Peptide News Digest

#Thymosin beta-4

3 stories

Regulatory · View digest

Day 1 Afternoon Session Vote Tallies Clarified for Thursday July 23: PCAC Voted 8-6 to Recommend Adding TB-500 (Thymosin Beta-4 Fragment for Tissue Repair) to the Section 503A Bulks List and Voted 7-5 With 2 Abstentions to Recommend Adding MOTS-c (Mitochondrial-Derived Peptide for Obesity and Metabolic Disease) Alongside the Morning Session Votes for BPC-157 (8-6-1) and KPV (8-6-1); All Four Day-1 Peptides Cleared the Panel and All Four Wins Override FDA Career-Staff Recommendations

Day 1 afternoon session vote tallies clarified Friday for Thursday July 23, 2026: the FDA Pharmacy Compounding Advisory Committee (PCAC) voted 8-6 to recommend adding TB-500 (thymosin beta-4 fragment, marketed for wound healing and tissue repair) to the Section 503A Bulks List, and voted 7-5 with 2 abstentions to recommend adding MOTS-c (mitochondrial-derived peptide, nominated for obesity and metabolic disease). Both afternoon votes followed the morning session votes on BPC-157 (8-6, 1 abstention) and KPV (8-6, 1 abstention), making Thursday a clean sweep of all four Day-1 peptides. Every Day-1 win overrode the FDA career-staff briefing documents released June 29-30, which recommended against adding any of the seven peptides under review. Coverage across US News, ABC News, Bloomberg, The Hill, and Medical Daily converged on the framing that FDA career scientists were rebuked by the advisory panel on Day 1. TB-500 has been actively marketed alongside BPC-157 in 'tissue repair' and 'recovery' peptide-clinic protocols; MOTS-c has been marketed for metabolic health and mitochondrial function despite thin human clinical evidence.

Clinical Trials · View digest

HLB Therapeutics' ReGenTree Misses Primary Endpoint in European SEER-3 Phase 3 Trial of RGN-259 Thymosin Beta-4 Eye Drop for Neurotrophic Keratitis — Placebo Response Carries Control Arm

HLB Therapeutics (KOSDAQ: 115450) announced in late May 2026 that its US subsidiary ReGenTree failed to meet the primary endpoint in the European Phase 3 SEER-3 trial of RGN-259, a thymosin beta-4-based eye drop designed to rival Dompé's Oxervate (cenegermin) — the only FDA-approved prescription drop for neurotrophic keratitis. The trial did not show a statistically significant difference in complete corneal healing at 4 weeks compared to placebo, with a company spokesperson telling Korea Biomedical Review that 'a stronger-than-expected placebo effect in the control arm led to a puzzling outcome.' RGN-259 is licensed from RegeneRx and is also in Phase 3 development for dry eye syndrome (ARISE-3). HLB Therapeutics CEO Ahn Gi-hong said the company will analyze the SEER-3 results and focus resources on the ongoing US Phase 3 SEER-2 trial, with topline H2 2026.