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Apogee Therapeutics (APGE) FDA Events

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FDA Events for Apogee Therapeutics (APGE)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Apogee Therapeutics (APGE). Over the past two years, Apogee Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as APG333, APG777, APG808, and APG990. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Apogee Therapeutics' Drugs in FDA Review

APG333 - FDA Regulatory Timeline and Events

APG333 is a drug developed by Apogee Therapeutics for the following indication: Treatment of Respiratory and Broader I&I Conditions. 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.

APG777 - FDA Regulatory Timeline and Events

APG777 is a drug developed by Apogee Therapeutics for the following indication: For the Treatment for Atopic Dermatitis and Other Inflammatory Diseases. 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.

APG808 - FDA Regulatory Timeline and Events

APG808 is a drug developed by Apogee Therapeutics for the following indication: In Patients with Mild-to-Moderate Asthma. 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.

APG990 - FDA Regulatory Timeline and Events

APG990 is a drug developed by Apogee Therapeutics for the following indication: For the Treatment of Atopic Dermatitis and Other Inflammatory Diseases. 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.

Apogee Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Apogee Therapeutics (APGE) has reported FDA regulatory activity for the following drugs: APG990, APG777, APG808 and APG333.

The most recent FDA-related event for Apogee Therapeutics occurred on July 6, 2025, involving APG777. The update was categorized as "Data," with the company reporting: "Apogee Therapeutics, Inc announced it will report Part A 16-week data from the Phase 2 APEX trial of APG777 on Monday, July 7, 2025. Following the announcement, the Company will host a conference call and webcast at 8:00 a.m. ET to discuss the results."

Current therapies from Apogee Therapeutics in review with the FDA target conditions such as:

  • For the Treatment of Atopic Dermatitis and Other Inflammatory Diseases - APG990
  • For the Treatment for Atopic Dermatitis and Other Inflammatory Diseases - APG777
  • In Patients with Mild-to-Moderate Asthma - APG808
  • Treatment of Respiratory and Broader I&I Conditions - APG333

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:APGE) was last updated on 7/9/2025 by MarketBeat.com Staff
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