Bellicum’s Share Price Drops Sharply During Intraday Trading on January 31, 2018
Post-market, on January 30, 2018, Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM) announced (“Bellicum Pharmaceuticals Announces Clinical Hold on BPX-501 Clinical Trials in the United States”) that Bellicum Pharmaceuticals
. . . has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501 have been placed on a clinical hold following three cases of encephalopathy deemed as possibly related to BPX-501.
Bellicum is awaiting formal communications from the FDA to determine the requirements for resuming studies, and will be working closely with the FDA to address their questions. The FDA clinical hold does not affect the ongoing BP-004 registration trial in Europe.
Encephalopathy has been reported in the allogeneic stem cell transplant literature. Risk factors for encephalitis/encephalopathy after allogeneic stem cell transplants include prolonged immunodeficiency, selected medications, infections, and inflammatory processes such as graft versus host disease. Bellicum has treated more than 240 patients with BPX-501 cells on three allogeneic haploidentical stem cell transplantation protocols. These three cases are complex, with a number of potential confounding factors—including, in certain of the cases, prior failed transplants, prior history of immunodeficiency, concurrent infection, and administration of rimiducid in combination with other medications. Bellicum is working with FDA to evaluate the risk of encephalopathy in patients receiving BPX-501.
On January 31, 2018, The Motley Fool reported (“Why Bellicum Pharmaceuticals Stock is Crashing Today”) that the
. . . clinical setback may be the beginning of the end for Bellicum. [Bellicum] has staked the bulk of its value proposition on producing a safer adoptive cell therapy than the current industry leaders. So, a serious safety issue like encephalopathy — if shown to be treatment-related — would be a big blow to Bellicum’s claim of developing a “best-in-class” adoptive cell therapy.
On the news of the clinical hold on Bellicum’s lead product candidate BPX-501, Bellicum shares dropped significantly during intraday trading on January 31, 2018.
Bellicum Pharmaceuticals Investors
Kehoe Law Firm, P.C. is investigating whether Bellicum and certain of its officers or directors engaged in securities fraud or other unlawful business practices. Bellicum shareholders with questions or concerns may contact John Kehoe, Esq., (215) 792-6679, Ext. 801, [email protected], complete the form above on the right or e-mail [email protected] for additional information.