PALO ALTO, Calif. - BridgeBio Pharma, Inc. (NASDAQ:BBIO) has announced positive outcomes from its PROPEL 2 trial, evaluating the efficacy of infigratinib in children with achondroplasia, a genetic condition leading to dwarfism.
The Phase 2 trial data revealed a significant increase in annualized height velocity (AHV) and improvement in body proportionality in participants, indicating potential benefits for those affected by the condition.
The study, which included children receiving a daily oral dose of infigratinib, showed a sustained mean increase in AHV of +2.51cm/year at 12 months and +2.50 cm/yr at 18 months, with a p-value of 0.0015. Moreover, a meaningful change in body proportionality was observed, with the mean upper to lower body segment ratio improving from 2.02 at baseline to 1.88 at 18 months (p=0.001).
The safety profile of infigratinib has been well-received, as no treatment-related adverse events were reported among the trial participants. The ongoing PROPEL 3, a global Phase 3 registrational study of infigratinib, continues to enroll as planned, with completion anticipated by the end of 2024.
In parallel, BridgeBio has initiated ACCEL, an observational study for infigratinib in children with hypochondroplasia, a skeletal dysplasia closely related to achondroplasia. The first child consented to participate in the study in May 2024.
The findings from PROPEL 2 suggest that infigratinib could enhance functionality for those living with achondroplasia, beyond promoting growth. Dr. Ravi Savarirayan, the global lead investigator for the trial, expressed optimism for the ongoing studies to establish infigratinib as a safe and effective oral therapy for the achondroplasia community.
BridgeBio's commitment to addressing unmet needs in skeletal dysplasias extends to the development of infigratinib for hypochondroplasia. The company has garnered positive feedback from the U.S. FDA and EMA, supporting the advancement of infigratinib in children with this condition.
The company plans to share further insights during an investor call scheduled for today at 8:00 am ET. This information is based on a press release statement.
InvestingPro Insights
As BridgeBio Pharma, Inc. (NASDAQ:BBIO) progresses with its clinical trials for infigratinib, investors have been closely monitoring the company's financial health and market potential. The latest data from InvestingPro shows a company with a market capitalization of $5.42 billion and significant revenue growth over the last twelve months as of Q1 2024, with a striking 181.05% increase. This rapid growth is further highlighted by an astronomical quarterly revenue growth of 11,461.88% in Q1 2024.
While the company does not pay dividends, indicating a reinvestment of earnings into research and development, there are positive signs from analysts who have revised their earnings upwards for the upcoming period. This could be a reflection of the company's promising trial outcomes and the potential market for infigratinib. Still, it is worth noting that analysts do not anticipate the company to be profitable this year, and it is trading at a high revenue valuation multiple, with a current P/E ratio of -9.01.
For those considering an investment in BridgeBio, it's important to recognize the company's high return over the last year, with a 103.23% one-year price total return as of the 156th day of 2024. This performance may be appealing to investors seeking growth in the biotech sector.
For more detailed analysis and additional InvestingPro Tips, such as the observation that BridgeBio's liquid assets exceed short-term obligations, interested parties can visit https://www.investing.com/pro/BBIO. There are currently 7 additional InvestingPro Tips available, which could provide further insights into making informed investment decisions.
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