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Alkermes (NASDAQ: NASDAQ:ALKS) has retained its Outperform rating and $35.00 price target from Mizuho.
The firm's latest commentary highlighted recent data from a Phase 1 Single Ascending Dose (SAD) trial by Centessa for ORX750.
The trial involved acutely sleep-deprived, healthy volunteers at doses of 1 and 2.5 mg. Although the results showed promise in terms of efficacy and safety, the firm noted that these findings are preliminary and not conclusive for determining the best-in-class molecule for treating sleep disorders.
The analyst emphasized the need for additional data from trials involving patients with narcolepsy types 1 and 2 (NT1, NT2) and idiopathic hypersomnia (IH) to fully assess ORX750's efficacy and safety in these specific sleep disorders.
The comparison was drawn to Alkermes' ALKS-2680, which did not present adverse events at 1 and 3 mg doses in healthy volunteers during SAD or Multiple Ascending Dose (MAD) trials. However, adverse events were reported at these doses in NT1 patients. Furthermore, visual disturbances associated with ALKS-2680 were only observed at doses of 15 mg or higher.
The update on ALKS-2680 and ORX750 is part of a broader evaluation of potential treatments for sleep disorders. Alkermes' ALKS-2680 is being positioned against other candidates in the field, with its safety profile being a significant point of comparison.
The mention of off-target adverse events with ORX750 at certain doses indicates a nuanced assessment of the competitive landscape for sleep disorder therapies.
Mizuho's reiteration of the Outperform rating and price target reflects a continued positive outlook for Alkermes, despite the complex and competitive nature of developing treatments for sleep disorders.
In other recent news, Alkermes has reported substantial advances on multiple fronts. The company's second quarter of 2024 saw impressive financial results, with total revenue reaching $399 million, largely driven by robust sales of proprietary products such as Lybalvi and Aristada.
Analyst firms Baird and H.C. Wainwright have both raised their share targets for Alkermes, reflecting a positive outlook on the company's performance.
In addition to financial growth, Alkermes has initiated the Vibrance-2 phase 2 clinical trial to evaluate the safety and efficacy of its investigational drug ALKS 2680 for adults with narcolepsy type 2. The trial aims to address significant unmet medical needs within the narcolepsy patient community. This development is part of Alkermes' broader effort to innovate within the field of neuroscience and follows the launch of Vibrance-1, a phase 2 study for narcolepsy type 1.
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