Shots:
- The US FDA has accepted BLA of INO-3107 for the treatment for adults with RRP, granting PDUFA target action date of Oct 30, 2026
- INOVIO filed a BLA for INO-3107 under the accelerated approval pathway & plans to engage with the FDA to align on requirements, while confirming it is not pursuing approval under the traditional regulatory pathway
- BLA was supported by the P-I/II trial data in adults with RRP who had ≥2 surgeries pre-treatment, along with long-term durability data from a retrospective trial, showing most evaluable pts maintained clinical benefit into a second 12mos. period without re-dosing; data were published in Nature Communications & The Laryngoscope
Ref: PRnewswire | Image: INOVIO | Press Release
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