On Monday, TD Cowen maintained a Buy rating on shares of BridgeBio Pharma (NASDAQ: NASDAQ:BBIO), in light of recent data released by Alnylam Pharma (NASDAQ: NASDAQ:ALNY). The data from Alnylam's study reported co-primary endpoint p-values between 0.01-0.02, which were considered less impressive compared to BridgeBio's p-value of 0.0008. The analyst highlighted that this outcome indicates that the study's results at the European Society of Cardiology (ESC) will likely not show a clear distinction over the majority of the study period.
The comparative analysis of the data suggests that Alnylam's 28-33% relative risk reduction (RRR) on all-cause mortality plus cardiovascular hospitalization (ACM+CVH) falls short of the 45% or more that was expected to be demonstrated by acoramidis (acor) at 33-36 months. Moreover, the 35-36% mortality reduction seen in the study is comparable or inferior to the results shown by tafamidis, implying that gene silencers might be considered second-line agents.
The analyst had previewed on Friday that both co-primary endpoints in the HELIOS-B study were expected to be met. However, the p-values achieved did not meet the high expectations set by BridgeBio's ATTRibute-CM trial results. The analyst expressed concern over the lack of clear and convincing separation of the curves throughout the study period, as was observed in BridgeBio's trial where event separation occurred as early as three months.
BridgeBio's ATTRibute-CM trial outcomes had previously set a high bar with its p-value of 0.0008, alongside a robust statistical plan and a longer timepoint for the study, which included more Class I/II patients. These factors contributed to the strong performance of BridgeBio's trial data.
The analyst's commentary anticipates that the presentation of the full study results at the ESC conference at the end of the summer will be crucial for evaluating the comparative effectiveness of the treatments studied. The market will be closely watching the ESC presentation for a clearer understanding of the study's implications.
In other recent news, Alnylam Pharmaceuticals has reported successful outcomes from its HELIOS-B Phase 3 trial for vutrisiran, a drug designed for ATTR amyloidosis with cardiomyopathy. The trial resulted in a significant reduction in mortality and recurrent cardiovascular events in patients, prompting Alnylam to plan for global regulatory approval for vutrisiran. The company's Q1 2024 results revealed revenues of $365 million, marking a 32% increase compared to the same period the previous year, largely driven by its Transthyretin (TTR) franchise. Analyst firms Stifel, RBC Capital, and BMO Capital have all maintained positive ratings for Alnylam following the promising study results. Stifel reiterated its Buy rating with a price target of $247, while RBC Capital and BMO Capital maintained their Outperform ratings, with price targets of $235 and $234 respectively. These recent developments underscore Alnylam's strong performance and potential for future growth. The company is aiming for net product revenues between $1.4 billion and $1.5 billion for 2024 and plans to file Investigational New Drug applications for nine programs by the end of 2025.
InvestingPro Insights
Turning our focus to Alnylam Pharmaceuticals, InvestingPro data showcases a company with a significant market cap of 28.76 billion USD, reflecting its substantial presence in the biopharmaceutical sector. Despite the challenges highlighted in the comparative analysis, Alnylam has demonstrated impressive revenue growth, with a 75.2% increase in the last twelve months as of Q1 2024, and a gross profit margin of 83.95%, indicating strong underlying business performance.
InvestingPro Tips reveal that Alnylam operates with a moderate level of debt and has liquid assets that exceed its short-term obligations, suggesting a healthy financial position. However, analysts do not anticipate the company will be profitable this year, which aligns with the concerns raised in the article regarding the competitive landscape. Additionally, it's worth noting that Alnylam's stock is trading near its 52-week high, which could be of interest to investors monitoring the company's performance relative to the industry.
To delve deeper into the financials and strategic outlook for Alnylam Pharmaceuticals, readers can explore more InvestingPro Tips by visiting https://www.investing.com/pro/ALNY. There are six additional tips available, offering comprehensive insights that could inform investment decisions. For those interested in a full suite of analytics and tips, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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