 18.

The independent data monitoring committee (DMC) reviewed the adverse event on April 3 and concluded that the overall benefit-risk profile remains favorable to continue dosing. The affected studies include SRP-9001-302 (ENVOL), SRP-9001-303 (ENVISION), and SRP-9001-104.

Sarepta and Roche will submit their response to EU regulators within a week. The company maintains that monitoring and data collection for already-enrolled participants continues, and they do not anticipate material impact on study timelines.

Sarepta Therapeutics (NASDAQ:SRPT) has announced equity awards granted to 39 new employees hired in Q1 2025 under its 2024 Employment Commencement Incentive Plan. The grants, approved by the Compensation Committee and compliant with Nasdaq Listing Rule 5635(c)(4), include:

• 31,344 stock options with an exercise price of $63.82 per share
• 77,442 restricted stock units (RSUs)

The stock options will vest over four years, with 25% vesting after one year and the remaining vesting monthly at 1/48th. RSUs will vest annually at 25% over four years. Both are subject to continued employment.

Sarepta Therapeutics (NASDAQ:SRPT) has launched the 8th Annual Route 79 Duchenne Scholarship Program for the 2025-2026 academic year. The program will award academic scholarships of up to $5,000 to as many as 20 individuals living with Duchenne muscular dystrophy and 5 siblings of those affected.

Applications will be accepted until May 30, 2025, with recipients notified before August 2025. Eligible applicants must be accepted to or enrolled in an accredited U.S. college, university, or trade school. The selection process is conducted by an independent committee, with awards distributed for fall 2025 enrollment.

The scholarship program, named after the 79 exons of the dystrophin gene, allows recipients to receive awards up to four times. Selection is made without consideration of whether applicants use Sarepta products or therapies.

Sarepta Therapeutics (NASDAQ:SRPT) reported strong Q4 2024 financial results with net product revenues of $638.2 million, up 75% year-over-year. ELEVIDYS, their gene therapy for Duchenne muscular dystrophy, generated $384.2 million in quarterly revenue, with additional $4.9 million in royalties from Roche sales.

The company achieved GAAP net income of $159.0 million and non-GAAP net income of $206.0 million in Q4 2024. For 2025, Sarepta projects net product revenue guidance of $2.9-3.1 billion, representing 70% year-over-year growth.

Key developments include establishing a $600 million credit facility, positive EMBARK study results for ELEVIDYS, and a global licensing agreement with Arrowhead Pharmaceuticals for siRNA programs. The company completed enrollment in the EMERGENE Phase 3 trial for LGMD2E/R4 gene therapy, with data expected in H1 2025.

Sarepta Therapeutics (NASDAQ:SRPT) has secured a $600 million senior secured revolving credit facility through a bank syndicate led by JPMorgan Chase Bank. This non-dilutive financing arrangement enhances the company's financial flexibility while complementing its existing strong balance sheet.

The credit facility, which received oversubscribed demand, demonstrates lenders' confidence in Sarepta's future cash and EBITDA growth trajectory. The syndicate includes major financial institutions such as Barclays Bank, Citizens Bank, Goldman Sachs USA, Morgan Stanley, Royal Bank of Canada, Fifth Third Bank, UBS AG, and Bank of America.

The facility is designed to provide contingent liquidity as the company executes its strategic plan toward achieving its Sarepta 2030 objectives.

Sarepta Therapeutics (NASDAQ:SRPT), a leader in precision genetic medicine for rare diseases, has announced it will release its fourth quarter and full-year 2024 financial results after the Nasdaq Global Market closes on Wednesday, February 26, 2025.

The company will host a conference call at 4:30 p.m. E.T. to discuss the results. The event will be webcast live on Sarepta's investor relations website, with a replay available for one year. Phone participants must register online to receive dial-in details and a personal PIN for access.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has completed its global licensing and collaboration agreement with Sarepta Therapeutics (NASDAQ: SRPT). The deal includes a $500 million upfront payment and $325 million through Sarepta's purchase of Arrowhead stock at $27.25 per share. Additionally, Arrowhead will receive $250 million in annual $50 million installments over 5 years.

The agreement covers multiple clinical-stage programs including ARO-DUX4 for facioscapulohumeral muscular dystrophy, ARO-DM1 for myotonic dystrophy, ARO-MMP7 for idiopathic pulmonary fibrosis, and ARO-ATXN2 for spinocerebellar ataxia 2. Three preclinical programs are also included. Arrowhead can earn up to $300 million in near-term payments for ARO-DM1 study enrollment, plus development milestones of $110-410 million and sales milestones of $500-700 million per program, along with tiered royalties up to low double digits.

Sarepta Therapeutics (SRPT) announced positive topline results from Part 2 of the EMBARK study for ELEVIDYS, their approved gene therapy for Duchenne muscular dystrophy. Crossover-treated patients showed significant improvements, with a 2.34-point increase in North Star Ambulatory Assessment (NSAA) compared to controls (P<0.0001).

Two-year results demonstrated sustained benefits, with Part 1 patients showing clinically meaningful improvements in NSAA (+2.88 points), Time to Rise, and 10-meter walk/run tests compared to external controls. Muscle biopsies at 64 weeks showed consistent expression of ELEVIDYS micro-dystrophin, supporting the observed functional outcomes.

MRI results revealed minimal muscle pathology progression, and no new safety signals were observed. The therapy is currently approved in the U.S. and several other countries for patients aged four years and over.