FDA Plans July Review of Seven Peptides as Novo Nordisk Drops Hims & Hers Lawsuit

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FDA scheduled a July 2026 meeting to consider adding seven peptides to compounding pharmacies’ approved list. Novo Nordisk dropped its March patent infringement lawsuit against Hims & Hers and has seen its stock fall 23% year-to-date due to regulatory concerns over GLP-1 therapies.

1. FDA to Evaluate Seven Peptides in July

The FDA has set a meeting for July 2026 to assess whether seven specific peptides should move from Category 2 to the Pharmacy Compounding Advisory Committee’s review list. This shift would allow compounding pharmacies to produce these substances pending PCAC’s evaluation of clinical, pharmacological and safety data.

2. Patent Lawsuit Withdrawal by Novo Nordisk

In March, Novo Nordisk withdrew its patent infringement suit against telehealth provider Hims & Hers over compounded versions of semaglutide and related GLP-1 therapies. The move eliminates a legal hurdle but raises questions about competition for Novo Nordisk’s branded weight-loss drugs.

3. Potential Impact on GLP-1 Market and Stock

The prospect of broader compounding access to peptides has increased competitive pressures on GLP-1 pricing and market share. Novo Nordisk’s stock has declined 23% year-to-date, reflecting investor concern over regulatory developments and potential revenue erosion from compounded alternatives.

Sources

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