ASH ’24: Arcellx Mounts Strong Challenge To Myeloma CAR-T Rival Carvykti

The biotech’s challenger CAR-T is matching Carvytki in efficacy and showing an edge in safety in abstract data released ahead of the December meeting.

San Diego
The San Diego Convention Center hosts this year's ASH congress.

The current leader in the multiple myeloma CAR-T market, Legend and J&J’s Carvykti, looks to have a serious challenger in the shape of Arcellx/Gilead’s anitocabtagene autoleucel (anito-cel).

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RemeGen Fast-Tracks Potential World-First BLys/APRIL Agent For gMG In Global Phase III Trial

 

RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.

Equillium Seeks Accelerated Approval For GVHD Drug Despite Primary Endpoint Miss

 

The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.

Almirall CEO Sounds Alarm Over Europe’s Reduced Competitiveness

 
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The head of the Spanish medical dermatology specialist told Scrip that maintaining the status quo will only result in the continent’s life sciences sector slipping further behind the US and China.

Wave Aspires To Accelerated Approval In DMD With 48-Week Data

 
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With its exon 53-skipping candidate already showing promise in 24-week data, Wave now has 48-week data showing improvements in muscle health and functional outcomes.

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Quotables: Pharma Leaders On The Month’s Hot Topics

 

The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.

RemeGen Fast-Tracks Potential World-First BLys/APRIL Agent For gMG In Global Phase III Trial

 

RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.

Finance Watch: European And Japanese Biotechs See VC Investor Interest In March

 
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Private Company Edition: The latest group of drug developers to announce venture capital financings is remarkable for its geographic diversity, from Character Biosciences’ $93m series B round in the US to Augustine’s $85m series B in Belgium to a $29.2m series C for Aculys in Japan.