On Tuesday, Goldman Sachs reiterated a Neutral rating with a $45.00 price target for Celldex (NASDAQ:CLDX) Therapeutics (NASDAQ:CLDX). The focus was on the latest interim data presented by a competitor in the ongoing Phase 1b/2a SPOTLIGHT study. The study examined the effects of briquilimab at different dosages on Chronic Inducible Urticaria (CIndU), a condition also known as ColdU or SD.
The data showed that 83% of patients (10 out of 12) treated with a 120 mg single dose of briquilimab experienced complete responses after 6 weeks. This result is comparable to Celldex's barzolvolimab, which had shown a 95% complete response rate in its own Phase 1b study with a single dose of 3 mg/kg intravenously.
Notably, the study of briquilimab reported no serious adverse events, Grade 3 adverse events, or changes in skin and hair color, which contrasts with the hair color effects observed in 76% of patients treated with barzolvolimab.
Despite the promising single-dose data for briquilimab, Goldman Sachs cautioned that it is premature to determine how its efficacy will compare to barzolvolimab's subcutaneous administration after multiple doses. Additionally, briquilimab demonstrated a less significant impact on tryptase levels compared to barzolvolimab, which Celldex believes might lead to lower efficacy in larger studies.
The analyst also highlighted that while briquilimab showed fewer on-target KIT adverse events, the full spectrum of potential adverse events after multiple doses remains uncertain. The significant drop in the complete response rate from the Phase 1b to Phase 2 studies of barzolvolimab (from 95% to 42-58%) was cited as a reason to be cautious about drawing conclusions from these single-dose results with a small sample size.
In other recent news, Celldex Therapeutics has been making significant strides in its research and development efforts. The company has reported positive results from its Phase 2 studies on barzolvolimab, a potential treatment for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). The studies revealed sustained efficacy and a well-tolerated safety profile, with 71% of CSU patients achieving a complete response after a 52-week treatment period.
In addition, Celldex has initiated global Phase 3 trials for barzolvolimab in adults with CSU who have not responded adequately to H1 antihistamine treatments. The company has also completed patient enrollment for its Phase 2 trial of barzolvolimab for CIndU, with data expected later this year.
On the analyst front, firms like Citi, Goldman Sachs, TD Cowen, Leerink Partners, H.C. Wainwright, Guggenheim, Stifel, and Wolfe Research have provided their assessments on Celldex. Despite some concerns over the safety and tolerability of barzolvolimab, these firms underscore the drug's potential as a leading treatment for CSU.
InvestingPro Insights
To complement the analysis of Celldex Therapeutics' (NASDAQ:CLDX) drug development efforts, let's consider some financial insights from InvestingPro. Despite the promising clinical data for barzolvolimab, InvestingPro data reveals that Celldex's revenue for the last twelve months as of Q2 2023 was only $8.3 million, with a striking revenue growth of 155.16% over the same period. This suggests that while the company is rapidly increasing its revenue, it's still in the early stages of commercialization.
An InvestingPro Tip indicates that Celldex holds more cash than debt on its balance sheet, which is crucial for a biotech company investing heavily in research and development. This financial stability could provide the runway needed to continue developing barzolvolimab and other pipeline candidates.
Another relevant InvestingPro Tip notes that analysts do not anticipate the company will be profitable this year. This aligns with the typical trajectory of biotech firms focusing on drug development, where significant investments precede potential commercial success.
For investors seeking a more comprehensive analysis, InvestingPro offers 8 additional tips that could provide deeper insights into Celldex's financial health and market position.
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