Protagonist Therapeutics, Inc., a biopharmaceutical company headquartered in Newark, California, recently disclosed a material definitive agreement amendment with Janssen Biotech, Inc., a Pennsylvania corporation, in a current report filed on November 13, 2024. The amendment modifies their amended and restated License and Collaboration Agreement, focusing on milestone payments related to the development of licensed products.
The agreement’s key amendments include an increase in milestone payments for the successful completion of a Phase 3 clinical trial, elimination of certain milestone payments related to FDA acceptance and dosing of patients, and acceleration of payments linked to recent Phase 3 clinical trial outcomes.
The results from the ICONIC-LEAD study revealed substantial skin clearance with icotrokinra compared to a placebo, with a high percentage of patients achieving clear or almost clear skin by week 24. The ICONIC-TOTAL study also met its primary endpoint, emphasizing the efficacy of icotrokinra in patients with plaque psoriasis in challenging-to-treat areas.
Dr. Dinesh V. Patel, President and CEO of Protagonist, expressed confidence in the Phase 3 results, emphasizing the compound’s effectiveness and safety profile. Further results from the studies are expected to be shared at medical congresses and submitted to health authorities for review and approval.
Protagonist anticipates receiving milestone payments totaling $165 million under the collaboration agreement with Johnson & Johnson, reflecting successful milestones achieved. The company remains eligible for additional future milestone payments and royalties based on product development and sales performance.
Future clinical studies involving icotrokinra, including Phase 2b ulcerative colitis trials and Phase 3 psoriatic arthritis studies, are on the horizon for Protagonist. The company’s innovative peptide technology platform continues to demonstrate promise in addressing unmet medical needs across various disease indications.
Investors and stakeholders are encouraged to refer to Protagonist Therapeutics’ filings with the Securities and Exchange Commission for a comprehensive overview of risk factors and business developments. The company remains committed to advancing its pipeline and delivering innovative therapies to patients in need.
For further details regarding Protagonist Therapeutics, its pipeline, and ongoing clinical studies, interested parties can visit the company’s official website.
Contact:
– Investor Relations: Corey Davis, Ph.D., LifeSci Advisors, [email protected], +1 212 915 2577
– Media Relations: Virginia Amann, ENTENTE Network of Companies, [email protected], +1 833 500 0061 ext 1
This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Protagonist Therapeutics’s 8K filing here.
Protagonist Therapeutics Company Profile
Protagonist Therapeutics, Inc, a biopharmaceutical company, develops peptide-based drugs for hematology and blood disorders, and inflammatory and immunomodulatory diseases. It is developing Rusfertide (PTG-300), an injectable hepcidin mimetic that completed phase 2 clinical trials for the treatment of polycythemia vera and other blood disorders; and JNJ-2113, an orally delivered investigational drug to block biological pathways that completed phase 2b clinical trials for the treatment of moderate-to-severe plaque psoriasis; and PN-943, an orally delivered, gut-restricted alpha 4 beta 7 specific integrin antagonist completed a phase 2 clinical trials in patients with moderate to severe ulcerative colitis.
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