Monday, BridgeBio Pharma Inc BBIO and Bayer AG BAYRY BAYZF announced a partnership wherein BridgeBio grants Bayer an exclusive license to commercialize acoramidis for ATTR-CM in Europe.
In exchange, BridgeBio will receive up to $310 million, including upfront and near-term milestone payments and additional undisclosed sales milestones.
BridgeBio will also receive royalties in a tiered structure beginning in the low-thirties percent on sales of acoramidis in Europe.
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Acoramidis is an investigational, next-generation, orally-administered, highly potent small molecule stabilizer of transthyretin (TTR).
The FDA has accepted BridgeBio’s NDA for acoramidis for the treatment of ATTR-CM with a PDUFA action date of November 29, 2024; additionally, the EMA has accepted the MAA for acoramidis with potential EU approval in 2025.
In July 2023, BridgeBio Pharma released results from ATTRibute-CM Phase 3 study of acoramidis in transthyretin amyloid cardiomyopathy (ATTR-CM).
A highly statistically significant improvement in the primary endpoint (a hierarchical analysis prioritizing in order: all-cause mortality, then the frequency of cardiovascular-related hospitalization, then change from baseline in NT-proBNP, then change from baseline in 6-minute walk distance) demonstrated by a Win Ratio of 1.8.
On-treatment survival rate of 81% versus placebo survival rate of 74% (absolute risk reduction of 6.43%; relative risk reduction of 25%).
During the early trading session, BridgeBio Pharma stock traded higher and reached as high as $36.67.
Price Action: BBIO shares are down 7.77% at $32.86 on the last check Monday.
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