Knight Therapeutics Announces Supplemental Regulatory Submission for MINJUVI® (tafasitamab) in Brazil

MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. ("Knight") (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI(®) (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.

“This supplemental submission to ANVISA marks an important step in our efforts to expand MINJUVI(®)’s potential in earlier lines of therapy in Brazil,” said Samira Sakhia, President and Chief Executive Officer of Knight. “Patients with previously untreated DLBCL and HGBL continue to face significant unmet medical needs. We are encouraged by the clinical data supporting the addition of tafasitamab and look forward to working with regulators under Project Orbis to bring this potential new first-line treatment option to patients as quickly as possible.”