Prothena Corporation plc (NASDAQ: PRTA) shares were surging 43% to $15.73 in extended-hours session. The stock also suffered a loss of -11.15% over the past one month, -2.31 % loss in three months, and -10.13 % loss in six months.
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Feb. 01, 2021, Prothena Corporation plc (NASDAQ: PRTA) reported that after further inquiries by the Organization and many in-depth consultations with the U.S. Food and Drug Administration, Prothena is advancing birtamimab into the confirmatory Phase 3 AFFIRM-AL trial in this group of patients with AL amyloidosis in compared to the earlier review of patients classified as Mayo Stage IV at baseline in the Detailed review.
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This registration-enabling research, under a Special Protocol Appraisal Arrangement with the FDA, will be performed with a primary endpoint of all-cause mortality at p<0.10. Birtamimab seems to be the only experimental therapy that in a placebo-controlled trial demonstrated a substantial survival advantage in Mayo Stage IV patients with AL amyloidosis, with 74% of birtamimab-treated patients alive at 9 months versus 49% of patients in the Critical control group (hazard ratio (HR)=0.413, p=0.025, over 9 months). AFFIRM-AL is scheduled to begin in mid-2021.
Furthermore, the critical survival advantage observed for VITAL with birtamimab was accompanied by proof of clinical benefit for secondary endpoints, including significant improvements reported for both the Short Form-36 version 2 Physical Part Score (SF-36v2 PCS), the Quality of Life Calculation (p=0.026), and the 6 Minute Walk Test (6MWT), and the Adaptive Ability Evaluation (p=0.046).
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In the end…
From Prothena Corporation plc’s Ownership summary, we can see that Institutional owners comprise 94.8% of its total stock ownership. In total, they own 39.92 million shares. Looking specifically at the top three stockholders, Ecor1 Capital LLC owns 9.43 million shares, followed by Fidelity Management & Research Co. LLC with 3.33 million shares and BlackRock Fund Advisors with 3.15 million shares.