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Approval Delayed, But Janssen/Legend’s Cilta-Cel May Hit Market Just In Time

BMS/Bluebird’s Abecma Approved But Demand Exceeds Supply

Executive Summary

The US FDA has extended the user fee date by three months for the partners’ BCMA-targeting CAR-T therapy but its first-to-market rival is facing manufacturing challenges that limit access to treatment.

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Janssen/Legend Plan Phased US Launch For BCMA-Targeting CAR-T Carvykti

Janssen priced the one-time autologous treatment at $465,000, well above the $419,500 list price for Bristol’s first-to-market CAR-T, but expects broad commercial and Medicare coverage. 

Decision Moment: Clinical Hold For Legend's CAR-T Amid Bated Breath Over BCMA Decision

Nanjing-based Chinese biotech says it has had a US clinical hold put in place for it CAR-T, amid broader challenges for China's cell therapy sector and more measured reaction to the setback than the recent immuno-oncology decision in the US.

Finance Watch: Five More Small IPOs Squeeze Through The US Window

Public Company Edition: Genenta, Cingulate, ImmixBio, Bionomics and NeuroSense launched initial public offerings, grossing just $118m between them. But Amylyx, with a recently filed ALS drug, has filed to raise up to $100m. In follow-on offerings, Legend took advantage of ASH goodwill to raise $300m. 

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