What are the regulatory timelines and potential risks for FDA approval of the supplemental NDA, and how could this impact the stock volatility?

Regulatory timeline & risk – A supplemental NDA for a new pediatric indication typically follows the FDA’s standard 6‑month review clock, with a possible 4‑month “priority” timeline if Arctis secures a priority review designation (which it has not announced yet). The agency will focus on safety in the 2‑to‑5‑year cohort, the adequacy of the existing efficacy data, and any pediatric‐specific pharmacokinetic concerns. The chief risks are a complete response letter (CRL) requesting additional data or a more restrictive label, and the inherent uncertainty of pediatric safety signals that could delay approval beyond the statutory window. A CRL would likely trigger a 30‑day extension for the company to respond, pushing the “decision date” out by a month or more and adding a second wave of volatility.

Impact on ARCT volatility & trade ideas – Because the market is already pricing a modest upside (sentiment ≈ 60 % positive) and the stock is trading near its 20‑day SMA with bullish momentum, the upcoming PDUFA decision is a classic “binary” catalyst that can double‑digit swing moves. Expect heightened options volume and widening implied volatility in the weeks leading up to the FDA decision. A pragmatic approach is to buy on a break above the short‑term resistance (~$X) with a tight stop just below the 20‑day SMA, effectively betting on a rapid approval rally; alternatively, a neutral‑to‑slightly‑bearish trader could sell a straddle/strangle to capture premium from the expected IV crush if the outcome is a modest “yes.” Keep an eye on any FDA briefing documents or advisory committee minutes—those releases can compress the risk premium and trigger abrupt price corrections before the formal decision.