Free Trial

Innate Pharma (IPHA) FDA Events

Innate Pharma logo
$1.81 +0.09 (+5.23%)
Closing price 07/10/2025 03:59 PM Eastern
Extended Trading
$1.80 -0.01 (-0.28%)
As of 07/10/2025 04:04 PM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for Innate Pharma (IPHA)

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 IPH45, IPH4502, IPH6101/SAR443579, IPH6501, and Lacutamab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Innate Pharma's Drugs in FDA Review

IPH45 - FDA Regulatory Timeline and 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.

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.

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.

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.

Innate Pharma FDA Events - Frequently Asked Questions

However, the company does has had 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 June 13, 2025, involving IPH6501. The update was categorized as "Presentation," with the company reporting: "Innate Pharma SA announced the presentation of preclinical data for IPH6501, its proprietary ANKET® targeting CD20 currently under investigation in a Phase 1/2 study in relapsed and/or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) (NCT06088654), at the European Hematology Association (EHA) Congress 2025, taking place June 12-15 in Milan, Italy."

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 7/11/2025 by MarketBeat.com Staff
From Our Partners