On Tuesday, Oppenheimer maintained a Perform rating on Alnylam Pharmaceuticals (NASDAQ:ALNY) after reviewing the broader Helios-B trial results. The firm highlighted that the survival and cardiovascular event curves from the trial were not significantly different compared to those from previous ATTR-ACT and ATTRibute-CM trials for other treatments.
The data showed a separation around the 18-month mark, which was consistent with the performance of competing drugs tafamidis and acoramidis.
Despite Alnylam Management's confidence in their drug vutrisiran, providing an improved level of treatment, the comparison with tafamidis was deemed unfair by the analyst due to the differences in trial design and patient populations.
Notably, the Helios-B trial included a large number of patients who were on concomitant therapies, which could potentially confound the results. About 80% of patients were on baseline diuretics, nearly 40% were using SGLT2 inhibitors, and up to approximately 60% were taking tafamidis.
The analyst also pointed out that the longer 36-month endpoint in Alnylam's trial may affect comparisons, as the separation in survival curves became more pronounced after 30 months. Furthermore, the Helios-B trial enrolled a smaller proportion of NYHA class 3 patients compared to the ATTR-ACT trial, which could skew the results in favor of vutrisiran when comparing it to treatments that have shown limited success in more severe cases.
The report concluded that it is difficult to favor any specific drug among the stabilizers and silencers for ATTR cardiomyopathy, echoing sentiments from cardiologists at the conference. Market access and commercial execution were seen as likely determinants for the uptake of vutrisiran, tafamidis, and acoramidis.
Pfizer (NYSE:PFE), with its substantial resources and first-mover advantage, was noted to have a significant edge over Alnylam Pharmaceuticals and other competitors in the market.
In other recent news, BridgeBio Pharma (NASDAQ:BBIO) has been the focus of several analyst firms. Mizuho maintained a positive stance on the company, emphasizing potential underappreciated factors that could affect the company's outlook. H.C. Wainwright and TD (TSX:TD) Cowen reaffirmed their Buy ratings for BridgeBio, highlighting the promising results of the company's investigational drug, acoramidis, in the Phase 3 ATTRibute-CM study.
Recent developments also include BridgeBio's significant joint venture, GondolaBio, backed by a $300 million investment from a consortium of investors, aiming to expedite the development of new therapies. Furthermore, BridgeBio has partnered with Yale School of Medicine's CarDS Lab to leverage artificial intelligence for the early detection of ATTR-CM, a frequently underdiagnosed heart condition.
In addition to these, BridgeBio has submitted a New Drug Application for acoramidis to the U.S. Food and Drug Administration, with a decision expected by November 29, 2024.
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