Bellicum Pharmaceuticals Inc. (NASDAQ: BLCM) saw its shares rise early on Thursday after the firm announced a critical decision from the U.S. Food and Drug Administration (FDA). As we have said before, FDA decisions can make or break health care companies. In this case, Bellicum saw a handy gain.
The firm announced that the FDA lifted the clinical hold on studies of BPX-501 in the United States. 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 U.S. 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.
For some quick background, BPX-501 is an adjunct T-cell therapy administered after allogeneic hematopoietic stem cell transplants.
While stem cell transplants can be life-saving for patients with orphan inherited blood disorders and hematologic malignancies who lack a matched donor, they also carry the risk of life-threatening infections and uncontrolled graft versus host disease. The potential benefit of BPX-501 is layered: the patient gets the benefit of having T cells to fight infection, support engraftment and prevent disease relapse.
Shares of Bellicum were last seen up over 16% at $7.96, with a consensus analyst price target of $17.25 and a 52-week range of $5.02 to $14.49.