On Tuesday, Alnylam Pharmaceuticals (NASDAQ:ALNY) maintained its Buy rating and a $400.00 price target from H.C. Wainwright, following the announcement of successful Phase 3 trial results. The company's recent study on AMVUTTRA (vutrisiran), a therapeutic designed for patients with TTR amyloidosis with cardiomyopathy (ATTR-CM), met its primary endpoint, showcasing significant improvements in cardiovascular outcomes, including survival rates.
The study, named HELIOS-B, tested the once-quarterly subcutaneous RNA interference (RNAi) therapeutic and found positive results in both the overall and monotherapy populations. These findings are expected to be presented in detail at the European Society of Cardiology congress scheduled for August 30 to September 2 in London, UK.
Alnylam plans to submit a supplemental New Drug Application (sNDA) to the FDA for AMVUTTRA in ATTR-CM by the end of 2024. The submission is anticipated to be expedited using a priority review voucher, with additional global regulatory filings to follow. This sets the stage for a potential market launch of AMVUTTRA for ATTR-CM treatment in the second half of 2025.
The reiteration of the Buy rating and price target reflects the firm's confidence in Alnylam's stock performance and the commercial prospects of AMVUTTRA. The positive trial outcomes align with H.C. Wainwright's expectations and underpin the investment firm's outlook for the pharmaceutical company's growth trajectory.
In other recent news, Alnylam Pharmaceuticals has seen a series of significant developments. The biopharmaceutical company reported successful outcomes from its HELIOS-B Phase 3 trial for vutrisiran, a drug developed for ATTR amyloidosis with cardiomyopathy. The trial resulted in a notable reduction in mortality and recurrent cardiovascular events in patients, paving the way for a supplemental New Drug Application filing in late 2024.
Morgan Stanley increased the price target for Alnylam to $250 from the previous $164, maintaining an Equalweight rating. This adjustment came after reviewing the HELIOS-B study results, which exceeded expectations. Other analyst firms such as Stifel, RBC Capital, and BMO Capital also maintained positive ratings for Alnylam.
On the financial front, Alnylam's Q1 2024 revenues reached $365 million, marking a 32% increase from the same period the previous year. The company's Transthyretin (TTR) franchise continues to fuel this growth. Alnylam is targeting net product revenues between $1.4 billion and $1.5 billion for 2024.
In light of Alnylam's data, TD Cowen maintained a Buy rating on shares of BridgeBio Pharma (NASDAQ:BBIO). The comparative analysis of the data suggests that Alnylam's results fall short of the high bar set by BridgeBio's ATTRibute-CM trial. The full study results presentation at the ESC conference will be crucial for evaluating the comparative effectiveness of the treatments studied.
InvestingPro Insights
Alnylam Pharmaceuticals' (NASDAQ:ALNY) recent clinical success has not gone unnoticed in the market. According to InvestingPro data, the company has experienced a significant return over the past week, with a 44.87% price total return. This bullish trend extends over the last month and three months, with returns of 50.85% and 46.58% respectively, underscoring investor confidence following the HELIOS-B trial results. Despite the company's impressive revenue growth of 75.2% over the last twelve months as of Q1 2024, the firm operates at a loss, with a negative operating income margin of -8.78%. The company's market cap stands at a robust 28.2 billion USD, reflecting its substantial size in the biopharmaceutical sector.
While analysts do not anticipate Alnylam will be profitable this year, as per InvestingPro Tips, the company's liquid assets exceed its short-term obligations, indicating a solid financial position for near-term operations. Moreover, Alnylam operates with a moderate level of debt, suggesting a balanced approach to leveraging and financial management. For investors interested in a deeper analysis, there are additional InvestingPro Tips available, which can be accessed with a subscription. Take advantage of the exclusive offer by using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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