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OraSure Technologies, Inc.

OSUR
MedTech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$3.73
▼ -0.02 · -0.64%

Financials

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Total Assets
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52W LOW $2.0852W HIGH $4.58
Volume
435.06 K
Value Traded
1.62 M
Short % Float
4.93%
-3.87%Week
+10.03%1 Month
-12.95%3 Month
+21.9%6 Month
-63.24%5 Year
+69.88%All Time

Cash Data

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

Key Stats

Market Cap
257.25 M
EPS (TTM)
-0.71
P/E Ratio
-
Ent. Value
96.67 M
Total Shares
68.97 M
Float Shares
64.41 M
Insiders
6.61%
Institutions
86.01%

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.

OSUR Catalyst Timeline

Dated clinical, regulatory and corporate events for OraSure Technologies, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for OraSure Technologies, Inc.

781Total events
2Upcoming
181Tier-1 (high impact)
2009 to 2027Coverage

Upcoming catalysts 2

T2Product Launch
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T2Quarterly Update
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Event history 50

●Quarterly UpdateCorporate
Q2 2026 financial results and earnings call
▲Emergency Use AuthorizationFDA Decision
FDA Emergency Use Authorization for OraQuick™ Ebola 2.0 Rapid Antigen Test
Ebola diseasesource ↗
▼IND WithdrawalIND
Withdrawal of current submission for InteliQuick™ CT/NG molecular self-test
Chlamydia trachomatis and Neisseria gonorrhoeaesource ↗
●Quarterly UpdateCorporate
Q3 2026 revenue guidance provided
▲FDA ApprovalFDA Decision
FDA clearance of Colli-Pee™•Dx Urine Collection Kit for use with Roche's tests
Sexually transmitted infections (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium)source ↗
▲FDA ApprovalColli-Pee™•DxApprovedFDA Decision
FDA clearance of Colli-Pee™•Dx Urine Collection Kit
Sexually transmitted infections (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium)source ↗
●Quarterly UpdateCorporate
First Quarter 2026 Financial Results and Earnings Call
▲Management ChangeCorporate
John D. Bertrand appointed to Board of Directors
▲Partnership / LicenseCorporate
Cooperation Agreement with Altai Capital
●Quarterly UpdateCorporate
Q4 2025 earnings call scheduled
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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 OSUR 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

D21 / 100
Pipeline Score
$0M
Pipeline Value
Not rated
Valuation Signal
1
Drugs Scored
-
rNPV / MCap
Top 94%
Micro Cap
(rank 619 of 658)
Percentile Rank
OraSure Technologies, Inc. faces pipeline headwinds (21/100), with 1 assets in development.
Showing 0 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
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Clinical Trial Results

Readouts, endpoints and source filings for every OSUR 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
Boyd Steven KyleDirectorGrant/Award 3,666 163,234 held$4.43 06/26/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
SOLEUS CAPITAL MANAGEMENT, L.P. 0.3 % (-88.9 %) 2.14 M 565.00 K -81.51% ( -2.49 M)
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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.

OSUR Institutional Ownership Trends

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
2026-10-16
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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

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Competitive positioning

How OSUR ranks across every disease it competes in

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

OSUR
Aug 5, 2026
OSURGeneral

OraSure Announces Second Quarter 2026 Financial Results

OraSure Technologies reported its Q2 2026 financial results, showing a 9.7% sequential revenue increase to $30.6 million. The company achieved FDA clearance for its Colli-Pee™•Dx urine collection device and received Emergency Use Authorization for the OraQuick™ Ebola 2.0 Rapid Antigen Test. Despite these advancements, total revenues decreased by 2% year-over-year, and the company recorded a non-GAAP operating loss.

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OSUR
Jul 22, 2026
OSURConferences/Events
▲ +6.3%on this news

OraSure to Announce Second Quarter 2026 Financial Results and Host Earnings Call on August 5th

OraSure Technologies, Inc. will announce its second quarter 2026 financial results on August 5, 2026, after market close. The company will host a conference call at 5 p.m. Eastern Time to discuss these results. A webcast of the call will be available on their investor relations page and archived for one year.

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OSUR
Jun 11, 2026
OSURFDA Updates

OraSure Technologies, Inc. Announces FDA Clearance that Expands Patient‑Friendly Access to Testing for Sexually Transmitted Infections

OraSure Technologies has received FDA clearance for its Colli-Pee™•Dx Urine Collection Kit, enabling at-home self-collection for STI testing. This advancement allows for convenient sample collection while maintaining sample integrity. The kit supports Roche's molecular diagnostic systems and aims to improve access for underserved populations, facilitating scalable testing and public health initiatives.

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OSUR
May 7, 2026
OSURGeneral

OraSure Announces First Quarter 2026 Financial Results

OraSure Technologies, Inc. reported a revenue of $27.9 million for Q1 2026, surpassing its guidance midpoint. The company highlighted gross margin expansion and a strong balance sheet, which positions it well for growth and potential acquisitions. OraSure aims to decentralize diagnostics to improve healthcare accessibility and affordability.

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OSUR
May 6, 2026
OSURGeneral

OraSure Technologies, Inc. 2OTI Proprietary Disclaimers Forward-Looking Statements: This presentation of OraSure Technologies, Inc. (the "Company" or "OraSure") contains certain "forward-looking statements" within the me

OraSure Technologies, Inc. has provided an investor update discussing its transformation strategy and financial performance. In Q1, the company reported a 4% growth in total revenue, demonstrating positive traction in its core business segments. The update highlights key operational improvements, including a focus on disciplined execution and the return to breakeven for its core business. Additionally, there is an optimistic outlook for growth driven by innovation and improved visibility into funding for critical testing programs.

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OSUR
Apr 22, 2026
OSURGeneral

OraSure to Announce First Quarter 2026 Financial Results and Host Earnings Call on May 6th

OraSure Technologies, Inc. will announce its first quarter 2026 financial results during an earnings call scheduled for May 6, 2026. The call will take place at 5 p.m. ET and will be accessible via a webcast on the company's investor relations page. This event is part of OraSure's commitment to transparency and stakeholder engagement.

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OSUR
Apr 17, 2026
OSURGeneral

OraSure Technologies Appoints John D. Bertrand to its Board of Directors

OraSure Technologies has appointed John D. Bertrand as an independent director to its Board of Directors. His extensive experience in healthcare technology and AI-enabled diagnostics is expected to bolster the company's strategic initiatives. Additionally, OraSure plans to seek shareholder approval to declassify its Board at the upcoming 2026 Annual Meeting, reflecting its commitment to governance and shareholder engagement.

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OSUR
Mar 30, 2026
OSURGeneral

Strategy & Growth Outlook OraSure is executing a focused strategy with near-term catalysts expected to drive revenue growth, margin expansion, and profitability Public health funding environment stabilizing across U.S. a

OraSure is actively pursuing a focused strategy designed to enhance revenue growth and profitability, with several product launches on the horizon. The company's diagnostics segment is poised for expansion, leveraging existing infrastructures and improving efficiency through operational transitions. Despite facing challenges, including pressure from Altai Capital regarding board decisions, OraSure aims for a strong market position as health funding stabilizes and testing volumes recover post-2025.

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OSUR
Mar 18, 2026
OSURGeneral

OraSure Highlights Significant Operational Progress and Value Creation Initiatives Following Letter from Altai Capital

OraSure Technologies, Inc. is responding to Altai Capital's demands for board representation, emphasizing its commitment to shareholder value and upcoming milestones in 2026. The company has engaged extensively with Altai but has faced rejection of settlement proposals. OraSure's Board has been refreshed with new independent directors to guide the company through this critical phase.

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OSUR
Feb 26, 2026
OSURGeneral
▲ +10%on this news

OraSure Announces Fourth Quarter 2025 Financial Results

OraSure Technologies reported its Q4 2025 financial results, achieving revenue of $26.8 million, which surpassed expectations. The company is optimistic about growth in 2026, driven by anticipated regulatory clearances and new product launches. OraSure's CEO highlighted the stability in key segments and the company's strategic investments to enhance value.

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OSUR
Feb 10, 2026
OSURGeneral

OraSure to Launch OraQuick™ HIV Self-Test in Canada

OraSure Technologies has announced that its OraQuick HIV Self-Test has received licensing from Health Canada, making it the first oral HIV self-test available in Canada. The test allows individuals to determine their HIV status using a simple oral swab in just 20 minutes. This initiative aims to improve access to HIV testing and support public health efforts in combating the epidemic.

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OSUR
Feb 10, 2026
OSURConferences/Events

OraSure to Announce Fourth Quarter 2025 Financial Results and Host Earnings Call on February 25th

OraSure Technologies, Inc. will hold its earnings conference call on February 25, 2026, at 5 p.m. ET to discuss its fourth quarter 2025 financial results and business developments. The call will be accessible via a webcast on the company's investor relations page, which will also archive the session afterward.

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OSUR
Jan 15, 2026
OSURGeneral

OraSure Technologies Confirms Receipt of Director Nominations from Altai Capital

OraSure Technologies has confirmed the receipt of director nominations from Altai Capital for the upcoming 2026 Annual Meeting of Stockholders. The nominations include Altai's founder, Rishi Bajaj. However, since interviewing Mr. Bajaj, OraSure's Board has appointed alternative candidates and has not engaged further with Altai. The Board has seen a significant refreshment with seven departures and three new independent members, aiming to enhance its oversight of growth and value creation.

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OSUR
Jan 5, 2026
OSURFDA Updates

OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review

OraSure Technologies has submitted applications to the FDA for a rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae, alongside its Colli-Pee™ urine collection device. These submissions aim to enhance accessibility and convenience in STI testing. The company anticipates significant market opportunities, although regulatory approvals and competition pose potential risks.

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OSUR
Jan 5, 2026
OSURFDA Updates

OraSure Submits CT NG Molecular Self-Test and Colli-Pee Urine Collection Device for FDA Review

OraSure Technologies has submitted applications for FDA clearance of two new products: a rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae, and an at-home urine collection device called Colli-Pee. The rapid test aims to decentralize diagnostics by providing near-instant results in a convenient format. Additionally, the Colli-Pee device targets patients' preferences for private testing. These submissions are part of OraSure's strategy to expand its market presence and improve access to STI testing.

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OSUR
Dec 17, 2025
OSURGeneral

OraSure Technologies Issues Statement Regarding Altai Capital’s Intent to Nominate Director Candidates

OraSure Technologies has confirmed the intent of Altai Capital to nominate two candidates for election to its Board of Directors at the 2026 Annual Meeting. The company maintains a commitment to shareholder value and has engaged in dialogue with Altai, evaluating its founder, Rishi Bajaj, for board service. Despite not appointing him, OraSure has made efforts to enhance its Board and is actively pursuing innovation in diagnostics. The company remains well-positioned financially with substantial cash reserves and no debt as it strives for sustainable profitability.

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OSUR
Nov 17, 2025
OSURConferences/Events

OraSure to Participate in Upcoming Investor Conference

OraSure Technologies, Inc. (NASDAQ: OSUR) has announced its participation in the upcoming Stephens Annual Investment Conference on November 19, which includes a Q&A session at 10 a.m. CT. The company will provide a live webcast and replay of the session on their investor relations website. OraSure focuses on decentralizing diagnostics, innovating in health technology, and improving access to healthcare through various products. This initiative indicates their commitment to maintaining transparent communication with shareholders and the market.

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OSUR
Nov 5, 2025
OSURGeneral
▼ -6.6%on this news

OraSure Announces Third Quarter 2025 Financial Results

OraSure Technologies reported a revenue of $27.1 million for Q3 2025, with optimism for growth in 2026 driven by diversification and new product launches. CEO Carrie Eglinton Manner emphasized the company's strategy to decentralize diagnostics and improve healthcare access. The company anticipates Q4 revenues between $25 million and $28 million, with minimal contributions from COVID-19 testing.

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About OraSure Technologies, Inc.

Bethlehem, PA 500 employees orasure.com
Headquarters220 E FIRST ST, BETHLEHEM, PA, 18015
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