Phio Pharmaceuticals Completes First Commercial-Scale Batch of PH-762
Phio Pharmaceuticals Corp. (PHIO) has successfully finished its initial commercial-scale batch of the PH-762 drug substance under current Good Manufacturing Practice standards. A Certificate of Analysis and Compliance verified that the batch satisfied cGMP, Master Batch Record, and international guidelines, confirming its regulatory compliance and quality.
The achievement marks a key step in preparing the drug for clinical use by demonstrating supply chain readiness and lowering manufacturing risks. The validated drug substance is now ready for final drug product formulation steps as the business builds out its supply pipeline for upcoming clinical testing.
Investors will look ahead to the next stage of preparation leading into the planned initiation of a Phase 2b clinical study in the first quarter of 2027. Shares of Phio Pharmaceuticals Corp. traded down 5.80% to $0.922 following the announcement.
Key points
- Phio Pharmaceuticals finished its first commercial-scale cGMP batch of the PH-762 drug substance.
- The batch met cGMP, Master Batch Record, and ICH Q7 guidelines, backed by a Certificate of Analysis and Compliance.
- The validated material will move to final product steps to support a planned Phase 2b trial in the first quarter of 2027.
- The milestone confirms supply chain readiness and mitigates manufacturing and development risks.
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How we writeDisclaimerQuestions and answers
What did Phio Pharmaceuticals announce regarding PH-762?
Phio Pharmaceuticals completed its first commercial-scale batch of the PH-762 drug substance in compliance with regulatory standards.
When is the Phase 2b trial for PH-762 planned to start?
Phio Pharmaceuticals plans to initiate the Phase 2b clinical study for PH-762 in the first quarter of 2027.
Why is completing this batch important for the company?
The milestone demonstrates supply chain readiness, reduces development and manufacturing risks, and provides material for final drug product formulation.