FDA Hold

As previously announced, Denali Therapeutics Inc (NASDAQ: DNLI) was informed via e-mail communication from the FDA that DNL919 (ATV:TREM2) Investigational New Drug (IND) application was placed on clinical hold.  Denali has now received a formal clinical hold letter and is...

Shares for Bluebird Bio Inc (NASDAQ: BLUE) is hovering at a 52-week low after the FDA placed a clinical hold on clinical studies of elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy for cerebral adrenoleukodystrophy (CALD). The company reported an adverse reaction to...

Shares of Cara Therapeutics Inc (NASDAQ: CARA) were trading higher by more than 9 percent early Wednesday morning after the company confirmed the U.S. Food and Drug Administration (FDA) removed a hold on a clinical trial. Cara Therapeutics said it received notice from the FDA that the agency...