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MLYS: Mgmt Check-In Highlights Lorundrostat Regulatory and Launch Prep On Track Ahead of Dec 22 PDUFA; Early ASI Launch Trends Encouraging

Published: 2026-07-13Institution: Guggenheim Securities LLCCompany / ticker: MLYS.OQPages: 6Original language: 英语Evidence page: 1

Research evidence excerpt

MLYS: Mgmt Check-In Highlights Lorundrostat Regulatory and Launch Prep On Track Ahead of Dec 22 PDUFA; Early ASI Launch Trends Encouraging

FLASH NOTE

July 13, 2026

Seamus Fernandez seamus.fernandez@guggenheimpartners.com MLYS: Mgmt Check-In Highlights Lorundrostat

617 859 4637 Regulatory and Launch Prep On Track Ahead of Dec

Colleen Garvey, Ph.D.

colleen.garvey@guggenheimpartners.com 22 PDUFA; Early ASI Launch Trends Encouraging

617 859 4664

Evan Wang Key Message: We believe lorundrostat's multi-blockbuster potential remains

evan.wang@guggenheimpartners.com underappreciated as the company approaches its December 22 PDUFA and prepares 212 651 9756

for launch. Our check-in with mgmt highlighted: (1) interactions ahead of PDUFA are

Zach Dunn, Ph.D. progressing well, with a positive mid-cycle review with the agency completed; (2)

zach.dunn@guggenheimpartners.com commercial preparations are on track, with expansion of MSLs across national and

617 859 4603 regional levels completed, sales force leadership in place, and a full sales force to be hired

Alana Lelo, Ph.D. 90 days before PDUFA; (3) AZN's launch of Baxfendy is promoting to a broad 3L+ ASI

alana.lelo@guggenheimpartners.com market - while early, we are encouraged by early launch trends (see below) and believe

212 518 9955 the $900/mo price is not yet reflected in MLYS' stock, likely as investors anticipate heavy

discounting from AZN (we model $350/mo WAC, $268/mo net price at steady state –

which may be consistent with early discounted assumptions but likely not with longer-term

MLYS netreductionprice prospects);and lower rates(4) mgmtof confirmedis confidenthyperkalemia,in lorundrostat'smgmt hasprofile,strongwithconvictionbest-in-classin a BICBP

Mineralys Therapeutics, Inc.

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