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Organon & Co. (OGN) FDA Events

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FDA Events for Organon & Co. (OGN)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Organon & Co. (OGN). Over the past two years, Organon & Co. has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as HLX14, OG-6219, Perjeta, and VTAMA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Organon & Co.'s Drugs in FDA Review

HLX14 - FDA Regulatory Timeline and Events

HLX14 is a drug developed by Organon & Co. for the following indication: (denosumab) Biosimilar Candidate. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

OG-6219 - FDA Regulatory Timeline and Events

OG-6219 is a drug developed by Organon & Co. for the following indication: In Patients with Endometriosis-Related Pain. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Perjeta - FDA Regulatory Timeline and Events

Perjeta is a drug developed by Organon & Co. for the following indication: A neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

VTAMA (tapinarof) cream - FDA Regulatory Timeline and Events

VTAMA (tapinarof) cream is a drug developed by Organon & Co. for the following indication: Plaque psoriasis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Organon & Co. FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Organon & Co. (OGN) has reported FDA regulatory activity for the following drugs: VTAMA (tapinarof) cream, OG-6219, Perjeta and HLX14.

The most recent FDA-related event for Organon & Co. occurred on July 7, 2025, involving VTAMA (tapinarof) cream. The update was categorized as "Recommendation," with the company reporting: "Organon announced that VTAMA® (tapinarof) cream, 1%,was granted a strong recommendation by the American Academy of Dermatology (AAD) in their 2025 focused guideline update for the management of adults with moderate to severe atopic dermatitis (AD)."

Current therapies from Organon & Co. in review with the FDA target conditions such as:

  • Plaque psoriasis - VTAMA (tapinarof) cream
  • In Patients with Endometriosis-Related Pain - OG-6219
  • A neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen. - Perjeta
  • (denosumab) Biosimilar Candidate - HLX14

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NYSE:OGN) was last updated on 7/9/2025 by MarketBeat.com Staff
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