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Lantern Pharma (LTRN) FDA Approvals

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Lantern Pharma's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Lantern Pharma (LTRN). Over the past two years, Lantern Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as LP-184, LP-284, LP-300, and RADR. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

LP-184 FDA Regulatory Timeline and Events

LP-184 is a drug developed by Lantern Pharma for the following indication: Prostate 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.

LP-284 FDA Regulatory Events

LP-284 is a drug developed by Lantern Pharma for the following indication: Hematologic Cancers. 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.

LP-300 + Chemotherapy (Harmonic) FDA Regulatory Timeline and Events

LP-300 + Chemotherapy (Harmonic) is a drug developed by Lantern Pharma for the following indication: Never Smokers with Non-Small Cell Lung Cancer (NSCLC). 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.

RADR FDA Regulatory Timeline and Events

RADR is a drug developed by Lantern Pharma for the following indication: AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs). 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.

Lantern Pharma FDA Events - Frequently Asked Questions

In the past two years, Lantern Pharma (LTRN) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Lantern Pharma (LTRN) has reported FDA regulatory activity for the following drugs: LP-184, LP-300 + Chemotherapy (Harmonic), RADR and LP-284.

The most recent FDA-related event for Lantern Pharma occurred on July 31, 2025, involving RADR. The update was categorized as "Enrollment Completion," with the company reporting: "Lantern Pharma Inc. ( announced the successful completion of targeted enrollment for its Phase 2 HARMONIC™ clinical trial in Japan."

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

  • Prostate cancer - LP-184
  • Never Smokers with Non-Small Cell Lung Cancer (NSCLC) - LP-300 + Chemotherapy (Harmonic)
  • AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs). - RADR
  • Hematologic Cancers - LP-284

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:LTRN) was last updated on 8/2/2025 by MarketBeat.com Staff
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