普通外文研报
MLYS: Mgmt Check-In Highlights Lorundrostat Regulatory and Launch Prep On Track Ahead of Dec 22 PDUFA; Early ASI Launch Trends Encouraging
研报英文原文证据摘录
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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