On Friday, H.C. Wainwright maintained a positive outlook on shares of Alnylam Pharmaceuticals (NASDAQ:ALNY), reiterating a Buy rating and a $400.00 price target. The firm's confidence is anchored in the anticipated successful launch of AMVUTTRA for treating ATTR amyloidosis with cardiomyopathy (ATTR-CM) in the second half of 2025.
Alnylam's recent TTR Investor Day in New York City shed light on the potential of AMVUTTRA, a once-quarterly subcutaneous therapeutic, highlighting its robust Phase 3 program and the significant unmet medical need in ATTR-CM treatment.
During the event, Alnylam's management, alongside Dr. Ahmad Masri from the Oregon Health & Science University, outlined the strategy to focus on the estimated 18,000 new ATTR-CM patients annually, rather than converting patients from the current standard of care, Pfizer (NYSE:PFE)'s VYNDAQEL.
The company's approach is to position AMVUTTRA as a first-line treatment option, leveraging the positive momentum from its successful launch for ATTR polyneuropathy (ATTR-PN).
Alnylam has made significant regulatory strides with submissions to the FDA on October 9 and the EMA on October 16. The submission to the FDA included a Priority Review Voucher, which is expected to expedite the review process. If the supplemental New Drug Application (sNDA) is approved, AMVUTTRA could be launched for ATTR-CM treatment in the latter half of 2025.
The company's growing commercial footprint and the increasing familiarity with AMVUTTRA among cardiologists and patients are seen as positive indicators for the drug's potential label expansion. H.C. Wainwright's reiteration of the Buy rating and price target reflects a high confidence in the approval and subsequent market penetration of AMVUTTRA for ATTR-CM.
In other recent news, Alnylam Pharmaceuticals has submitted a regulatory application to the European Medicines Agency for vutrisiran, a drug aimed at treating ATTR amyloidosis with cardiomyopathy (ATTR-CM) based on the positive outcome of the HELIOS-B Phase 3 study.
Alnylam has also submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for the same drug. The company's Q2 earnings report exceeded expectations in both revenue and profit, leading to an updated 2024 revenue guidance of between $1.575 billion and $1.65 billion.
Alnylam has revised its patient prevalence estimate for ATTR-CM to over 300,000, indicating a larger potential market for its drug, Amvuttra. Analyst firms such as Canaccord Genuity, TD Cowen, BMO Capital, Piper Sandler, and Oppenheimer have maintained positive ratings on Alnylam. The company's commercial strategy for the launch of Amvuttra in treating ATTR-CM received positive feedback from BofA Securities.
In collaboration with BridgeBio Pharma (NASDAQ:BBIO), Alnylam presented a new post hoc analysis of recurrent all-cause mortality and cardiovascular-related hospitalization events. These are recent developments in Alnylam's ongoing efforts to address unmet medical needs in the treatment of ATTR-CM.
InvestingPro Insights
Alnylam Pharmaceuticals' (NASDAQ:ALNY) strong market position and potential for growth are reflected in recent InvestingPro data and tips. The company's revenue growth is particularly impressive, with a 107% increase in quarterly revenue as of Q2 2024. This aligns well with H.C. Wainwright's positive outlook on the company's future, especially considering the anticipated launch of AMVUTTRA for ATTR-CM treatment.
InvestingPro Tips highlight Alnylam's "impressive gross profit margins," which is evident in the data showing a gross profit margin of 87% for the last twelve months as of Q2 2024. This strong financial performance supports the company's ability to invest in research and development, crucial for bringing new treatments like AMVUTTRA to market.
The market's optimism about Alnylam's prospects is reflected in its stock performance, with InvestingPro data showing a robust 79.76% price return over the past year. This aligns with the company's regulatory progress and potential for AMVUTTRA's label expansion.
It is worth noting that InvestingPro offers 13 additional tips for Alnylam Pharmaceuticals, providing investors with a more comprehensive analysis of the company's financial health and market position.
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