PRAX - Relutrigine PDUFA Extended Three Months to December 27, 2026; Delay Likely Workload Related

研报英文原文证据摘录

PRAX - Relutrigine PDUFA Extended Three Months to December 27, 2026; Delay Likely Workload Related

FLASH NOTE

June 30, 2026

Yatin Suneja yatin.suneja@guggenheimpartners.com PRAX - Relutrigine PDUFA Extended Three Months

212 518 9565 to December 27, 2026; Delay Likely Workload

Eddie Hickman, Ph.D.

eddie.hickman@guggenheimpartners.com Related

212 518 9904

Delma Caiati, M.D., Ph.D. Key Message: PRAX announced yesterday that the FDA extended the review period for

delma.caiati@guggenheimpartners.com its relutrigine NDA in SCN2A and SCN8A DEEs by three months, pushing the PDUFA 617 859 4606

date from September 27, 2026 to December 27, 2026. This was driven by company's

Min Lee, Ph.D. submission of additional sensitivity analyses of existing clinical data that the agency

min.lee@guggenheimpartners.com classified as a "major amendment". Notably, no new clinical studies were requested and

212 823 6744 the FDA flagged no safety or manufacturing concerns, with the review remaining active

Iris Gao, Ph.D. and ongoing. We spoke with the company following the release, and while management

iris.gao@guggenheimpartners.com acknowledged some disappointment with the timing slip, they reassured us that the

212 518 9013 filing package remains robust. Their read is that the FDA simply needs more time to

work through the materials, likely reflecting summer scheduling dynamics and broader

reviewer workload pressures rather than any issue with the underlying data or application

PRAX quality.which effectivelyImportantly,giveslaunchthe salesplansforceremaina longeron trackrunwayagainstin thethefieldoriginalto identifyPDUFAandtimeline,engage

Praxis Precision Medicines, Inc. target DEE patients ahead of approval. Management reiterated confidence in relutrigine's