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Outset Medical, Inc.

OMFDA catalysts, PDUFA dates & pipeline intelligence
$4.09
▼ -0.12 · -2.85%

Financials

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52W LOW $2.8452W HIGH $16.16
Volume
241.02 K
Value Traded
784.52 K
Short % Float
5.03%
+3.28%Week
+23.56%1 Month
-7.67%3 Month
-2.62%6 Month
-99.37%5 Year
-99.45%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
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  • SEC Filing

Key Stats

Market Cap
76.88 M
EPS (TTM)
-3.95
P/E Ratio
-
Ent. Value
27.33 M
Total Shares
18.80 M
Float Shares
17.69 M
Insiders
5.90%
Institutions
75.53%

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.

OM Catalyst Timeline

Dated clinical, regulatory and corporate events for Outset Medical, Inc.

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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 OM actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
-Example Drug Phase 3 data readout 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

No drug pipeline

Outset Medical, Inc. is a medical device company. The clinical trials it takes part in test other companies' drugs, so it has no drug pipeline of its own to score.

Clinical Trial Results

Readouts, endpoints and source filings for every OM 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
Leonard Braden Michael10% OwnerBuy 16,575 2,764,610 held$3.88 10/02/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
PERCEPTIVE ADVISORS LLC 0.1 % 3.60 M 833.33 K
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

OM Institutional Ownership Trends

Options Data

Option Volume

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OI 30-day avg
Today vs avg
Option Volume
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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 OM ranks across every disease it competes in

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

OM
Aug 6, 2026
OMGeneral
▼ -5.8%on this news

Outset Medical Reports Second Quarter 2026 Results

Outset Medical reported its second quarter 2026 financial results, revealing a net revenue of $31.6 million, a slight year-over-year increase. The company achieved a gross margin of 42%, reflecting improved profitability. Despite a net loss of $18 million, Outset signed a significant $40 million agreement with HCA Healthcare, positioning itself for future growth. The company reiterated its revenue guidance for 2026, projecting an increase over the previous year.

Read more →
OM
Jul 23, 2026
OMGeneral

Outset Medical to Report Second Quarter 2026 Financial Results on Thursday, August 6, 2026

Outset Medical, Inc. will announce its second quarter 2026 financial results on August 6, 2026. Following the release, CEO Leslie Trigg and CFO Renee Gaeta will host a conference call to discuss the results. The company is known for its innovative Tablo® Hemodialysis System, which simplifies dialysis processes.

Read more →
OM
Jul 2, 2026
OMGeneral
▲ +7.6%on this news

Outset Medical Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Outset Medical, Inc. has announced the approval of equity awards for three newly hired employees under its Inducement Plan. This move, compliant with Nasdaq Listing Rule 5635(c)(4), includes restricted stock units and performance-based stock units. The awards are designed to attract and retain talent as the company continues to innovate in dialysis technology.

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OM
May 22, 2026
OMGeneral

Outset Medical Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) - May 21, 2026

Outset Medical, Inc. has announced the approval of equity awards for two newly appointed non-executive employees as part of its Inducement Plan. This decision aligns with Nasdaq Listing Rule 5635(c)(4) and involves the granting of 45,000 restricted stock units (RSUs) that will vest over three years. The company is recognized for its innovative Tablo® Hemodialysis System, which aims to enhance dialysis care.

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OM
May 11, 2026
OMConferences/Events

Outset Medical to Present at RBC Global Healthcare Conference

Outset Medical, Inc. will participate in the RBC Capital Markets Global Healthcare Conference on May 19, 2026. The company's innovative Tablo® Hemodialysis System is designed to enhance dialysis care by integrating water purification and dialysate production. This system is FDA-cleared and is already in use at over 1,000 healthcare facilities in the U.S.

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OM
May 7, 2026
OMGeneral

Outset Medical Reports First-Quarter Results

Outset Medical, Inc. reported its financial results for the first quarter of 2026, revealing a net revenue of $27.9 million, representing a decline of 6% from the previous year. Despite the revenue decrease, the company achieved a gross margin of 43.4%, an increase of over 600 basis points compared to the same quarter in 2025. The net loss was reduced significantly, indicating an improvement in financial performance. Outset reiterated its revenue guidance for 2026, projecting a growth between 5% and 9% over 2025.

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OM
May 7, 2026
OMGeneral

Outset Medical Reports First-Quarter Results San Jose, CA &#x2013

Outset Medical, Inc. reported its first quarter financial results for 2026, revealing a net revenue of $27.9 million, which reflects a 6% decline from the previous year. While recurring revenue remained stable at $22.5 million, the company achieved a gross margin expansion to 43.4%, marking significant progress in profitability. Operating expenses increased by 6%, driven by investments in systems and personnel, contributing to a net loss of $19 million, yet improved from the net loss recorded last year. Outset maintains its revenue guidance for 2026, projecting an increase of 5% to 9%, although challenges in product revenue persist.

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OM
Apr 28, 2026
OMConferences/Events

Outset Medical to Report First Quarter 2026 Financial Results on Thursday, May 7, 2026

Outset Medical, Inc. will announce its financial results for Q1 2026 on May 7, 2026. The announcement will be followed by a conference call hosted by CEO Leslie Trigg and CFO Renee Gaeta. The company is known for its innovative Tablo® Hemodialysis System, which aims to improve dialysis care.

Read more →
OM
Apr 6, 2026
OMGeneral

Outset Medical Names Derick Elliott as Executive Vice President of Commercial

Outset Medical has appointed Derick Elliott as Executive Vice President of Commercial. Elliott, who has over 30 years of experience in sales and marketing, will oversee the company's commercial organizations. His previous roles include Chief Commercial Officer at SpendMend and various positions at Stryker and Cardinal Health. This appointment comes as Outset aims to expand its technology offerings in the dialysis sector.

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OM
Feb 12, 2026
OMGeneral
▼ -16.3%on this news

Outset Medical Reports Fourth Quarter and Full Year 2025 Financial Results

Outset Medical reported its financial results for Q4 and full year 2025, showing a 5% revenue increase to $119.5 million. Despite a slight revenue decline in Q4, the company improved its gross profit and reduced operating expenses significantly. The net loss decreased compared to the previous year, and the company provided optimistic revenue guidance for 2026.

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OM
Jan 28, 2026
OMFDA Updates
▼ -11.5%on this news

Next-Generation Tablo Hemodialysis System Receives FDA Clearance, Second Quarter Launch Planned

Outset Medical's next-generation Tablo Hemodialysis System has received 510(k) clearance from the FDA, marking it as the first dialysis system to meet the agency's stringent cybersecurity standards. The new platform is designed to enhance security, reliability, and user experience, with shipping planned for the second quarter of 2026. Healthcare providers currently using Tablo will have the option to upgrade to this new system.

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OM
Jan 27, 2026
OMConferences/Events
▲ +14.3%on this newsshared move

Outset Medical to Report Fourth Quarter 2025 Financial Results on Wednesday, February 11, 2026

Outset Medical, Inc. will announce its fourth quarter and full-year 2025 financial results on February 11, 2026. The announcement will be followed by a conference call hosted by CEO Leslie Trigg and CFO Renee Gaeta. The company is known for its innovative Tablo® Hemodialysis System, which aims to simplify dialysis processes.

Read more →
OM
Jan 13, 2026
OMGeneral
▼ -8.1%on this news

Outset Medical Reports Unaudited Fourth Quarter and 2025 Results

Outset Medical reported its unaudited revenue for Q4 and fiscal year 2025, highlighting a strong backlog and a positive outlook for 2026. The company also appointed Karen N. Prange to its board of directors, replacing Andrea Saia. Prange brings extensive experience in medical technology and leadership, which is expected to support Outset's growth strategy.

Read more →
OM
Jan 6, 2026
OMConferences/Events
▲ +12.9%on this news

Outset Medical to Present at the 44th Annual J.P. Morgan Healthcare Conference

Outset Medical, Inc. will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026. CEO Leslie Trigg will discuss the company's innovative dialysis technology, the Tablo® Hemodialysis System, which is designed to reduce costs and complexity in dialysis care. The system is FDA-cleared and has been adopted by over 1,000 healthcare facilities in the U.S.

Read more →
OM
Nov 10, 2025
OMGeneral
▼ -48.5%on this news· ran to -61% by day 3

Outset Medical Reports Third-Quarter Results

Outset Medical reported its third-quarter financial results for 2025, showing a 3% increase in revenue compared to the same quarter last year. However, the company revised its revenue guidance for the year downward, now expecting between $115 million and $120 million. Despite a reduction in operating expenses and an improvement in gross profit, the net loss remains significant. The CEO noted delays in closing large sales opportunities, which are now expected to finalize in early 2026.

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OM
Nov 10, 2025
OMGeneral

Outset Medical Reports Third-Quarter Results San Jose, CA &#x2013

Outset Medical reported its financial results for Q3 2025, indicating a slight revenue growth of 3% year over year, with a net revenue of $29.4 million. The company also revised its 2025 revenue guidance downwards to a range of $115 million to $120 million. While gross margins improved and operating expenses declined nearly 20%, the CEO noted that expected sales closures have shifted into early 2026, indicating a potential delay in realizing revenue.

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OM
Nov 5, 2025
OMGeneral
▼ -6%on this news· ran to -50% by day 3shared move

New Research Demonstrates the Advantages of an Insourced Dialysis Service Line for Acute-Care Facilities Using Outset Medical’s Tablo® Hemodialysis System

Outset Medical announced new research findings on its Tablo Hemodialysis System, showcasing over 1 million treatments and significant benefits from insourcing dialysis services. The results, which will be presented at the American Society of Nephrology's Kidney Week 2025, highlight improved patient outcomes and cost savings for hospitals. This research supports the adoption of insourced dialysis to enhance care for patients with renal issues.

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About Outset Medical, Inc.

San Jose, CA 310 employees outsetmedical.com
Headquarters3052 ORCHARD DRIVE, SAN JOSE, CA, 95134
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