Cytokinetics Launches MYQORZO; C4 Therapeutics Advances Cemsidomide Trial

Cytokinetics received FDA approval in December for MYQORZO (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. The company began its U.S. commercial launch of MYQORZO in January, deploying Cardiovascular Account Specialists who began promotion to healthcare providers in early January.

The company submitted a Supplemental New Drug Application (sNDA) to the FDA for MAPLE-HCM in Q1 2026 and expects to share topline results from ACACIA-HCM in Q2 2026. MYQORZO was also approved by the China National Medical Products Administration (NMPA) for the treatment of adults with New York Heart Association (NYHA) class II-III oHCM, to improve exercise capacity and symptoms. The European Commission approved MYQORZO for the treatment of symptomatic (NYHA class II-III) oHCM in adult patients.

Cytokinetics reported approximately $1.2 billion in cash, cash equivalents and investments as of December 31, 2025. The company launched patient and HCP marketing campaigns across promotional channels and activated an online portal for MYQORZO REMS simultaneous with drug availability. MYQORZO & You was launched to provide personalized patient support, access and reimbursement assistance and affordability programs for eligible patients.

The company advanced European commercial readiness activities, including preparing Health Technology Assessment (HTA) dossiers for all key European markets. Cytokinetics expanded launch readiness activities and continued hiring of medical and commercial teams in Germany ahead of an expected Q2 2026 launch. The New Drug Submission (NDS) for aficamten was accepted for review by Health Canada.

Cytokinetics continued conduct of ACACIA-HCM, a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM), including the Japan cohort. The company completed enrollment of CAMELLIA-HCM, a Phase 3 clinical trial of aficamten in Japanese patients with oHCM being conducted by Bayer in collaboration with Cytokinetics to support potential marketing authorization in Japan. Cytokinetics continued enrolling patients in CEDAR-HCM, a clinical trial of aficamten in a pediatric population with symptomatic oHCM.

C4 Therapeutics announced that the first patient has been dosed in the Phase 2 MOMENTUM trial evaluating cemsidomide in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (RRMM). Enrollment for the Phase 2 MOMENTUM trial is expected to be completed in Q1 2027. The Phase 1b trial of cemsidomide in combination with elranatamab is on track to initiate in Q2 2026.

The Phase 2 MOMENTUM trial is an open-label, single-arm, multicenter study to assess anti-myeloma activity and further characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of cemsidomide, an oral IKZF1/3 degrader, in combination with dexamethasone in RRMM patients for the fourth line or later. The trial will enroll approximately 100 patients to evaluate cemsidomide at the 100 µg dose level. Cemsidomide is administered with a daily dosing schedule of 14 days on and 14 days off, and dexamethasone is dosed once a week. The primary endpoint is the overall response rate per the International Myeloma Working Group response criteria as assessed by an independent review committee.

The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader.