Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES REGULATORY SUBMISSION OF CREXONT® (CARBIDOPA AND LEVODOPA) EXTENDED-RELEASE CAPSULES IN MEXICO

Knight Therapeutics Inc.'s Mexican affiliate, Grupo Biotoscana de Especialidad SA de CV, has submitted a marketing authorization application for Crexont to Cofepris, the Mexican health regulatory agency, for the treatment of Parkinson's disease (PD), postencephalitic 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 for the treatment of Parkinson's disease.

In January, 2024, Knight announced that it had 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.

"This submission of Crexont in Mexico demonstrates Knight's continued execution of our strategy to expand our neurology portfolio," 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."

About Crexont

Crexont is a novel, oral formulation of carbidopa/levodopa (CD/LD) capsule that combines both immediate-release granules and extended-release beads for the treatment of Parkinson's disease.

Crexont contains immediate-release (IR) granules and extended-release (ER) coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a sustained release polymer to allow for gradual drug release, a mucoadhesive polymer designed to prolong adhesion at absorption site, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach.

Crexont was studied in the RISE-PD clinical study which was a 20-week, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial with 630 patients.

The RISE-PD study successfully met its primary and secondary endpoints, demonstrating that treatment with Crexont significantly improved daily "Good On" time with fewer doses compared with IR CD/LD. Specifically, Crexont showed an improvement of 0.53 hour (least squares mean, 95 per cent CI, 0.09 to 0.97), with an average dosing frequency of three times per day versus five times per day for IR CD/LD1. A posthoc analysis of the primary end point on a per-dose basis showed 1.55 more hours of Good On time per dose of Crexont, compared with IR CD/LD.

About Parkinson's disease

Parkinson's disease has become the fastest-growing neurological disorder worldwide, with approximately one million patients diagnosed in the United States. In Mexico, the Parkinson's Movement Disorders Clinic at Manuel Velasco Suarez National Institute of Neurology and Neurosurgery estimates that 500,000 people between the ages of 45 and 60 are affected by the illness.

Parkinson's disease is characterized by slowness of movement, stiffness, resting tremor and impaired balance. While Parkinson's disease is not considered a fatal disease, it is associated with significant morbidity and disability. The average age at diagnosis for patients with Parkinson's disease is 60; as people live longer, the number of patients living with Parkinson's disease is predicted to grow significantly over the coming decades.

About Knight Therapeutics Inc.

Knight Therapeutics, headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics's shares trade on Toronto Stock Exchange under the symbol GUD.

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