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Mineralys Therapeutics, Inc.

MLYSFDA catalysts, PDUFA dates & pipeline intelligence
$20.43
▼ -0.12 · -0.58%

Financials

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52W LOW $20.1252W HIGH $47.65
Volume
294.48 K
Value Traded
23.38 M
Short % Float
12.83%
Days to Cover
5.2
-2.15%Week
-20.13%1 Month
-24.77%3 Month
-24.16%6 Month
+41.47%5 Year
+41.47%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
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  • SEC Filing

Key Stats

Market Cap
1.81 B
EPS (TTM)
-3.95
P/E Ratio
-
Ent. Value
1.14 B
Total Shares
88.41 M
Float Shares
60.84 M
Insiders
31.19%
Institutions
89.13%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA Date
lorundrostat
adults with hypertension
PDUFASmall MoleculesCardiovascular System
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

MLYS Catalyst Timeline

Dated clinical, regulatory and corporate events for Mineralys Therapeutics, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Mineralys Therapeutics, Inc.

193Total events
8Upcoming
46Tier-1 (high impact)
2022 to 2026Coverage

Upcoming catalysts 2

T1Late-Breaker
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lorundrostatFiled
T2Oral Presentation
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lorundrostatFiled

Event history 50

▲Oral PresentationlorundrostatFiledPresentation
Lorundrostat CKD subgroup data presented orally at ASN Kidney Week 2026
hypertension and chronic kidney diseasesource ↗
▲Subgroup AnalysislorundrostatFiledClinical Data
Launch-HTN CKD subgroup analysis: SBP reductions and 52% UACR reduction
hypertension with chronic kidney diseasesource ↗
●Management ChangeCorporate
Kristine Peterson and Lonnel Coats appointed to Board of Directors
▲Topline ReadoutlorundrostatFiledClinical Data
Launch-HTN Week 12 analysis: 46% achieved AHA/ACC SBP target <130 mmHg
difficult-to-treat hypertensionsource ↗
▲Oral PresentationlorundrostatFiledPresentation
New Launch-HTN analysis presented at AHA-HTN 2026: 46% achieved SBP <130 mmHg at Week 12
difficult-to-treat hypertensionsource ↗
▲Full ResultslorundrostatFiledClinical Data
Final results of Phase 2 Explore-OSA trial of lorundrostat
obstructive sleep apnea and hypertensionsource ↗
▲Safety Data UpdatelorundrostatFiledClinical Data
Explore-OSA safety data: favorable profile, no evidence of significant safety events including hyperkalemia
obstructive sleep apnea and hypertensionsource ↗
▲Secondary Endpoint DatalorundrostatFiledClinical Data
Explore-OSA secondary endpoint: 11.1 mmHg morning SBP reduction at Week 4
obstructive sleep apnea and hypertensionsource ↗
▲Oral PresentationlorundrostatFiledPresentation
Final Explore-OSA results presented at AHA Hypertension Scientific Sessions 2026
obstructive sleep apnea with hypertensionsource ↗
▲Additional DatalorundrostatFiledClinical Data
New Week 12 analysis from pivotal Launch-HTN trial
difficult-to-treat hypertensionsource ↗
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How MLYS actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-10-21lorundrostat Phase 3 data presentation Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

Pipeline Score
Pipeline Value
Valuation Signal
1
Drugs Scored
rNPV / MCap
Top Drug
Top 22%
Micro Cap
(rank 145 of 657)
Percentile Rank
Showing 3 of 3 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
lorundrostat Small moleculeNCT05968430HypertensionNDA/BLA ACTIVE NOT_RECRUITING 2,444May 1, 2027
lorundrostat Small moleculeCompletedNCT06785454Obstructive Sleep ApneaPhase 2 COMPLETED 48Dec 29, 2025
MLS-101 Small moleculeCompletedNCT05001945Hypertension, RenalNDA/BLA COMPLETED 200Oct 7, 2022
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PTRS, rNPV, enrollment velocity, trial design quality and ML risk signals for every asset above.
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Clinical Trial Results

Readouts, endpoints and source filings for every MLYS program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
lorundrostat hypertension and chronic kidney diseasePhase 32026-10-22systolic blood pressure reduction ckd: 9.6 mmHg; systolic blood pressure reduction non ckd: 12.2 mmHg; target sbp below 130mm Hg ckd: 44%; target sbp below 130mm Hg non ckd: 48%; albuminuria reduction: 52.2%Read MoreMineralys Therapeutics Presents New Lorundrostat Data in Participants with Hypertension and Chronic Kidney Disease at ASN Kidney Week 2026Read More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Congleton JonDirector, Officer (Chief Executive Officer)Sell -75,000 528,621 held$25.46 09/30/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
RA CAPITAL MANAGEMENT, L.P. 1.8 % (-18.2 %) 207.55 M 7.69 M
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Shares held by hedge funds each quarter, and who bought or sold.

MLYS Institutional Ownership Trends

MLYS Short Interest

Shares sold short, counted twice a month.

12.83%
Short % of Float
of tradable shares sold short
7.8M
Shares Sold Short
-15.0% vs prior count
5.2 High
Days to Cover
trading days of normal volume to buy every short share back
1.5M
Avg Daily Volume
the average used for days to cover
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Two years of days to cover and shares sold short, with every count and its change.
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Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-11-20
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

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Competitive positioning

How MLYS ranks across every disease it competes in

Competitive Position is a premium feature
See how MLYS ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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MLYS News

MLYS
Oct 22, 2026
MLYSPhases
▼ -0.6%today

Mineralys Therapeutics Presents New Lorundrostat Data in Participants with Hypertension and Chronic Kidney Disease at ASN Kidney Week 2026

Mineralys Therapeutics presented new data on lorundrostat at ASN Kidney Week 2026. The Phase 3 Launch-HTN trial demonstrated significant reductions in systolic blood pressure for participants with and without chronic kidney disease (CKD). Additionally, lorundrostat reduced albuminuria by 52% in CKD patients, supporting its efficacy and safety profile.

Read more →
MLYS
Oct 19, 2026
MLYSGeneral

Mineralys Therapeutics Expands its Board of Directors with the Appointments of Kristine Peterson and Lonnel Coats

Mineralys Therapeutics has appointed Kristine Peterson and Lonnel Coats to its Board of Directors. Both bring extensive experience in launching and commercializing therapies, particularly in cardiovascular and metabolic diseases. Their appointments come as the company prepares for the potential approval and launch of lorundrostat, aimed at treating uncontrolled hypertension.

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MLYS
Oct 9, 2026
MLYSPhases

Mineralys Therapeutics Presents New Data for Lorundrostat at the American Heart Association Hypertension Scientific Sessions 2026

Mineralys Therapeutics presented new data on lorundrostat at the AHA Hypertension Scientific Sessions 2026. In the Launch-HTN trial, 46% of participants with difficult-to-treat hypertension reached the recommended systolic blood pressure target at 12 weeks. The Explore-OSA trial also showed meaningful reductions in morning blood pressure without affecting apnea-hypopnea indices, highlighting lorundrostat's potential for treating hypertension and related conditions.

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MLYS
Oct 2, 2026
MLYSConferences/Events

Mineralys Therapeutics Announces Presentation of New Lorundrostat Data at the American Society of Nephrology (ASN) Kidney Week 2026

Mineralys Therapeutics announced that new data from the Launch-HTN trial of lorundrostat will be presented at the American Society of Nephrology Kidney Week 2026. The trial focuses on patients with uncontrolled hypertension despite multiple antihypertensive medications. Lorundrostat is an investigational drug aimed at addressing hypertension and related conditions, showing a favorable safety profile in previous studies.

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MLYS
Oct 1, 2026
MLYSConferences/Events

Mineralys Therapeutics Announces Presentation of Lorundrostat Data at American Heart Association Hypertension Scientific Sessions 2026

Mineralys Therapeutics announced the presentation of five abstracts related to lorundrostat at the AHA Hypertension Scientific Sessions 2026. The drug is being developed for uncontrolled hypertension and related comorbidities, showing efficacy in clinical trials. The company emphasizes the importance of addressing hypertension, a leading cause of death in the U.S.

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MLYS
Sep 29, 2026
MLYSGeneral

Mineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

Mineralys Therapeutics has announced the granting of inducement stock options and restricted stock units to two new non-executive employees. This decision, made by the Compensation Committee, is part of the company's strategy to attract talent under Nasdaq Listing Rule 5635(c)(4). The awards will vest over a four-year period, aligning with the company's focus on developing treatments for hypertension and related conditions.

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MLYS
Sep 24, 2026
MLYSConferences/Events

Mineralys Therapeutics to Participate in the Stifel 2026 Virtual Cardiometabolic Forum

Mineralys Therapeutics will participate in the Stifel 2026 Virtual Cardiometabolic Forum on September 30, 2026. The company focuses on developing treatments for hypertension and related comorbidities. Their investigational product candidate, lorundrostat, is a selective aldosterone synthase inhibitor. A live webcast of the event will be available on their website.

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MLYS
Sep 23, 2026
MLYSConferences/Events

Mineralys Therapeutics’ Transform-HTN Open-Label Extension Trial Data Selected for Late-Breaking Presentation at American Heart Association Scientific Sessions 2026

Mineralys Therapeutics announced that new data from the Transform-HTN trial of lorundrostat will be presented at the American Heart Association Scientific Sessions 2026. This trial assesses the long-term safety and efficacy of the aldosterone synthase inhibitor in patients with hypertension. The data highlights the potential benefits of lorundrostat in managing hypertension and related comorbidities.

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MLYS
Aug 26, 2026
MLYSConferences/Events

Mineralys Therapeutics to Participate in the Wells Fargo 21st Annual Healthcare Conference

Mineralys Therapeutics, Inc. will participate in the Wells Fargo 21st Annual Healthcare Conference from September 8-10, 2026. The company focuses on developing treatments for hypertension and related conditions. A live webcast of the event will be available on their website, showcasing their commitment to transparency and investor relations.

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MLYS
Aug 13, 2026
MLYSGeneral

Mineralys Therapeutics Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4)

Mineralys Therapeutics has granted inducement stock options and restricted stock units to Dr. Terry Ferguson, its new Chief Medical Officer. The awards, totaling 135,000 shares in options and 102,400 shares in restricted stock, are part of the company's 2025 Employment Inducement Incentive Award Plan. The vesting of these awards is contingent upon continued service over a four-year period.

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MLYS
Aug 11, 2026
MLYSFDA Updates

Mineralys Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update

Mineralys Therapeutics reported its second quarter 2026 financial results, highlighting a PDUFA target date of December 22, 2026, for lorundrostat. The company appointed Dr. Terry Ferguson as Chief Medical Officer to lead its medical activities. Despite a significant net loss of $241.1 million, Mineralys strengthened its financial position through strategic financing initiatives. Preparations for the commercial launch of lorundrostat are progressing well.

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MLYS
Aug 4, 2026
MLYSGeneral

Mineralys Therapeutics to Announce Second Quarter 2026 Financial Results and Host Conference Call on Tuesday, August 11, 2026

Mineralys Therapeutics, a biopharmaceutical company, will announce its second quarter 2026 financial results on August 11, 2026. The company is focused on developing treatments for hypertension and related comorbidities. A live webcast of the conference call will be available on their website.

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MLYS
Jun 14, 2026
MLYSFDA Updates

Mineralys Therapeutics Presents Late-Breaking Data on Lorundrostat and Heart Failure Risk Biomarkers at The Endocrine Society Annual Meeting (ENDO 2026)

Mineralys Therapeutics presented late-breaking data at ENDO 2026, showing that lorundrostat significantly reduces heart failure risk biomarkers in patients with uncontrolled hypertension. The analysis from the Launch-HTN and Advance-HTN trials indicates that lorundrostat may positively influence pathways involved in heart failure. The drug is currently under FDA review, with a target decision date set for December 22, 2026.

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MLYS
Jun 8, 2026
MLYSConferences/Events
▼ -5%on this news

Mineralys Therapeutics to Participate in the Goldman Sachs 47th Annual Global Healthcare Conference

Mineralys Therapeutics, a biopharmaceutical company, will participate in the Goldman Sachs 47th Annual Global Healthcare Conference from June 8-10, 2026. The event will take place in Miami, and a live webcast of the fireside chat will be available on their website. Mineralys focuses on developing treatments for hypertension and related comorbidities.

Read more →
MLYS
Jun 8, 2026
MLYSConferences/Events
▼ -5%on this news

Mineralys Therapeutics to Present Late-Breaking Data on Lorundrostat at The Endocrine Society Annual Meeting (ENDO 2026)

Mineralys Therapeutics announced that late-breaking data from their clinical trials of lorundrostat will be presented at the Endocrine Society's annual meeting, ENDO 2026. The poster presentation will showcase findings regarding the drug's ability to modulate heart failure risk biomarkers in participants with uncontrolled hypertension. This investigational therapy targets dysregulated aldosterone levels, a major contributor to hypertension. The presentation reflects confidence in lorundrostat's efficacy and safety based on completed late-stage clinical trials.

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MLYS
Jun 3, 2026
MLYSGeneral
▼ -13.1%on this newsshared move

Mineralys Therapeutics Announces Repurchase of Royalty Obligations in Tanabe License Agreement and Concurrent Financing

Mineralys Therapeutics has announced the repurchase of its royalty obligations related to lorundrostat from Tanabe Pharma for $200 million upfront and up to $100 million based on future milestones. Concurrently, the company secured a $500 million senior secured term loan and priced a $150 million common stock offering. These moves are expected to enhance Mineralys' financial position and operational flexibility.

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MLYS
Jun 3, 2026
MLYSGeneral
▼ -13.1%on this newsshared move

Mineralys Therapeutics Announces Pricing of $150 Million Underwritten Offering of Common Stock

Mineralys Therapeutics has announced the pricing of an underwritten offering of 5,660,378 shares at $26.50 each, aiming to raise approximately $150 million. The proceeds will be used to fund a $200 million upfront payment for repurchasing a royalty obligation. The offering is expected to close on June 4, 2026, pending customary conditions.

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About Mineralys Therapeutics, Inc.

Radnor, PA 76 employees mineralystx.com
Headquarters150 N. RADNOR CHESTER ROAD, RADNOR, PA
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