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In collaboration with @moderna_tx, we’re excited to share the first positive Phase 3 topline results for our investigational individualized neoantigen therapy (INT) in combination with our company’s immunotherapy in the adjuvant setting for certain patients with completely resected stage IIB-IV #melanoma#:

Today, we took long-overdue action to restore science, accountability, and the rule of law. In September 2023, the Biden FDA pushed a number of peptides into Category 2 — “Bulk Drug Substances that Raise Significant Safety Risks” — driving a dangerous black market that puts Americans at risk. Now, after nominators withdrew 12 peptides, the FDA will remove them from Category 2 and will bring them to PCAC at its next two meetings, beginning in July—where independent experts will rigorously evaluate each substance on its scientific merits using full clinical, pharmacological, and safety evidence. • BPC-157 • Thymosin beta-4 fragment (LKKTETQ) • Epitalon • GHK-Cu (injectable) • MOTS-c • DSIP (Emideltide) • Dihexa Acetate • Ibutamoren Mesylate • Melanotan II • KPV • Semax (heptapeptide) • Cathelicidin LL-37 This action begins to restore regulated access and will immediately begin shifting demand away from the black market. We will follow the science, enforce the law, and deliver the clarity patients, providers, and pharmacies deserve.