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Bellicum Pharmaceuticals Misleading Drug Trial Info Securities Class Action

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Gloved Hands Holding Vial of Blood

Drug trials are difficult to follow, so investors rely on companies to make honest statements about their results. The complaint for this class action alleges that Bellicum Pharmaceuticals, Inc. was not forthright during the class period about a problem uncovered in trials of its primary drug candidate.

The class for this action is all persons who acquired Bellicum’s securities between May 8, 2017 and January 30, 2018.

Bellicum is a clinical-stage biopharmaceutical company that develops novel cellular immunotherapies for various kinds of cancers. Bellicum’s lead product candidate, BPX-501, is an adjunct T-cell therapy given after allogeneic hematopoietic stem cell transplantation. The company has indicated that it is undergoing Phase 1 and 2 clinical trials.

During the class period, the complaint claims, Bellicum made optimistic statements on the progress of BPX-501, such as the following:

  • Two registration trials were advancing in the EU, one with BPX-501 and rimiducid for pediatric patients with orphan blood disorders or blood cancers who had received a haploidentical transplant, the other with matched unrelated donor transplants.
  • The company was preparing for US trials of the drug, one with pediatric patients with blood cancers and disorders and the other with adults with acute myeloid leukemia (AML).
  • Its BP-004 trial for a haploidentical transplants showed good results, including “a low incidence of transplant-related mortality, rapid immune recovery, a low rate of GvHD that was manageable … and no serious adverse events…”
  • Its BP-004 trial showed positive outcomes with pediatric leukemias.
  • The BP-004 trials were on track to be completed by the end of 2017.
  • Trials underway could be the basis of European Authorization Applications for the drug.

The company’s CEO Rick Fair also made positive statements, for example, saying he was “encouraged by the results from our ongoing BPX-501 pediatric studies and our progress toward a filing in Europe.”

However, on January 30, 2018, Bellicum put out a press release announcing that it had “received notice from the US Food and Drug Administration (FDA) that US studies of BPX-501 have been placed on a clinical hold following three cases of encephalopathy deemed as possibly related to BPX-501.”

At this news, the company’s stock price fell by more than 25%.

The complaint claims that the company knew about the risks of encephalopathy with the drug before they were announced, making its previous optimistic statements violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. 

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