We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
CLDX Stock Down Despite Upbeat Long-Term Data From Urticaria Study
Read MoreHide Full Article
Shares of Celldex Therapeutics (CLDX - Free Report) 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).
CSU 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.
The 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.
Please 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.
CLDX Shares Superior Long-Term Efficacy Data From CSU Study
Celldex 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.
Year to date, shares of Celldex have lost 9.2% compared with the industry’s 1.9% decline.
Image Source: Zacks Investment Research
Complete 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.
Furthermore, 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.
Per Celldex, these encouraging response data were observed regardless of whether the patients had previously undergone omalizumab therapy.
Safety Concerns Related to Treatment With CLDX’s CSU Drug
Despite the sustained efficacy data from the mid-stage study of Celldex’s CSU candidate, barzolvolimab, investors were not impressed by the safety data.
The company claimed that the candidate was overall well tolerated by the CSU patients and demonstrated a favorable safety profile through 52 weeks of treatment.
However, 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.
Celldex 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.
In 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.
Apart 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.
The 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.
In 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%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In 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%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In 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%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
CLDX Stock Down Despite Upbeat Long-Term Data From Urticaria Study
Shares of Celldex Therapeutics (CLDX - Free Report) 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).
CSU 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.
The 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.
Please 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.
CLDX Shares Superior Long-Term Efficacy Data From CSU Study
Celldex 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.
Year to date, shares of Celldex have lost 9.2% compared with the industry’s 1.9% decline.
Image Source: Zacks Investment Research
Complete 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.
Furthermore, 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.
Per Celldex, these encouraging response data were observed regardless of whether the patients had previously undergone omalizumab therapy.
Safety Concerns Related to Treatment With CLDX’s CSU Drug
Despite the sustained efficacy data from the mid-stage study of Celldex’s CSU candidate, barzolvolimab, investors were not impressed by the safety data.
The company claimed that the candidate was overall well tolerated by the CSU patients and demonstrated a favorable safety profile through 52 weeks of treatment.
However, 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.
Celldex 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.
Celldex Therapeutics, Inc. Price and Consensus
Celldex Therapeutics, Inc. price-consensus-chart | Celldex Therapeutics, Inc. Quote
Other Programs in CLDX’s Clinical-Stage Pipeline
In 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.
Apart 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.
The 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.
Zacks Rank & Stocks to Consider
Celldex currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In 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%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In 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%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In 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%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.