Daraxonrasib Phased/Rolling Submissions Have Begun + Commentary from RVMD

研报英文原文证据摘录

Daraxonrasib Phased/Rolling Submissions Have Begun + Commentary from RVMD

d that the rolling submission of their NDA for darax to the FDA is nearing Market Cap. (mil) US$37,637.0

completion. Recall that RVMD had most recently confirmed their intentions to submit data Avg Daily Vol (000) 3,484

under a Commissioner's National Priority Voucher following their ASCO 2026 plenary Div Yield 0.00%

presentation on 5/31/2026. Notably, in terms of a CNPV application timeline, RVMD Fiscal Year End Dec

highlighted that the process' steps are theoretically: (i) RVMD completes the rolling Price Performance - 1 Year

submission, (ii) FDA has 60 days to accept the filing, and (iii) then the 1-2 month review

period under the CNPV would begin. RVMD also confirmed that they are not commenting USD200

on what their communication strategy with the Street will look like i.e. whether they will PR

when the filing is completed, accepted, and/or approved. 150

Investor focus is on the near-term daraxonrasib launch and what exactly the initial 100

label might look like. Following the impressive Ph. 3 RASolute 302 trial readout of darax in

2L PDAC at ASCO (see our recap here), investor focus has shifted to (i) how quickly darax 50

could be approved, and (ii) how broad this initial label might be. Investors largely assume a

broader-than-RASolute 302 label could be possible i.e. one that includes 1L PDAC patients 0

despite RASolute 302 being conducted in 2L PDAC patients. RVMD confirmed that the FDA Jul-25 Sep-25 Nov-25 Jan-26 Mar-26 May-26 Jul-26

has access to a lot of information / clinical data from them, but the filing will be predominantly Source: Bloomberg

302 data and that the base case is that FDA is reviewing Ph. 3 data in 2L previously treated

PDAC patients.