FDA Events for Omega Therapeutics (OMGA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Omega Therapeutics (OMGA).
Over the past two years, Omega Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
OTX-2002. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
OTX-2002 - FDA Regulatory Timeline and Events
OTX-2002 is a drug developed by Omega Therapeutics for the following indication: MYC Driven Hepatocellular Carcinoma.
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.
- Drug:
- OTX-2002
- Announced Date:
- September 17, 2024
- Indication:
- MYC Driven Hepatocellular Carcinoma
Announcement
Omega Therapeutics, announced the publication of preclinical data from studies of OTX-2002 in Nature Communications.
AI Summary
Omega Therapeutics announced that preclinical studies of its novel therapy OTX-2002 have been published in Nature Communications. The research shows that OTX-2002 can precisely downregulate the MYC gene, a key oncogene involved in many cancers, including hepatocellular carcinoma (HCC). In the studies, treatment with OTX-2002 led to a significant reduction in MYC mRNA and protein levels, which in turn slowed the growth of tumors in both cell cultures and animal models. The data also highlighted that OTX-2002 works well when used alone or combined with standard treatments, such as tyrosine kinase inhibitors and immune checkpoint inhibitors. This proof-of-concept supports Omega’s claim that its OMEGA platform can design programmable epigenomic mRNA medicines to control difficult-to-target genes, paving the way for a new therapeutic approach in treating a broad range of diseases.
Read Announcement
Omega Therapeutics FDA Events - Frequently Asked Questions
As of now, Omega Therapeutics (OMGA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Omega Therapeutics (OMGA) has reported FDA regulatory activity for OTX-2002.
The most recent FDA-related event for Omega Therapeutics occurred on September 17, 2024, involving OTX-2002. The update was categorized as "Preclinical Data," with the company reporting: "Omega Therapeutics, announced the publication of preclinical data from studies of OTX-2002 in Nature Communications."
Currently, Omega Therapeutics has one therapy (OTX-2002) targeting the following condition: MYC Driven Hepatocellular Carcinoma.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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 (NASDAQ:OMGA) was last updated on 7/12/2025 by MarketBeat.com Staff
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