Immunotherapy group Inovio Pharmaceuticals Inc (NASDAQ:INO) said the US FDA have put the brakes on a proposed pivotal phase III clinical program for VGX-3100.
The drug is an immunotherapy targeting cervical dysplasia and reportedly could reach peak yearly sales of up to $500 million if it gains the regulatory green light.
The FDA has placed what’s called a clinical hold on the trial.
Inovio anticipates receiving a formal letter with complete information from the FDA within 30 days but initially, the organisation says it wants further data to support the shelf-life of the newly designed and manufactured disposable parts of the CELLECTRA 5PSP immunotherapy delivery device.
The study has not yet been started and it has not enrolled or dosed subjects. Moreover, the hold does not relate to any of Inovio’s other ongoing clinical studies.
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By midafternoon Monday, Inovio shares were down 16.8% at $6.96.
Story by ProactiveInvestors