FDA designations & expedited pathways

The FDA offers programs that speed development or review for drugs targeting serious or rare conditions. They aren't approvals, but they signal FDA engagement and are modest catalysts.

• Fast Track — more frequent FDA interaction and rolling review for serious conditions.
• Breakthrough Therapy — for drugs showing substantial early improvement over existing options; intensive FDA guidance.
• Orphan Drug — for rare diseases (<200k US patients); brings tax credits and 7 years of market exclusivity.
• Priority Review — shortens the review clock (~6 vs ~10 months).
• Accelerated Approval — approval on a surrogate endpoint, with confirmatory trials required afterward.

How they move stocks

Each is typically a modest positive (often +5% to +20%) — validation and a faster, cheaper path — but none guarantees approval. Accelerated approvals carry later risk if the confirmatory trial disappoints.