HLS Therapeutics Partners with Bayer to Commercialize Verquvo in Canada
HLS Therapeutics has entered into an agreement with Bayer to commercialize Verquvo (vericiguat) in Canada, marking HLS’s entry into the heart failure market and expanding its cardiovascular portfolio. Verquvo is an oral, once-daily treatment for adults with symptomatic chronic heart failure and reduced ejection fraction who have stabilized following a recent hospitalization or intravenous diuretic treatment. Already authorized and available in Canada since April 2023, the therapy is supported by the Phase III VICTORIA trial and has public and private reimbursement coverage in place. Beginning in Q1 2027, HLS will manage distribution, promotion, and medical education, while Bayer will retain regulatory and supply responsibilities. HLS will record net sales and pay royalties to Bayer under the agreement. The partnership provides HLS with access to an established, reimbursed cardiovascular therapy, potentially accelerating its entry into the heart failure market, while highlighting the role of commercialization partnerships in expanding pharmaceutical portfolios without internal drug development.
GSK Receives Health Canada Approval for Hibsago as First Finite Therapy for Chronic Hepatitis B
GSK has received Health Canada approval for Hibsago (bepirovirsen), the first and only finite therapy indicated to achieve functional cure of chronic hepatitis B (CHB) in eligible non-cirrhotic adults. The antisense oligonucleotide therapy is indicated for patients who have received nucleos(t)ide analogue treatment for at least six months, have HBV DNA levels below 90 IU/mL, and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less. In the Phase III B-Well trials, functional cure rates reached 19% among patients with baseline HBsAg levels of 3,000 IU/mL or less and 26% among those with levels of 1,000 IU/mL or less, compared with 0% for placebo. Granted under Health Canada’s Priority Review policy, the approval introduces a potential shift from lifelong disease management toward finite treatment and treatment-free disease control. Canadian supply is expected in early 2027, while Japan and the US have also authorized the therapy. The approval positions GSK as a first mover in Canada’s chronic hepatitis B market, with commercial uptake likely to depend on pricing, reimbursement, patient eligibility, and the anticipated launch.
Roche Receives Health Canada Approval for Ocrevus IV in Pediatric Multiple Sclerosis
Roche Canada has received Health Canada approval for Ocrevus IV (ocrelizumab) to treat children aged 10 years and older with relapsing-remitting multiple sclerosis (RRMS), expanding treatment options for pediatric patients. The approval is based on the Phase III OPERETTA 2 trial, in which Ocrevus demonstrated non-inferiority to fingolimod, the only other approved pediatric MS treatment in Canada, with a 48% reduction in annualized relapse risk. Ocrevus also reduced new or enlarging T2 brain lesions by 48% and gadolinium-enhancing T1 lesions by 87% compared with fingolimod, while demonstrating a safety profile consistent with that observed in adults. The approval addresses an important treatment gap, as pediatric MS can be associated with higher relapse rates and early neurological damage. Roche will work with public and private payers to support timely access across Canada. The expanded indication strengthens Roche’s position in the Canadian MS market and extends Ocrevus’ reach to younger patients, with broader adoption likely to depend on reimbursement and payer access decisions.
GotoDoctor Partners with Melanoma Canada to Expand Primary Care Access Through Mole Mobile
GotoDoctor has been selected as Melanoma Canada’s exclusive national primary care access partner, connecting Canadians with physician services and strengthening follow-up care through the Mole Mobile skin cancer screening initiative. The partnership will leverage GotoDoctor’s network of more than 100 physicians and healthcare providers, AI-enabled care matching, and virtual and in-person services to help patients access appropriate clinical care following community-based screening. Since its launch in 2023, the Mole Mobile has screened 22,483 Canadians across all 10 provinces and identified more than 3,184 suspicious lesions, highlighting the need for accessible screening and timely follow-up. As the initiative prepares to visit Quebec, the collaboration aims to bridge gaps between early skin cancer detection and clinical care, particularly for individuals facing barriers to primary care access. The partnership expands GotoDoctor’s national healthcare reach and highlights the growing role of digital health platforms and integrated screening-to-referral models in improving access to early diagnosis and follow-up care.
Specific Biologics Raises $35M Series A to Advance Dualase Gene-Editing Candidate for ALS
Specific Biologics has closed an oversubscribed US$35 million Series A financing led by Hatteras Venture Partners, with participation from Lumira Ventures, adMare BioInnovations, and new life sciences investors. The funding will support the advancement of its lead candidate, Dualase, through initial clinical biomarker proof-of-concept in patients with C9ORF72-associated amyotrophic lateral sclerosis (ALS). The candidate will be evaluated in the first cohort of an adaptive Phase I/II trial. Dualase is designed to precisely remove disease-causing DNA repeat expansions while preserving normal genetic sequences. Building on preclinical editing results across multiple neuromuscular repeat expansions, the platform has potential applications in more than 40 repeat expansion disorders. The financing highlights investor interest in precision gene-editing approaches for genetic and neurodegenerative diseases, while clinical validation of Dualase could establish a broader development opportunity across multiple serious genetic disorders and support future pharmaceutical partnerships.
