Tuesday, 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.
In comparison to the selected dosing for Phase 3, the 50 mg loading dose plus 25 mg QW regimen showed a proptosis response of 63% and a Clinical Activity Score (CAS) of 0/1 in 38% of the participants, whereas the 50 mg Q4W dose had a proptosis response of just 25% and a CAS 0/1 of 50%.
Bodnar posited that some investors might be disappointed by the less frequent dosing regimen chosen for Phase 3. Loni's subcutaneous dosing method, with the potential for long-term treatment up to 52 weeks, stands in contrast to competitor regimens, which are administered via fixed intravenous (IV) schedules over 12 and 24 week periods.
In light of these updates, the Neutral rating was reiterated, with the price target reduction reflecting the latest findings from the Phase 1/2 study. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 7.15 and more cash than debt on its balance sheet, though it's currently unprofitable with negative earnings of $2.68 per share.
For deeper insights into Acelyrin's financial health and growth prospects, subscribers can access the comprehensive Pro Research Report, which includes detailed analysis of the company's fundamentals and growth trajectory.
In other recent news, Acelyrin Inc. has been making significant strides in its clinical trials, particularly with its drug candidate lonigutamab. Piper Sandler confirmed its Overweight rating for the company, emphasizing the drug's positive Phase 1b/2a data in treating Thyroid Eye Disease (TED).
Acelyrin plans to proceed with Phase 3 trials, which are expected to start in the first quarter of 2025, with interim data anticipated in the second half of 2026. The company's financial position remains robust, despite rapid cash burn, a common characteristic for clinical-stage biotech firms.
Alongside this, TD Cowen has maintained its Buy rating on Acelyrin's shares, highlighting the progress of lonafarnib, the company's lead program for TED treatment. The Phase II study has completed its first three cohorts, with the fourth currently underway. The firm expects Acelyrin to share Phase II data and Phase III trial design details in the first quarter, following a meeting with regulatory authorities.
However, the company recently experienced a setback with its Phase 2b/3 study of izokibep for the treatment of uveitis, which did not achieve the primary endpoint. These are recent developments that could impact Acelyrin's ongoing efforts in advancing its clinical pipeline and maintaining financial stability.
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