BridgeBio Pharma Reports Financial Results & Progress on New Drug Application

By Tamara Parker • Thursday, February 22 10:56 • Permanent Link

BridgeBio Pharma, Inc. (NASDAQ: BBIO) has reported its financial results for the fourth quarter and full year ended December 31, 2023, as well as provided an update on the company’s operations. The company submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Acoramidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). The NDA has been accepted for review with a PDUFA date of November 29, 2024. Additionally, the marketing authorization application (MAA) for Acoramidis has been accepted by the European Medicines Agency (EMA).

Neil Kumar, Ph.D., founder and CEO of BridgeBio, stated, “Our focus this year is executing on the launch of Acoramidis for patients with ATTR cardiomyopathy. At the same time, we are also focused on fully enrolling three ongoing phase 3 clinical trials by the end of 2024. Finally, we hope that reading out potentially exciting data from our phase 1/2 trial in congenital adrenal hyperplasia later this year will let us take the next step in serving that patient community.”

The company's key programs include Acoramidis for the treatment of ATTR-CM, low-dose infigratinib for achondroplasia and hypochondroplasia, BBP-418 for limb-girdle muscular dystrophy type 2i/r9 (LGMD2i/r9), and encaleret for autosomal dominant hypocalcemia type 1 (ADH1). Notably, the company ended the quarter with $393 million in cash, cash equivalents, and short-term restricted cash, and $59 million of investments in equity securities.

Brian Stephenson, Ph.D., CFA, Chief Financial Officer of BridgeBio, stated, “Coming off of our recent royalty financing, we find ourselves well capitalized to launch Acoramidis this year alongside strong new partners who share our confidence in Acoramidis’ potential in the ATTR-CM market. We are excited for this launch, as well as for the continued advancement of our late-stage pipeline, which we hope will allow us to serve patients with genetic diseases both directly with the advancement of those medicines towards the market as well as by diversifying our top-line revenue and enabling reinvestment into the R&D and business development opportunities that will allow us to be sustainable in the long term.”

The company's shares have moved -2.5%, and are now trading at a price of $33.3.

The full 8-K submission by BridgeBio Pharma, Inc. is available here.

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