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Fresenius Medical Care AG

FMSFDA catalysts, PDUFA dates & pipeline intelligence
$22.49
▼ -0.65 · -2.83%

Financials

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R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
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Quarterly Cash
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52W LOW $20.0252W HIGH $27.16
Volume
685.00 K
Value Traded
17.84 M
Short % Float
0.74%
Days to Cover
3.5
-0.82%Week
+0.51%1 Month
-12.33%3 Month
+0.02%6 Month

Cash Data

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  • Monthly Burn
  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
11.04 B
EPS (TTM)
1.92
P/E Ratio
11.71
Ent. Value
25.53 B
Total Shares
490.48 M
Float Shares
532.21 M
Insiders
0.00%
Institutions
8.09%

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
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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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.

FMS Catalyst Timeline

Dated clinical, regulatory and corporate events for Fresenius Medical Care AG

Catalyst Timeline

Dated clinical, regulatory & corporate events for Fresenius Medical Care AG

322Total events
8Upcoming
88Tier-1 (high impact)
2006 to 2026Coverage

Upcoming catalysts 2

T2Quarterly Update
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T2Timing Guidance
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Event history 50

●Late-BreakerPresentation
Late-breaking poster: GLP-1 Receptor Agonist Initiation and Mortality in Patients on Maintenance Hemodialysis
maintenance hemodialysissource ↗
●Poster PresentationPresentation
Poster: Calcium Control and Electrolyte Stability During Regional Citrate Anticoagulation Using a Fully Integrated CRRT System at ASN Kidney Week 2026
critically ill patients receiving CRRTsource ↗
▲Product LaunchmultiFiltratePROApprovedPost-Market
U.S. launch of multiFiltratePRO System
acute kidney injury (continuous renal replacement therapy)source ↗
▲FDA ApprovalCalrezdyApprovedFDA Decision
FDA approved Calrezdy (calcium chloride solution) for RCA in CKRT
calcium substitution for regional citrate anticoagulation during CVVHD/CVVHDFsource ↗
▲FDA ApprovalCienbyApprovedFDA Decision
FDA approved Cienby (sodium citrate solution) for RCA in CKRT
regional citrate anticoagulation during CVVHD/CVVHDFsource ↗
▲FDA ApprovalmultiFiltratePROApprovedFDA Decision
FDA cleared multiFiltratePRO System for CRRT in AKI
acute kidney injury (continuous renal replacement therapy)source ↗
▲PublicationPresentation
Publication of multinational real-world evidence study in JASN
kidney failuresource ↗
▲Quarterly UpdateCorporate
Q2 2026 financial results: operating income excl. special items grew 23% yoy
▲Product LaunchPost-Market
5008X CAREsystem available in 227 U.S. clinics with >600,000 treatments
renal diseasesource ↗
▲Enrollment MilestoneTrial
BEACON-US scientific research initiative early insights
renal diseasesource ↗
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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 FMS actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-10-19Cienby (sodium ctirate) PDUFA Date ApprovedPDUFA
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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
2
Drugs Scored
rNPV / MCap
Top Drug
Top 46%
Mid Cap
(rank 303 of 657)
Percentile Rank
Showing 5 of 10 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Difelikefalin Small moleculeNCT06593392PruritusPhase 2 RECRUITING 18Aug 15, 2029
Difelikefalin Small moleculeCompletedNCT05885737Uremic PruritusPhase 3 COMPLETED 260Sep 25, 2024
Difelikefalin Small moleculeCompletedNCT05885763End Stage Renal Disease on HemodialysisPhase 1 COMPLETED 30Oct 9, 2023
Dialysis Small moleculeCompletedNCT05339139Acute Kidney InjuryPhase 3 COMPLETED 32Jun 30, 2025
Patiromer for Small moleculeCompletedNCT05136664HyperkalemiaPhase 3 COMPLETED 262Nov 18, 2025
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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 FMS program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
Example Drug Example indication for clinical evaluationPhase 32025-12-01The study met its primary endpoint demonstrating statistically significant improvement.Read MorePhase 3 Study Results AnnouncementRead 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
John SmithCEOBuy 50,000 150,000 held$45.50 01/10/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
INTEGRAL HEALTH ASSET MANAGEMENT, LLC 0.8 % 17.48 M 775.00 K 19.23% ( 125.00 K)
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Shares held by hedge funds each quarter, and who bought or sold.

FMS Institutional Ownership Trends

FMS Short Interest

Shares sold short, counted twice a month.

0.74%
Short % of Float
of tradable shares sold short
4.0M
Shares Sold Short
+39.7% vs prior count
3.5 Moderate
Days to Cover
trading days of normal volume to buy every short share back
1.1M
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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Live calls and puts by strike: last price, volume and open interest for every expiry.
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Calls vs Puts by Expiry

CallsPutsLog scale
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Competitive positioning

How FMS ranks across every disease it competes in

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

-FMS
Oct 21, 2026
FMSFDA Updates

Fresenius Medical Care Brings Kidney Care Innovation to Critical Care Patients with U.S. Launch of multiFiltratePRO™

Fresenius Medical Care announced the U.S. launch of the multiFiltratePRO System for patients with acute kidney injury. The FDA cleared the system, which integrates citrate and calcium pumps to simplify treatment. This innovation aims to enhance care for critically ill patients and reflects the company's commitment to advancing kidney care solutions.

Read more →
-FMS
Oct 19, 2026
FMSConferences/Events

Fresenius Medical Care presents new evidence and innovations advancing kidney care at ASN Kidney Week 2026

Fresenius Medical Care presented new research at ASN Kidney Week 2026, highlighting advancements in kidney care. Key findings include successful implementation of high-volume hemodiafiltration in the U.S. and the positive impact of GLP-1 receptor agonists on dialysis patient outcomes. The company emphasizes evidence-based care and innovative technologies to improve patient treatment.

Read more →
-FMS
Oct 7, 2026
FMSGeneral

Shervin J. Korangy appointed CEO of Fresenius Medical Care to lead the next phase of strategic development and long-term profitable growth

Fresenius Medical Care has appointed Shervin J. Korangy as CEO, effective October 12, 2026. He succeeds Helen Giza, who led the company through significant transformations, including the FME25+ program. Korangy aims to accelerate long-term growth and innovation while building on the company's strong foundation. His leadership experience in healthcare positions him well for this role.

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-FMS
Sep 25, 2026
FMSGeneral

Fresenius Medical Care Refines China Commercial Strategy with a Focus on Long-Term Growth and Market Leadership

Fresenius Medical Care has refined its commercial strategy in China to enhance long-term growth and market leadership. The new approach emphasizes a localized portfolio and innovation, with significant changes including the discontinuation of certain products. While these adjustments will incur one-time costs, the company remains optimistic about future growth in the region.

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-FMS
Aug 27, 2026
FMSGeneral

Fresenius Medical Care Announces Publication of a Multinational Real-World Evidence Study Associating High-Volume Hemodiafiltration with Lower Mortality Risk Than Conventional Hemodialysis

Fresenius Medical Care published a study demonstrating that high-volume hemodiafiltration (HDF) is associated with a 28% lower risk of all-cause mortality compared to conventional high-flux hemodialysis. The research analyzed nearly 20,000 patients across eight European countries and utilized advanced statistical methods to ensure reliability. This study adds to the growing evidence advocating for HDF as a standard treatment for kidney failure.

Read more →
-FMS
Aug 3, 2026
FMSGeneral

Fresenius Medical Care accelerates income growth to 23% in the second quarter of 2026 while advancing its strategic agenda

Fresenius Medical Care reported a 23% increase in operating income for Q2 2026, driven by strong organic revenue growth across all segments. The company successfully rolled out its innovative 5008X CAREsystem in 227 U.S. clinics, performing over 600,000 treatments. Despite a 3% decrease in reported net income, the firm reaffirmed its outlook for the fiscal year 2026.

Read more →
-FMS
Aug 3, 2026
FMSGeneral

Fresenius Medical Care appoints Cassie McLean as new Management Board Member for Care Delivery

Fresenius Medical Care has appointed Cassie McLean as a new Management Board member, effective August 1, 2026. She will serve as CEO of Care Delivery, succeeding Craig Cordola. McLean, who joined the company in 2025, is expected to enhance operational performance and accountability in the global clinic business. Her prior experience includes leadership roles at Monte Nido and DaVita Kidney Care.

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-FMS
Jul 29, 2026
FMSGeneral

Fresenius Medical Care announces BEACON-US, generating real-world evidence supporting high-volume hemodiafiltration for U.S. dialysis patients

Fresenius Medical Care has launched the BEACON-US initiative to evaluate high-volume hemodiafiltration (HVHDF) in U.S. dialysis patients. The initiative aims to gather real-world evidence on clinical outcomes and patient experiences. Early data indicates that HVHDF may lead to fewer hospitalizations and improved patient experiences, aligning with international studies.

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-FMS
Jul 20, 2026
FMSGeneral

Fresenius Medical Care introduces TherapyWise™ analytics for kidney replacement therapy

Fresenius Medical Care has launched TherapyWise™, a cloud-based analytics platform designed for kidney replacement therapy in acute care settings. Integrated with the NxStage® System One™ and NxView™ 4.0, it aggregates therapy data to identify trends and improve workflow. The platform aims to enhance oversight and quality of kidney replacement therapy programs.

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-FMS
May 28, 2026
FMSGeneral

Fresenius Medical Care AG ("FME") disclosed on May 26, 2026, to conduct the next share buyback program. The program is scheduled to commence on May 28, 2026, and to be

Fresenius Medical Care AG announced a share buyback program set to commence on May 28, 2026, allowing for the repurchase of up to 29,341,344 shares within a total budget of EUR 1 billion over the next twelve months. The program, authorized during the General Meeting on May 21, 2026, includes provisions for the cancellation of most repurchased shares to reduce share capital. A credit institution will manage the transactions independently, adhering to regulatory guidelines. This initiative aims to enhance shareholder value and reflects the company's confidence in its market position.

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-FMS
May 21, 2026
FMSGeneral

Fresenius Medical Care Annual General Meeting: Strengthening performance and advancing innovation in kidney care

Fresenius Medical Care held its Annual General Meeting, highlighting a strong financial performance with an organic revenue growth of 8%. Shareholders approved a dividend of EUR 1.49 per share, and the company announced the successful completion of a EUR 1 billion share buyback program. The introduction of the 5008X CAREsystem marks a significant advancement in kidney care, with full commercial launch planned for 2026. Management emphasized their commitment to sustainable value creation and adaptability in a volatile market landscape.

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-FMS
May 5, 2026
FMSGeneral
▼ -10.9%on this news

Fresenius Medical Care delivers strong operating income growth in Q1 2026 while advancing the U.S. rollout of 5008X CAREsystems at speed

Fresenius Medical Care reported strong operational performance in Q1 2026, achieving organic revenue growth and increased profitability alongside the successful rollout of the 5008X CAREsystem. Despite these advancements, the company faced a 6% revenue decline and a 14% decrease in operating income due to significant regulatory and market challenges. The FME Reignite strategy continues to foster long-term growth, while the company undertakes measures to optimize U.S. dialysis clinic operations. Management remains committed to maintaining operational stability and shareholder value.

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-FMS
Apr 14, 2026
FMSGeneral

Fresenius Medical Care AG Hof (Saale) ISIN: DE0005785802 // WKN: 578580 ISIN: US3580291066 // CUSIP: 358029106 Invitation to the Annual General Meeting We hereby invite our shareholders to the Annual General Meeting of F

Fresenius Medical Care AG has announced its Annual General Meeting scheduled for May 21, 2026, in Frankfurt. Shareholders will find available documents regarding the meeting on the company's website. The board approved the financial statements and proposed a dividend of EUR 1.49 per share, reflecting a robust distributable profit. Additionally, the company plans to renew its share buyback authorization for treasury shares over the next five years.

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-FMS
Feb 24, 2026
FMSGeneral
▼ -7.8%on this news

Fresenius Medical Care published Report on Form 20-F for fiscal year 2025

Fresenius Medical Care has filed its Annual Report on Form 20-F for the fiscal year 2025 with the SEC. The report is available on the company's website and provides complete audited financial statements. Fresenius Medical Care remains a global leader in providing products and services for patients with renal diseases, serving approximately 292,000 patients through its dialysis clinics worldwide. The release also includes warnings about potential risks that could affect future performance.

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-FMS
Jan 9, 2026
FMSGeneral

Fresenius Medical Care AG is continuing its share buyback program in an accelerated manner

Fresenius Medical Care AG has announced the continuation of its share buyback program, initially launched in June 2025, by initiating a second tranche. The company plans to repurchase shares worth approximately EUR 415 million from January 12, 2026, to May 8, 2026, with the aim of completing the program earlier than anticipated. This strategic move follows the earlier-than-expected completion of the first tranche in December 2025, reflecting the company's strong commitment to enhancing shareholder value.

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-FMS
Dec 10, 2025
FMSGeneral

Fresenius Medical Care appoints Charles Hugh-Jones as Global Chief Medical Officer and member of the Management Board

Fresenius Medical Care has appointed Charles Hugh-Jones as the new Global Chief Medical Officer, effective January 1, 2026. He succeeds Franklin W. Maddux, who is retiring. Hugh-Jones has extensive experience in the medical field, having previously served as CEO of Volastra Therapeutics and held senior leadership roles at Allergan, Pfizer, and Sanofi. His appointment is seen as a positive step for Fresenius Medical Care as it aims to advance its leadership in kidney care and introduces innovative treatment solutions.

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-FMS
Nov 17, 2025
FMSGeneral

Fresenius Medical Care places bond with a volume of 500 million

Fresenius Medical Care has successfully placed a bond valued at 500 million, with a maturity date in November 2030 and a coupon rate of 3.250%. The funds raised will be allocated towards general corporate purposes, including the refinancing of existing financial liabilities. The bond is part of the company's Debt Issuance Program and has been submitted for trading on the Luxembourg Stock Exchange. However, the announcement includes advisory notes on potential risks and restrictions regarding the bond's sale in certain countries.

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-FMS
Nov 4, 2025
FMSGeneral
▼ -7.8%on this news

Fresenius Medical Care further accelerates organic revenue development

Fresenius Medical Care reported a significant 28% increase in operating income for Q3 2025, highlighting positive momentum in their financial performance. The company's comprehensive FME Reignite strategy has advanced, contributing to a 10% organic growth across all three operating segments. Despite some negative impact from portfolio optimization divestitures, overall revenue showed a growth of 3% year-over-year. The organization also commenced a share buyback program, further indicating its commitment to returning value to shareholders.

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-FMS
Oct 1, 2025
FMSGeneral

Fresenius Medical Care appoints Joseph Turk as new Management Board Member for Care Enablement

Fresenius Medical Care has announced the appointment of Joseph Turk as the new Chief Executive Officer of the Care Enablement segment, effective January 1, 2026. This decision follows the planned retirement of Dr. Katarzyna Mazur-Hofs, who has led the segment since its inception. Turk, who has been with Fresenius since 2019, is expected to leverage his extensive experience to foster innovation and support the company's strategic initiatives. The appointment marks a transitional phase for the organization as it continues its operational enhancement strategies.

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-FMS
Sep 18, 2025
FMSGeneral

Fresenius Medical Care advances its FME Reignite strategy by increasing ownership in its Value-Based Care asset and appointing a new leader for the operating segment

Fresenius Medical Care has announced strategic advancements in its Value-Based Care (VBC) segment, including a significant investment and leadership changes. The company increased its ownership stake in Interwell Health, which reported a revenue growth of 23.5% in the first half of the year. Tommy P. O'Connor will take over as CEO of Interwell Health, bringing extensive leadership experience to reinforce the company's focus on improving kidney care outcomes. These developments are part of Fresenius' FME Reignite strategy aimed at enhancing care quality while reducing costs.

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About Fresenius Medical Care AG

108,165 employees freseniusmedicalcare.com
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