Friday, BridgeBio Pharma Inc. ( BBIO ) presented additional data from an analysis of its Phase 3 ATTRibute-CM and open-label extension study of acoramidis in ATTR-CM at the European Society of Cardiology (ESC) 2024.

The data included change from baseline in serum TTR levels in participants receiving acoramidis versus those receiving tafamidis in the placebo group in ATTRibute-CM at Month 30, as well as serum TTR levels in patients who transitioned from placebo and tafamidis to acoramidis.

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Transthyretin amyloidosis (ATTR-CM) occurs when the liver produces faulty transthyretin (TTR) proteins. Clumps of these abnormal proteins (called fibrils) build up in the heart's main pumping chamber.

In participants who switched from Pfizer Inc's ( PFE ) Vyndaqel (tafamidis) and placebo in the ATTRibute-CM study to acoramidis in its open-label extension (OLE), there was a mean of 3.0mg/dL increase in serum TTR at Month 1 of the OLE (n=21, p=0.01) and mean of 3.4mg/dL increase in serum TTR at Month 6 of the OLE (n=18, p=0.01).

BridgeBio submitted a marketing application to the FDA, which has been accepted with a PDUFA action date of November 29, and a marketing application to the European Medicines Agency, with a decision expected in 2025.

BridgeBio has granted Bayer AG ( BAYZF ) exclusive rights to commercialize acoramidis for ATTR-CM in Europe.

Price Action: BBIO stock is up 12.50% at $27.69 at the last check on Friday.

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