BridgeBio Pharma Drops 11.13% Amid FDA Gene Therapy Scrutiny

On June 25, 2025, BridgeBio Pharma's stock experienced a significant drop of 11.13% in pre-market trading.

The recent investigation by the FDA into the safety of Elevidys, a gene therapy developed by Sarepta Therapeutics for Duchenne muscular dystrophy, has raised concerns. Two patient deaths due to acute liver failure following Elevidys treatment have prompted the FDA to evaluate the need for further regulatory action. This investigation could impact BridgeBio Pharma, as it operates in a similar therapeutic area and faces similar regulatory scrutiny.

Capricor Therapeutics' decision to cancel an advisory committee meeting for its Duchenne treatment, deramiocel, due to skepticism from the FDA, highlights the regulatory challenges faced by companies in the gene therapy space. This development could influence investor sentiment towards BridgeBio Pharma, as it navigates its own regulatory landscape.

Nektar Therapeutics' positive mid-stage trial results for rezpegaldesleukin, a drug for atopic dermatitis, have shown significant improvements in skin clearance and itching relief. This success story in the biotechnology sector could boost investor confidence in BridgeBio Pharma, as it demonstrates the potential for innovative therapies to achieve clinical success.