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Innate Pharma (IPHA) FDA Approvals

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Innate Pharma's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Innate Pharma (IPHA). Over the past two years, Innate Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Lacutamab, IPH6501, IPH4502, IPH6101/SAR443579, and IPH45. 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.

Lacutamab FDA Regulatory Timeline and Events

Lacutamab is a drug developed by Innate Pharma for the following indication: Treatment of patients with relapsed or refractory Sézary syndrome. 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.

IPH6501 FDA Regulatory Timeline and Events

IPH6501 is a drug developed by Innate Pharma for the following indication: In B-cell non-Hodgkin lymphoma (B-NHL). 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.

IPH4502 FDA Regulatory Timeline and Events

IPH4502 is a drug developed by Innate Pharma for the following indication: Topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4. 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.

IPH6101/SAR443579 FDA Regulatory Timeline and Events

IPH6101/SAR443579 is a drug developed by Innate Pharma for the following indication: Solid Tumors. 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.

IPH45 FDA Regulatory Events

IPH45 is a drug developed by Innate Pharma for the following indication: a Novel Nectin-4 Antibody Drug Conjugate. 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.

Innate Pharma FDA Events - Frequently Asked Questions

In the past two years, Innate Pharma (IPHA) 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, Innate Pharma (IPHA) has reported FDA regulatory activity for the following drugs: Lacutamab, IPH4502, IPH6101/SAR443579, IPH6501 and IPH45.

The most recent FDA-related event for Innate Pharma occurred on September 17, 2025, involving Lacutamab. The update was categorized as "Provided Update," with the company reporting: "Innate Pharma SA provided Business Update"

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

  • Treatment of patients with relapsed or refractory Sézary syndrome - Lacutamab
  • Topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4. - IPH4502
  • Solid Tumors - IPH6101/SAR443579
  • In B-cell non-Hodgkin lymphoma (B-NHL) - IPH6501
  • a Novel Nectin-4 Antibody Drug Conjugate - IPH45

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:IPHA) was last updated on 10/3/2025 by MarketBeat.com Staff
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