Apellis Pharmaceuticals — acquired by Biogen on May 14, 2026, four days before NCT07020832 opened for enrollment — has suspended enrollment in its Phase 3 trial of pegcetacoplan (APL-2) in kidney transplant recipients, approximately four weeks after the trial opened, according to an update to the ClinicalTrials.gov registry. No reason for the suspension has been posted publicly by Biogen, Apellis, or in the registry record.
Pegcetacoplan is a complement C3 inhibitor approved in the United States under the brand names Syfovre (age-related macular degeneration, 2023) and Empaveli (paroxysmal nocturnal hemoglobinuria, 2021). As a Biogen subsidiary, Apellis had been exploring the drug’s potential in kidney transplant recipients on the basis of complement’s role in ischemia-reperfusion injury and transplant-mediated rejection.
The Phase 3 trial (NCT07020832) opened for enrollment on May 18, 2026 — four days after Biogen closed its acquisition of Apellis. The suspension, occurring roughly four weeks after opening, is unusual in its timing — Phase 3 trials typically enroll for months to years before any suspension decision. The absence of a posted explanation leaves the reason unknown: possible causes include a safety signal in early enrollees, a strategic business decision, a manufacturing issue, or a change in protocol design, but Biogen/Apellis has not disclosed the basis.
Neither Biogen nor Apellis issued a press release or 8-K filing describing the suspension as of June 19, 2026. The company’s pipeline page has not been updated. The ClinicalTrials.gov record shows enrollment status as “Suspended.”
The company’s two approved complement inhibitor franchises (Empaveli and Syfovre) address distinct mechanisms — systemic C3 inhibition for PNH versus intravitreal C3 inhibition for GA — and the kidney transplant programme represented an exploratory extension of the systemic indication.
Correction (2026-06-19): The original article attributed the trial and its suspension to “Apellis Pharmaceuticals” without disclosing that Biogen completed its acquisition of Apellis on May 14, 2026 — four days before NCT07020832 opened for enrollment on May 18, 2026. As a wholly owned subsidiary, Apellis decisions were made under Biogen’s corporate oversight. The article has been updated to reflect this corporate context throughout. The timing has also been corrected from “approximately five weeks” to “approximately four weeks” (start date May 18 to article date June 19 = approximately four weeks and one day).