On Wednesday, Stifel reiterated its favorable stance on Celldex Therapeutics (NASDAQ:CLDX) and Third Harmonic (NASDAQ:HLIT) Bio (NASDAQ:THRD), highlighting their potential as leaders in the mast cell disease space with first-in-class and oral treatment options. Celldex, which has seen a notable 9.2% gain in the past week, maintains strong analyst support with a "Strong Buy" consensus.
According to InvestingPro data, analyst price targets range from $42 to $90, suggesting significant upside potential. Stifel analysts commented on the importance of achieving deep and stable tryptase reductions to maintain clinical efficacy and acknowledged the challenges in avoiding on-target kinase inhibitor adverse events (AEs).
For Third Harmonic Bio, Stifel emphasized the significance of achieving biologic-like reductions in tryptase in their Phase 1 multiple ascending dose (MAD) study, which could position the company to potentially replicate this efficacy with an oral medication in a Phase 2 chronic spontaneous urticaria (CSU) study. The firm noted the difficulty in balancing the therapeutic index due to the strong association between tryptase reductions, clinical efficacy, and on-target AEs.
Regarding Celldex, the focus was on their drug candidate Briquilimab, a monoclonal antibody (mAb) targeting wild-type KIT (wtKIT), which aims to differentiate itself from competitors through an improved safety profile attributed to a shorter half-life. The company maintains a strong financial position with more cash than debt and a robust current ratio of 24.27, providing ample runway for its clinical development programs.
InvestingPro subscribers can access 8 additional key financial health indicators and detailed analysis in the comprehensive Pro Research Report. However, preliminary data from the BEACON study suggests a safety profile similar to that of barzolvolimab, with comparable rates of hair color changes and neutropenia.
The study also reported a single Grade 3 neutropenia event not related to the drug and three Grade 1 neutropenia events that resolved before the next dose, with no associated fevers or infections. Additionally, there was one grade 2 hypersensitivity reaction with full recovery post-treatment.
Stifel's analysis indicates that while the tolerability profiles of Briquilimab and barzolvolimab appear similar, larger and longer-term datasets might be necessary to fully understand the potential advantages of Briquilimab. Celldex is currently conducting their Phase 3 program, with early management commentary suggesting no significant safety concerns.
In conclusion, Stifel's comments support the potential of both Celldex and Third Harmonic Bio to lead in the development of treatments for mast cell diseases, with Celldex advancing in its Phase 3 trials and Third Harmonic Bio working towards demonstrating efficacy in its early-stage studies. While Celldex's current market capitalization stands at $1.78 billion, InvestingPro analysis indicates the stock is fairly valued based on its proprietary Fair Value model.
In other recent news, Celldex Therapeutics has made significant strides in its clinical trials, with positive Phase 2 data for its drug barzolvolimab. The trials demonstrated sustained efficacy and a well-tolerated safety profile in treating Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CIndU). Analyst firms such as H.C. Wainwright, TD Cowen, and Citi have maintained their Buy ratings on Celldex, reflecting confidence in the company's clinical developments.
Goldman Sachs, however, reiterated a Neutral rating with a focus on the latest interim data from a competitor's study. Despite some concerns over the safety and tolerability of barzolvolimab, these firms underscore the drug's potential as a leading treatment for CSU. Celldex has also initiated global Phase 3 trials for barzolvolimab in adults with CSU who have not responded adequately to H1 antihistamine treatments.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.