CLDX Stock Down Despite Upbeat Long-Term Data From Urticaria Study

Zacks09-26

Shares of Celldex Therapeutics CLDX lost 12.1% on Wednesday due to unsatisfactory 52-week safety data from a mid-stage study of its investigational candidate, barzolvolimab, which is being developed ...

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The exact cause is often unknown, but it can be linked to immune system dysfunction, where the body mistakenly triggers allergic reactions. While CSU is not life-threatening, it can significantly impact a person’s quality of life due to persistent itching and discomfort.The phase II study evaluated the efficacy and safetyof three dosing regimens of barzolvolimab  compared with placebo in 208 CSU patients, who remain symptomatic despite antihistamine therapy to determine the optimal dosing strategy.Please note that Celldex had previously reported achieving the primary efficacy endpoint of the mid-stage study, observing a statistically si","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"ANIP":"ANI Pharmaceuticals, Inc.","KRYS":"Krystal Biotech Inc.","BK4139":"生物科技","CLDX":"塞德斯医疗","BK4007":"制药","FULC":"Fulcrum Therapeutics"},"translate_title":"尽管荨麻疹研究的长期数据乐观，CLDX股价仍下跌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ANIP":1,"CLDX":1,"FULC":1,"KRYS":1},"content_text":"Shares of Celldex Therapeutics CLDX lost 12.1% on Wednesday due to unsatisfactory 52-week safety data from a mid-stage study of its investigational candidate, barzolvolimab, which is being developed for treating chronic spontaneous urticaria (CSU).\nCSU is a type of skin disease, characterized by the sudden appearance of hives (raised, itchy welts) without an identifiable trigger. The exact cause is often unknown, but it can be linked to immune system dysfunction, where the body mistakenly triggers allergic reactions. While CSU is not life-threatening, it can significantly impact a person’s quality of life due to persistent itching and discomfort.\nThe phase II study evaluated the efficacy and safety of three dosing regimens of barzolvolimab (75 mg, 150 mg or 300 mg) compared with placebo in 208 CSU patients, who remain symptomatic despite antihistamine therapy to determine the optimal dosing strategy.\nPlease note that Celldex had previously reported achieving the primary efficacy endpoint of the mid-stage study, observing a statistically significant mean change from baseline to week 12 in UAS7 (weekly urticaria activity score) compared with placebo at all dose levels of barzolvolimab.\nCLDX Shares Superior Long-Term Efficacy Data From CSU Study\nCelldex reported that the statistically significant improvements in UAS7, which were observed upon treatment with barzolvolimab at week 12, were noted as early as week one and sustained or deepened at week 52, compared with placebo. Additionally, CSU patients receiving the 75 mg dose of the candidate, after transitioning to the 150 mg or 300 mg dosing groups, continued to experience similar clinically meaningful disease responses as the rest of the study population.\nYear to date, shares of Celldex have lost 9.2% compared with the industry’s 1.9% decline.\nImage Source: Zacks Investment Research\nComplete response, characterized by no itch/hives and a UAS7 score of 0, was observed in 71% of patients treated with barzolvolimab 150 mg and 52% of patients treated with 300 mg at week 52. Celldex claimed that these responses were observed early in the study and sustained through 52 weeks.\nFurthermore, 74% of patients treated with barzolvolimab 150 mg and 68% of patients treated with 300 mg experienced well-controlled disease, characterized by a UAS7 score lesser than 6, at Week 52.\nPer Celldex, these encouraging response data were observed regardless of whether the patients had previously undergone omalizumab therapy.\nSafety Concerns Related to Treatment With CLDX’s CSU Drug\nDespite the sustained efficacy data from the mid-stage study of Celldex’s CSU candidate, barzolvolimab, investors were not impressed by the safety data.\nThe company claimed that the candidate was overall well tolerated by the CSU patients and demonstrated a favorable safety profile through 52 weeks of treatment. \nHowever, treatment-related adverse events (mostly mild in severity) were observed in greater than 10% of barzolvolimab-treated patients, leading to hair color changes, neutropenia, urticaria, skin hypopigmentation (areas of skin lightening) and nasopharyngitis (common cold). This raised concerns among investors.\nCelldex clarified that adverse events were not related to the dosage level. Per CLDX, neutrophil counts remained stable with ongoing treatment, and there was no link between neutropenia and infections. Hypopigmentation occurred with prolonged exposure but did not result in stopping treatment.\n\nCelldex Therapeutics, Inc. Price and Consensus\n\nCelldex Therapeutics, Inc. price-consensus-chart | Celldex Therapeutics, Inc. Quote\n\nOther Programs in CLDX’s Clinical-Stage Pipeline\nIn July, Celldex initiated a global phase III program for barzolvolimab which comprises two late-stage studies that will evaluate the efficacy and safety of the candidate in adult patients with CSU. Both studies are currently enrolling patients.\nApart from the CSU indication, CLDX is also developing barzolvolimab for several other inflammatory disease indications like prurigo nodularis, chronic inducible urticaria, eosinophilic esophagitis and atopic dermatitis in separate mid-stage studies.\nThe company’s clinical stage pipeline also comprises another candidate, CDX-585, which is currently being developed to treat advanced or metastatic solid tumors in a phase I study.\nZacks Rank & Stocks to Consider\nCelldex currently carries a Zacks Rank #3 (Hold).\nSome better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 3.9%.\nANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.\nIn the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $2.09 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have jumped 44.7%.\nKRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.\nIn the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 48.6%.\nFULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nCelldex Therapeutics, Inc. (CLDX) : Free Stock Analysis Report\nANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report\nKrystal Biotech, Inc. (KRYS) : Free Stock Analysis Report\nFulcrum Therapeutics, Inc. (FULC) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2470754135"}