--- title: 'Regulatory Daily Summary: What Happened on November 3, 2026' headline: FDA clears INOVIO’s Voceryq under accelerated approval description: The FDA also accepted uniQure’s Huntington’s gene-therapy application for priority review. A court upheld the rejection of Taiho’s late patent-extension filing. url: https://thebench.bio/news/regulatory/2026-11-03 topic: regulatory date: '2026-11-03' covers: - '2026-11-03' date_published: '2026-11-03T12:02:15Z' date_modified: '2026-11-03T12:02:15Z' tags: - Regulatory - Clinical - Industry sources: 10 publisher: TheBench.Bio --- # Regulatory Daily Summary: What Happened on November 3, 2026 **FDA clears INOVIO’s Voceryq under accelerated approval** The FDA also accepted uniQure’s Huntington’s gene-therapy application for priority review. A court upheld the rejection of Taiho’s late patent-extension filing. ## Today in brief The FDA granted accelerated approval to INOVIO’s Voceryq to reduce surgery frequency in adults with recurrent respiratory papillomatosis, a rare airway disease. [1] [2] [3] Seven of 26 patients went a year without surgery, and continued approval depends on a confirmatory study. [2] [3] [4] The FDA accepted uniQure’s AMT-130 application for priority review, with a target decision date of May 1, 2027. [5] [6] A federal court upheld the government’s finding that Taiho filed too late for a patent-term extension on LYTGOBI. [7] ## Voceryq wins accelerated approval, with follow-up evidence and device review ahead The FDA approved Voceryq to reduce surgery frequency in adults with recurrent respiratory papillomatosis, which causes growths in the airway. [1] [2] Patients use the treatment with INOVIO’s Cellectra 5PSP delivery device. [4] [8] In a single-arm study, seven of 26 efficacy-evaluable patients had no surgery during the 12 months after treatment. [3] [4] These patients had undergone a median of 4.5 surgical excisions in the preceding year. [3] [9] The FDA granted accelerated approval based on reduced surgery frequency, an intermediate measure considered reasonably likely to predict clinical benefit. [4] INOVIO must conduct a confirmatory study and submit its final report by August 30, 2032. The FDA may withdraw approval if the study fails to verify benefit or is not pursued diligently. [4] The agency directed INOVIO to reassess human-factors data for the delivery device and test its sharps-injury protection. [4] INOVIO expects orders and shipments to begin in about 60 days, with full commercial launch anticipated in the first quarter of 2027. [3] [4] ## FDA sets May 1, 2027, target date for uniQure’s Huntington’s gene therapy The FDA accepted uniQure’s application for AMT-130 and granted priority review under the accelerated approval pathway. [5] [6] The target action date is May 1, 2027. The agency is tentatively considering an advisory committee meeting. [5] [6] AMT-130 is a one-time gene therapy delivered by MRI-guided brain surgery to the striatum, where it is designed to silence the huntingtin gene. [5] [6] The application draws on 36-month results from Phase 1/2 studies compared with an external control built from Enroll-HD data. [5] At four years, results from 12 high-dose participants showed 44% less decline on a composite disease scale than an updated external control, but the difference was not statistically significant. [5] [6] The same analysis showed 61% less decline in functional capacity, with a nominal p-value of 0.008. [6] The FDA had questioned whether earlier data could support approval and initially sought a prospective randomized study. It later accepted the three-year analysis as the primary basis for an accelerated-approval application. [5] [6] uniQure plans a randomized confirmatory trial of about 200 participants. Screening in the United States is expected to start by the end of 2026. [5] [6] ## Court upholds rejection of Taiho’s late LYTGOBI patent-extension filing A New Jersey federal court upheld the government’s decision that Taiho missed the deadline to seek a patent-term extension for LYTGOBI. [7] Taiho filed on November 29, 2022, one day after the Patent and Trademark Office’s November 28 deadline. [7] The FDA issued LYTGOBI’s initial approval on September 30, 2022, then sent a corrected letter on October 5 that retained September 30 as the effective action date. [7] The court held that the 60-day filing period starts on and includes the day FDA transmits marketing permission. It found no basis to use October 5 as the approval date. [7] The court said the loss of patent rights was severe, but the statute and administrative record left it no discretion to reach another result. [7] ## Also worth knowing - The UK Medicines and Healthcare products Regulatory Agency and Health Research Authority published findings from a six-month pilot in 2025 involving seven studies, and updated guidance for preparing clinical-trial Inclusion and Diversity Plans. [10] ## The day in numbers - **7 of 26**: Voceryq trial participants who went 12 months without surgery, the basis for accelerated approval. [3] [4] - **May 1, 2027**: FDA target action date for uniQure’s AMT-130 application. [5] [6] - **1 day late**: Taiho’s LYTGOBI patent-term-extension application missed the calculated deadline by one day. [7] ## Also published - [uniQure set for May FDA verdict on Huntington's gene therapy](), pharmaphorum - [Inovio’s DNA-Based Immunotherapy Lands Speedy FDA Nod for Rare Type of Tumor](), MedCity News - [Inovio stock rises 2.5-fold on plasmid DNA drug approval](), pharmaphorum ## Sources 1. [ACT Brief: Embedding AI Across Operations, Faster Trial Decisions, and Voceryq Approval](), Applied Clinical Trials, 2026-11-03 2. [Inovio’s Voceryq receives FDA accelerated approval for RRP](), Pharmaceutical Technology, 2026-11-02 3. [FDA Grants Accelerated Approval to INOVIO’s Voceryq for RRP, Reducing Surgical Burden](), Pharmaceutical Executive, 2026-11-02 4. [FDA approved Inovio’s Voceryq with open questions about its delivery device](), Drug Discovery and Development, 2026-11-02 5. [FDA Accepts uniQure’s Huntington’s Disease Gene Therapy BLA for Priority Review](), BioPharm International, 2026-11-02 6. [FDA Sets May 1 PDUFA Action Date for uniQure’s Huntington’s Disease Gene Therapy](), GEN, 2026-11-02 7. [A Day Late, A Buck Short: Or How to Lose PTE Without Really Trying](), FDA Law Blog, 2026-11-03 8. [FDA Grants Accelerated Approval to Inovio DNA Immunotherapy for RRP](), BioPharm International, 2026-11-02 9. [Pharmaceutical Executive Daily: FDA Approves Voceryq](), Pharmaceutical Executive, 2026-11-02 10. [Clinical trials for medicines: Inclusion and Diversity Plan pilot findings published](), MHRA, 2026-11-03 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: [4]: [5]: [6]: [7]: [8]: [9]: [10]: