Aclaris targets multi-billion sales for BSI-045B by 2030 in key markets.
HC Wainwright & Co. analyst Raghuram Selvaraju upgraded Aclaris Therapeutics Inc ACRS from Neutral to Buy and a price target of $20. The stock gained after the rerating.
In a press release last month, Aclaris announced that it had entered into an exclusive license agreement with privately held Biosion, Inc. for worldwide rights (excluding Greater China) to BSI-045B, a potential best-in-class, clinical-stage, novel anti-TSLP monoclonal antibody, and BSI-502, a potential best-in-class, preclinical-stage, novel bispecific antibody directed against both TSLP and IL4R.
Despite recent advances in anti-TSLP and anti-IL4R therapies, there remains a substantial unmet need for more effective and convenient treatment options.
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In a completed Phase 2a, single-arm, proof-of-concept trial conducted in the U.S. in 22 patients with moderate-to-severe atopic dermatitis, BSI-045B was observed to have a pharmacodynamic, safety, and efficacy profile that could position it as a potential best-in-class therapy.
BSI-045B is also being advanced in multiple Phase 2 studies in China by Biosion's regional partner, targeting severe asthma and chronic rhinosinusitis with nasal polyps, accelerating the potential to show proof-of-concept across additional indications.
Selvaraju expects Aclaris to initiate multiple mid-stage clinical studies next year in the U.S. due to potential positive results from the Chinese trials.
This should pave the way for registration programs in the coming years. From Selvaraju's vantage point, BSI-045B could generate billions of dollars in sales across solely the U.S. and European Union markets in only chronic asthma and atopic dermatitis indications.
This candidate could reach the U.S. market in 2029 to treat chronic asthma and in 2030 for treating AD, with potential peak annual sales of roughly $9.8 billion.
Selvaraju's forecasts include pricing in the $30K range in the U.S. and the $10K range in Europe, roughly in line with net pricing for Dupixent (dupilumab), the most commercially successful of the currently-marketed anti-IL-4R monoclonal antibodies with estimated 2024 sales totaling roughly 13 billion euros.
Selvaraju noted that an earlier-generation monoclonal antibody, the anti-IgE agent Xolair (omalizumab), generated sales approaching $4 billion in 2023. Selvaraju ascribed a 30% probability of approval to BSI-045B in chronic asthma and a 20% probability of approval to this candidate in AD.
Selvaraju projected fourth-quarter revenue of $2.9 million and EPS of $(0.10).
Price Action: ACRS stock is up 8% at $2.94 at last check Monday.
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