Less than two months after scoring what analysts deemed a "best-case" FDA approval for its cardiomyopathy drug Attruby, California’s BridgeBio is stepping into the spotlight of the J.P. Morgan Healthcare Conference to tout just how quickly its potential blockbuster is catching on.
Since the drug’s Nov. 22 green light—and formal market debut on Dec. 11—248 separate healthcare providers have written some 430 Attruby prescriptions, BridgeBio said in a release Monday. The company hailed the milestone as “remarkable” and noted Attruby has enjoyed “broad uptake” across both academic centers and community centers in “all patient types.”
Attruby, also known as acoramidis, was approved in late November to treat the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM). The drug, which carries blockbuster sales hopes, is now competing directly with Pfizer’s entrenched cardiomyopathy med Vyndaqel.
While Pfizer’s Vyndaqel franchise is already a powerhouse in the cardiomyopathy space, Attruby is equipped with an advantageous label highlighting the pill’s ability to reduce the risk of both death and hospitalization. Late last year, analysts from Evercore ISI and Mizuho Securities hailed the label a “best-case” outcome for BridgeBio, insofar as it is near identical to Vyndaqel’s.
BridgeBio is “grateful” for the enthusiasm it’s already seeing around Attruby’s launch, the company’s CEO and founder, Neil Kumar, Ph.D., said in a statement.
Analysts were quick to get on board with the excitement around Attruby’s uptake, too. Cory Kasimov’s team at Evercore wrote in a Monday note to clients that it was “highly encouraged” by the early commercial traction for BridgeBio’s drug, while Mizuho’s Salim Syed called Attruby’s debut a “launch to own.”
The Evercore team noted that the prescription numbers BridgeBio reported don’t account for patients who were enrolled in Attruby clinical trials, who will indefinitely receive the drug for free.
Breaking the numbers down further, the analysts said it remains unclear how many of those Attruby prescriptions come from patients new to treatment and those switching over from Vyndaqel, citing discussions with BridgeBio management. The Evercore team also caveated that the 28-day free trial program BridgeBio is offering to new patients could lead to “erroneous” prescription-to-sales translation during the early days of the med’s launch.
Syed’s team at Mizuho, for its part, noted that Bloomberg’s $80 million sales consensus for Attruby in 2025 is “likely light,” adding that they “expect this number to increase.”
In another potential boon for BridgeBio’s drug, the initial patient numbers seem to point to “fairly deep penetration” into new patient populations, plus “some capture of the [Vyndaqel] switch market,” the Mizuho analysts said.
Attruby’s approval late last year marked the culmination of an impressive comeback story, not just for the drug but for BridgeBio itself.
Back in 2021, BridgeBio saw its share price get wiped out by more than 80% when Attruby missed the mark in an interim report from a phase 3 study in which patients on placebo scored better outcomes than those taking acoramidis on a six-minute walk test.
Undeterred, BridgeBio executed a pair of layoff rounds and retooled its strategy, ultimately delivering impressive data in mid-2023 showing that its drug could keep cardiomyopathy patients alive longer and curb their trips to the hospital.
The Palo Alto-based company isn’t content to rest on its laurels after Attruby’s approval, either.
As part of its Monday progress report, BridgeBio laid out timelines for three separate phase 3 trials that have been “fully- and over-enrolled” since 2024’s fourth quarter, according to the analysts at Evercore.
The company’s glycosylation substrate candidate for limb-girdle muscular dystrophy type 2I/R9—coded BBP-418—is poised for a top-line readout from an interim analysis cohort in the second half of the year, as is encaleret, a calcium-sensing receptor antagonist for autosomal dominant hypocalcemia type 1.
As for infigratinib, BridgeBio's FGFR1-3 inhibitor for achondroplasia and hypochondroplasia, that drug’s phase 3 trial is expecting to log its last participant visit around the same time as the other trials’ projected top-line readouts.
BridgeBio also expects to clinch green lights for Attruby in the EU and Japan within the first half of 2025.