Potential bad news for Regeneron (REGN) from this news report:
A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected today may be delayed due to "deficiencies" found during a manufacturing site inspection in France.
In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that "manufacturing deficiencies have been raised by the FDA during a routine Current Good Manufacturing Practice (CGMP) inspection of a Sanofi manufacturing facility..."
Sanofi spokesman Jack Cox confirmed in an email that the facility, which conducts the final manufacturing steps for biologic drugs, is known as "Le Trait" and is located in Normandy, France.
"Given that the CGMP status of this facility is still under review by the FDA, it is unclear whether this situation will impact the approval for sarilumab," the company said in the release.
Sarilumab has a PDUFA date of Sunday, meaning today was viewed as the de facto PDUFA date.
There's no way to know how long it would take Sanofi to correct the deficiencies, obtain FDA's reinspection and validation, and thus allow sarilumab to be approved, assuming it does not gain FDA approval despite these ongoing issues.
The only good thing I can say about this as a REGN shareholder looking for a successful launch of its sarilumab product, to be marketed by SNY globally and probably co-marketed by REGN in the US with SNY, is that it's better this happen with sarilumab than with dupilumab.
I do not know where the joint SNY-REGN drug Praluent is manufactured; I'm not aware of any FDA or EMA issues with it.
I am seeing an indication for REGN of perhaps down 1% pre-market; it normally does not trade actively other than during normal hours.
Here is the relevant 8-K from REGN.