Draft label shared + clean manufacturing inspections + quiet review favor approval ~58%. But 2 prior CRLs and failed field trial limit conviction. Steady-state cap reduced request to $1000.00.
No cash available to trade. Market is nearly balanced at 52.
FDA issued a draft label in Dec 2025, signaling approval intent based on the successful chamber trial. The CEO's Feb 25 update of a "quiet" review suggests the failed field trial's data raised no new deficiencies.
The FDA has issued two prior Complete Response Letters citing a lack of efficacy data and requesting at least one new trial. The current resubmission is based on a trial that failed its primary endpoint. Steady-state cap reduced request to $1000.00. Position cap reduced buy size.
Resubmitted NDA addressing CRL with positive Phase 3 symptom data primary approval driver (est 65% prob); FDA acceptance reduces rejection risk. Approval drives ALDX stock 200-400% surge boosting valuation. Steady-state cap reduced request to $1000.00.
