This company has been marked as potentially delisted and may not be actively trading. HOOKIPA Pharma (HOOK) FDA Approvals Add Compare Share Share FDA Events Stock AnalysisFDA EventsInsider TradesNews and Trends HOOKIPA Pharma's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by HOOKIPA Pharma (HOOK). Over the past two years, HOOKIPA Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as HB-500. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. HB-500 FDA Regulatory Events HB-500 is a drug developed by HOOKIPA Pharma for the following indication: For the Treatment of Human Immunodeficiency Virus. 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. Provided Update - January 30,2025Provided Update Drug: HB-500Announced Date: January 30, 2025Target Action Date: H2 2025Estimated Target Date Range: July 1, 2025 - December 31, 2025Indication: For the Treatment of Human Immunodeficiency VirusAnnouncementHOOKIPA Pharma announced that Primary completion expected H2 2025AI SummaryHOOKIPA Pharma has announced an important milestone in its Phase 1b clinical trial for HB-500, a next-generation therapeutic vaccine targeting HIV. The trial, conducted in collaboration with Gilead Sciences, enrolled 30 participants across five U.S. sites to study the safety, tolerability, reactogenicity, and immunogenicity of repeated vaccine doses in individuals with HIV who are on suppressive antiretroviral therapy. The first dosing took place on July 1, 2024, and primary completion of the clinical trial is expected in the second half of 2025. This timeline marks a significant step forward for HB-500, which is designed to induce robust and durable immunity. Following the trial, Gilead will have the exclusive right to assume further development of the program, highlighting a key aspect of this promising collaboration.Read AnnouncementEnrollment Update - January 30,2025Enrollment Update Phase 1bDrug: HB-500Announced Date: January 30, 2025Indication: For the Treatment of Human Immunodeficiency VirusAnnouncementHOOKIPA Pharma announced that enrollment is complete in the Phase 1b clinical trial evaluating HB-500 for the treatment of HIV, with 30 participants enrolled across five sites in the United States.AI SummaryHOOKIPA Pharma has reached an important milestone in its HIV therapeutic vaccine program with HB-500. The Phase 1b clinical trial aimed at evaluating HB-500 for HIV treatment has successfully enrolled 30 participants across five United States sites. This next-generation vaccine is being developed in collaboration with Gilead Sciences, and it is designed to boost the immune system’s ability to fight HIV. The trial will assess the safety and tolerability of repeated HB-500 doses, along with its ability to stimulate a strong immune response in participants already on antiretroviral therapy. Primary completion of the study is expected in the second half of 2025, marking a significant step forward in the search for a potential functional cure for HIV.Read Announcement HOOKIPA Pharma FDA Events - Frequently Asked Questions Has HOOKIPA Pharma received FDA approval? As of now, HOOKIPA Pharma (HOOK) has not received any FDA approvals for its therapy in the last two years. What drugs has HOOKIPA Pharma submitted to the FDA? In the past two years, HOOKIPA Pharma (HOOK) has reported FDA regulatory activity for HB-500. What is the most recent FDA event for HOOKIPA Pharma? The most recent FDA-related event for HOOKIPA Pharma occurred on January 30, 2025, involving HB-500. The update was categorized as "Enrollment Update," with the company reporting: "HOOKIPA Pharma announced that enrollment is complete in the Phase 1b clinical trial evaluating HB-500 for the treatment of HIV, with 30 participants enrolled across five sites in the United States." What conditions do HOOKIPA Pharma's current drugs treat? Currently, HOOKIPA Pharma has one therapy (HB-500) targeting the following condition: For the Treatment of Human Immunodeficiency Virus. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Biomea Fusion FDA EventsANI Pharmaceuticals FDA EventsEnvoy Medical FDA EventsCytokinetics FDA EventsMirum Pharmaceuticals FDA EventsOdyssey Therapeutics FDA EventsOrganogenesis FDA EventsPalisade Bio FDA EventsPhathom Pharmaceuticals FDA EventsRegeneron Pharmaceuticals FDA EventsSyndax Pharmaceuticals FDA EventsStoke Therapeutics FDA EventsSavara FDA EventsFirst Tracks Biotherapeutics FDA EventsZenas BioPharma FDA Events 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 Related Companies Connect Biopharma FDA Events INmune Bio FDA Events ImageneBio FDA Events Celularity FDA Events Instil Bio FDA Events Werewolf Therapeutics FDA Events Metagenomi FDA Events Edesa Biotech FDA Events Briacell Therap FDA Events Aligos Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:HOOK last updated on 6/20/2025 by MarketBeat.com Staff. 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Provided Update - January 30,2025Provided Update Drug: HB-500Announced Date: January 30, 2025Target Action Date: H2 2025Estimated Target Date Range: July 1, 2025 - December 31, 2025Indication: For the Treatment of Human Immunodeficiency VirusAnnouncementHOOKIPA Pharma announced that Primary completion expected H2 2025AI SummaryHOOKIPA Pharma has announced an important milestone in its Phase 1b clinical trial for HB-500, a next-generation therapeutic vaccine targeting HIV. The trial, conducted in collaboration with Gilead Sciences, enrolled 30 participants across five U.S. sites to study the safety, tolerability, reactogenicity, and immunogenicity of repeated vaccine doses in individuals with HIV who are on suppressive antiretroviral therapy. The first dosing took place on July 1, 2024, and primary completion of the clinical trial is expected in the second half of 2025. This timeline marks a significant step forward for HB-500, which is designed to induce robust and durable immunity. Following the trial, Gilead will have the exclusive right to assume further development of the program, highlighting a key aspect of this promising collaboration.Read Announcement
Enrollment Update - January 30,2025Enrollment Update Phase 1bDrug: HB-500Announced Date: January 30, 2025Indication: For the Treatment of Human Immunodeficiency VirusAnnouncementHOOKIPA Pharma announced that enrollment is complete in the Phase 1b clinical trial evaluating HB-500 for the treatment of HIV, with 30 participants enrolled across five sites in the United States.AI SummaryHOOKIPA Pharma has reached an important milestone in its HIV therapeutic vaccine program with HB-500. The Phase 1b clinical trial aimed at evaluating HB-500 for HIV treatment has successfully enrolled 30 participants across five United States sites. This next-generation vaccine is being developed in collaboration with Gilead Sciences, and it is designed to boost the immune system’s ability to fight HIV. The trial will assess the safety and tolerability of repeated HB-500 doses, along with its ability to stimulate a strong immune response in participants already on antiretroviral therapy. Primary completion of the study is expected in the second half of 2025, marking a significant step forward in the search for a potential functional cure for HIV.Read Announcement
