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Atossa Genetics (ATOS) FDA Events

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FDA Events for Atossa Genetics (ATOS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Atossa Genetics (ATOS). Over the past two years, Atossa Genetics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Endoxifen, endoxifen-Z, and EVANGELINE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Atossa Genetics' Drugs in FDA Review

Endoxifen - FDA Regulatory Timeline and Events

Endoxifen is a drug developed by Atossa Genetics for the following indication: Breast Cancer. 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.

endoxifen-Z - FDA Regulatory Timeline and Events

endoxifen-Z is a drug developed by Atossa Genetics for the following indication: for Breast Cancer. 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.

EVANGELINE - FDA Regulatory Timeline and Events

EVANGELINE is a drug developed by Atossa Genetics for the following indication: for premenopausal women with estrogen receptor-positive (ER+)/HER2-negative breast cancer. 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.

Atossa Genetics FDA Events - Frequently Asked Questions

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

In the past two years, Atossa Genetics (ATOS) has reported FDA regulatory activity for the following drugs: Endoxifen, endoxifen-Z and EVANGELINE.

The most recent FDA-related event for Atossa Genetics occurred on May 14, 2025, involving endoxifen-Z. The update was categorized as "Results," with the company reporting: "Atossa Therapeutics, today reported full results from the Phase 2 Endocrine Optimization Pilot (EOP) sub‑study within the I‑SPY 2 TRIAL evaluating low‑dose oral (Z)‑endoxifen (10 mg daily) as a neoadjuvant treatment in 20 women with stage II/III estrogen‑receptor–positive (ER+), HER2‑negative breast cancer."

Current therapies from Atossa Genetics in review with the FDA target conditions such as:

  • Breast Cancer - Endoxifen
  • for Breast Cancer - endoxifen-Z
  • for premenopausal women with estrogen receptor-positive (ER+)/HER2-negative breast cancer. - EVANGELINE

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 (NASDAQ:ATOS) was last updated on 7/10/2025 by MarketBeat.com Staff
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