TLDR
- TEZSPIRE gains first-in-class FDA nod for chronic nasal polyps.
- Amgen stock jumps as TEZSPIRE expands beyond severe asthma.
- Phase III data shows strong relief and reduced surgery needs.
- TEZSPIRE sets new benchmark in biologic respiratory therapies.
- Global submissions next as Amgen eyes wider immunology reach.
Amgen Inc. closed higher on October 17, climbing $3.00 to $298.81, marking a 1.01% increase.
Amgen Inc., AMGN
The gain followed the U.S. FDA’s approval of TEZSPIRE® (tezepelumab-ekko) as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps (CRSwNP). This approval positions TEZSPIRE as the first biologic targeting TSLP for patients 12 years and older with inadequately controlled CRSwNP.
FDA Clears TEZSPIRE® for CRSwNP, Targets Unmet Needs
The FDA based its decision on data from the Phase III WAYPOINT trial, which showed a significant reduction in nasal polyp severity. TEZSPIRE nearly eliminated the need for nasal polyp surgery while reducing systemic corticosteroid use compared to placebo. The approval offers a novel pathway for CRSwNP management by targeting thymic stromal lymphopoietin (TSLP).
Chronic rhinosinusitis with nasal polyps affects up to 320 million people globally, often leading to airflow obstruction and impaired sense of smell. Current therapies, including corticosteroids and sinus surgeries, fail to provide lasting relief for many patients. TEZSPIRE now introduces a long-acting, biologic alternative that addresses inflammation at its source.
Amgen and AstraZeneca jointly developed TEZSPIRE and plan additional regulatory submissions worldwide. Authorities in Europe, China, Japan, and other regions are currently reviewing applications. With this approval, TEZSPIRE becomes the only biologic targeting TSLP approved for both severe asthma and CRSwNP.
Trial Results Support Clinical Impact and Safety Profile
The WAYPOINT trial results were presented at the 2025 AAAAI/WAO Congress and published in The New England Journal of Medicine. The treatment showed rapid, sustained symptom improvement and helped reduce reliance on systemic steroids. Participants in the TEZSPIRE group reported significantly fewer surgical interventions compared to the placebo group.
The most common side effects in the CRSwNP trial group included nasopharyngitis, upper respiratory infections, and injection site reactions. The safety profile remained consistent with previous trials in severe asthma, reinforcing its clinical viability. COVID-19 also appeared among reported adverse events.
Warnings include risks of hypersensitivity reactions, such as rash and allergic conjunctivitis, and potential issues with abrupt corticosteroid withdrawal. TEZSPIRE should not treat acute asthma symptoms or status asthmaticus and may interact with live attenuated vaccines. Physicians are advised to supervise corticosteroid tapering during treatment initiation.
Amgen Stock Sees Gains Amid Market Reaction
Shares of Amgen responded positively following the FDA’s approval announcement, reflecting strong market confidence in the new indication. The approval marks a strategic expansion of TEZSPIRE’s therapeutic reach beyond severe asthma. This milestone reinforces Amgen’s focus on developing biologics targeting complex inflammatory pathways.
Amgen’s continued collaboration with AstraZeneca supports its broader immunology portfolio. The approval adds momentum to its pipeline and strengthens its positioning in respiratory medicine. The stock’s upward movement aligns with TEZSPIRE’s growing commercial and clinical potential.
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