On Friday, Goldman Sachs adjusted its stance on Alnylam Pharmaceuticals (NASDAQ:ALNY), shifting the rating to Neutral from Buy and reducing the price target to $173 from the previous $230. The revision follows Alnylam's fourth-quarter earnings report which included significant updates to its Phase 3 HELIOS-B study of Amvuttra in ATTR-cardiomyopathy (CM).
The primary analysis will now occur three months later than originally planned, pushing the anticipated data release to late June or early July of this year, rather than the beginning of 2024.
The study modifications also involve a new approach to primary endpoint testing, now including results from a monotherapy subgroup which comprises 60% of the participants, in contrast to the initial plan of testing in the overall population of 655 patients. Additionally, there have been adjustments to the secondary endpoints of the study.
"We believe the update suggests a limited benefit on top of standard-of care PFE (NYSE:PFE)'s Vyndaqel/Vyndamax, in addition to requiring additional time to improve HELIOS B's probability-of-success," said Goldman Sachs.
The competitive landscape for Alnylam is becoming increasingly challenging with upcoming potential market entrants. BridgeBio Pharma (NASDAQ:BBIO)'s acoramidis is awaiting a PDUFA decision by November 29, and a partnership between AstraZeneca (NASDAQ:AZN) and Ionis Pharmaceuticals (NASDAQ:IONS) is expected to release Phase 3 Wainua data in 2025. These developments could impact the commercial prospects for Amvuttra, especially considering the expected limited use as a frontline monotherapy without strong comparative data against the current standard-of-care.
Goldman Sachs has outlined scenarios reflecting the potential financial impact on Alnylam's stock, estimating approximately over 60% upside to around $240 per share in the most favorable outcome, and about 60% downside to around $60 per share in less favorable circumstances. Despite the downgrade, Goldman Sachs is keeping an eye on other Alnylam developments, including the partnered projects with Roche on zilebesiran for hypertension, with Phase 2 combination data expected in April, and with Regeneron (NASDAQ:REGN) on ALN-APP for Alzheimer's, where the Phase 1 multiple ascending dose portion has been approved by the FDA, with results anticipated later in the year.
InvestingPro Insights
As Alnylam Pharmaceuticals (NASDAQ:ALNY) faces a pivotal moment with its Phase 3 HELIOS-B study, recent market data from InvestingPro reflects the company’s current financial health and analysts’ expectations. With a market capitalization of $18.55 billion, Alnylam's financial position remains robust despite the lack of profitability in the last twelve months. The revenue growth has been impressive, with a 76.23% increase over the last twelve months as of Q4 2023, and a quarterly growth of 31.25% in Q4 2023.
One of the key InvestingPro Tips highlights that 4 analysts have revised their earnings upwards for the upcoming period, indicating a potential positive outlook on Alnylam's future financial performance. Additionally, the stock is currently trading near its 52-week low and the Relative Strength Index (RSI) suggests it is in oversold territory, which may attract investors looking for an entry point in anticipation of a rebound.
InvestingPro also notes that Alnylam’s liquid assets exceed its short-term obligations, which provides financial flexibility and could be a reassuring factor for investors concerned about the company’s ability to fund ongoing research and operations. However, analysts do not anticipate the company will be profitable this year, and the stock has fared poorly over the last month with a price total return of -21.37%.
For readers looking to delve deeper into Alnylam's stock performance and financials, InvestingPro offers additional insights and tips. There are currently 9 more tips available on InvestingPro, which can be accessed by visiting InvestingPro. To enhance your research, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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