Wednesday, 10 June 2026

Vol. 1 · No. 8 Wednesday, 10 June 2026 “Medicine, measured.”

MAPLE-HCM: Change in Peak VO₂ at 24 Weeks

Primary endpoint. LS mean difference +2.3 mL/kg/min (95% CI 1.5–3.1; P<0.001). Source: NEJM 10.1056/NEJMoa2504654 / NCT05767346.

Clinical Trials

Aficamten Beats Metoprolol on Exercise Capacity in Phase 3 Head-to-Head Trial for Obstructive HCM

In 175 patients randomized over 24 weeks, the FDA-approved cardiac myosin inhibitor aficamten (Myqorzo) improved peak oxygen uptake by 1.1 mL/kg/min while metoprolol reduced it by 1.2 mL/kg/min — a 2.3 mL/kg/min treatment difference that drove superiority across five of six pre-specified secondary endpoints; left ventricular mass index did not differ significantly.

Dr. Priya Raman, Clinical Trials Desk · 3 min read

A Phase 3 head-to-head trial has found that aficamten (Myqorzo), an oral selective cardiac myosin inhibitor, outperformed the beta-blocker metoprolol on exercise capacity, symptoms, and hemodynamics in adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Primary results from the MAPLE-HCM trial (NCT05767346), sponsored by Cytokinetics, were presented at the European Society of Cardiology Congress in Madrid on August 30, 2025, and simultaneously published in The New England Journal of Medicine (DOI: 10.1056/NEJMoa2504654). Results were posted to ClinicalTrials.gov this week.

Trial Design

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Opinion

A First-Line Challenger: What MAPLE-HCM Means for the Clinic

The MAPLE-HCM data are cleaner than expected — but a 24-week trial of 175 patients cannot yet rewrite guideline-recommended first-line therapy for obstructive HCM.

Armando Cuesta, MD · 2 min

Biotech Business

Investigational Once-Weekly HIV Pill Meets Primary Endpoints in Both Phase 3 ISLEND Trials

Merck's islatravir-based oral regimen matched or outperformed daily antiretroviral comparators in ISLEND-1 and ISLEND-2 — but the drug is not yet approved and full data have not been published.

Sofia Mendes, Biotech Business & Markets Desk · 2 min

Trials Today

3 MAPLE-HCM: Aficamten vs. Metoprolol in symptomatic oHCM (n=175) — Results posted to ClinicalTrials.gov this week; simultaneously published NEJM Aug 30, 2025.
3 ISLEND-1/ISLEND-2: Islatravir-based once-weekly regimen vs. daily ART in HIV — Both trials met primary virologic suppression endpoints — topline June 8, 2026.
3 REIMAGINE 5: CagriSema vs. tirzepatide in type 2 diabetes (n=1,023) — Dual primary endpoints reached completion June 2, 2026; results imminent.
3 MIRA-1 / MIRA-2: Sonelokimab vs. placebo in hidradenitis suppurativa — Both trials completed this week; HiSCR75 at Week 16 is the primary endpoint.
3 NCT03301220: Daratumumab SC vs. active monitoring in high-risk smoldering myeloma (n=390) — Results posted to ClinicalTrials.gov this week.

At the Agencies

VRBPAC meets June 18 on Moderna MFLUSIVA (mRNA-1010) BLA — first mRNA flu vaccine before an FDA panel — PDUFA date August 5, 2026.
Olezarsen (APOC3 ASO, Ionis/AstraZeneca) sNDA PDUFA June 30 — severe hypertriglyceridemia — Priority Review; up to 72% triglyceride reduction in Phase 3.
Cytisinicline NDA PDUFA June 20 — first new smoking-cessation drug in 20 years — Phase 3 ORCA-2/-3 supported the NDA.
Nomlabofusp (frataxin-replacement, Larimar) rolling BLA filed — Friedreich's ataxia — Breakthrough Therapy; novel skin-frataxin surrogate endpoint under accelerated approval.

Who's Who

Simon Alexander Krooss

Principal Investigator, Hannover Medical School

Led the first reported in vivo base editing case in a human patient, reporting 54–57% on-target SERPINA1 correction in a liver biopsy at ten weeks without detectable off-target effects.

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On the Wire

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Full wire (160) →

In brief

Public Health Clover Hill Dairy Recalls Requesón and Soft Ricotta After Listeria Kills One and Hospitalizes Eight in Three-State Outbreak Whole genome sequencing linked cheese from a Mechanicsville, Md., dairy to an active multistate outbreak; Maryland has suspended the company's operating license and the CDC is urging consumers to discard all affected products.
FDA & Regulatory VRBPAC Convenes June 18 on Moderna's MFLUSIVA — First mRNA Seasonal Influenza BLA Before an FDA Panel Four months after a Refuse-to-File stumble, the mRNA-1010 flu vaccine reaches its most consequential regulatory checkpoint yet, with a split approval strategy for adults 50–64 versus those 65 and older.
Research AstraZeneca's Oral GLP-1 Pill Trims 11.8% Body Weight in Phase 2 — Phase 3 Now Enrolling Twin Lancet trials — VISTA in obesity and SOLSTICE in type 2 diabetes — clear the bar for a broad Phase 3 programme, but Lilly's already-approved Foundayo raises the competitive stakes for any oral GLP-1 that arrives later.
Public Health New World Screwworm Reaches New Mexico as Mexico Halts Live Animal Imports — First Mainland U.S. Re-Emergence Since 1966 Five confirmed cases across Texas and New Mexico mark the first sustained mainland re-emergence of Cochliomyia hominivorax since 1966, triggering parallel trade actions and renewed public-health guidance for people with open wounds.
Research Preprint: New Sublineage BA.3.2.2 Appears to Sidestep Pediatric Antibodies; Adults With Prior Ancestral Exposure Retain Some Protection A not-yet-peer-reviewed study from Peking University's Cao lab finds children who never encountered ancestral SARS-CoV-2 lack the antibody gene usage needed to neutralize this heavily mutated Omicron descendant.
Devices & Diagnostics BD BACTEC FXI Receives 510(k) Clearance, Detecting Sepsis Pathogens About Three Hours Faster Than Its Predecessor The upgraded automated blood culture system achieves shorter median time-to-detection for common bacteremic organisms — a gap that matters in sepsis, where each hour of delay in effective antibiotic therapy correlates with rising mortality.

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