PharmaEssentia Reports the US FDA’s sBLA Acceptance of Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia

Shots: The US FDA has accepted sBLA of ropeginterferon alfa-2b-njft for the treatment of adults with essential thrombocythemia, with a PDUFA target action date of Aug 30, 2026 sBLA is supported by the statistically significant and clinically meaningful data from the P-III (SURPASS-ET) trial as well as North American P-IIb (EXCEED-ET) trial Ropeginterferon alfa-2b-njft received…

ByRidhi RastogiJanuary 14, 2026

PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential Thrombocythemia (ET)

Shots: PharmaEssentia has reported topline data from a P-III (SURPASS-ET) study assessing P1101 (n=91) vs anagrelide (n=83) in patients (N=174) as a 2L treatment of ET for 12mos. with the US FDA filing for label extension to ET is expected by YE’25 The study achieved its 1EP of durable hematologic response at 9 &…

BySenior EditorJanuary 8, 2025

Insights+: Key Deals of J.P. Morgan Healthcare Conference 2020

The 2020 JP Morgan Healthcare Conference was loaded with insights from key pharma companies. An analysis of events and catalysts that were announced or updated at the conference these days are included. Our PharmaShots team summarized the key deals which were presented during the updates from companies from Jan 13 to Jan 16, 2020. Date…

BySenior EditorFebruary 7, 2020

PharmaEssentia Reports the US FDA’s sBLA Acceptance of Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia

PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential Thrombocythemia (ET)

Insights+: Key Deals of J.P. Morgan Healthcare Conference 2020

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