BridgeBio Announces ATTRibute-CM Month 12 Primary Endpoint Miss; Shares Plunge 72%

Nasdaq listed BridgeBio Pharma, Inc. (BBIO) has revealed Month 12 topline results from the Phase 3 ATTRibute-CM study. Following the results, shares of the biopharmaceutical company crashed 72% on Monday to close at $11.38.

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ATTRibute-CM, an ongoing global Phase 3 study evaluating acoramidis, an investigational, orally-administered small molecule designed to treat symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM), did not meet its primary endpoint at Month 12.

ATTR is an underdiagnosed and life-threatening disease that can damage the heart and nervous system. With over 400,000 patients affected globally, treatment options are limited.

Outcome

Despite disappointing results from the six-minute walk test, the company believes that acoramidis has the potential to show positive Month 30 endpoint results, which include all-cause mortality and cardiovascular hospitalizations. An independent data monitoring committee also recommends continuing the study based on unblinded data reviews.

Official Comments

BridgeBio CEO Neil Kumar said, “This result is disappointing and baffling. I am, along with many others, searching for answers regarding the six-minute walk distance (6MWD). The results do not appear to be due to a baseline imbalance. The hypotheses we are currently evaluating include context bias, training bias, and an evolution in diagnosis and standard of care.”

“The drug does appear to be pharmacologically active and well-tolerated, and we observed improvement on quality of life with promising trends on adverse events leading to death. The drug seems to be doing what we are asking of it. If we observe enough clinical outcome events at Month 30, I am still hopeful that we will demonstrate the benefit of acoramidis treatment,” Kumar added.

Outlook

According to the company, BridgeBio is well-capitalized through the completion of ATTRibute-CM and remains on track to deliver additional catalysts in 2022 and 2023.

CFO BridgeBio Brian Stephenson said, “With the financing announced in November 2021, we currently have approximately $800 million in cash, cash equivalents and marketable securities with access to up to $300 million on achieving portfolio milestones through year-end 2022. We have ongoing clinical trials in multiple genetic diseases, including achondroplasia, autosomal dominant hypocalcemia type 1, limb-girdle muscle dystrophy type 2i and dystrophic epidermolysis bullosa, and we believe we are well-positioned to deliver in 2022.”

Wall Street’s Take

Following the recent clinical update, J.P. Morgan analyst Anupam Rama maintained a Buy rating on the stock but lowered the price target to $36 (216.34% upside potential) from $77.

Rama still has a positive stance on BridgeBio as he foresees “an interesting catalyst pathway” for the company.

Consensus among analysts is a Strong Buy based on 6 unanimous Buys. The average BridgeBio price target of $63.80 implies 460.63% upside potential from current levels. However, shares have fallen 83.2% over the past year.

Risk Analysis

According to the new TipRanks Risk Factors tool, BridgeBio stock is at risk mainly from three factors: Finance and Corporate, Tech and Innovation, and Legal & Regulatory, which contribute 31%, 31%, and 18%, respectively, to the total 91 risks identified for the stock.