BridgeBio Shares Surge 25% Following Attruby's FDA Approval

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BridgeBio Shares Surge 25% Following Attruby's FDA Approval

BridgeBio Pharma, Inc. (NASDAQ:BBIO) has received approval from the U.S. Food and Drug Administration (FDA) for its oral medication Attruby™ (acoramidis), aimed at reducing cardiovascular mortality and hospitalizations in adults with ATTR-CM. The approval followed positive results from the ATTRibute-CM Phase 3 study. Following this news, BridgeBio's stock rose by 25%.

The ATTRibute-CM study demonstrated that Attruby significantly reduces mortality and cardiovascular-related hospitalizations while improving patients' quality of life. It stands out as the first and only product approved with a label indicating nearly complete stabilization of Transthyretin (TTR), a protein associated with ATTR-CM.

The Phase 3 study, which included 632 participants, achieved its primary endpoint with a statistically significant treatment effect, resulting in a 1.8 Odds Ratio. The effect of Attruby was observed in the Kansas City Cardiomyopathy Questionnaire and the 6-minute walk test, showing significant improvements in patient outcomes.

Attruby's approval has been enthusiastically welcomed by medical professionals and patient support groups. Muriel Finkel, President of Amyloidosis Support Groups, expressed that it symbolizes hope and opportunity for patients with amyloidosis, emphasizing the importance of new therapies for better outcomes.

Dr. Martha Grogan from the Mayo Clinic highlighted the significance of having a new treatment that offers excellent TTR stabilization and improves patient outcomes, stating that it could transform a potentially fatal disease into a manageable condition.

BridgeBio also offers a patient support services program called ForgingBridges™, designed to provide access to treatment, insurance resources, and financial assistance to patients and families in the U.S. prescribed Attruby.

Looking ahead, BridgeBio's CEO, Neil Kumar, Ph.D., thanked the participants in the study and indicated that the company aims to obtain global approvals, with the next targets being Europe, Japan, and Brazil. BridgeBio has submitted a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025. Additionally, it granted Bayer exclusive rights to commercialize acoramidis in Europe.

In light of these developments, Scotiabank analyst Greg Harrison raised his price target for BridgeBio Pharma from $45.00 to $48.00 while maintaining an Outperform rating.