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BridgeBio Surges After Heart Drug Succeeds in Pivotal Trial


(Bloomberg) — BridgeBio Pharma Inc. shares surged after the biotech company’s experimental drug cut deaths among patients suffering from a heart condition in a late-stage trial.

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Survival among patients with transthyretin amyloid cardiomyopathy who received BridgeBio’s acoramidis was 81% after 2 1/2 years, compared with 74% among patients who received a placebo, the company said Monday in a statement. The shares rose as much as 70%, giving the company a market value of about $4.7 billion.

The same drug failed in a final-stage trial at the end of 2021, when it didn’t outperform a placebo treatment, and the shares slumped 72%. For that trial, BridgeBio used a test that measures how far people can walk within six minutes as a proxy for heart function.

The Palo Alto, California-based company is now preparing to file for US market clearance, BridgeBio said Monday.

Transthyretin amyloid cardiomyopathy occurs when a misshapen version of a naturally occurring human protein gets deposited in heart tissue. The condition was once considered rare but is turning out to be relatively common. About 5,000 to 7,000 new cases are identified annually in the US, according to review of data published in April.

The condition “is an increasingly recognized cause of heart failure,” said Muriel Finkel, president of Amyloidosis Support Groups advocacy group, said in the statement, and the results “are very exciting and bring much hope to amyloidosis patients and their loved ones.”

Pfizer Inc. currently sells two drugs that use the same active ingredient, tafamidis, to treat the condition. The medicines brought in about $2.5 billion in sales for Pfizer last year. Meanwhile, Alnylam Pharmaceuticals Inc. is seeking approval from US regulators to expand its drug Onpattro into cardiomyopathy, with a decision expected in October. Onpattro is already used for a type of amyloidosis that affects nerves.

BridgeBio’s results should pave the way for acoramidis’ approval next year and make the drug a preferred option over Onpattro, Bloomberg Intelligence analyst Marc Engelsgjerd wrote. That’s because Alnylam’s “supporting data don’t include mortality or hospitalization benefit, critical endpoints achieved by BridgeBio,” he said.

(Updates shares in second paragraph, adds competing products and analyst comment in seventh and eighth paragraphs.)

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