Cytokinetics

FDA rejects Astellas' label change for eye drug Izervay; Cytokinetics and Bayer partner for heart drug aficamten in Japan; Eli Lilly's muvalaplin and Silence Therapeutics' zerlasiran show promise in reducing lipoprotein(a) levels; former NCI director Ned Sharpless launches biotech Jupiter; Merck's new Keytruda formulation proves effective; global drug access in low- and middle-income countries remains limited; AHA conference highlights obesity drugs, blood pressure management, and novel treatments for heart conditions.

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Cytokinetics and Bayer form exclusive licensing deal for aficamten in Japan, focusing on hypertrophic cardiomyopathy (HCM). The agreement includes €50 million upfront, potential €90 million in milestones, and up to €490 million in commercial milestone payments, plus tiered royalties on Japanese sales. Bayer will conduct Phase 3 trials for obstructive HCM, while Cytokinetics expands ACACIA-HCM and CEDAR-HCM trials into Japan.

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Cytokinetics presented new post-hoc analyses of GALACTIC-HF, showing omecamtiv mecarbil's efficacy in reducing heart failure risks in high-risk patients, including older adults and those with ventricular arrhythmias. The treatment effect was consistent across age groups and reduced the primary outcome risk in severe heart failure patients. Omecamtiv mecarbil also showed safety regarding ventricular arrhythmias and potential benefits for those with severely reduced LVEF.

Milind Desai, MD, MBA, discusses the results of the Risk Evaluation and Mitigation Strategy (REMS) program for mavamecten, showing low incidence of ejection fraction drop and heart failure hospitalization. Desai also highlights ongoing advancements in hypertrophic cardiomyopathy treatment, including new drugs and potential use of artificial intelligence.

Cytokinetics presented new post-hoc analyses of GALACTIC-HF, showing omecamtiv mecarbil reduced risk of adverse cardiac outcomes in severe heart failure patients across age groups, with significant risk reductions in both <65 and ≥65 years, and potential benefits in reducing ventricular arrhythmia risk.

CORXEL Pharmaceuticals, an RTW Biotech Opportunities portfolio company, has had its new drug application for Aficamten, a selective small molecule cardiac myosin inhibitor, accepted by China's NMPA for treating obstructive hypertrophic cardiomyopathy (HCM). Aficamten has received Breakthrough Therapy Designation from both the FDA and NMPA. HCM affects approximately 132,000-330,000 diagnosed and 748,000-1,870,000 undiagnosed patients in China.

B.Riley Financial's Mayank Mamtani reiterates Buy rating on Altimmune (ALT) with $20.00 target, citing successful FDA End of Phase 2 meeting for pemvidutide, paving way for Phase III obesity program. UBS also initiated coverage with a Buy rating and $26.00 target.