July 25, 2026

Novo Files TRO Against Lilly Ads, EMA CHMP Backs Lerodalcibep, Alnylam ALN-6222 Phase 1 Obesity Trial

Novo TRO filed Friday to block Lilly ads. EMA CHMP recommends lerodalcibep monthly PCSK9. AIDS 2026 opens Sunday. Alnylam siRNA obesity Phase 1.

4 stories · Covering industry, regulatory, clinical-trials

Editor's Note

Saturday's peptide news carries three regulatory and clinical throughlines beyond the two-day FDA Pharmacy Compounding Advisory Committee (PCAC) session that closed Friday. First, the Novo Nordisk versus Eli Lilly ad-war litigation escalated Friday when Novo filed for a temporary restraining order and preliminary injunction in the US District Court for the District of New Jersey to immediately block Lilly's Zepbound and Mounjaro direct-to-consumer campaigns, three days after the July 21 lawsuit alleging Lilly's ads use outdated Wegovy dose comparisons. Second, on the European regulatory side, the EMA Committee for Medicinal Products for Human Use (CHMP) closed its July 20-23 meeting with a recommendation for marketing authorisation of Lyrokaul (lerodalcibep), a once-monthly self-administered subcutaneous PCSK9 fusion-protein injection with 59-65% placebo-adjusted LDL-C reductions in the Phase 3 LIBerate-HeFH trial, adding a third-generation PCSK9 modality to the EU cholesterol formulary alongside Merck's US-approved oral LIPFENDRA (enlicitide) and the injectable antibody incumbents Repatha and Praluent. Third, the 26th International AIDS Conference (AIDS 2026) opens Sunday July 26 in Rio de Janeiro with Gilead Sciences's twice-yearly lenacapavir long-term PURPOSE 1 and PURPOSE 2 extension data and the Gilead-Merck once-weekly oral islatravir/lenacapavir ISLEND-1 and ISLEND-2 Phase 3 late-breaker Wednesday July 29. Alnylam Pharmaceuticals (NASDAQ: ALNY) also joined the obesity Phase 1 pipeline with a first-in-human trial of ALN-6222.

Industry

Novo Nordisk Files for Temporary Restraining Order (TRO) and Preliminary Injunction Friday July 24, 2026 in US District Court for the District of New Jersey to Immediately Block Eli Lilly's National Zepbound (Tirzepatide) and Mounjaro (Tirzepatide) Direct-to-Consumer Advertising Campaigns in the Escalating GLP-1 Advertising-Litigation Docket; Original Complaint Filed Tuesday July 21 Alleges Lilly's Campaigns Rely on Outdated Wegovy Dose Comparisons That Do Not Account for the FDA-Approved Higher-Dose Semaglutide Options Currently Available

Novo Nordisk announced Friday July 24, 2026 that it has filed for a temporary restraining order (TRO) and preliminary injunction in the US District Court for the District of New Jersey to immediately block Eli Lilly's national Zepbound (tirzepatide) and Mounjaro (tirzepatide) direct-to-consumer advertising campaigns. The escalation comes three business days after Novo's original complaint filed Tuesday July 21 alleging that Lilly's ads rely on outdated Wegovy (semaglutide) dose comparisons that do not account for the newer, higher-dose FDA-approved semaglutide options currently available. Through the TRO and preliminary injunction motions, Novo Nordisk seeks immediate court-ordered removal of the disputed Lilly campaigns pending a full merits ruling on the underlying deceptive-advertising claims. Novo also seeks a permanent injunction requiring Lilly to pull all misleading comparative advertising across platforms and to conduct a corrective advertising campaign. The GLP-1 ad war has moved from network TV pharmacy-facing PBM negotiation into full federal court litigation for the first time in the class's US commercialization history. Court hearing dates on the TRO/preliminary injunction have not yet been reported publicly.

#novo-nordisk #nvo #eli-lilly #lly #wegovy #zepbound #mounjaro #tirzepatide #semaglutide #tro #preliminary-injunction #district-of-new-jersey #ad-war-litigation #deceptive-advertising

Regulatory

European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) Closes July 20-23, 2026 Meeting With a Recommendation for EU Marketing Authorisation of Lyrokaul (Lerodalcibep), a Once-Monthly Self-Administered Subcutaneous Third-Generation PCSK9 Inhibitor Fusion Protein, for Adult Primary Hypercholesterolaemia and Mixed Dyslipidaemia With 59-65% Placebo-Adjusted LDL-C Reductions From the Phase 3 LIBerate-HeFH Registrational Trial in Adults With Heterozygous Familial Hypercholesterolaemia on Maximally Tolerated Statin Therapy; European Commission Marketing Authorisation Decision Typically Follows 2-3 Months

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) closed its July 20-23, 2026 meeting with a recommendation for EU marketing authorisation of Lyrokaul (lerodalcibep). Lerodalcibep is a third-generation PCSK9 inhibitor administered as a once-monthly self-administered subcutaneous injection. The active substance is an adnectin-Fc fusion protein that binds proprotein convertase subtilisin/kexin type 9 (PCSK9), preventing PCSK9-mediated degradation of LDL receptors in the liver and enhancing LDL-C clearance from circulation. In the Phase 3 LIBerate-HeFH registrational trial, adults with heterozygous familial hypercholesterolaemia (HeFH) on maximally tolerated statin therapy achieved placebo-adjusted LDL-C reductions of roughly 59-65% by Week 24, with approximately two-thirds of participants reaching European Society of Cardiology-recommended targets. The CHMP recommendation covers use in addition to diet, alone or in combination with other lipid-lowering therapies. European Commission marketing authorisation decisions typically follow CHMP recommendations by 2-3 months. Lerodalcibep received US FDA approval earlier in 2026 under the brand name Lerochol. The EU authorization would add a third-generation PCSK9 modality alongside injectable antibodies (Repatha/evolocumab, Praluent/alirocumab), the siRNA (Leqvio/inclisiran), and the oral macrocyclic peptide (LIPFENDRA/enlicitide, US-only as of July 25, 2026).

#ema #chmp #lerodalcibep #lyrokaul #lerochol #pcsk9-inhibitor #fusion-protein #adnectin #hefh #liberate-hefh #monthly-injection #european-commission

Clinical Trials

26th International AIDS Conference (AIDS 2026) Opens Sunday July 26, 2026 in Rio de Janeiro, Brazil and Runs Through Friday July 31; Gilead Sciences to Present Twice-Yearly Lenacapavir (First-in-Class HIV Capsid Inhibitor) Long-Term Extension Data From the Phase 3 PURPOSE 1 Trial (Zero New HIV Infections Across 7,178 Person-Years of Follow-Up at Week 52) and the Phase 3 PURPOSE 2 Trial (One HIV Infection Across 5,295 Person-Years of Follow-Up), and Gilead-Merck Once-Weekly Oral Islatravir/Lenacapavir ISLEND-1 and ISLEND-2 Phase 3 Detailed Data Late-Breaker on Wednesday July 29

The 26th International AIDS Conference (AIDS 2026) opens Sunday July 26, 2026 in Rio de Janeiro, Brazil and runs through Friday July 31. Two peptide-adjacent HIV modality readouts anchor the industry program. Gilead Sciences (NASDAQ: GILD) will present twice-yearly lenacapavir (first-in-class HIV capsid inhibitor) long-term open-label extension data from the Phase 3 PURPOSE 1 trial, where zero new HIV infections occurred among participants receiving lenacapavir across more than 7,178 person-years of follow-up at Week 52, and from PURPOSE 2, where one HIV infection occurred among participants continuing lenacapavir across 5,295 person-years of follow-up. Separately, Gilead and Merck's once-weekly oral single-tablet islatravir 2 mg / lenacapavir 300 mg (ISL/LEN) Phase 3 ISLEND-1 and ISLEND-2 detailed data is scheduled for the late-breaking session on Wednesday July 29. Topline released July 21 showed 0% of ISLEND-1 once-weekly ISL/LEN participants had HIV-1 RNA at 50 copies/mL or higher at Week 48 (versus 0.3% remaining on daily Biktarvy). Merck plans separate presentations across its daily, weekly, and monthly HIV treatment and prevention pipeline including alimatravir (MK-8527), the investigational once-monthly oral HIV prevention pill licensed Friday July 24 to Aspen Pharmacare and six other generic manufacturers for 129 low- and middle-income countries.

#aids-2026 #gilead #gild #lenacapavir #purpose-1 #purpose-2 #islend-1 #islend-2 #islatravir #merck #hiv-prevention #capsid-inhibitor #rio-de-janeiro #twice-yearly

Clinical Trials

Alnylam Pharmaceuticals (NASDAQ: ALNY) Enters the Obesity Race With First-in-Human Phase 1 Randomized Double-Blind Placebo-Controlled Single-Ascending-Dose Study (NCT07624071) of ALN-6222, an Investigational Subcutaneous siRNA With an Undisclosed Molecular Target Administered as a Single Dose in Adults With Obesity; Trial Enrolls Approximately 88 Participants With BMI 30 to Less Than 40 kg/m² and HbA1c Below 6.5% at a Single Trial Site in Mount Royal, Canada, With Trial Completion Targeted for December 2027

Alnylam Pharmaceuticals (NASDAQ: ALNY) confirmed a first-in-human Phase 1 trial of ALN-6222, an investigational subcutaneous siRNA therapeutic in adults with obesity, in a July 22 filing update on ClinicalTrials.gov (NCT07624071). The randomized, double-blind, placebo-controlled, single ascending dose study will enroll approximately 88 participants with a BMI of 30 to less than 40 kg/m² and an HbA1c below 6.5% (excluding participants with diabetes). The primary endpoints are safety and pharmacodynamics; secondary endpoints include changes in body weight and metabolic markers. The molecular target of ALN-6222 has not been publicly disclosed. The trial is set to run through December 2027 at a single site in Mount Royal, Canada. ALN-6222 marks Alnylam's first clinical-stage entry into the obesity therapeutic area, joining a broader wave of nucleic-acid, peptide, and peptide-fusion modalities entering the space beyond the GLP-1 incumbents (Wegovy, Ozempic, Mounjaro, Zepbound) and the Alnylam-PeptiDream peptide-siRNA conjugate collaboration announced in 2021. Alnylam separately reports Q2 2026 earnings later this week and is expected to discuss the ALN-6222 program on the call.

#alnylam #alny #aln-6222 #sirna #obesity #phase-1 #first-in-human #subcutaneous #single-ascending-dose #mount-royal-canada #clinicaltrials-gov