Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 1:01 PM ET
The FDA issued a Complete Response Letter for clemidsogene lanparvovec (RGX-121) on Feb 9, 2026. 1 FDA decision on record below. Every date links its source.
We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
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Questions
When is clemidsogene lanparvovec (RGX-121)'s next FDA decision or readout?
No upcoming catalyst is on our calendar for clemidsogene lanparvovec (RGX-121); 1 FDA decision is on record below.
What happened at clemidsogene lanparvovec (RGX-121)'s most recent FDA decision?
On Feb 9, 2026 the FDA issued a Complete Response Letter. The decision page carries the source document and the measured share-price reaction.
Has clemidsogene lanparvovec (RGX-121) been approved by the FDA?
Not in our records. The FDA issued a Complete Response Letter on Feb 9, 2026.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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