I do think there is irreparable harm and would find that element met.
An especially creative judge could devise a workaround such as ordering the FDA to grant priority review for a specified number of SNY’s future BLA/NDA filings. This is not as far-fetched as it sounds insofar as the FDA already issues priority-review vouchers to drug companies who conduct clinical studies desired by the FDA that the companies would otherwise not conduct.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”