Knight Therapeutics Submits Application for CREXONT in Mexico, Partners with Amneal Pharmaceuticals for Distribution in Canada and Latin America

Amneal Pharmaceuticals has partnered with Knight Therapeutics for the distribution of CREXONT, an oral extended-release capsule for treating parkinsonism in adults. The agreement grants Knight exclusive rights to pursue regulatory approval and market the drug across Canada and Latin America. Amneal has a diverse portfolio of essential medicines and operates across the US, India, and Ireland. Despite a decline in revenue growth, the company maintains a gross margin of 36.69% and an EBITDA margin of 19.39%. However, its balance sheet reveals concerns, with an Altman Z-Score of 1.48 indicating a potential risk of bankruptcy.

MONTREAL, July 02, 2025 (GLOBE NEWSWIRE) — Knight Therapeutics Inc. (TSX: GUD), a pan-American specialty pharmaceutical company, has announced that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., has submitted a marketing authorization application for CREXONT® to COFEPRIS, the Mexican health regulatory agency. The submission is for the treatment of Parkinson’s disease (PD), post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults.

CREXONT® is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules. In January 2024, Knight entered into an agreement with Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) for the exclusive rights to seek regulatory approval and commercialize CREXONT® in Canada and Latin America. In July 2025, Knight announced that CREXONT® submission was accepted for review by Health Canada.

"Knight’s continued execution of our strategy to expand our neurology portfolio is evident with this submission of CREXONT® in Mexico," said Samira Sakhia, President and Chief Executive Officer of Knight. "There is a high unmet medical need in the treatment of Parkinson’s disease, and we are confident that, with CREXONT®, we will be bringing a much-needed novel treatment option to Parkinson’s patients."

CREXONT® combines immediate-release granules and extended-release beads, designed to provide rapid and sustained drug release. The drug was studied in the RISE-PD clinical trial, which demonstrated significant improvements in daily "Good On" time with fewer doses compared to immediate-release CD/LD.

Parkinson’s disease is a rapidly growing neurological disorder, affecting approximately 1 million patients in the U.S. and 500,000 people in Mexico between the ages of 45 and 60. The average age at diagnosis is 60, and the number of patients is predicted to grow significantly over the coming decades [1].

Knight Therapeutics Inc. is headquartered in Montreal, Canada, and focuses on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. The company's shares trade on TSX under the symbol GUD.

References:
[1] https://finance.yahoo.com/news/knight-therapeutics-announces-regulatory-submission-113000550.html