Quick Look:
- Alnylam’s stock surged 38% to $225.35 after positive study results for its heart drug, vutrisiran.
- Vutrisiran showed a 33% reduction in deaths and cardiovascular events in a 655-patient study.
- Alnylam will file for FDA approval later this year, aiming for a priority review.
On Monday, Alnylam Pharmaceuticals experienced a significant boost in its stock price. It surged by 38% following the announcement of promising study results for its heart drug, vutrisiran. This leap in stock value brought the new price to $225.35. This remarkable gain represents the company’s largest single-day increase since August 3, 2022, when the stock soared by 49% to $210.
Alnylam’s Vutrisiran Achieves 33% Drop in Deaths and Events
The positive outcome for vutrisiran, which intends to treat transthyretin amyloid cardiomyopathy (ATTR-CM), was demonstrated in a comprehensive study involving 655 patients. The results showed a substantial 33% reduction in deaths and cardiovascular events among participants. This reduction was more impressive when compared to the 28% reduction achieved by Pfizer’s competing drug and a placebo. Vutrisiran’s treatment regimen, administered once every three months for up to three years, proved to be statistically significant in curbing the progression of the disease and improving patients’ walking distances in six-minute tests.
Alnylam Seeks FDA Priority Review for Vutrisiran in 2024
Alnylam Pharmaceuticals plans to submit a filing for regulatory approval later this year, aiming to secure a priority review from the FDA. If approved, vutrisiran could establish a new standard of care for patients suffering from ATTR-CM.
The announcement of the study results had an immediate impact on the stock market, with Alnylam’s shares climbing over 31% in premarket trading and reaching $219.09 by 10:20 a.m. ET. This upward movement in stock price reflects a 14% increase year-to-date. In contrast, BridgeBio, a competitor, saw its stock drop by 17% on the same morning.
ATTR-CM Affects 300,000 Globally, 5,000-7,000 New US Cases Yearly
ATTR-CM affects up to 300,000 people worldwide, with the United States seeing between 5,000 to 7,000 new cases each year. Alnylam faces competition from Pfizer, which markets Vyndaqel and Vyndamax, and BridgeBio and Ionis Pharmaceuticals. However, with the strong performance and promising study results of vutrisiran, Alnylam is poised to impact this therapeutic area significantly.
Alnylam Execs Aim to Expedite Vutrisiran Approval and Access
Chief Medical Officer Dr Pushkal Garg expressed the company’s determination to expedite the regulatory filing process to make this vital treatment available to patients globally. CEO Dr Yvonne Greenstreet highlighted Vutrisiran’s potential to revolutionise ATTR-CM treatment, underscoring its role in driving the company’s future growth.
With the anticipated regulatory approval and subsequent market introduction of vutrisiran, Alnylam Pharmaceuticals stands on the brink of a transformative era, potentially altering the treatment landscape for transthyretin amyloid cardiomyopathy and significantly enhancing patient outcomes worldwide.
