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R&D Expenses
Operating CF
Total Assets
Total Liabilities
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Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $1.2552W HIGH $7.08
Volume
402.07 K
Value Traded
2.22 M
Short % Float
19.83%
0%Week
-15.69%1 Month
-43.17%3 Month
-45.8%6 Month
-83.47%5 Year
-72.99%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
165.99 M
EPS (TTM)
-0.65
P/E Ratio
-
Ent. Value
119.89 M
Total Shares
128.70 M
Float Shares
71.19 M
Insiders
44.67%
Institutions
51.63%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
PoA blends historical approval base rates, trial design score and FDA review track record.
ORGO Catalyst Timeline
Dated clinical, regulatory and corporate events for Organogenesis Holdings Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Organogenesis Holdings Inc.
187Total events
4Upcoming
29Tier-1 (high impact)
2018 to 2027Coverage
Upcoming catalysts 2
Event history 50
▲PublicationAffinityDiscontinuedPresentation
Publication of peer-reviewed RCT results in Journal of Wound Care
complex venous leg ulcerssource ↗
▲FDA Filing AcceptedReNuFiledRegulatory Filing
FDA accepts BLA filing for ReNu
symptomatic knee osteoarthritissource ↗
●BLA SubmissionReNuFiledRegulatory Filing
BLA submission for ReNu
symptomatic knee osteoarthritissource ↗
▲Rolling Submission CompletedReNuFiledRegulatory Filing
Completed rolling BLA submission for ReNu
symptomatic knee osteoarthritissource ↗
▲Primary Endpoint MetPuraPly®AMClinical Data
PuraPly®AM plus SOC achieved statistically significant wound closure at 12 weeks vs SOC alone (p<0.0477)
non-healing diabetic foot ulcerssource ↗
▲Type B MeetingReNuFiledFDA Meeting
Successful Type-B meeting with FDA confirming rolling BLA submission plan
knee osteoarthritis painsource ↗
●BLA SubmissionReNuFiledRegulatory Filing
Completion of BLA submission with final modules
symptomatic knee osteoarthritissource ↗
◆Timing GuidanceReNuFiledPresentation
ReNu BLA submission expected by end of 2025
knee osteoarthritissource ↗
●BLA SubmissionReNuFiledRegulatory Filing
Initiation of rolling BLA submission for ReNu
symptomatic knee osteoarthritissource ↗
▲Type B MeetingReNuFiledFDA Meeting
Successful Type-B meeting with FDA confirming rolling BLA submission plan
Knee Osteoarthritissource ↗
●Rolling Submission InitiatedReNuFiledRegulatory Filing
Initiated rolling BLA submission for ReNu
symptomatic knee osteoarthritissource ↗
●Timing GuidanceReNuFiledPresentation
Rolling BLA submission planned before end of 2025
knee osteoarthritis painsource ↗
◆Pre BLA MeetingReNuFiledFDA Meeting
Request pre-BLA meeting with FDA by end of October 2025
knee osteoarthritissource ↗
▼Primary Endpoint MissedReNuFiledClinical Data
Second Phase 3 RCT of ReNu did not achieve statistical significance for primary endpoint
knee osteoarthritissource ↗
◆Timing GuidanceReNuFiledPresentation
Topline data from second Phase 3 study of ReNu for knee OA expected September 2025
knee osteoarthritissource ↗
◆Topline ReadoutReNuFiledClinical Data
Topline data from second phase 3 study of ReNu for knee OA expected
knee osteoarthritissource ↗
◆Enrollment CompleteReNuFiledTrial
All patients expected to complete second phase 3 study by end of Q2 2025
▲Enrollment CompleteReNuFiledTrial
Enrollment in second Phase 3 trial completed significantly ahead of expectations with 594 patients
symptomatic knee osteoarthritissource ↗
▲Other Regulator MilestoneEx-US Regulatory
LCD becomes effective for Medicare coverage of skin substitute grafts/CTPs
diabetic foot ulcers (DFU) and venous leg ulcers (VLU)source ↗
◆Timing GuidanceReNuFiledPresentation
ReNu BLA submission expected by end of 2025
knee osteoarthritissource ↗
●Quarterly UpdateCorporate
FY2024 revenue guidance reaffirmed, profitability guidance updated
▲Manufacturing MilestoneCMC / Inspection
Long-term lease for 122,000 sq ft biomanufacturing facility in Smithfield, RI
▲Other Regulator MilestoneEx-US Regulatory
CMS final LCD covering skin substitute grafts/CTPs for DFU and VLU
diabetic foot ulcers (DFU) and venous leg ulcers (VLU)source ↗
▲Other Regulator MilestoneNuShieldEx-US Regulatory
NuShield added to list of covered products under final LCD
diabetic foot ulcers (DFU)source ↗
▼Equity OfferingCorporate
Announced $130 million private placement of Series A Convertible Preferred Stock
▲Interim AnalysisReNuFiledTrial
Favorable interim analysis of second Phase 3 trial of ReNu for knee OA
knee osteoarthritissource ↗
▲Full ResultsNuShieldClinical Data
Publication of randomized clinical trial results for NuShield in diabetic foot ulcers
diabetic foot ulcerssource ↗
▲Enrollment CompleteReNuFiledTrial
Enrollment completed in second Phase 3 trial with 594 patients
knee osteoarthritissource ↗
▲Subgroup AnalysisReNuFiledClinical Data
Subgroup analysis showed KL4 subjects responded comparably to KL3
knee osteoarthritissource ↗
◆FDA Feedback ReceivedReNuFiledFDA Meeting
Type-B meeting with FDA completed
knee osteoarthritissource ↗
▲Primary Endpoint MetReNuFiledClinical Data
Phase 3 trial of ReNu achieves primary endpoint with statistically significant reduction in knee pain at six months
knee osteoarthritissource ↗
◆Full ResultsReNuFiledClinical Data
Complete analysis of Phase 3 trial expected
knee osteoarthritissource ↗
Past FDA Catalysts and PDUFA Decisions
How ORGO actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2025-12-31 | ReNu (cryopreserved, amniotic suspension allograft) | BLA Submission | BLA |
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
F17 / 100
Pipeline Score
$6M
Pipeline Value
Richly Valued
Valuation Signal
1
Drugs Scored
0.0x
rNPV / MCap
Top 97%
Micro Cap(rank 640 of 660)
Percentile Rank
Organogenesis Holdings Inc. has significant pipeline risk (17/100), with $144M risk-adjusted pipeline value, led by Amniotic Allograft in Knee Osteoarthritis (Phase 3), but cash runway is a concern.
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Amniotic Allograft Monoclonal antibodyCompletedNCT06000410 | Knee Osteoarthritis | Phase 3 | COMPLETED | 1,110 | Nov 1, 2025 |
Clinical Trial Results
Readouts, endpoints and source filings for every ORGO program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| Affinity | complex venous leg ulcers | 2026-07-27 | significantly higher rates of wound closure than SoC alone at weeks 12 and 16 (p<0.05)Read More | Organogenesis Announces Publication of Peer-Reviewed Clinical Trial Results Demonstrating Clinical Benefit of Affinity™ in the Most Challenging and Complex Venous Leg UlcersRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Leibowitz Arthur SDirector | Buy | 5,000 291,014 held | $2.68 | 03/09/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in ORGO
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| SOLEUS CAPITAL MANAGEMENT, L.P. | 0.8 % (-57.9 %) | 24.64 M | 10.14 M | 1.55% ( 155.00 K) |
ORGO 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
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-10-16 | ||||||||||||
Real-Time Option Chain
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|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How ORGO ranks across every disease it competes in
Competitive Position is a premium feature
See how ORGO ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialORGO News
ORGO▼ -22.8%on this news
Organogenesis Holdings Inc. Reports Second Quarter 2026 Financial Results
Organogenesis Holdings Inc. reported a significant decline in financial performance for Q2 2026, with net revenue dropping to $42.8 million, a 58% decrease from Q2 2025. The company experienced a net loss of $96.3 million, compared to a loss of $9.4 million in the same period last year. Despite these challenges, management expressed optimism about gradual improvement in business trends and the potential of the ReNu program.
Read more →ORGOOrganogenesis Announces Publication of Peer-Reviewed Clinical Trial Results Demonstrating Clinical Benefit of Affinity™ in the Most Challenging and Complex Venous Leg Ulcers
Organogenesis Holdings Inc. has published positive results from a randomized controlled trial of Affinity for treating complex venous leg ulcers. The study demonstrated significant improvements in wound closure rates when Affinity was used alongside standard care. These findings support the efficacy of Affinity in challenging wound cases, potentially benefiting patients and healthcare systems.
Read more →ORGOOrganogenesis Holdings Inc. to Report Second Quarter of Fiscal Year 2026 Financial Results on August 6, 2026
Organogenesis Holdings Inc. will report its financial results for the second quarter of fiscal year 2026 on August 6, 2026. The announcement includes a conference call scheduled for 5:00 p.m. ET on the same day, where management will discuss the results and provide a corporate update. The event will be accessible via webcast and teleconference.
Read more →ORGOOrganogenesis Announces FDA Acceptance of Biologics License Application for ReNu® for the Management of Symptomatic Knee Osteoarthritis
Organogenesis Holdings Inc. announced that the FDA has accepted its Biologics License Application for ReNu, a treatment for symptomatic knee osteoarthritis. The FDA has set a target action date of April 24, 2027. ReNu is designed to be a non-surgical option for the millions suffering from knee OA pain, which affects an estimated 31 million Americans.
Read more →ORGOOrganogenesis Holdings Inc. Reports First Quarter 2026 Financial Results
Organogenesis Holdings Inc. reported a challenging first quarter for 2026, with net revenue falling to $36.3 million, a significant decrease from $86.7 million in the same period last year. The company experienced a net loss of $53.2 million, compared to a loss of $18.8 million in Q1 2025. Despite these setbacks, management remains optimistic about future market share growth in the second half of 2026, citing their extensive portfolio and the recent ReNu BLA submission as key supportive factors.
Read more →ORGOOrganogenesis Completes Rolling Submission of Biologics License Application for ReNu®
Organogenesis Holdings Inc. has completed a rolling Biologics License Application (BLA) submission for ReNu®, a cryopreserved amniotic suspension allograft aimed at treating symptomatic knee osteoarthritis (OA). This submission marks a crucial step in bringing a new regenerative therapy to patients. The company is optimistic about its discussions with the FDA as it seeks approval for this innovative treatment.
Read more →ORGOOrganogenesis Holdings, Inc. Investigated by the Portnoy Law Firm
Organogenesis Holdings, Inc. is under investigation by the Portnoy Law Firm for potential securities fraud following a significant drop in stock price. This decline, amounting to 10.14%, was prompted by a regulatory change announced by the Centers for Medicare & Medicaid Services affecting skin substitute grafts and related products. Analysts noted that the absence of key Local Coverage Determinations has intensified competition in an already crowded market, undermining investor confidence and projecting a concerning outlook for future revenues. The law firm is encouraging affected investors to reach out for legal recourse.
Read more →ORGOOrganogenesis Achieves Primary Endpoint in Randomized Controlled Trial of PuraPly®AM
Organogenesis Holdings Inc. announced the successful completion of a randomized controlled trial for PuraPly®AM, showing significant wound closure in diabetic foot ulcers compared to standard care. The trial involved 170 patients and achieved its primary endpoint, indicating the product's clinical efficacy. The company plans to publish these findings in a peer-reviewed journal, which may influence future coverage policies.
Read more →ORGOOrganogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu for Knee Osteoarthritis Pain
Organogenesis Holdings Inc. has announced a successful Type-B meeting with the FDA, confirming plans to submit a rolling Biologics License Application (BLA) for its product ReNu by the end of 2025. This application targets the management of knee osteoarthritis, which affects millions in the U.S. The ReNu program is built on extensive clinical data and has received Regenerative Medicine Advanced Therapy designation. However, the path to commercial approval still carries significant uncertainties and risks.
Read more →ORGOOrganogenesis Holdings Inc. to Report First Quarter of Fiscal Year 2026 Financial Results on May 7, 2026
Organogenesis Holdings Inc. will report its first quarter financial results for fiscal year 2026 on May 7, 2026. A conference call is scheduled for the same day at 5:00 p.m. Eastern Time to discuss these results and provide a corporate update. The call will also include a question and answer session for participants.
Read more →ORGO▼ -10%on this news· ran to -30% by day 3
Organogenesis Holdings Inc. Reports Fourth Quarter 2025 Financial Results, Posts Record Revenue
Organogenesis Holdings Inc. reported strong financial results for the fourth quarter and fiscal year ended December 31, 2025, achieving record revenues and significant increases in net income and adjusted EBITDA. The fourth quarter saw net product revenue rise to $225.1 million, driven largely by the Advanced Wound Care segment, which reported an 83% increase. Despite these gains, the company faced a slight decline in revenue from Surgical & Sports Medicine products and anticipates market challenges ahead as it navigates reimbursement reforms in 2026. Overall, the outlook remains positive with a focus on long-term growth potential.
Read more →ORGOOrganogenesis Holdings Inc. to Report Fourth Quarter and Fiscal Year 2025 Financial Results on February 26, 2026
Organogenesis Holdings Inc. announced that it will report its fourth quarter and fiscal year 2025 financial results on February 26, 2026, after the market closes. Following the release, management will host a conference call at 5:00 p.m. ET to discuss results and provide updates, including a question and answer session. This announcement highlights the company's ongoing commitment to providing insights into its financial performance and operations in the regenerative medicine sector.
Read more →ORGOOrganogenesis Announces Initiation of Biologics License Application for ReNu®
Organogenesis Holdings Inc. has initiated a rolling submission of a Biologics License Application (BLA) for ReNu, a cryopreserved amniotic suspension allograft aimed at treating symptomatic knee osteoarthritis. The final modules of the BLA are expected to be submitted in the first half of 2026. If approved, ReNu would be the first non-surgical biologic therapy for knee OA, addressing a significant patient need.
Read more →ORGO▲ +7%on this news
Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu® for Knee Osteoarthritis Pain
Organogenesis Holdings Inc. has successfully completed a Type-B meeting with the FDA, confirming the appropriateness of their clinical development program for ReNu, a treatment for knee osteoarthritis. The company plans to file a rolling Biologics License Application by the end of 2025. ReNu aims to meet the medical needs of millions affected by knee osteoarthritis.
Read more →ORGO▲ +44.7%on this news· ran to +68% by day 1
Organogenesis Holdings Inc. Reports Third Quarter 2025 Financial Results, Posts Record Revenue and Raises 2025 Guidance
Organogenesis Holdings Inc. reported record revenue of $150.5 million for Q3 2025, marking a 31% increase from the previous year. The growth was primarily driven by strong sales in Advanced Wound Care and Surgical & Sports Medicine products. Despite a rise in operating expenses, the company remains optimistic about future performance, especially with new market opportunities on the horizon.
Read more →ORGOOrganogenesis Applauds CMS’s Significant Step In Payment Reform
Organogenesis Holdings Inc. has praised the Centers for Medicare & Medicaid Services (CMS) for its recent payment reform for skin substitutes under the CY 2026 Physician Fee Schedule. The new policy aims to enhance access to PMA products and address issues in the existing system. CEO Gary S. Gillheeney expressed confidence that this reform will incentivize innovation and investment in regenerative medicine.
Read more →About Organogenesis Holdings Inc.
Headquarters85 DAN ROAD, CANTON, MA, 02021
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