Tonix Pharmaceuticals stock halted ahead of FDA approval news
On Wednesday, Stifel reiterated its Buy rating for Celldex (NASDAQ:CLDX) Therapeutics (NASDAQ:CLDX) with a consistent price target of $58.00. The firm's analysis follows the presentation of full 52-week Phase 2 study results for chronic spontaneous urticaria (CSU) at the European Academy of Dermatology and Venereology (EADV).
The study showcased sustained and improved reductions in UAS7 scores across all dosing arms. Notably, the 150mg every four weeks arm achieved a 71% rate of UAS7 equal to zero, which is significantly higher than the approximately 45% rate seen with competitor remibrutinib's 52-week results.
The firm noted that the day's stock movement was largely attributed to concerns regarding the limited detailed disclosure of adverse events (AEs), which may affect the clarity of understanding specific AEs like neutropenia and hypopigmentation.
These AEs were reported to have increased over time. However, management highlighted that there was no clear dose-response relationship for these AEs. Additionally, there were no treatment discontinuations due to neutropenia, infection, or hypopigmentation, and the overall AE rates stood at 25%, comparable to the 18-22% rates seen with remibrutinib.
Stifel pointed out that while safety concerns may persist as an issue for Celldex's stock, the efficacy of the treatment appears to be distinct within the mast cell activation disorder market. The firm emphasized that despite the safety profile concerns, the treatment's efficacy remains a strong point.
The study's findings are significant as they suggest that Celldex's treatment may offer a more effective alternative to current options for CSU patients. The absence of anaphylaxis events is also a critical safety highlight from the trial results.
In other recent news, Celldex Therapeutics has reported positive results from a Phase 2 study of barzolvolimab, a treatment for chronic spontaneous urticaria (CSU). The study showed a sustained efficacy with a well-tolerated safety profile, with 71% of patients achieving a complete response at week 52. The company is now enrolling patients for global Phase 3 CSU trials.
In addition, Celldex's barzolvolimab has shown promising effects in a Phase 2 trial for chronic inducible urticaria (CIndU). The company plans to advance barzolvolimab into Phase 3 registration development, with full 12-week data expected later this year.
Furthermore, Celldex has initiated a global Phase 3 program to evaluate the efficacy and safety of barzolvolimab in adults with CSU who have not responded adequately to H1 antihistamine treatments.
On the analyst front, Stifel initiated coverage on Celldex with a Buy rating, citing the potential of barzolvolimab. Similarly, Wolfe Research assigned an Outperform rating to the company. These are recent developments in Celldex Therapeutics' ongoing efforts to develop treatments for severe inflammatory and allergic diseases.
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