Knight Therapeutics Inc. (GUD.TO), Tuesday announced that its Brazilian affiliate, United Medical Ltda. has received approval from ANVISA, the Brazilian health regulatory agency, for an additional indication for MINJUVI.
The approval comes after a supplemental regulatory filing and review by ANVISA under Project Orbis for MINJUVI, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma.
Notably, the approval is backed by findings from clinical studies, which demonstrated meaningful response rates and durable disease control in patients.
CEO Samira Sakhia commented, "The rapid review and approval under Project Orbis reflect Knight's strong regulatory capabilities and focused execution for the benefit of Knight and our partners."
Currently, Knight's stock is trading at C$6.14, up 0.66 percent on the Toronto Exchange.
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