Everest Clinical Research Helps Deliver FDA Approval for PharmaEssentia Launch and Achieves Successful FDA Inspection with No Findings
TORONTO – November 09, 2026 – Everest Clinical Research (“Everest”) today announced its role as the primary contract research organization (CRO) supporting PharmaEssentia Corporation (“PharmaEssentia”) in achieving FDA approval of BESREMi® (ropeginterferon alfa-2b-njft) for adults with essential thrombocythemia (ET). This is first FDA-approved treatment for ET in nearly three decades and provides physicians and patients with an important new therapeutic option. The milestone builds on Everest’s deep oncology experience and its longstanding focus on supporting complex clinical development programs.
Everest is a full-service, global CRO providing integrated clinical development and biometrics services across multiple complex therapeutic areas. With over 20 years of experience, Everest has supported more than 200 oncology studies in the past five years, spanning solid tumors and hematologic malignancies across all phases of development. That expertise supported its partnership with PharmaEssentia, a global and rapidly growing biopharmaceutical innovator focused on developing effective new biologics across hematology, oncology, and immunology.
As the primary CRO supporting PharmaEssentia’s ET launch program in the U.S., Everest initially provided biostatistics, statistical programming, and data management services before expanding its role to assume responsibility for clinical operations and full-service execution from a larger CRO. Everest subsequently partnered with PharmaEssentia to develop the supplemental Biologics License Application (BLA) strategy, secure FDA alignment, prepare the submission package, support regulatory review activities, and respond to FDA information requests throughout the review process.
As part of that review process, the FDA conducted an on-site Bioresearch Monitoring (BIMO) inspection of Everest across its full-service operations. The inspection successfully concluded with a No Action Indicated (NAI) outcome and no findings.
“Our teams were proud to support PharmaEssentia on this important research and to help bring this treatment to patients,” said Jin Dai, Chief Executive Officer at Everest Clinical Research. “In addition, the successful FDA inspection is a testament to the discipline, attention to detail, and commitment to quality that underpin our work in every study we conduct.”
