US clinical hold on BPX-501 lifted

14 April 2018

Shares in US cell therapy specialist Bellicum Pharmaceuticals (Nasdaq: BLCM) were higher by 25.40% to $8.59 per share in after-hours trade, after the company announced that the US Food and Drug Administration has lifted the clinical hold on studies of BPX-501 in the USA.

The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events. Bellicum will be working with US clinical sites to resume patient recruitment based on the amended protocols. The FDA clinical hold did not affect the BP-004 registrational trial in Europe, which is fully enrolled.

Bellicum is developing BPX-501 to improve outcomes in patients who receive partial-match hematopoietic stem cell transplants to treat blood cancers and inherited blood disorders.

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