PRTA News & Events

The company states: "Prothena (PRTA) announced that the FDA has granted Fast Track Designation to coramitug, a potential best-in-class amyloid depleter antibody currently in Phase 3 development for the treatment of ATTR amyloidosis with cardiomyopathy. Fast Track Designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and fill an unmet medical need. ATTR-CM is a progressive disease caused by the deposition of transthyretin as amyloid in the myocardium. Current therapies may slow disease progression but do not clear existing deposits. Coramitug is a humanized monoclonal antibody that targets misfolded transthyretin, designed to promote clearance of transthyretin amyloid through antibody-mediated phagocytosis4. Novo Nordisk (NVO) is evaluating coramitug in the ongoing Phase 3 CLEOPATTRA clinical trial in approximately 1280 participants with ATTR-CM with primary completion expected in 2029. Novo Nordisk gained full worldwide rights to the intellectual property and related rights of the ATTR amyloidosis business and pipeline it acquired from Prothena in July 2021. Under the terms of the acquisition agreement, Prothena is eligible to receive up to $1.2 billion including an upfront payment and upon achievement of clinical development and sales milestones, with $150 million earned to date."

Prothena announced updates to its leadership team. Annie Kingston is being promoted to Chief Strategy Officer and Michael Isaacs is being promoted to General Counsel and Corporate Secretary. Isaacs succeeds Michael Malecek who will be departing from Prothena. Kingston and Isaacs will join Prothena's leadership team and will report to Gene Kinney, Ph.D., President and CEO. Kingston's promotion is effective immediately and Isaacs' promotion will take effect following Malecek's departure in June. Kingston joined Prothena in 2023, serving most recently as Vice President, Corporate Strategy and Chief of Staff. Isaacs joined Prothena in 2020, serving most recently as Deputy General Counsel.

The company states: "Prothena (PRTA) announced that the Company earned a $50 million milestone payment from Novo Nordisk (NVO) related to the achievement of a prespecified enrollment target in the ongoing Phase 3 CLEOPATTRA clinical trial evaluating coramitug, a potential first-in-class amyloid depleter antibody, for the treatment of ATTR amyloidosis with cardiomyopathy. Novo Nordisk is evaluating coramitug in the ongoing Phase 3 CLEOPATTRA clinical trial in approximately 1280 participants with ATTR-CM with primary completion expected in 2029."

Prothena (PRTA) had cash, cash equivalents and restricted cash of $308.4M and no debt as of December 31, 2025. Excluding any potential purchases under its share repurchase plan, Prothena expects to end the year with approximately $255M in cash, cash equivalents, and restricted cash. This financial guidance does not include the potential to earn up to $105M of aggregate clinical milestone payments from strategic partners in 2026 related to the advancement of both coramitug for ATTR amyloidosis with cardiomyopathy by Novo Nordisk (NVO) and PRX019 for neurodegenerative diseases by Bristol Myers Squibb (BMY).