Acoramidis fda approval

BridgeBio Pharma, Inc. announced that the FDA has accepted for filing the Company's New Drug Application (NDA) for acoramidis

After publishing an extra dive into its phase 3 data in August, BridgeBio reaffirmed plans to submit a new drug approval application to the FDA for acoramidis before the end of this year, with

Acoramidis and vutrisiran have not yet been approved by the FDA for ATTR-CM, and the manufacturers have not announced US prices for each therapy if approved. ICER has calculated a health benefit price benchmark (HBPB) for TTR stabilizers such as tafamidis and acoramidis to be between $13,600 to $39,000 per year.

The U.S. FDA has accepted our NDA for acoramidis for the treatment of ATTR-CM with a PDUFA date of Novem.

BridgeBio Pharma's Acoramidis NDA for Transthyretin Amyloid Cardiomyopathy Accepted by FDA - A Promising Milestone.

BridgeBio Pharma, Inc. today announced that it has submitted an NDA for acoramidis to the US FDA for the treatment of ATTR-CM.

BridgeBio plans to submit an approval application to the U.S. Food and Drug Administration (FDA) later this year, hoping to bring acoramidis to patients as soon as possible. If approved, acoramidis could represent a significant advancement in the treatment of ATTR-CM and offer a new therapeutic option for patients with this life-threatening

$500 million cash payment upon FDA approval of acoramidis to help support the Company's commercial launch in exchange for future royalties

On Decem, BridgeBio Pharma, Inc. announced the submission of a New Drug Application (NDA) to the U.S. FDA for acoramidis to treat