Cantor Daily Research Highlights

研报英文原文证据摘录

Cantor Daily Research Highlights

LA and

that the data were properly organized and mapped to facilitate an efficient review by the Agency.

■ And recall, DBV intends to ask for Priority Review, so this organization will be critical for a timely review.

■ In our opinion, DBVT's ongoing interactions with the FDA de-risk VIASKIN ahead of the completed BLA submission, as

these discussions are more characteristic of an active regulatory review than the pre-submission phase.

■ Furthermore, the Agency did not request any additional data (or point anything else out), and the delay instead relates

to the organization and formatting of the existing data package.

■ Overall, we are not concerned by this modest delay and believe it reflects the company's proactive engagement with

the FDA to address administrative matters now rather than allowing them to become review issues later in the

approval process.

June 29

Septerna, Inc. (SEPN, $34.75, Overweight, Price Target: $60.00)

Josh Schimmer (310-282-6513, Josh.Schimmer@cantor.com)

Next Steps On X2 & Broader Portfolio

We had a chance to catch up with SEPN management following this morning's EVMN update (OW, Prakhar, his summary

note HERE) and came away with some useful insights/updates.

■ It's important to remember that SEPN's unique GPCR-drugging platform is just that - a modular modality. As such,

we're keen to see what the company's next targets & indications will be.

■ Whereas SEPN's PTH and TSHR targeting programs have essentially no target risk (which is why we find endo innovation

generally quite compelling in general), MRGPRX2 is obviously not as well a validated target.

■ SEPN expects its next 2 targets to be more proximal to PTH and TSHR than to MRGPRX2. It's possible we may hear