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AstraZeneca and Amgen TEZSPIRE Phase III Trial Results Positive

Positive high-level results from the Phase III CROSSING trial in patients with eosinophilic esophagitis showed that AstraZeneca (AZN) and Amgen's (AMGN) TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across both co-primary and all key secondary endpoints at week 24, which were sustained through week 52 in both doses tested. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia compared to placebo. The safety profile of TEZSPIRE in the trial was generally consistent with its approved indications.

Amgen and AstraZeneca Announce Phase 3 CROSSING Trial Results for Tezspire

Amgen (AMGN) and AstraZeneca (AZN) announced top-line results from the Phase 3 CROSSING trial of Tezspire in patients living with eosinophilic esophagitis. Tezspire demonstrated statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24 which were sustained through week 52. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia. The safety profile of Tezspire was generally consistent with its approved indications. CROSSING is a randomized, double-blind trial that evaluated the efficacy and safety of Tezspire at one of two doses administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy. In the trial, the first co-primary endpoint, histologic remission, was defined as having a low count of peak eosinophils in the esophageal tissue. The second co-primary endpoint, the frequency and severity of dysphagia, was assessed using the patient-reported Dysphagia Symptom Questionnaire and measured as a mean change from baseline in DSQ score. Full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting. Hypersensitivity reactions were observed in the clinical trials following the administration of Tezspire. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset. In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with Tezspire. The most common adverse reactions are asthma: pharyngitis, arthralgia, and back pain. Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia.

Canada Raises Tariffs on U.S. Steel and Aluminum to 50%

Catch up on the top industries and stocks that were impacted, or were predicted to be impacted, by the comments, actions and policies of President Donald Trump with this daily recap compiled by The Fly.RETALIATORY TARIFFS:Canada is matching Trump's weekend tariff escalation with a sweeping package of counter tariffs that directly targets U.S. steel, aluminum and downstream manufacturing. Prime Minister Mark Carney will double Canada's existing counter-tariffs on U.S. steel and aluminum to 50%, while adding new 50% duties on U.S. furniture, clothing, electronics, smartphones, and gaming consoles. Overall, the retaliatory levies cover roughly $20B in annual imports. The measures take effect on September 8 and represent a sharp reversal in Carney's earlier conciliatory stance after trade talks between Canada and U.S. collapsed on Friday. Publicly traded companies in the space include ArcelorMittal, Cleveland-Cliffs, Nucor, Steel Dynamicsand U.S. Steel. Publicly traded companies in the aluminum space include Alcoa, Kaiser Aluminum, Rio Tinto, Century Aluminum, and Constellium.DEPUTY ROLES:The Department of Health and Human Services is planning to create two new deputy commissioner roles at the Food and Drug Administration, one of which would focus on technology and the intersection of health and artificial intelligence, CNBC's Annika Kim Constantino. The other new position is for a deputy commissioner for drugs, according to two sources familiar with the plan. Publicly-traded companies operating in the space include Pfizer, Merck, Bristol Myers, Eli Lilly, AbbVie, Amgen, Medtronic, Abbott, Boston Scientific, Stryker, Intuitive Surgical, GE HealthCare, Teladoc, and Oracle.U.S.-IRAN:In a post on Truth Social, President Trump stated, "The failing Islamic Republic of Iran is not paying large segments of their military, while at the same time killing protesters, even when they are not protesting, at levels not seen before. It is a humanitarian crisis of epic proportions, and must be stopped, NOW."