Peptide News Digest

Wegovy Pill UK MHRA Approval Today, Novartis Del-Brax FSHD Biomarker Hit, Wegovy Pill UAE Launch, Moes Group GHK-Cu Private-Label Manufacturing

Novo Wegovy pill clears UK MHRA today, Novartis del-brax met FSHD biomarker primary, Wegovy pill launched UAE June 3, Moes Group enters GHK-Cu OEM.

5 stories · Covering regulatory, clinical-trials, industry

Editor's Note

Today produced a real story under the post-ADA cover. Novo Nordisk's Wegovy pill cleared its first European regulator: the UK MHRA approved oral semaglutide 25 mg for chronic weight management on June 11, the third national approval after the US in January and the UAE in June. The UAE launch on June 3 was the molecule's first international move; the UK approval, gated next by a NICE cost-effectiveness appraisal before NHS coverage, opens the European track. Novartis (post-Avidity acquisition) added an antibody-oligonucleotide conjugate readout in facioscapulohumeral muscular dystrophy, sibling chemistry to the peptide-oligonucleotide conjugates from PepGen and Vertex. And the cosmetic peptide thread continued to broaden, with Moes Group opening GHK-Cu private-label manufacturing in California ahead of the July PCAC meeting that may rule on injectable forms.

Regulatory

UK MHRA Approves Wegovy Pill (Oral Semaglutide 25 mg) for Chronic Weight Management

Novo Nordisk announced on June 11 that the UK Medicines and Healthcare products Regulatory Agency had approved the Wegovy pill (oral semaglutide tablets 25 mg) for adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related comorbidity, making the UK the third national authority to license the molecule after the FDA and the UAE's EDE. The approval rests on the Phase 3 OASIS 4 trial, which showed about 13.6% weight loss with the 25 mg tablet versus 2% on placebo. Private-prescription availability is expected within weeks; NHS coverage requires a separate NICE cost-effectiveness appraisal.

#novo-nordisk #wegovy-pill #oral-semaglutide #mhra #uk-approval #oasis-4
Clinical Trials

Novartis Del-Brax FORTITUDE Phase 1/2 Biomarker Cohort Meets Primary Endpoint in Facioscapulohumeral Muscular Dystrophy

Novartis (which acquired Avidity Biosciences in February 2026) announced June 11 that the biomarker cohort of the Phase 1/2 FORTITUDE trial of delpacibart braxlosiran (del-brax, AOC 1020) met its primary and key secondary endpoints, with reductions in KHDC1L (cDUX target) and creatine kinase indicating strong target engagement and reduced muscle damage in adults with FSHD. The data validate the dosing regimen now being used in the Phase 3 FORWARD trial enrolling 200 patients across the US and Europe. Del-brax is an antibody-oligonucleotide conjugate aimed at aberrant DUX4 expression, the same conjugate-modality family as the peptide-oligonucleotide conjugates from PepGen (PGN-EDODM1 for DM1) and Vertex (VX-670).

#novartis #avidity-biosciences #del-brax #fshd #fortitude #antibody-oligonucleotide-conjugate #muscular-dystrophy
Industry

Wegovy Pill Launched in UAE on June 3 as Novo's First International Rollout Outside the US

Novo Nordisk launched the Wegovy pill in the United Arab Emirates on June 3, the first country outside the US to make the oral semaglutide tablet available since the January 5 US launch. The UAE rollout used a distribution structure that piggybacks on existing diabetes-channel infrastructure rather than a parallel direct-to-consumer build, and arrived ahead of the UK MHRA approval today. Novo had previously guided to second-half 2026 for international rollouts.

#novo-nordisk #wegovy-pill #uae #international-launch #oral-semaglutide
Industry

Moes Group Opens GHK-Cu Private-Label Skincare and Haircare Manufacturing in California

Moes Group, a California-based private and white-label skincare manufacturer, announced June 6 that it is producing blue copper peptide (GHK-Cu / copper tripeptide-1) skincare and haircare formulations for brand partners, with cosmetic-grade GHK-Cu in stock and production already running. The launch arrives as the topical GHK-Cu market broadens after FDA materials in May indicated that non-injectable GHK-Cu would return to Category 1 under the 503A process; the injectable form remains pending the second PCAC review scheduled before February 2027.

#moes-group #ghk-cu #copper-peptide #cosmetic-peptides #private-label #skincare
Regulatory

Camurus Oclaiz Acromegaly Decision Still Pending After June 10 PDUFA Date

Camurus's PDUFA target action date for Oclaiz (CAM2029), a monthly subcutaneous octreotide depot built on FluidCrystal technology, was June 10, and as of June 11 neither the FDA nor Camurus has announced an approval. The acromegaly decision sits in the unannounced-pending bucket that sometimes precedes a same-week communication. Camurus has previously said its US commercial team is launch-ready, with about 20 sales reps active and a Q3 2026 launch targeted if approved; EU and UK marketing authorizations landed in 2025.

#camurus #oclaiz #octreotide #acromegaly #pdufa #fda-decision