FDA Events for Innate Pharma (IPHYF)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Innate Pharma (IPHYF).
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
IPH6501. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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.
- Drug:
- IPH6501
- Announced Date:
- November 19, 2024
- Indication:
- In B-cell non-Hodgkin lymphoma (B-NHL)
Announcement
Innate Pharma SA announced the publication in Science Immunology of preclinical data demonstrating the potential of IPH6501, Innate's proprietary NK cell engager including an IL-2v and targeting CD20 from the ANKET® platform.
AI Summary
Innate Pharma SA recently announced the publication in Science Immunology of preclinical data highlighting the potential of IPH6501, its proprietary NK cell engager. IPH6501 is a first-in-class tetra-specific molecule that includes an IL-2 variant and targets CD20, using the company’s ANKET® platform. The published research shows that IPH6501 can boost natural killer (NK) cell proliferation and enhance their cytotoxicity against B-cell non-Hodgkin lymphoma. Data from in vitro, in vivo, and ex vivo studies demonstrated that IPH6501 not only effectively inhibits tumor cells even in cases of low CD20 expression but also promotes NK cell migration and infiltration into tumors. These promising findings support the further clinical development of IPH6501, currently under investigation in a Phase 1/2 trial for relapsed and refractory B-NHL, and may offer a safer, targeted alternative to traditional therapies.
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Innate Pharma FDA Events - Frequently Asked Questions
As of now, Innate Pharma (IPHYF) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Innate Pharma (IPHYF) has reported FDA regulatory activity for IPH6501.
The most recent FDA-related event for Innate Pharma occurred on November 19, 2024, involving IPH6501. The update was categorized as "Publication," with the company reporting: "Innate Pharma SA announced the publication in Science Immunology of preclinical data demonstrating the potential of IPH6501, Innate's proprietary NK cell engager including an IL-2v and targeting CD20 from the ANKET® platform."
Currently, Innate Pharma has one therapy (IPH6501) targeting the following condition: In B-cell non-Hodgkin lymphoma (B-NHL).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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 (OTCMKTS:IPHYF) was last updated on 7/14/2025 by MarketBeat.com Staff
