First Commercial Product Launch and Initial Revenue
Launched MYCorzo in the U.S. (available to patients Jan 27). Recorded $4.8 million in net product revenue in Q1 (approx. nine weeks of commercial sales); over 70% of dispensed patients on a paid prescription and average conversion to paid in <2 weeks.
Strong Early Commercial Adoption Metrics
By end of Q1 ~275 unique HCPs prescribed MYCorzo (50%+ from high-volume prescribers); through April >425 HCPs prescribing. Average prescriptions per HCP: 2.4 overall / 2.6 for high-volume prescribers. Internal estimate of new-to-brand Q1 exit share >30%. Over 1,400 HCPs REMS-certified and >2,100 enrolled in the patient community; ~680 patients prescribed by end of Q1 rising to ~1,100 through April.
European Regulatory Progress and Commercial Expansion
European Commission approved MYCorzo in February; German commercial launch planned in Q2 2026. Six HTA dossiers submitted with five more expected this quarter; MAA submitted to Swissmedic; Canadian decision expected in H2 2026.
Positive Pivotal Acacia HCM Results (aficamtin in nHCM)
Acacia HCM met both dual primary endpoints: KCCQ improvement LS mean difference 3.0 points (11.4 vs 8.4; p=0.021) and peak VO2 LS mean difference 0.67 mL/kg/min (0.64 increase vs -0.03; p=0.003). Statistically significant secondary endpoint improvements (NYHA class, composite ventilatory efficiency/peak VO2, NT-proBNP). No new safety signals identified overall. Company plans regulatory discussions and potential sNDA submission.
Regulatory and Label Expansion Pathway
sNDA for MAPLE HCM accepted for filing by FDA with PDUFA date 11/14/2026; MAA submitted for oHCM in Switzerland; marketing application under review in Canada; Sanofi partner progressing potential approvals in Hong Kong and Taiwan.
Collaboration and Milestone Revenue Recognition
Recorded $11.9 million milestone under the Bayer license agreement tied to first U.S. commercial sale. Collaboration revenue $2.6M in Q1 vs $1.6M in Q1 2025 (+62.5%).
Pipeline and Ongoing Trials Progress
Ongoing global programs: CAMELLIA-HCM (Japan), CEDAR-HCM (pediatric; adolescent cohort enrollment expected complete by end of 2026), COMET-HS enrollment progressing (omicamtiv program), and AMBER-HFpEF cohort 1 enrollment expanded (expect completion in 2H 2026). Afibcamtin received orphan designation in Japan for nHCM and pediatric oHCM.
Maintained Full-Year Financial Guidance and Large Cash Position
Maintained full-year 2026 GAAP combined R&D and SG&A guidance of $830M-$870M (excluding stock comp $700M-$750M). Ended Q1 with approximately $1.1 billion in cash and investments.