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Autolus Therapeutics (AUTL) FDA Events

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FDA Events for Autolus Therapeutics (AUTL)

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

Autolus Therapeutics' Drugs in FDA Review

AUCATZYL - FDA Regulatory Timeline and Events

AUCATZYL is a drug developed by Autolus Therapeutics for the following indication: For the treatment of hematological malignancies, solid tumors and autoimmune 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.

obe-cel - FDA Regulatory Timeline and Events

obe-cel is a drug developed by Autolus Therapeutics for the following indication: adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL). 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.

Obe-cel (AUTO1 - ALLCAR19) ALL - FDA Regulatory Timeline and Events

Obe-cel (AUTO1 - ALLCAR19) ALL is a drug developed by Autolus Therapeutics for the following indication: Adult Acute lymphoblastic leukemia (ALL). 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.

Autolus 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, Autolus Therapeutics (AUTL) has reported FDA regulatory activity for the following drugs: Obe-cel (AUTO1 - ALLCAR19) ALL, AUCATZYL and obe-cel.

The most recent FDA-related event for Autolus Therapeutics occurred on May 23, 2025, involving obe-cel. The update was categorized as "Approved," with the company reporting: "Autolus Therapeutics announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended European Commission (EC) approval of obecabtagene autoleucel (obe-cel) for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL)."

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

  • Adult Acute lymphoblastic leukemia (ALL) - Obe-cel (AUTO1 - ALLCAR19) ALL
  • For the treatment of hematological malignancies, solid tumors and autoimmune diseases. - AUCATZYL
  • adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL). - obe-cel

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:AUTL) was last updated on 7/11/2025 by MarketBeat.com Staff
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