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Mesoblast (MESO) FDA Events

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FDA Events for Mesoblast (MESO)

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

Mesoblast's Drugs in FDA Review

Revascor - FDA Regulatory Timeline and Events

Revascor is a drug developed by Mesoblast for the following indication: In the treatment of the congenital heart disease hypoplastic left heart syndrome (HLHS). 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.

rexlemestrocel-L - FDA Regulatory Timeline and Events

rexlemestrocel-L is a drug developed by Mesoblast for the following indication: For Chronic Low Back Pain. 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.

RYONCIL - FDA Regulatory Timeline and Events

RYONCIL is a drug developed by Mesoblast for the following indication: For the treatment of severe and life-threatening inflammatory 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.

Mesoblast FDA Events - Frequently Asked Questions

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

In the past two years, Mesoblast (MESO) has reported FDA regulatory activity for the following drugs: RYONCIL, Revascor and rexlemestrocel-L.

The most recent FDA-related event for Mesoblast occurred on June 30, 2025, involving Revascor. The update was categorized as "Provided Update," with the company reporting: "Mesoblast announced alignment with the United States Food and Drug Administration (FDA) on items required for filing a Biologics License Application (BLA) for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation."

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

  • For the treatment of severe and life-threatening inflammatory conditions. - RYONCIL
  • In the treatment of the congenital heart disease hypoplastic left heart syndrome (HLHS). - Revascor
  • For Chronic Low Back Pain - rexlemestrocel-L

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