Analysts Stay Bullish On Arcellx's CART-ddBCMA's Long-term Therapeutic Potential

The FDA lifted the partial clinical hold on Arcellx Inc's ACLX iMMagine-1 Phase 2 Clinical Program.

The move follows alignment with FDA on modifications to the iMMagine-1 trial protocol related to preventing and managing the risk of adverse events within the trial. 

Needham analyst Gil Blum is encouraged by the timely, albeit expected (note), resolution of the clinical hold and maintaining the conviction.

The analyst notes that despite the expected 4-8 weeks required for sites to acclimate the new study protocols, timelines for CART-ddBCMA remain relatively on track as initial data from iMMagine-1 is now guided for 2H:24, with potential commercial launch in 2026. 

Longer-term follow-up analysis (~2 years) is guided for later this year. It will be an essential initial barometer for CART-ddBCMA's durability and how it compares to competitors in the crowded multiple myeloma landscape. 

William Blair analysts Sami Corwin and Brooke Schuster view the resolution of the clinical hold positively and highlight the rapidness with which it was resolved (less than two months).

In essence, William Blair analysts do not see the clinical hold as a major enduring hindrance for the company. 

The revised timeline for interim data and regulatory submissions indicates a delay of just one to two quarters. The analysts remain optimistic about the lasting therapeutic value of CART-ddBCMA and anticipate the company's release of updated clinical data from the Phase 1 trial by the end of the year, which could positively influence the stock.

Price Action: ACLX shares were up 5.8% at $35.65 on the last check Tuesday.

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