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AZN/AMGN's Tezspire Hits Primary Goal in Eosinophilic Esophagitis Study
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Key Takeaways
AstraZeneca's Tezspire met all primary and secondary endpoints in the phase III CROSSING study in EoE.
Tezspire significantly improved histologic remission and dysphagia versus placebo at week 24.
Results also showed gains in endoscopic features, histologic severity and inflammatory remission.
AstraZeneca (AZN - Free Report) and its partner Amgen (AMGN - Free Report) jointly announced positive top-line data from the late-stage CROSSING study, which evaluated Tezspire (tezepelumab) in adults and adolescents with eosinophilic esophagitis (EoE). The study met all its primary and secondary endpoints.
Tezspire is a first-in-class monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), a key cytokine involved in multiple inflammatory pathways. The drug is currently approved for the treatment of patients with severe asthma globally and for chronic rhinosinusitis with nasal polyps (CRSwNP) in the United States, European Union, China and Japan.
EoE is a chronic, progressive inflammatory disease of the esophagus that can cause painful swallowing, food impaction, nausea and chest or abdominal pain, significantly affecting quality of life. Nearly half of patients do not respond adequately to current treatments, highlighting a significant unmet need.
Year to date, shares of AstraZeneca have lost 9.6% against the industry’s 12.5% growth. In contrast, AMGN’s shares have gained 34.5% year to date compared with the industry’s 12.6% growth.
Image Source: Zacks Investment Research
Image Source: Zacks Investment Research
Key Highlights of AZN/AMGN’s CROSSING Study Data in EoE
In the placebo-controlled phase III CROSSING study, patients aged 12 to 80 years with symptomatic and histologically active EoE were randomized equally to receive a low dose of Tezspire, a high dose or placebo, administered subcutaneously every four weeks alongside stable background therapy.
The study’s co-primary endpoints were histologic remission and improvement in the frequency and severity of dysphagia. Histologic remission was defined as having six or fewer eosinophils per high-power field in esophageal tissue, while dysphagia was measured using the patient-reported dysphagia symptom questionnaire.
Tezspire achieved statistically significant improvements versus placebo on both co-primary endpoints at week 24, with the treatment effect sustained through week 52. Key secondary measures showed improvements in endoscopic disease features, histologic severity, inflammatory remission and overall endoscopic remission.
The results mark the third indication in which Tezspire has demonstrated clinically meaningful efficacy, following severe asthma and CRSwNP, supporting the potential of its TSLP-targeting mechanism.
Apart from the reported study in EoE, significant label-expansion studies are ongoing with the phase III JOURNEY and EMBARK studies in chronic obstructive pulmonary disease (COPD).
AZN-AMGN Deal on Tezspire
AstraZeneca has a collaboration agreement with Amgen to develop and commercialize Tezspire. Per the agreement, both companies share Tezspire’s costs and profits equally. While AstraZeneca leads development, AMGN oversees manufacturing of the drug. The companies jointly commercialize Tezspire in the United States, where Amgen records product sales while AZN records its share of profits as Alliance revenues. AZN records product sales in markets outside the United States.
Over the past 30 days, earnings per share estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, estimates for earnings per share increased from $1.12 to $1.21 for 2027. AMRX shares have risen 42.8% year to date.
Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have declined 9.3% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
View the Zacks #1 Rank List
Image: Bigstock
AZN/AMGN's Tezspire Hits Primary Goal in Eosinophilic Esophagitis Study
Key Takeaways
AstraZeneca (AZN - Free Report) and its partner Amgen (AMGN - Free Report) jointly announced positive top-line data from the late-stage CROSSING study, which evaluated Tezspire (tezepelumab) in adults and adolescents with eosinophilic esophagitis (EoE). The study met all its primary and secondary endpoints.
Tezspire is a first-in-class monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), a key cytokine involved in multiple inflammatory pathways. The drug is currently approved for the treatment of patients with severe asthma globally and for chronic rhinosinusitis with nasal polyps (CRSwNP) in the United States, European Union, China and Japan.
EoE is a chronic, progressive inflammatory disease of the esophagus that can cause painful swallowing, food impaction, nausea and chest or abdominal pain, significantly affecting quality of life. Nearly half of patients do not respond adequately to current treatments, highlighting a significant unmet need.
Year to date, shares of AstraZeneca have lost 9.6% against the industry’s 12.5% growth. In contrast, AMGN’s shares have gained 34.5% year to date compared with the industry’s 12.6% growth.
Image Source: Zacks Investment Research
Image Source: Zacks Investment Research
Key Highlights of AZN/AMGN’s CROSSING Study Data in EoE
In the placebo-controlled phase III CROSSING study, patients aged 12 to 80 years with symptomatic and histologically active EoE were randomized equally to receive a low dose of Tezspire, a high dose or placebo, administered subcutaneously every four weeks alongside stable background therapy.
The study’s co-primary endpoints were histologic remission and improvement in the frequency and severity of dysphagia. Histologic remission was defined as having six or fewer eosinophils per high-power field in esophageal tissue, while dysphagia was measured using the patient-reported dysphagia symptom questionnaire.
Tezspire achieved statistically significant improvements versus placebo on both co-primary endpoints at week 24, with the treatment effect sustained through week 52. Key secondary measures showed improvements in endoscopic disease features, histologic severity, inflammatory remission and overall endoscopic remission.
The results mark the third indication in which Tezspire has demonstrated clinically meaningful efficacy, following severe asthma and CRSwNP, supporting the potential of its TSLP-targeting mechanism.
Apart from the reported study in EoE, significant label-expansion studies are ongoing with the phase III JOURNEY and EMBARK studies in chronic obstructive pulmonary disease (COPD).
AZN-AMGN Deal on Tezspire
AstraZeneca has a collaboration agreement with Amgen to develop and commercialize Tezspire. Per the agreement, both companies share Tezspire’s costs and profits equally. While AstraZeneca leads development, AMGN oversees manufacturing of the drug. The companies jointly commercialize Tezspire in the United States, where Amgen records product sales while AZN records its share of profits as Alliance revenues. AZN records product sales in markets outside the United States.
AZN’s Zacks Rank & Stocks to Consider
AZN currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Amneal Pharmaceuticals (AMRX - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy) and AC Immune (ACIU - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings per share estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, estimates for earnings per share increased from $1.12 to $1.21 for 2027. AMRX shares have risen 42.8% year to date.
Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have declined 9.3% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.