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A Strong Launch For Sarepta’s Elevidys, But Future Hinges On FDA Decision

 
• By Andrew McConaghie

Strong demand from physicians and families of boys with Duchenne has seen a rapid take-off in sales of the $3.2m gene therapy – but the FDA will have the final say on the product's future after a failed Phase III study.

Sarepta building

Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys has achieved better than expected initial sales, but its future hangs in the balance after its confirmatory Phase III study missed its primary endpoint.

The disappointing news that Elevidys (delandistrogene moxeparvovec-rokl) failed its Phase III EMBARK study was revealed on 30 October, creating uncertainty...

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Stock Watch: On Q1 Vaccine Sales And Measles Outbreaks

 
• By Andy Smith

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Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
• By Anju Ghangurde

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

More from Business

AstraZeneca Taps Into China’s R&D Engine With CSPC Alliance

 
• By Andrew McConaghie

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Finance Watch: Insmed Cashes In On Positive Data With $750m Offering

 
• By Mandy Jackson

Public Company Edition: Insmed raised $750m after reporting positive Phase IIb data in PAH, Cogent accessed up to $400m in new debt, Kelun-Biotech netted $250m in a placement of shares and ADC revealed a $100m private placement. In strategic updates, Recursion cut 20% of its jobs.

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• By Joseph Haas

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