Gotrade News - Eli Lilly announced that its oral obesity drug Foundayo (orforglipron) passed cardiovascular safety testing in the ACHIEVE-4 Phase 3 study. Separately, Hims & Hers Health stock surged 14% after the FDA scheduled a meeting to review expanded access for peptide therapies.
Key Takeaways:
- Foundayo showed 16% lower cardiovascular risk versus insulin glargine
- The study also recorded 57% lower mortality risk with a hazard ratio of 0.43
- FDA scheduled a July 23-24 peptide review that could expand compounding pharmacy access
The ACHIEVE-4 study was the largest clinical trial for Foundayo with over 2,700 participants across 15 countries. The drug met the non-inferiority endpoint for major adverse cardiovascular events (MACE-4) compared to insulin glargine.
More strikingly, the risk of cardiovascular events was 16% lower in the Foundayo group with a hazard ratio of 0.84. Mortality risk was 57% lower with a hazard ratio of 0.43, according to data reported by Benzinga.
Patients on Foundayo achieved greater improvements in A1C levels and body weight at week 52, with results sustained through 104 weeks. The discontinuation rate due to adverse events was 10.6% during a minimum 52-week treatment period.
Lilly plans to file for FDA approval by the end of Q2 using the Commissioner's National Priority Review Voucher pathway. LLY shares gained 0.77% to $912 in pre-market trading following the announcement.
On a separate regulatory front, the FDA announced meetings on July 23-24 to evaluate seven peptide compounds including BPC-157. This represents a reversal from its 2023 policy that restricted nearly 20 peptides from compounding pharmacies.
Health Secretary Robert F. Kennedy Jr. has publicly backed broader peptide access. Hims & Hers Health stock jumped 14% in pre-market after the company expressed support for the FDA's plan to "clarify the regulatory status of peptide therapies."
Lilly's $6.3 billion acquisition of Centessa Pharmaceuticals further strengthens its pipeline. The lead drug from the acquisition, cleminorexton for sleep-wake disorders, uses a novel mechanism targeting the OX2R receptor.
With $7.2 billion in cash reserves and annual revenue exceeding $65 billion, Lilly has the financial flexibility to fund aggressive expansion. The combination of Foundayo, Zepbound, and Mounjaro positions Lilly at the forefront of the obesity treatment revolution.
Sources:
- Benzinga, Eli Lilly Foundayo Clears Cardiovascular Bar, 2026
- Benzinga, FDA to Review Peptide Therapies, 2026
- Motley Fool, Eli Lilly $6.3B Centessa Deal, 2026
