DUBLIN - Alkermes plc (NASDAQ:ALKS) has initiated the phase 2 clinical trial, named Vibrance-2, to evaluate the safety and efficacy of its investigational drug ALKS 2680 for adults with narcolepsy type 2 (NT2). The trial aims to address the significant unmet medical needs within the narcolepsy patient community.
The Vibrance-2 study is a randomized, double-blind, placebo-controlled trial designed to test three doses of the oral selective orexin 2 receptor agonist ALKS 2680. Approximately 80 participants will be enrolled across various sites in the United States, Australia, and Europe, receiving the treatment once daily for eight weeks. The primary measure of the study is the change in mean sleep latency on the maintenance of wakefulness test (MWT). Secondary measures include changes in the Epworth Sleepiness Scale (ESS) score and the incidence of adverse events.
Narcolepsy is a chronic neurological disorder that disrupts the brain's ability to regulate sleep-wake cycles, leading to excessive daytime sleepiness and other symptoms. ALKS 2680 targets the orexin system, which plays a crucial role in maintaining wakefulness, and could potentially benefit patients regardless of the underlying cause of their hypersomnolence disorder.
The development of ALKS 2680 is part of Alkermes' broader effort to innovate within the field of neuroscience. The company has a portfolio of proprietary commercial products and a pipeline of clinical and preclinical candidates targeting various neurological disorders.
Alkermes has also launched Vibrance-1, a phase 2 study for narcolepsy type 1, which is currently enrolling participants. The initiation of Vibrance-2 reflects the company's commitment to exploring potential treatments for both types of narcolepsy, with the goal of improving patient outcomes.
The information about the trial is based on a press release statement from Alkermes plc. The company cautions that forward-looking statements are uncertain and subject to risks and that actual results may differ materially from those projected. Investors are advised not to place undue reliance on these forward-looking statements.
In other recent news, Alkermes has reported robust financial results for the second quarter of 2024. The company's total revenue reached $399 million, largely driven by strong sales of its proprietary products. The standout performance was from Lybalvi, generating sales of $71.4 million, surpassing consensus estimates. In addition, Aristada reported sales of $86 million, marking a 4% year-over-year growth.
Baird and H.C. Wainwright have both raised their share target for Alkermes, maintaining a positive outlook on the company. Baird's adjustment to $38 from $37 follows the strong quarter report, while H.C. Wainwright increased its target to $37 from $35 after witnessing robust second-quarter sales.
These recent developments highlight Alkermes' financial performance and the potential of its pipeline. The company is also making advancements with ALKS 2680, a treatment under development for narcolepsy type 1 and potentially other sleep disorders. Investors are advised to look out for further updates on this compound.
InvestingPro Insights
Alkermes plc (NASDAQ:ALKS) is making significant strides in the biopharmaceutical sector, particularly with the initiation of the phase 2 clinical trial for ALKS 2680. As investors assess the company's potential, InvestingPro data provides valuable insights into Alkermes' financial health and market performance.
With a market capitalization of $4.65 billion, Alkermes is a substantial player in its field. The company's P/E ratio stands at 16.45, reflecting investor expectations of future earnings growth. Additionally, Alkermes has demonstrated a solid revenue growth rate of 3.14% over the last twelve months as of Q2 2024, underlining its capacity to increase sales over time.
InvestingPro Tips highlight that Alkermes' management has been actively buying back shares, which can be a sign of confidence in the company's future prospects. Moreover, the firm holds more cash than debt on its balance sheet, providing financial flexibility and potentially reducing risk for investors. These factors could be particularly relevant for those considering investment in the context of the company's ongoing clinical trials and product development efforts.
For a deeper dive into Alkermes' financials and performance, including additional InvestingPro Tips, investors can explore the company's profile on InvestingPro, where 11 tips are available that further elucidate the company's financial standing and market potential. With a fair value estimation by analysts at $35 and InvestingPro's fair value at $33.06, the current price of $28.26 suggests that the company might be undervalued, offering an enticing entry point for investors.
The upcoming earnings date on October 23rd will be a significant event for the company, as it will provide further context on the financial implications of its clinical trials and R&D investments. As Alkermes continues to innovate in the neuroscience space, these financial metrics and insights from InvestingPro could be critical for investors monitoring the company's progress.
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