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TOKYO - The Japanese Ministry of Health, Labour and Welfare has granted approval to BridgeBio Pharma, Inc.’s acoramidis, marketed under the brand name Beyonttra, for the treatment of adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), a progressive, fatal heart disease. This decision comes after a Japanese Phase 3 study and the global ATTRibute-CM Phase 3 trial showcased promising results, including a notable reduction in cardiovascular-related hospitalizations and mortality. According to InvestingPro data, BridgeBio’s stock has shown strong momentum, with a 45% price return over the past six months, reflecting investor confidence in the company’s pipeline developments.
The Japanese study reported no mortality over a 30-month period and found acoramidis to be well-tolerated. The global ATTRibute-CM trial further demonstrated a 42% reduction in all-cause mortality and recurrent cardiovascular hospitalizations, and a 50% decrease in the cumulative frequency of cardiovascular hospitalizations at the 30-month mark compared to placebo.
Acoramidis is an orally administered medication that stabilizes transthyretin (TTR), a protein whose destabilization is linked to ATTR-CM. Increased stability of TTR has been associated with a reduced risk of cardiovascular mortality. With this approval, patients in Japan now have access to a treatment that offers early and sustained reductions in cardiovascular events.
BridgeBio will receive a $30 million milestone payment from Alexion, AstraZeneca Rare Disease, which holds an exclusive license to commercialize acoramidis in Japan. Additionally, BridgeBio is set to earn royalties in the low double digits on net sales of the drug in Japan. The commercial launch of Beyonttra is planned for the first half of 2025. With a current ratio of 4.67, InvestingPro analysis shows the company maintains strong liquidity to support its commercialization efforts, though analysts don’t expect profitability this year. Get deeper insights into BridgeBio’s financial health and growth potential with InvestingPro’s comprehensive research reports, available for over 1,400 US stocks.
This approval marks a significant advancement for those affected by ATTR-CM in Japan, providing a new option that addresses the urgent need for effective treatments. Beyonttra’s safety profile is consistent with that observed in the U.S., where it is approved as Attrubyt, with the most common side effects being mild, including diarrhea and abdominal pain.
BridgeBio Pharma, founded in 2015, is dedicated to creating and delivering innovative medicines for genetic diseases. This recent approval aligns with the company’s mission to translate scientific discoveries into treatments for patients swiftly. The company has demonstrated remarkable revenue growth, with its market capitalization now reaching $6.9 billion, though it currently trades at a premium to InvestingPro’s Fair Value estimate.
The information in this article is based on a press release statement from BridgeBio Pharma, Inc.
In other recent news, BridgeBio Pharma announced a $500 million offering of convertible senior notes due 2031, aimed at refinancing existing debt to reduce interest expenses and enhance operational flexibility. This financial maneuver is expected to terminate the company’s current Financing Agreement, which had significant interest obligations. Additionally, BridgeBio might use a portion of the proceeds to repurchase shares, potentially impacting the stock’s market price. Meanwhile, Scotiabank raised its price target for BridgeBio to $52, citing the strong commercial performance of the drug Attruby, which exceeded expectations with a notable increase in prescriptions and prescribers. In the fourth quarter of 2024, BridgeBio reported net product revenues of $2.9 million, surpassing both Scotiabank’s and consensus estimates. Cantor Fitzgerald maintained an Overweight rating on BridgeBio, setting a price target of $95, and discussing the implications of Medicare drug coverage on the company’s financial prospects. The firm highlighted complexities in Medicare Advantage and Part D, which could affect the marketability of BridgeBio’s drugs. In other developments, Deep Track Capital, holding a significant stake in Dynavax Technologies, has pushed for board changes, criticizing the company’s financial strategies and governance. The firm argues that a board revamp could lead to improved strategic decisions for Dynavax.
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