Arbutus reaches FDA alignment on imdusiran Phase 2b design, advances Pfizer/BioNTech LNP suits
The company also began collecting on its $950 million Moderna settlement and outlined a plan to return up to $230 million to shareholders, though timing remains unconfirmed.
Arbutus Biopharma reported on August 12, 2026 that in May 2026 the company reached alignment with the FDA on the design and safety parameters of a proposed Phase 2b clinical trial evaluating imdusiran for the treatment of chronic hepatitis B.1 Arbutus intends to incorporate the FDA's feedback into a final Phase 2b protocol.1 This follows an earlier regulatory step: in April 2026, the FDA granted Fast Track designation for imdusiran for the treatment of chronic hepatitis B.1
On the litigation front, in July 2026 the company, along with Genevant, filed three international lawsuits against Pfizer, BioNTech and certain of their affiliates seeking to enforce patents protecting Arbutus' LNP technology across 21 countries.1 This comes after Arbutus's settlement with Moderna: on March 3, 2026, Arbutus and its exclusive licensee Genevant entered a settlement agreement resolving all global patent infringement litigation and revocation proceedings with Moderna, under which Moderna paid $950 million in July 2026 and will pay an additional $1.3 billion contingent on an appellate ruling regarding a legal bar to certain infringement claims.1 On July 8, 2026, Arbutus received $178.4 million as its share of the noncontingent payment, including reimbursement of litigation costs.1 The company also owns approximately 16% of Genevant's outstanding common equity and anticipates a material dividend from Genevant in the third quarter of 2026.1
Separately, Arbutus said it expects to return capital to shareholders commencing in the third quarter of 2026 through repurchases of up to approximately $230 million of common shares, potentially via a tender offer, open market purchases, accelerated share repurchases or other means, though the form and timing remain subject to board approval and no assurance was given that repurchase activity will occur in that quarter or at all.1
Financially, as of June 30, 2026, Arbutus had cash, cash equivalents and investments in marketable securities of $92.6 million, compared to $91.5 million at the end of 2025.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.