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AnaptysBio (ANAB) FDA Events

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FDA Events for AnaptysBio (ANAB)

This section highlights FDA-related milestones and regulatory updates for drugs developed by AnaptysBio (ANAB). Over the past two years, AnaptysBio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ANB032, JEMPERLI, and Rosnilimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

AnaptysBio's Drugs in FDA Review

ANB032 - FDA Regulatory Timeline and Events

ANB032 is a drug developed by AnaptysBio for the following indication: for moderate-to-severe atopic dermatitis (AD) or eczema. 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.

JEMPERLI (dostarlimab-gxly) - FDA Regulatory Timeline and Events

JEMPERLI (dostarlimab-gxly) is a drug developed by AnaptysBio for the following indication: Recurrent or Advanced dMMR/MSI-H Endometrial 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.

Rosnilimab (formerly ANB030) - FDA Regulatory Timeline and Events

Rosnilimab (formerly ANB030) is a drug developed by AnaptysBio for the following indication: Healthy Volunteer. 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.

AnaptysBio FDA Events - Frequently Asked Questions

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

In the past two years, AnaptysBio (ANAB) has reported FDA regulatory activity for the following drugs: Rosnilimab (formerly ANB030), ANB032 and JEMPERLI (dostarlimab-gxly).

The most recent FDA-related event for AnaptysBio occurred on June 3, 2025, involving Rosnilimab (formerly ANB030). The update was categorized as "Provided Update," with the company reporting: "AnaptysBio, Inc. announced that investigational rosnilimab, a depleter and agonist targeting PD-1+ T cells, demonstrated a best-in-disease profile in patients with moderate-to-severe rheumatoid arthritis (RA)."

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

  • Healthy Volunteer - Rosnilimab (formerly ANB030)
  • for moderate-to-severe atopic dermatitis (AD) or eczema. - ANB032
  • Recurrent or Advanced dMMR/MSI-H Endometrial Cancer - JEMPERLI (dostarlimab-gxly)

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