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PharmaEssentia Reports the US FDA Approval of BESREMi (Ropeginterferon Alfa-2b-njft) for Essential Thrombocythemia

Shots: The US FDA has approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythemia (ET), expanding BESREMi product label beyond polycythemia vera Approval was supported by durable ELN responses and hematologic control in adults with ET. In P-III (SURPASS-ET) trial, it outperformed anagrelide in durable response rates & reduced thromboembolic events over…
2 hours ago

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NEWS

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…
January 14, 2026

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Incyte
NEWS

Incyte Reports Positive P-I Data of INCA033989 in Essential Thrombocythemia (ET) at ASH 2025 

Shots: Incyte reported updated data from two P-I trials showing the safety, tolerability, and efficacy of INCA033989 (INCA33989-101 and INCA33989-102) in 455 adults(age≥18) with mutCALR-positive MPNs, including ET & MF, findings were presented at ASH'25 In ET pts receiving higher starting doses of INCA033989 (400–2,500 mg; n=30), 90% achieved a HR, including 83.3% with CHR…
December 9, 2025

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NEWS

Incyte Partners with Enable Injections for enFuse On-Body Delivery System

Shots: Incyte has partnered with Enable Injections to develop and commercialize specific assets in Incyte’s portfolio, incl. INCA033989, a mutCALR selective mAb, with Enable’s enFuse On-Body Delivery System As per the deal, Incyte will obtain exclusive global rights to use enFuse tech with INCA033989 for essential thrombocythemia & myelofibrosis, with potential expansion to other assets &…
October 28, 2025

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NEWS

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 &…
January 8, 2025

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