Shares of Prothena Corporation plc (NASDAQ:PRTA) tumbled 24.8% in after-hours trading following the announcement that its Phase 3 AFFIRM-AL clinical trial for birtamimab did not meet its primary endpoint. The disappointing results have led the company to discontinue the development of the drug, which was being evaluated for the treatment of patients with AL amyloidosis.
The trial’s failure to achieve its primary endpoint of time to all-cause mortality, along with not meeting secondary endpoints, has prompted Prothena to halt the open label extension of the AFFIRM-AL clinical trial. The company expressed surprise and disappointment at the outcome, acknowledging the impact on patients, families, and caregivers within the AL amyloidosis community.
Prothena’s President and CEO, Gene Kinney, Ph.D., stated, "This is not the outcome that we expected, and we are surprised and disappointed by these results for patients, their families and caregivers, and for the entire AL amyloidosis community." In light of these findings, the company believes that ceasing all development of birtamimab is the most appropriate course of action.
Despite the setback, Prothena remains focused on its pipeline, with several data readouts and updates expected over the next 18 months. Daniel G. Welch, Chair of Prothena’s Board of Directors, expressed optimism about upcoming clinical trials and partnerships, including initial data from the Phase 1 ASCENT trials on PRX012 in Alzheimer’s disease, and updates from collaborations with Roche, Novo Nordisk (NYSE:NVO), and Bristol Myers (NYSE:BMY) Squibb.
The company also announced impending plans to significantly reduce its workforce and decrease spending to align with its current business strategy. Details on the cost-cutting measures will be revealed in June, with the aim of preserving shareholder value. Prothena will communicate the results of its business review and subsequent strategies once plans are finalized.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.