| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology |
Recent Updates
Recently added Catalysts
Organon & Co.$13.54
+0.02 (+0.15%)
B 77Pipeline Score Undervalued Pharma · Commercial
Market Cap
3.53 B
EPS
0.95
P/E Ratio
14.31 $
Value Trade
34.38 M
SEC Financials
Q1 2026Dilution Risk
Revenue
1.46 B
R&D Expenses
93.00 M
Operating CF
225.00 M
Total Assets
13.00 B
Total Liabilities
12.09 B
Equity
903.00 M
D/E Ratio
12,345
0.45 %
Week
49.72 %
1 Month
74.64 %
3 Month
87.57 %
6 Month
-65.12 %
5 Year
-56.68 %
All Time
Cash Data
Cash Position
1.12 B
Monthly Burn
-
Runway
12,345 mo
Burn Trend
StableSEC Filing
May 4, 2026
Overview
Volume
2.65 M
52 Week Range
5.69 - 13.48
% held by Insiders
0.37 %
% held by Institutions
76.27 %
Enterprise Value
10.98 B
Total Shares
262.52 M
Short %
6.21 %
Float Shares
261.47 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Organon & Co.
122Total events
1Upcoming
51Tier-1 (high impact)
2020 – 2027Coverage
Upcoming catalysts 1
TBD
T1Acquisition
Subscribe to view catalyst details
Event history 2
TBD
◆Oral PresentationVTAMAApprovedPresentation
Subscribe to view catalyst details
TBD
●Quarterly UpdateCorporate
Subscribe to view catalyst details
Past FDA Catalysts & PDUFA Decisions
| Date | Drug | Catalyst | Stage | Outcome | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|---|
2026-01-16 | Implanon (etonogestrel) | PDUFA Date | PDUFA | Approved | – | – | – |
2026-01-16 | Implanon (etonogestrel) | PDUFA Date | PDUFA | Approved | – | – | – |
2026-01-16 | Implanon (etonogestrel) | PDUFA Date | PDUFA | Approved | – | – | – |
Drug Pipeline Intelligence
B77
Pipeline Score $37.5B
Pipeline ValueUndervalued
Valuation Signal63
Drugs Scored15.0x
rNPV / MCap Top 97%
Small Cap (rank 28 of 913)
Percentile RankOrganon & Co. holds a solid B-grade pipeline (77/100), with $57.7B risk-adjusted pipeline value, led by MK0653A, ezetimibe simvastatin in Type 2 Diabetes Mellitus (Phase 3).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MK0653A, ezetimibe simvastatin Small molecule | Hypercholesterolemia | Phase 3 | NCT00092690 | 53% | $12.4B | COMPLETED | 7,000 | - | - | Mar 1, 2004 | - | May 10, 2024 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
VTAMA | atopic dermatitis | Phase 3 | 2026-07-24 | Statistically significant ≥75% improvement in Eczema Area and Severity Index (EASI75) response was achieved as early as week 1 and continued through week 8; Improvements in Eczema Area and Severity Index (EASI) scores were achieved by the majority of patients (96.9%) from baseline at week 8; Significant vIGA-AD response was observed, defined as clear (vIGA-AD=0) or almost clear (vIGA-AD=1) skin with a ≥2-grade improvement from baseline, as early as week 1 (5.8% vs. 1.6%, P=0.0315) and continued through week 8 (45.9% vs. 15.9%, P<0.0001); Significant EASI75 response was achieved as early as week 1 (9.0% vs. 3.3%, P=0.0164) and continued through week 8 (57.4% vs 22.1%, P<0.0001); Significant itch improvement, defined as a ≥4-point reduction in PP-NRS score for patients with a baseline score of ≥4, was achieved as early as week 1 (18.8% vs. 11.3%, P=0.0128) and continued through week 8 (59.3% vs. 33.5%, P<0.0001) Read More | New Analysis of Phase 3 Pooled Data for Organon’s VTAMA® (tapinarof) cream, 1%, Demonstrates Early, Consistent Improvements in Atopic Dermatitis Patients Across Pediatric Age Groups and in Adults1 Read More | |
VTAMA | atopic dermatitis | Phase 3 | 2026-07-24 | Statistically significant ≥75% improvement in Eczema Area and Severity Index (EASI75) response was achieved as early as week 1 and continued through week 8; Improvements in Eczema Area and Severity Index (EASI) scores were achieved by the majority of patients (96.9%) from baseline at week 8; Significant vIGA-AD response was observed, defined as clear (vIGA-AD=0) or almost clear (vIGA-AD=1) skin with a ≥2-grade improvement from baseline, as early as week 1 (5.8% vs. 1.6%, P=0.0315) and continued through week 8 (45.9% vs. 15.9%, P<0.0001); Significant EASI75 response was achieved as early as week 1 (9.0% vs. 3.3%, P=0.0164) and continued through week 8 (57.4% vs 22.1%, P<0.0001); Significant itch improvement, defined as a ≥4-point reduction in PP-NRS score for patients with a baseline score of ≥4, was achieved as early as week 1 (18.8% vs. 11.3%, P=0.0128) and continued through week 8 (59.3% vs. 33.5%, P<0.0001) Read More | New Analysis of Phase 3 Pooled Data for Organon’s VTAMA® (tapinarof) cream, 1%, Demonstrates Early, Consistent Improvements in Atopic Dermatitis Patients Across Pediatric Age Groups and in Adults1 Read More | |
VTAMA | atopic dermatitis | Phase 3 | 2026-07-24 | Statistically significant ≥75% improvement in Eczema Area and Severity Index (EASI75) response was achieved as early as week 1 and continued through week 8; Improvements in Eczema Area and Severity Index (EASI) scores were achieved by the majority of patients (96.9%) from baseline at week 8; Significant vIGA-AD response was observed, defined as clear (vIGA-AD=0) or almost clear (vIGA-AD=1) skin with a ≥2-grade improvement from baseline, as early as week 1 (5.8% vs. 1.6%, P=0.0315) and continued through week 8 (45.9% vs. 15.9%, P<0.0001); Significant EASI75 response was achieved as early as week 1 (9.0% vs. 3.3%, P=0.0164) and continued through week 8 (57.4% vs 22.1%, P<0.0001); Significant itch improvement, defined as a ≥4-point reduction in PP-NRS score for patients with a baseline score of ≥4, was achieved as early as week 1 (18.8% vs. 11.3%, P=0.0128) and continued through week 8 (59.3% vs. 33.5%, P<0.0001) Read More | New Analysis of Phase 3 Pooled Data for Organon’s VTAMA® (tapinarof) cream, 1%, Demonstrates Early, Consistent Improvements in Atopic Dermatitis Patients Across Pediatric Age Groups and in Adults1 Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in OGN
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
OGN Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
| 2027-12-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2027-12-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2027-12-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
OGNNew Analysis of Phase 3 Pooled Data for Organon’s VTAMA® (tapinarof) cream, 1%, Demonstrates Early, Consistent Improvements in Atopic Dermatitis Patients Across Pediatric Age Groups and in Adults1
Organon has presented new analysis from Phase 3 pooled data for its VTAMA (tapinarof) cream, 1%. The data indicates early and consistent improvements in patients with atopic dermatitis across various pediatric age groups and adults. This analysis highlights the potential effectiveness of VTAMA in treating eczema.
Read more →OGNOrganon to Report Second Quarter 2026 Results in Its Regularly Scheduled Form 10-Q Filing
Organon plans to announce its second quarter 2026 financial results through a Form 10-Q filing with the SEC. The report will include certain non-GAAP financial measures along with their reconciliation to GAAP measures. This move reflects the company's commitment to transparency in its financial reporting.
Read more →OGNOrganon to Present New Analysis on VTAMA® (tapinarof) cream, 1%, at the 2026 Society for Pediatric Dermatology Annual Meeting
Organon is set to present a new analysis of VTAMA® (tapinarof) cream, 1% at the upcoming 2026 Society for Pediatric Dermatology Annual Meeting. This presentation highlights the company's ongoing commitment to pediatric dermatology. Details regarding the analysis and its implications for treatment will be shared during the meeting.
Read more →OGNOrganon Canada and Henlius Expand Access to Denosumab Treatments With Launch of BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection), Biosimilars to PROLIA and XGEVA
Organon Canada and Henlius have launched BILDYOS® and TUZEMTY®, biosimilars to PROLIA and XGEVA, aimed at expanding access to denosumab treatments. This initiative is expected to enhance treatment options for patients requiring denosumab therapy. The launch reflects a strategic move to provide more affordable alternatives in the market.
Read more →OGNOrganon Completes Agreement to License MIUDELLA®, Sebela Pharmaceuticals’ Hormone-Free Intrauterine Device
Organon has finalized an agreement to license MIUDELLA®, a hormone-free intrauterine device developed by Sebela Pharmaceuticals. This collaboration aims to enhance Organon's portfolio in women's health. The details regarding the financial terms of the agreement have not been disclosed.
Read more →OGNOrganon and Samsung Bioepis Expand Agreement to Commercialize PYZCHIVA® (ustekinumab), a Biosimilar Referencing STELARA® (ustekinumab) in Canada
Organon and Samsung Bioepis have expanded their agreement to commercialize PYZCHIVA®, a biosimilar referencing STELARA® (ustekinumab), in Canada. This collaboration aims to enhance the availability of this treatment in the Canadian market. Further details regarding the terms of the agreement or expected timelines were not disclosed.
Read more →OGNOrganon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19
Organon has secured FDA approval for TOFIDENCE® (tocilizumab-bavi), expanding its indications to include treatment for Cytokine Release Syndrome (CRS) and pediatric COVID-19. This approval enhances the therapeutic options available for these conditions, particularly benefiting younger patients. The decision reflects the ongoing need for effective treatments in critical health scenarios.
Read more →OGNOrganon präsentiert auf der ISPOR 2026 neue Forschungsergebnisse rund um Zugang und Nutzen
Organon presented new research findings at ISPOR 2026 regarding access and benefits. The details of the research were not disclosed in the article. The presentation aimed to highlight the company's commitment to improving healthcare access. Further insights into the findings may be available from the conference proceedings.
Read more →OGNオルガノン、ISPOR 2026でアクセスと価値に関する新たな研究成果を発表へ
The article mentions OGN's upcoming presentation at ISPOR 2026 regarding new research results related to access and value. However, no specific details about the findings or implications are provided.
Read more →OGNOrganon présentera de nouvelles recherches sur l’accès et la valeur lors de l’ISPOR 2026
Organon is set to present new research focused on access and value at ISPOR 2026. The presentation aims to highlight important findings relevant to healthcare stakeholders. Further details on the specific topics of the research have not been disclosed.
Read more →OGNOrganon presentará nuevos estudios sobre acceso y valor en ISPOR 2026
Organon is set to present new studies focused on access and value at ISPOR 2026. The details of these studies are currently unspecified, but they aim to contribute to discussions on healthcare access and value assessment. This presentation highlights Organon's ongoing commitment to addressing critical healthcare issues.
Read more →OGNOrganon apresentará novas pesquisas sobre acesso e valor no ISPOR 2026
Organon is set to present new research focused on access and value at the ISPOR 2026 conference. The details of the research and its implications for the healthcare sector are yet to be disclosed. The presentation aims to contribute to ongoing discussions about healthcare accessibility and value assessment.
Read more →OGNOrganon將在ISPOR 2026大會上發表醫療可及性與價值領域最新研究
Organon is set to present at the ISPOR 2026 conference, focusing on the latest research in therapeutic efficacy and value domains. This presentation aims to highlight advancements in the field, although specific details about the research or findings have not been disclosed.
Read more →OGNFelicia Bisaro Investor Contacts: Jennifer Halchak (646) 703-1807 (201) 275-2711 Kate Vossen Renee McKnight (732) 675-8448 (551) 204-6129 Organon Reports Results for the First Quarter Ended
Organon (NYSE: OGN) reported its financial results for the first quarter of 2026, revealing total revenue of $1.460 billion, down 4% year-over-year. The company's Women's Health sector saw a notable decline of 16%, while Biosimilars revenue experienced significant growth of 23%. Despite an overall drop in established brands, net income increased 68%, leading to a declared quarterly dividend of $0.02 per share. The company's performance was affected by unfavorable pricing pressures and a decline in global sales for several key products.
Read more →OGNEuropese Commissie (EC) keurt POHERDY® (pertuzumab) van Henlius en Organon goed, de eerst goedgekeurde biosimilar voor PERJETA (pertuzumab) in Europa
The European Commission has granted marketing approval for POHERDY® (pertuzumab), the first biosimilar for PERJETA in Europe. This approval marks a significant milestone in improving access to treatments for patients with HER2-positive breast cancer. The drug is indicated for various treatment regimens, enhancing therapeutic options for patients. The collaboration between Henlius and Organon aims to support healthcare sustainability and patient access.
Read more →OGNLa Commission européenne (CE) approuve le POHERDY® (pertuzumab) de Henlius et Organon, premier médicament biosimilaire du PERJETA (pertuzumab) autorisé en Europe
The European Commission has granted marketing authorization for POHERDY® (pertuzumab), the first biosimilar of PERJETA approved in Europe. This approval is significant for increasing access to treatments for HER2-positive breast cancer patients. The drug is indicated for various treatment scenarios, including metastatic and early-stage breast cancer. The approval builds on prior FDA authorization in the U.S.
Read more →OGNEuropäische Kommission erteilt Marktzulassung für POHERDY® (Pertuzumab) von Henlius und Organon, das erste in Europa zugelassene Biosimilar zu PERJETA (Pertuzumab)
The European Commission has granted market authorization for POHERDY® (Pertuzumab), the first biosimilar to PERJETA in Europe. This approval is significant for improving access to treatments for patients with HER2-positive breast cancer. The decision is based on extensive clinical data showing POHERDY's similarity to the reference product, enhancing Organon's biosimilar portfolio.
Read more →OGNLa Commissione Europea (CE) approva POHERDY® (pertuzumab), messo a punto da Henlius e Organon, il primo biosimilare di PERJETA (pertuzumab) approvato in Europa
The European Commission has approved POHERDY® (pertuzumab), the first biosimilar of PERJETA, developed by Henlius and Organon. This approval allows POHERDY to be used for various indications in HER2-positive breast cancer patients. The approval is seen as a significant step in improving access to effective treatments for patients in Europe. Both companies express commitment to enhancing healthcare sustainability and patient access.
Read more →OGNLa Comisión Europea (CE) aprueba POHERDY® (pertuzumab) de Henlius y Organon, el primer biosimilar de PERJETA (pertuzumab) autorizado en Europa
The European Commission has approved POHERDY® (pertuzumab), the first biosimilar of PERJETA in Europe, for all indications. This approval is significant for improving access to treatments for HER2-positive breast cancer patients. The drug is indicated for use in combination with trastuzumab and chemotherapy for various stages of breast cancer. The approval follows a comprehensive analysis demonstrating POHERDY's similarity to the reference product.
Read more →OGNOrganon Reports Results for the First Quarter Ended March 31, 2026
Organon reported its Q1 2026 financial results, showing a total revenue of $1.460 billion, down 4% from the previous year. Women's Health revenue saw a significant decline, particularly in Nexplanon sales, which dropped 21% due to decreased physician demand and funding uncertainties. However, the company experienced growth in its biosimilars segment, with a 23% increase in revenue. Net income rose to $146 million, reflecting a 68% increase compared to Q1 2025.
Read more →OGNOrganon Cancels First Quarter Earnings Call
Organon has canceled its first quarter 2026 earnings conference call, originally set for May 7, 2026. This decision follows the announcement of its acquisition by Sun Pharmaceutical Industries Limited. Organon will still release its financial results on April 30, 2026, via a press release and Form 10-Q filing with the SEC.
Read more →OGNEuropean Commission (EC) Approves Henlius and Organon's POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe
The European Commission has approved POHERDY® (pertuzumab), the first biosimilar to PERJETA in Europe, for all indications of the reference product. This approval is expected to enhance access to treatments for patients with HER2-positive breast cancers. The drug is indicated for various treatment combinations and reflects a significant milestone for both Henlius and Organon.
Read more →OGNSun Pharma signe un accord définitif pour acquérir Organon
Sun Pharmaceutical Industries has finalized an agreement to acquire Organon & Co. for $14.00 per share, valuing the company at $11.75 billion. This acquisition aims to enhance Sun Pharma's portfolio in women's health and biosimilars, positioning it among the top global players in these sectors. The deal is pending regulatory approvals and shareholder consent, with completion expected by early 2027.
Read more →OGN▲ +16.9%on this newsshared move
Samenvatting: Sun Pharma tekent definitieve overeenkomst voor de overname van Organon
Sun Pharmaceutical Industries Limited has announced a definitive agreement to acquire Organon & Co. for $14.00 per share, totaling an enterprise value of $11.75 billion. This acquisition marks a significant strategic move for Sun Pharma, enhancing its portfolio in the biopharma sector. The transaction will be executed entirely in cash.
Read more →OGN▲ +16.9%on this newsshared move
Sun Pharma unterzeichnet endgültige Vereinbarung zur Übernahme von Organon
Sun Pharmaceutical Industries Limited has finalized an agreement to acquire Organon & Co. for $14.00 per share, valuing the deal at $11.75 billion. This acquisition aligns with Sun Pharma's strategy to expand its innovative drug business and strengthen its presence in women's health and biosimilars. The transaction is expected to close in early 2027, pending regulatory approvals and shareholder consent.
Read more →OGN▲ +16.9%on this newsshared move
Sun Pharma acuerda la adquisición de Organon
Sun Pharmaceutical Industries Limited has announced a definitive agreement to acquire Organon & Co. for $14.00 per share, valuing the company at $11.75 billion. This acquisition aligns with Sun Pharma's strategy to expand its innovative medicines business and enhance its presence in women's health and biosimilars. The deal is expected to close in early 2027, pending regulatory approvals and shareholder consent.
Read more →OGN▲ +16.9%on this newsshared move
Sun Pharma beams up Organon in $11.75B acquisition
Sun Pharma has announced an $11.75 billion acquisition of Organon, which will expand its product portfolio significantly. This deal positions Sun Pharma as a major player in the biosimilars market and among the top three companies in women's health globally. The acquisition is expected to close early next year, enhancing business continuity and value creation.
Read more →OGN▲ +16.9%on this newsshared move
Riassunto: Sun Pharma firma un accordo definitivo per acquisire Organon
Sun Pharmaceutical Industries Limited has announced a definitive agreement to acquire Organon & Co. for $14.00 per share, amounting to a total valuation of $11.75 billion. This acquisition reflects Sun Pharma's strategic growth ambitions and confidence in Organon's business potential. The transaction will be conducted in cash.
Read more →OGN▲ +16.9%on this newsshared move
A Sun Pharma assina acordo definitivo para adquirir a Organon
Sun Pharmaceutical Industries Limited has signed a definitive agreement to acquire Organon & Co. for $14.00 per share, valuing the company at $11.75 billion. This acquisition aims to enhance Sun Pharma's business in innovative medicines and strengthen its position in the established brands and biosimilars market. The transaction is expected to close in early 2027, pending regulatory approvals and shareholder consent.
Read more →OGN▲ +16.9%on this newsshared move
Sun Pharma signs Definitive Agreement to Acquire Organon
Sun Pharma has signed a definitive agreement to acquire Organon. The details regarding the acquisition, including the financial terms and strategic implications, have not been disclosed in the article. This move may impact both companies' market positions and future operations.
Read more →OGNOrganon To Report First Quarter 2026 Results and Host Conference Call on May 7, 2026
Organon will announce its first quarter 2026 financial results on May 7, 2026, followed by a conference call. The company does not anticipate any milestone expenses for this quarter, and the results are still subject to finalization. Interested parties can access the call via webcast or by phone.
Read more →OGNOrganon Debuts New Analysis of VTAMA® (tapinarof) cream, 1%, Phase 3 Pooled Data Demonstrating Early and Consistent Skin Clearance and Itch Improvement in Atopic Dermatitis Patients Down to 2 Years of Age
Organon presented a post-hoc analysis of pooled data from Phase 3 trials for VTAMA cream, showing significant improvements in skin clearance and itch relief in atopic dermatitis patients aged two and older. The findings indicate that VTAMA cream is well tolerated and effective, particularly in children. The results will be shared at the upcoming AAD Annual Meeting.
Read more →OGNNew Analysis of Organon’s VTAMA® (tapinarof) cream, 1%, Phase 3 Data Showed Early and Consistent Improvement in Patient-Reported Sleep Subdomains in Pediatric Patients Down to 2 Years of Age with Atopic Dermatitis
Organon is set to present new findings from the Phase 3 ADORING trials at the AAAAI Annual Meeting. The analysis reveals that VTAMA cream significantly improves sleep-related issues in pediatric patients with moderate to severe atopic dermatitis. Improvements were noted as early as week 1, with consistent results across various age groups. The findings underscore the importance of addressing sleep disturbances in children suffering from this condition.
Read more →OGNOrganon Enters into Agreement to License MIUDELLA®, Sebela Pharmaceuticals’ Hormone-Free Intrauterine Device
Organon has entered into an exclusive licensing agreement for MIUDELLA, a hormone-free copper IUD developed by Sebela Pharmaceuticals. This marks the first approval of a hormone-free copper IUD in the U.S. in 40 years. The agreement involves an upfront payment and potential milestone payments, contingent upon regulatory approvals.
Read more →OGN▼ -8.2%on this news
Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2025
Organon reported its financial results for Q4 and full year 2025, revealing a 5% decline in total revenue for Q4 compared to the previous year. The company faced challenges in its Women's Health segment, with significant sales decreases in products like Nexplanon. Despite these setbacks, Organon aims to maintain operational performance in 2026 while focusing on expense management and capital deployment.
Read more →OGN▼ -8.2%on this newsshared move
Felicia Bisaro Investor Contacts: Jennifer Halchak (646) 703-1807 (201) 275-2711 Kate Vossen Renee McKnight (732) 675-8448 (551) 204-6129 Organon Reports Results for the Fourth Quarter and Full Year Ended
Organon reported a challenging fourth quarter and full year for 2025, with total revenue decreasing by 5% compared to the previous year. The decline was driven primarily by reduced sales in the Women's Health division, particularly the Nexplanon implant, and a significant net loss due to a goodwill impairment. Despite growth in its Biosimilars segment, overall performance fell short, leading to a loss of financial flexibility. The company emphasized its focus on disciplined expense management and capital deployment going forward.
Read more →OGNOrganon To Report Fourth Quarter and Full Year 2025 Results and Host Conference Call on February 12, 2026
Organon will report its fourth quarter and full year 2025 financial results on February 12, 2026. A conference call will follow the release, allowing investors to engage directly. The company does not anticipate any milestone expenses for the quarter, and the results are subject to finalization, indicating potential variability.
Read more →OGN▲ +8%on this news
Organon Announces US Food and Drug Administration Approval of Supplemental New Drug Application Extending Duration of Use of NEXPLANON® (etonogestrel implant) 68 mg Radiopaque
Organon has received FDA approval for a supplemental New Drug Application (sNDA) that extends the duration of NEXPLANON's use from three years to five years. The approval is based on clinical trial data showing no pregnancies during the extended use period. The new REMS program will ensure proper training for healthcare providers to mitigate risks associated with insertion and removal of the implant.
Read more →OGN▲ +13.7%on this news
Felicia Bisaro Investor Contacts: Jennifer Halchak (646) 703-1807 (201) 275-2711 Kate Vossen Renee McKnight (732) 675-8448 (551) 204-6129 Organon Reports Results for the Third Quarter Ended
Organon Holdings reported disappointing financial results for the third quarter of 2025, with total revenue increasing only 1% year-over-year to $1.602 billion. Women's Health revenue saw a notable decline of 3%, mainly due to lower sales of Nexplanon in the U.S. Furthermore, net income plummeted 55% compared to the previous year, primarily influenced by higher costs and a decrease in gross margin. The company has also revised its full-year revenue guidance downward, reflecting the challenging market conditions.
Read more →OGN▼ -22.9%on this news
Felicia Bisaro Investor Contacts: Jennifer Halchak (646) 703-1807 (201) 275-2711 Kate Vossen Renee McKnight (732) 675-8448 (551) 204-6129 Organon Appoints Company Executive Joseph Morrissey
Organon has appointed Joseph Morrissey as Interim CEO following Kevin Ali's resignation linked to an Audit Committee investigation into improper wholesaler sales practices. Carrie Cox will support Morrissey in her role as Executive Chair. The investigation revealed that certain wholesalers were encouraged to purchase excess inventory, which impacted previous sales reports, although the financial impact was minor. The company aims to enhance its financial controls while searching for a permanent CEO.
Read more →OGN▼ -13.1%on this news
Felicia Bisaro Investor Contacts: Jennifer Halchak (646) 703-1807 (201) 275-2711 Kate Vossen Renee McKnight (732) 675-8448 (551) 204-6129 Organon Reports Results for the Second Quarter Ended
Organon reported its second quarter 2025 financial results, indicating a revenue of $1.594 billion, down 1% year-over-year. The company achieved a diluted EPS of $0.56, but net income was reported at $145 million, a decline from the previous year's $195 million. Despite some challenges, the revenue guidance for the full year was raised, reflecting a positive outlook on financial performance. Additionally, Organon highlighted significant progress in debt repayment and a solid Adjusted EBITDA margin of 32.7%. The quarter also saw successful growth in their Women's Health portfolio, particularly in fertility products.
Read more →OGNOrganon’s Endometriosis Drug Discontinued After Failing To Improve Pain
Organon's endometriosis drug, OG-6219, has been discontinued after failing to show improvement in pelvic pain during a Phase II trial. The trial, part of the ELENA study, did not meet its primary goal compared to placebo. Despite this setback, Organon remains committed to exploring new treatment options for women suffering from endometriosis.
Read more →OGN▲ +5.2%on this news
US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon HADLIMA (adalimumab-bwwd) Injection 05/27/2025 HADLIMA (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL i
The FDA has granted an interchangeability designation to HADLIMA (adalimumab-bwwd) injection, produced by Samsung Bioepis and Organon. This allows pharmacists to substitute HADLIMA for Humira without consulting prescribers, significantly enhancing patient access to care. The interchangeability is supported by studies showing comparability in pharmacokinetics, efficacy, and safety profiles. However, patients using HADLIMA must be monitored closely for serious infections, such as tuberculosis, due to increased risks associated with TNF blockers.
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Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Renee McKnight (551) 204-6129 Organon Reports Results for the First Quarter Ended
Organon reported its first quarter results for 2025, highlighting a 7% decline in total revenue year-over-year. Despite affirming its full year financial guidance, the company faces challenges including a substantial 57% drop in net income. The Women's Health sector showed growth, but significant declines in other product categories, alongside a reset of the dividend payout, indicate underlying financial pressures. The management's focus on deleveraging aims to position the company for improved future prospects.
Read more →OGNFelicia Bisaro Investor Contacts: Jennifer Halchak (646) 703-1807 (201) 275-2711 Kate Vossen (732) 675-8448 Organon Appoints Ramona A. Sequeira to the Company's Board of Directors JERSEY CITY
Organon has appointed Ramona A. Sequeira, previously President of the Global Portfolio Division at Takeda, to its Board of Directors, effective July 1, 2025. Sequeira's extensive experience in the pharmaceutical sector, including pivotal roles at Takeda and Eli Lilly, positions her as a valuable asset to the Board's Talent Committee. This addition brings the total number of directors on Organon's Board to 12 and reflects the company's commitment to enhancing its strategic direction. Organon's mission focuses on improving women's health, supported by a diverse portfolio of over 70 medicines and a strong international presence.
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Organon Lets Go of 93 Employees in New Jersey in Continuing Workforce Cuts
Organon is laying off 93 employees at its Jersey City headquarters as part of ongoing workforce reductions aimed at optimizing operations. This move follows a series of restructuring initiatives that began in 2023 and are expected to continue into 2025. The company has also faced challenges, including the loss of exclusivity for its cholesterol-lowering drug Atozet, which has contributed to declining sales.
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Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 (201) 275-2711 Kate Vossen Renee McKnight (732) 675-8448 (551) 204-6129 Organon Reports Results for the Fourth Quarter and Full Year Ended
Organon has reported its financial results for Q4 and full year 2024, indicating stable revenue growth but significant challenges in profitability. The company achieved a constant currency revenue growth for the third consecutive year, although their net income saw a sharp 80% decline year-over-year. Adjusted EBITDA margins remained consistent, but they face pressures from market competition, particularly in their Biosimilars and fertility products. Overall, while some segments experienced growth, the financial outlook reflects potential hurdles due to product exclusivity losses and competitive pricing pressures.
Read more →OGNMerck’s Former Asthma Blockbuster Singulair Could Be Linked to Mental Health Problems: Reuters
FDA researchers presented findings linking montelukast, marketed as Singulair, to neuropsychiatric issues at the 2024 Annual Meeting of the American College of Toxicology. Despite evidence of its effects on brain receptors, the FDA does not plan to update the drug's label. Singulair, once a top-selling drug, has faced scrutiny for its potential risks, leading to a black box warning in 2020.
Read more →OGNFelicia Bisaro Investor Contacts: Jennifer Halchak (646) 703-1807 (201) 275-2711 Kim Hamilton (908) 391-0131 Update on FDA Review of VTAMA (tapinarof) Cream, 1% for the Treatment of Atopic De
Organon announced that the FDA extended the review of VTAMA (tapinarof) cream, 1% for atopic dermatitis by three months, with a new action date set for March 12, 2025. This extension follows a request from the FDA for final datasets and a clinical study report from long-term studies of VTAMA. Despite the delay, the FDA has not expressed any safety or efficacy concerns regarding the product, and Organon remains optimistic about its prospects in the market.
Read more →OGNKarissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 (201) 275-2711 Kate Vossen Renee McKnight (732) 675-8448 (551) 204-6129 Organon Reports Results for the Third Quarter Ended
Organon reported its third quarter results for 2024, showcasing a 4% increase in total revenue to $1.582 billion, driven by strong performance in Women's Health and Biosimilars. Nexplanon's anticipated revenue for the upcoming year is projected to hit $1 billion, reflecting its robust market demand. The company's disciplined approach to managing operating costs has led to a notable increase in net income, which surged 519% year-over-year. However, some products faced significant sales declines, particularly NuvaRing and Ontruzant, impacting overall performance.
Read more →OGNRoivant Deals Again, Sending Dermavant to Organon in Sale Worth Up to $1.2B
Roivant has sold Dermavant to Organon in a deal valued at up to $1.2 billion. The agreement includes an upfront payment of $175 million and additional milestone payments based on regulatory approvals and sales performance. This move allows Roivant to allocate resources towards its autoimmune-focused company, Immunovant, which is preparing for pivotal Phase III studies.
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Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 (201) 275-2711 Kate Vossen Renee McKnight (732) 675-8448 (551) 204-6129 Organon Reports Results for the Second Quarter Ended
Organon reported its second quarter 2024 results, showing stable overall revenue of $1.607 billion, flat compared to the previous year, yet a 2% increase when excluding foreign currency effects. A notable growth of 22% was achieved in biosimilars, driven by the successful launch of Hadlima in the U.S., while the Women's Health franchise experienced a sales dip in certain products due to competition. The company also declared a quarterly dividend of $0.28 per share. Despite some growth areas, declines in specific segments raised concerns about overall profitability.
Read more →OGNKarissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 (201) 275-2711 Kate Vossen Renee McKnight (732) 675-8448 (551) 204-6129 Organon Reports Results for the First Quarter Ended
Organon reported its first-quarter financial results for 2024, highlighting a 5% revenue increase to $1.622 billion compared to the same period last year. Significant growth was noted in the Women's Health segment, with revenues rising 11%, largely driven by the success of Nexplanon. The biosimilars division also showed robust performance, growing revenues by 46%. Despite this, the company faced challenges such as a decline in NuvaRing sales and a decrease in overall gross margins.
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Organon & Co. has filed an 8-K form with the SEC, which includes important details about the company, such as its entity file number and central index key. The filing appears to comply with various SEC requirements, indicating procedural adherence. However, no significant news or changes regarding the company's operations or financial status are mentioned in the document. Thus, the filing serves primarily as a formal regulatory update.
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Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 (201) 275-2711 Kate Vossen Alex Arzeno (732) 675-8448 (203) 550-3972 Organon Reports Results for the Third Quarter Ended
Organon reported its third quarter results for 2023, indicating a slight decline in total revenue to $1,519 million, a 1% decrease year-over-year. The Women’s Health division faced challenges, showing an 8% decline in revenue primarily due to competition from generics. In contrast, the Biosimilars segment grew by 10%, contributing positively to the overall performance. The company also reduced its full-year revenue guidance, now estimating between $6.15 billion and $6.25 billion, attributing the adjustments to various macroeconomic factors and market dynamics.
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Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 (201) 275-2711 Kate Vossen Alex Arzeno (732) 675-8448 (203) 550-3972 Organon Reports Results for the Second Quarter Ended
Organon reported its second-quarter results for 2023, revealing a modest revenue increase of 1% year-over-year to $1.608 billion, with a 4% rise adjusting for currency fluctuations. The Women's Health and Biosimilars segments exhibited strong growth, particularly with the recent launch of Hadlima, a biosimilar to Humira. However, Established Brands faced challenges as revenue declined by 2%. The company's board declared a quarterly dividend of $0.28 per share, illustrating its commitment to returning value to shareholders amidst an evolving market landscape.
Read more →OGNFirst Round of Humira Biosimilar Launches in US
The U.S. has seen the launch of several lower-priced biosimilars to AbbVie's Humira, including Celltrion's Yuflyma and Organon's Hadlima. These biosimilars offer significant discounts, with Hadlima priced at $1,038 compared to Humira's higher costs. The introduction of these products is expected to enhance patient access and promote competition in the biologics market, although AbbVie is already facing declining sales. Additionally, some biosimilars are pursuing FDA interchangeability designations.
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Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 (201) 275-2711 Kate Vossen Alex Arzeno (732) 675-8448 (203) 550-3972 Organon Reports Results for the First Quarter Ended
Organon reported its first quarter 2023 financial results, showing a decrease in total revenue to $1.538 billion, a drop of 2% year-over-year. Notably, the company achieved growth in both Women's Health and Biosimilars product lines, though Established Brands faced challenges resulting in a 5% revenue decline. Despite the revenue decrease, the company maintains a positive outlook with a continued focus on capital allocation for strategic investments. Organon also declared a quarterly dividend of $0.28 per share, payable on June 15, 2023.
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Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 (201) 275-2711 Kate Vossen Alex Arzeno (732) 675-8448 (203) 550-3972 Organon Reports Results for the Fourth Quarter and Full Year Ended
Organon announced its financial results for the fourth quarter and full year ending December 31, 2022. The company reported a 2% decrease in total revenue for the year but showed growth in its Women's Health and Biosimilars segments. CEO Kevin Ali noted that Organon had set quarterly sales records and maintained a focus on innovation in women's health. Challenges included declines in Established Brands revenue primarily due to competition and regulatory impacts.
Read more →OGNKarissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Organon rep orts results for the third quarter ended
Media Contacts: Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 reports results for the third quarter ended September 30, 2022 Third quarter 2022 revenues of $1,537 million Third quarter diluted earnings per share
Read more →OGNFDA Weekly Review: Daewoong, Novavax, Preceptis and More
This week's FDA activities highlight significant advancements in drug approvals and clearances. Daewoong Pharmaceutical's IND application for DWP213388 for autoimmune diseases was cleared, while Novavax submitted an EUA for its COVID-19 vaccine booster. Other notable approvals include Preceptis Medical's Hummingbird TTS for pediatric procedures and Bluebird bio's Zynteglo for beta-thalassemia.
Read more →OGNKarissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon reports results for the second quarter ended
Media Contacts: Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon reports results for the second quarter Second quarter 2022 revenues of $1,585 million Second quarter diluted earn
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Organon & Co. Moderator: Ali, Kevin
Moderator: Ali, Kevin Operator: Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to the Organon First Quarter 2020 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's rem
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Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon reports results for the first quarter ended
Media Contacts: Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon reports results for the first quarter ended March 31, 2022 Jersey City, N.J., May 5, 2022 - Organon (NYSE: OGN) (the
Read more →OGNKarissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon reports results for the fourth quarter and full year ended
Media Contacts: Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon reports results for the fourth quarter and full year ended December 31, 2021 Nexplanon (etonogestrel implant), fert
Read more →OGNOrganon Declares International Women’s Day a Corporate Holiday
Organon has declared March 8, International Women’s Day, as an annual corporate holiday to promote healthcare equality for women. This initiative provides paid time off for employees to focus on their health, aiming to inspire other companies to follow suit. The move is part of a broader effort to address women's healthcare needs, especially in light of challenges exacerbated by the pandemic.
Read more →OGNKarissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon reports results for the third quarter ended
Media Contacts: Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon reports results for the third quarter ended September 30, 2021 Jersey City, N.J., November 11, 2021 - Organon (NYSE:
Read more →OGNOrganon Recommends Stockholders Reject Below-Market Mini-Tender Offer by TRC Capital Investment Corporation
Organon Recommends Stockholders Reject Below-Market Mini-Tender Offer by TRC Capital Investment Corporation JERSEY CITY, N.J. - June 29, 2021 - Organon (NYSE: OGN) has been notified of an unsolicited mini-tender offer by TRC Capital Investment Corporation ("TRC") to purchase u
Read more →OGNMerck Spinout Launches to Tackle Global Women’s Health Care Problems
Merck's spinout, Organon, has launched as a global women's health company, trading under the ticker OGN. The company aims to address reproductive health and conditions unique to women, supported by over 60 products. Organon emphasizes women's leadership, with a board comprising 70% women, and plans to enhance maternal health through the acquisition of Alydia Health.
Read more →OGNKarissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon Launches as New Global Women s Health Company On
Media Contacts: Karissa Peer Investor Contacts: Jennifer Halchak (614) 314-8094 Kate Vossen (732) 675-8448 (201) 275-2711 Edward Barger (267) 614-4669 Organon Launches as New Global Women s Health Company Only company of its size focused on women s health Launching wit
Read more →OGNMovers and Shakers Oct. 1
Several biopharma companies have announced leadership changes, including Second Genome appointing Karim Dabbagh as CEO and Curis, Inc. naming James E. Dentzer as its new president. Acadia Pharmaceuticals and Vividion Therapeutics also made notable appointments, indicating a trend of strategic leadership shifts within the industry. These changes may drive innovation and operational improvements.
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