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Artelo Biosciences (ARTL) FDA Events

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FDA Events for Artelo Biosciences (ARTL)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Artelo Biosciences (ARTL). Over the past two years, Artelo Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ART12.11, ART26.12, ART27.13, and FABP7. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Artelo Biosciences' Drugs in FDA Review

ART12.11 - FDA Regulatory Timeline and Events

ART12.11 is a drug developed by Artelo Biosciences for the following indication: For overcoming problematic drug properties which allows for precise control over purity, potency, and consistency. 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.

ART26.12 - FDA Regulatory Timeline and Events

ART26.12 is a drug developed by Artelo Biosciences for the following indication: For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy. 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.

ART27.13 (CAReS) - FDA Regulatory Timeline and Events

ART27.13 (CAReS) is a drug developed by Artelo Biosciences for the following indication: Cancer anorexia and Weight loss. 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.

FABP7 - FDA Regulatory Timeline and Events

FABP7 is a drug developed by Artelo Biosciences for the following indication: Promising Novel Target in Cancer Therapy. 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.

Artelo Biosciences FDA Events - Frequently Asked Questions

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

In the past two years, Artelo Biosciences (ARTL) has reported FDA regulatory activity for the following drugs: ART26.12, ART12.11, ART27.13 (CAReS) and FABP7.

The most recent FDA-related event for Artelo Biosciences occurred on July 9, 2025, involving ART26.12. The update was categorized as "Data Presentation," with the company reporting: "Artelo Biosciences, announced the presentation of preclinical data in an osteaoarthritis (OA) pain model on its lead fatty acid binding protein 5 (FABP5) inhibitor, ART26.12, at the 35th Annual International Cannabinoid Research Society (ICRS) Symposium, being held July 6–10 in Bloomington, Indiana."

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

  • For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy. - ART26.12
  • For overcoming problematic drug properties which allows for precise control over purity, potency, and consistency. - ART12.11
  • Cancer anorexia and Weight loss - ART27.13 (CAReS)
  • Promising Novel Target in Cancer Therapy - FABP7

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:ARTL) was last updated on 7/10/2025 by MarketBeat.com Staff
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