Cytokinetics’ Myqorzo Receives Health Canada Approval for Obstructive Hypertrophic Cardiomyopathy
Cytokinetics has received Health Canada authorization for Myqorzo (aficamten), a once-daily oral cardiac myosin inhibitor, to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults with NYHA Class II–III disease. The authorization is supported by the Phase III SEQUOIA-HCM trial, which demonstrated improvements in exercise capacity, symptoms, cardiac hemodynamics, and biomarkers over 24 weeks. Patients receiving Myqorzo improved peak oxygen uptake by 1.76 mL/kg/min from baseline, compared with no change in the placebo group, while treatment-emergent serious adverse events occurred in 5.6% of patients versus 9.3% with placebo. Myqorzo carries a boxed warning for heart failure associated with reduced left ventricular ejection fraction (LVEF), requiring echocardiographic monitoring before and during treatment. The Canadian authorization follows approvals in the US, China, the EU, and UK, positioning Myqorzo as another treatment option alongside Bristol Myers Squibb’s Camzyos.
Stealth Health Acquires Kramer to Expand Integrated Digital Healthcare Services in Canada
Stealth Health has completed its acquisition of Kramer, a Canadian network connecting retail pharmacies with specialized compounding partners, advancing its strategy to integrate telemedicine, prescribing, medication compounding, and direct-to-patient delivery. Kramer’s platform provides nationwide compounding access, streamlined prescription transfers, and coordinated medication delivery while allowing referring pharmacies to retain their patient relationships. The acquisition will strengthen Stealth Health’s digital healthcare platform and white-label services for clinics, healthcare organizations, and wellness brands, supporting expansion across longevity medicine, weight management, hormone optimization, and personalized care. The transaction closed on October 16, 2026, with financial terms undisclosed. Stealth Health plans to integrate Kramer’s pharmacy network into its broader platform, connecting virtual consultations with specialized pharmaceutical fulfillment across Canada.
Devonian Health Receives Health Canada Approval for Thykamine Study in Radiodermatitis Prevention
Devonian Health Group has received Health Canada authorization for a 150-patient clinical study evaluating its proprietary Thykamine 0.1% topical formulation to prevent radiodermatitis in women undergoing breast cancer radiotherapy. The randomized, double-blind study will compare Thykamine with Glaxal Base cream, assessing time to Grade 2 or higher radiodermatitis as its primary endpoint. Secondary measures include incidence, pain, patient satisfaction, and safety. The study builds on Thykamine’s preclinical antioxidant and anti-inflammatory findings, expanding the platform into supportive oncology. However, its clinical efficacy and safety in preventing radiation-induced skin injury remain to be established. Devonian is preparing for site activation, ethics requirements, and clinical supply readiness, while exploring a potential medical-device regulatory pathway in Canada, the US, and Europe, subject to regulatory confirmation and successful development.
AbbVie’s Skyrizi Receives Health Canada Approval for Pediatric Plaque Psoriasis
abbVie has received Health Canada approval for Skyrizi (risankizumab) to treat children and adolescents aged 6 to under 18 with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The approval is supported by the Phase III OptIMMize-1 study, in which 79.6% of patients aged 12 to under 18 and 90.0% of children aged 6 to under 12 achieved clear or almost clear skin at Week 16. At least 75% improvement in psoriasis severity was observed in 85.2% of adolescents and 86.7% of younger children. The pediatric safety profile was generally consistent with that seen in adults. Skyrizi uses weight-based dosing, with treatment at baseline, Week 4, and every 12 weeks thereafter. The approval expands treatment options for young Canadians and strengthens AbbVie’s position against biologics such as Cosentyx and Taltz, with long-term safety and reimbursement likely to influence uptake.
AbbVie Advances Elahere Toward Public Reimbursement in Canada
abbVie has completed negotiations with Canada’s pan-Canadian Pharmaceutical Alliance (pCPA) and signed a Letter of Intent for Elahere (mirvetuximab soravtansine), bringing the treatment closer to potential public reimbursement. The antibody-drug conjugate is indicated for FRα-positive, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer in patients who have received one to three prior systemic treatment regimens. Elahere is the first novel targeted monotherapy to demonstrate statistically significant and clinically meaningful overall survival improvement versus single-agent chemotherapy in FRα-positive, platinum-resistant ovarian cancer. The agreement advances access discussions for eligible patients through provincial and territorial public drug plans. However, further collaboration and provincial reimbursement decisions will determine the timing and extent of access, with FRα testing requirements and treatment costs likely to influence uptake and equitable availability across Canada.
