Tonix Pharmaceuticals stock halted ahead of FDA approval news
On Tuesday, H.C. Wainwright reaffirmed its Buy rating and $80.00 price target for Celldex Therapeutics (NASDAQ:CLDX) stock, which currently trades at $19.35. According to InvestingPro data, analysts maintain a strong buy consensus, with price targets ranging from $36 to $90, suggesting significant upside potential. The stock appears undervalued based on InvestingPro’s Fair Value analysis. The firm’s analyst highlighted the company’s recent presentation at the American Academy of Allergy, Asthma, and Immunology (AAAAI) 2025, where Celldex showcased new preclinical data on its bispecific antibody, CDX-622. The data demonstrated the antibody’s ability to neutralize two key inflammation and fibrosis mediators, stem cell factor (SCF) and alarmin thymic stromal lymphopoietin (TSLP), simultaneously. While the company maintains a strong financial position with more cash than debt and a healthy current ratio of 18.91, InvestingPro analysis reveals 11 additional key financial insights available to subscribers.
The dual inhibition of SCF and TSLP by CDX-622 has shown promising results, including reduced tissue mast cells and suppressed type 2 inflammatory responses. These findings bolster the ongoing Phase 1 study of the antibody, with initial results anticipated to be released later in the year. The simultaneous targeting of both pathways by CDX-622 may provide a greater clinical benefit than focusing on either one individually.
Key points from the presentation included evidence that CDX-622 inhibited TSLP and SCF with potencies similar to the parental antibodies, tezepelumab and barzolvolimab. Additionally, the antibody preferentially inhibited the soluble form of SCF over the membrane-bound form and effectively suppressed SCF- and TSLP-dependent inflammatory signatures in a human skin explant model.
The preclinical studies also revealed that CDX-622 was well-tolerated across all tested doses. In non-human primates, the treatment led to reductions in mast cell signatures from ear punch biopsies, indicating a favorable safety profile.
Celldex’s presentation at AAAAI 2025 has provided further evidence supporting the potential of CDX-622 in treating inflammatory conditions. With the Phase 1 study underway and promising preclinical data, H.C. Wainwright has reiterated its confidence in the stock with a Buy rating and an $80 price target. Despite the stock’s recent volatility and significant decline of 56.56% over the past six months, the company maintains a market capitalization of $1.28 billion. Discover comprehensive analysis and detailed financial metrics with InvestingPro’s exclusive research report, part of their coverage of over 1,400 US stocks.
In other recent news, Jasper Therapeutics reported initial results from its BEACON study, evaluating the efficacy of briquilimab in treating Chronic Spontaneous Urticaria (CSU). The study showed promising results, with several patient cohorts experiencing a significant reduction in urticaria activity scores, and all patients in the 240mg single-dose cohort achieving a complete response lasting eight weeks. In terms of safety, most adverse events were mild, with only one instance of Grade 3 neutropenia, which was unrelated to the treatment. Encouraged by these findings, Jasper Therapeutics plans to expand the study cohorts and initiate a Phase 2b study in 2025.
Guggenheim maintained its Buy rating and $90 price target for Celldex Therapeutics, highlighting its competitive position in the CSU treatment market. Celldex’s barzolvolimab demonstrated a comparable reduction in urticaria activity scores, and its ongoing Phase III program positions it as a leader in the mast-cell space. Stifel also reiterated a positive outlook on Celldex and Third Harmonic (NASDAQ:HLIT) Bio, noting the potential of both companies to lead in the mast cell disease treatment market. Celldex is advancing in its Phase 3 trials, while Third Harmonic Bio aims to demonstrate efficacy in its early-stage studies.
Stifel highlighted the importance of achieving deep and stable tryptase reductions for clinical efficacy, acknowledging the challenges in avoiding adverse events. Despite some safety concerns, Celldex’s early management commentary suggests no significant safety issues in its ongoing trials. The potential for Celldex and Third Harmonic Bio to advance in their respective programs remains a focal point for analysts.
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