BridgeBio Pharma Reports Positive Results for Investigational Drug in Treatment of ATTR-CM

BridgeBio Pharma, a commercial-stage biopharmaceutical company, has announced positive results from its Phase 3 study of acoramidis, an investigational drug for transthyretin amyloid cardiomyopathy (ATTR-CM).

Significant Improvement in Survival Rate

According to the company, the study demonstrated a statistically significant improvement in the primary endpoint, with the treatment group achieving an 81% survival rate compared to a 74% survival rate in the placebo group.

Plans for Drug Application Submission

BridgeBio Pharma intends to submit a new drug application for acoramidis to the U.S. Food and Drug Administration before the end of the year.

"We are extremely encouraged by the robustly positive and consistent findings of the ATTRibute-CM study, which confirm our position that highly potent TTR stabilization has the potential to profoundly impact patients' lives," said Jonathan Fox, Chief Medical Officer of BridgeBio's Cardiorenal unit.

Understanding ATTR-CM

ATTR-CM is a rare but potentially fatal disease of the heart muscle, as stated by the American Heart Association.

Market Response

In response to the positive results, shares of BridgeBio Pharma soared by nearly 63% to $29.65 in premarket trading on Monday.