Phio Pharmaceuticals completes first commercial‑scale cGMP batch of PH‑762, enabling Phase 2b start in early 2027
Phio Pharmaceuticals announced that it has produced its inaugural commercial‑scale cGMP batch of the siRNA drug PH‑762. The batch satisfied all required specifications and quality checks, and will be used to finish the drug product for a Phase 2b trial slated to begin in the first quarter of 2027. CEO Robert Bitterman said the achievement caps a 16‑month effort that lowers manufacturing risk and readies the supply chain for upcoming clinical and regulatory steps.
Why it matters
The company states the milestone reduces development and manufacturing risk and positions it to meet upcoming clinical and regulatory timelines. Investors should expect the trial start date to remain on track, which could influence future financing and valuation.
Key facts
- 1Phio released its first commercial‑scale cGMP batch of PH‑762 drug substance. stocktitan.net
- 2The batch complied with current Good Manufacturing Practice, the approved Master Batch Record and ICH Q7 guidelines. investing.com
- 3Quality and specification compliance were confirmed by a Certificate of Analysis and a Certificate of Compliance. investing.com
- 4The drug substance will be used to complete the drug product for a Phase 2b clinical study expected to start in Q1 2027. stocktitan.net
- 5Robert Bitterman, President and CEO, said the achievement caps a 16‑month coordination effort among scientists and engineers. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.