Feb. 2 at 8:17 AM
$PHAR Watching the Euronext price action right now (€1.385, down ~19%), and it’s a classic massive overreaction to a headline.
If you actually read the CRL details, this is a "Soft Rejection":
Underexposure (Not Toxicity!): The FDA isn't saying the drug is unsafe. They are worried low-weight kids aren't getting ENOUGH of it. This is a dosing/PK math problem to solve, not a safety failure.
CMC / Batch Testing: This is a bureaucratic dispute over analytical methods in the lab. The factory isn't broken, the drug isn't contaminated. It's paperwork.
The Reality:
Safety: Clean. No serious adverse events.
Revenue: Joenja is ALREADY approved for 12+. The cash cow is safe and unaffected by this.
The market is pricing this like a total failure. It’s just a delay for the younger cohort. Let the weak hands in Europe fold—this dip is irrational based on the filings.
