CAR-T, Regulatory

Bellicum outlines a few quick steps the FDA wants before lifting its hold on lead cell therapy, shares rise

Bellicum rocked investors at the end of last month with news that its “safer” lead cell therapy had been put on hold by the FDA. And this morning the biotech is following up with an explanation of what it needs to do to get that hold lifted.

By Bellicum’s account, that’s not a lot.

Rick Fair, president and CEO of Bellicum

In a statement out this morning Bellicum $BLCM says that it needs to revise its study protocols, with regulators looking for “more comprehensive monitoring and management of neurotoxicity.”

And there’s this note:

In addition, the Company will revise the Investigator Brochure and Informed Consent Documents to inform healthcare providers, patients and caregivers of the changes. The Company expects to provide a full response to the FDA within a few weeks.

Investors saw the glass as half full this morning, spurring a rally for the biotech’s shares  — which shot up 18% in pre-market trading.

Bellicum’s shares got hit hard after researchers tracked three cases of encephalopathy — a broad term for brain damage — among patients taking the drug to support allogeneic stem cell transplants. The cases were deemed as possibly linked to BPX-501, which was being billed as a safer version of the cell therapies now making their way to the market.

The biotech, though, didn’t interrupt a registrational study of BPX-501 in Europe dubbed BP-004.

Bellicum made it sound straightforward enough, implying that it won’t be in regulatory limbo for much longer. Now it has to deliver.


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