H.C. Wainwright analyst adjusted the price target on shares of Acelyrin Inc (NASDAQ: SLRN) to $6.00 from the previous $8.00 but maintained a Neutral rating on the company's shares. Currently trading at $3.49, InvestingPro analysis suggests the stock is fairly valued, though analyst targets range from $5 to $20.
Despite recent challenges, the stock has shown resilience with an 11.15% gain over the past week. Bodnar provided commentary on the recent developments from Acelyrin, noting that the company had announced updated data from its Phase 1/2 study of lonigutamab (loni) for the treatment of thyroid eye disease (TED) after the market closed on Monday.
The company also shared details about the forthcoming Phase 3 program, which is set to begin in the first quarter of 2025.
Acelyrin revealed that the dosing regimen for the next phase would be a 100 mg loading dose followed by 50 mg every two weeks (Q2W). This decision was based on the updated data, which showed that lower doses administered every four weeks (Q4W) were subtherapeutic.
The ideal minimum concentration (Cmin) required for consistent and maximized efficacy was determined to be 3 ug/ml, a level achieved with a 50 mg loading dose followed by 25 mg weekly (QW). This regimen resulted in a Cmin of 3.6 ug/ml, while the 50 mg Q4W regimen only reached a Cmin of 0.1 ug/ml, leading to a loss of proptosis response after Week 6.
The company's analysis indicated that the pharmacokinetic (PK) data with the 100 mg loading dose plus 50 mg Q2W regimen was comparable to the 50 mg loading plus 25 mg QW regimen, suggesting that it could achieve receptor saturation and therapeutic concentration within days.
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