PRAX: Relutrigine's PDUFA Pushed Back by 3 Months; Not Thesis-Changing, in Our View

研报英文原文证据摘录

PRAX: Relutrigine's PDUFA Pushed Back by 3 Months; Not Thesis-Changing, in Our View

Equity Research

Flash Comment — June 30, 2026

Biotechnology

Praxis Precision Medicines, Inc.

Relutrigine's PDUFA Pushed Back by 3 Months; Not Thesis- Equal Weight

Changing, in Our View Price Target: $323.00

Ticker PRAX

Our Call Upside/(Downside) to Target (7.9)%

We don't read a lot into the PDUFA extension, and continue to see SCN2A/8A approval as the Price (06/29/2026) $350.56

most likely outcome. Mgmt. conveyed that the additional analyses submitted to the FDA don't 52 Week Range $37.19 - 366.52

alter conclusions about efficacy. Market Cap (MM) $10,125

Source: Company Data, Wells Fargo Securities estimates, and Factset.

Initial Thoughts NA = Not Available, NC = No Change, NE = No Estimate

What happened? PRAX disclosed that the FDA delayed the PDUFA date for relutrigine's Benjamin Burnett, PhD

NDA (under review for SCN2A/8A DEEs) from 9/27/2026 to 12/27/2026. The company Equity Analyst | Wells Fargo Securities, LLC

Benjamin.J.Burnett@wellsfargo.com | 212-214-5909

notes that:

Orfeas Sfyrlas

• The extension came following PRAX's submission of 'additional sensitivity analyses of Associate Equity Analyst | Wells Fargo Securities, LLC

existing clinical data', which the FDA deemed a major amendment, Orfeas.Sfyrlas@wellsfargo.com | 646-425-2547

Tianqi Hang, PhD

• There was no citation of any safety/manufacturing concerns, and Associate Equity Analyst | Wells Fargo Securities, LLC

• Preparations for relu's potential launch continue. Tianqi.Hang@wellsfargo.com | 212-214-5018

We connected w/ mgmt following the disclosure.

• They conveyed that the additional analyses requested by the agency were relatively

straightforward, and didn't alter conclusions about efficacy in their view.

• Mgmt.